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Pfizer seeks approval for updated COVID booster

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Pfizer has sent an application to the Food and Drug Administration for emergency use authorization of its updated COVID-19 booster vaccine for the fall of 2022, the company announced on Aug. 22.

The vaccine, which is adapted for the BA.4 and BA.5 Omicron variants, would be meant for ages 12 and older. If authorized by the FDA, the doses could ship as soon as September.

“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the statement.

Earlier this year, the FDA ordered vaccine makers such as Pfizer and Moderna to update their shots to target BA.4 and BA.5, which are better at escaping immunity from earlier vaccines and previous infections.

The United States has a contract to buy 105 million of the Pfizer doses and 66 million of the Moderna doses, according to The Associated Press. Moderna is expected to file its FDA application soon as well.

The new shots target both the original spike protein on the coronavirus and the spike mutations carried by BA.4 and BA.5. For now, BA.5 is causing 89% of new infections in the United States, followed by BA.4.6 with 6.3% and BA.4 with 4.3%, according to the latest Centers for Disease Control and Prevention data.

There’s no way to tell if BA.5 will still be the dominant strain this winter or if new variant will replace it, the AP reported. But public health officials have supported the updated boosters as a way to target the most recent strains and increase immunity again.

On Aug. 15, Great Britain became the first country to authorize another one of Moderna’s updated vaccines, which adds protection against BA.1, or the original Omicron strain that became dominant in the winter of 2021-2022. European regulators are considering this shot, the AP reported, but the United States opted not to use this version since new Omicron variants have become dominant.

To approve the latest Pfizer shot, the FDA will rely on scientific testing of prior updates to the vaccine, rather than the newest boosters, to decide whether to fast-track the updated shots for fall, the AP reported. This method is like how flu vaccines are updated each year without large studies that take months.

Previously, Pfizer announced results from a study that found the earlier Omicron update significantly boosted antibodies capable of fighting the BA.1 variant and provided some protection against BA.4 and BA.5. The company’s latest FDA application contains that data and animal testing on the newest booster, the AP reported.

Pfizer will start a trial using the BA.4/BA.5 booster in coming weeks to get more data on how well the latest shot works. Moderna has begun a similar study.

The full results from these studies won’t be available before a fall booster campaign, which is why the FDA and public health officials have called for an updated shot to be ready for distribution in September.

“It’s clear that none of these vaccines are going to completely prevent infection,” Rachel Presti, MD, a researcher with the Moderna trial and an infectious diseases specialist at Washington University in St. Louis, told the AP.

But previous studies of variant booster candidates have shown that “you still get a broader immune response giving a variant booster than giving the same booster,” she said.

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

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Pfizer has sent an application to the Food and Drug Administration for emergency use authorization of its updated COVID-19 booster vaccine for the fall of 2022, the company announced on Aug. 22.

The vaccine, which is adapted for the BA.4 and BA.5 Omicron variants, would be meant for ages 12 and older. If authorized by the FDA, the doses could ship as soon as September.

“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the statement.

Earlier this year, the FDA ordered vaccine makers such as Pfizer and Moderna to update their shots to target BA.4 and BA.5, which are better at escaping immunity from earlier vaccines and previous infections.

The United States has a contract to buy 105 million of the Pfizer doses and 66 million of the Moderna doses, according to The Associated Press. Moderna is expected to file its FDA application soon as well.

The new shots target both the original spike protein on the coronavirus and the spike mutations carried by BA.4 and BA.5. For now, BA.5 is causing 89% of new infections in the United States, followed by BA.4.6 with 6.3% and BA.4 with 4.3%, according to the latest Centers for Disease Control and Prevention data.

There’s no way to tell if BA.5 will still be the dominant strain this winter or if new variant will replace it, the AP reported. But public health officials have supported the updated boosters as a way to target the most recent strains and increase immunity again.

On Aug. 15, Great Britain became the first country to authorize another one of Moderna’s updated vaccines, which adds protection against BA.1, or the original Omicron strain that became dominant in the winter of 2021-2022. European regulators are considering this shot, the AP reported, but the United States opted not to use this version since new Omicron variants have become dominant.

To approve the latest Pfizer shot, the FDA will rely on scientific testing of prior updates to the vaccine, rather than the newest boosters, to decide whether to fast-track the updated shots for fall, the AP reported. This method is like how flu vaccines are updated each year without large studies that take months.

Previously, Pfizer announced results from a study that found the earlier Omicron update significantly boosted antibodies capable of fighting the BA.1 variant and provided some protection against BA.4 and BA.5. The company’s latest FDA application contains that data and animal testing on the newest booster, the AP reported.

Pfizer will start a trial using the BA.4/BA.5 booster in coming weeks to get more data on how well the latest shot works. Moderna has begun a similar study.

The full results from these studies won’t be available before a fall booster campaign, which is why the FDA and public health officials have called for an updated shot to be ready for distribution in September.

“It’s clear that none of these vaccines are going to completely prevent infection,” Rachel Presti, MD, a researcher with the Moderna trial and an infectious diseases specialist at Washington University in St. Louis, told the AP.

But previous studies of variant booster candidates have shown that “you still get a broader immune response giving a variant booster than giving the same booster,” she said.

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

Pfizer has sent an application to the Food and Drug Administration for emergency use authorization of its updated COVID-19 booster vaccine for the fall of 2022, the company announced on Aug. 22.

The vaccine, which is adapted for the BA.4 and BA.5 Omicron variants, would be meant for ages 12 and older. If authorized by the FDA, the doses could ship as soon as September.

“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the statement.

Earlier this year, the FDA ordered vaccine makers such as Pfizer and Moderna to update their shots to target BA.4 and BA.5, which are better at escaping immunity from earlier vaccines and previous infections.

The United States has a contract to buy 105 million of the Pfizer doses and 66 million of the Moderna doses, according to The Associated Press. Moderna is expected to file its FDA application soon as well.

The new shots target both the original spike protein on the coronavirus and the spike mutations carried by BA.4 and BA.5. For now, BA.5 is causing 89% of new infections in the United States, followed by BA.4.6 with 6.3% and BA.4 with 4.3%, according to the latest Centers for Disease Control and Prevention data.

There’s no way to tell if BA.5 will still be the dominant strain this winter or if new variant will replace it, the AP reported. But public health officials have supported the updated boosters as a way to target the most recent strains and increase immunity again.

On Aug. 15, Great Britain became the first country to authorize another one of Moderna’s updated vaccines, which adds protection against BA.1, or the original Omicron strain that became dominant in the winter of 2021-2022. European regulators are considering this shot, the AP reported, but the United States opted not to use this version since new Omicron variants have become dominant.

To approve the latest Pfizer shot, the FDA will rely on scientific testing of prior updates to the vaccine, rather than the newest boosters, to decide whether to fast-track the updated shots for fall, the AP reported. This method is like how flu vaccines are updated each year without large studies that take months.

Previously, Pfizer announced results from a study that found the earlier Omicron update significantly boosted antibodies capable of fighting the BA.1 variant and provided some protection against BA.4 and BA.5. The company’s latest FDA application contains that data and animal testing on the newest booster, the AP reported.

Pfizer will start a trial using the BA.4/BA.5 booster in coming weeks to get more data on how well the latest shot works. Moderna has begun a similar study.

The full results from these studies won’t be available before a fall booster campaign, which is why the FDA and public health officials have called for an updated shot to be ready for distribution in September.

“It’s clear that none of these vaccines are going to completely prevent infection,” Rachel Presti, MD, a researcher with the Moderna trial and an infectious diseases specialist at Washington University in St. Louis, told the AP.

But previous studies of variant booster candidates have shown that “you still get a broader immune response giving a variant booster than giving the same booster,” she said.

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

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Are we up the creek without a paddle? What COVID, monkeypox, and nature are trying to tell us

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Monkeypox. Polio. Covid. A quick glance at the news on any given day seems to indicate that outbreaks, epidemics, and perhaps even pandemics are increasing in frequency.

Granted, these types of events are hardly new; from the plagues of the 5th and 13th centuries to the Spanish flu in the 20th century and SARS-CoV-2 today, they’ve been with us from time immemorial. 

What appears to be different, however, is not their frequency, but their intensity, with research reinforcing that we may be facing unique challenges and smaller windows to intervene as we move forward.

Findings from a modeling study, published in 2021 in Proceedings of the National Academy of Sciences, underscore that without effective intervention, the probability of extreme events like COVID-19 will likely increase threefold in the coming decades.

“The fact is, pandemic preparedness is not something that people have valued or thought of as important, or paid much attention to,” Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, told this news organization.

“It’s all been based on some unusual cluster of cases that were causing severe disease and overwhelming local authorities. So often, like Indiana Jones, somebody got dispatched to deal with an outbreak,” Dr. Adalja said.

In a perfect post-COVID world, government bodies, scientists, clinicians, and others would cross silos to coordinate pandemic prevention, not just preparedness. The public would trust those who carry the title “public health” in their daily responsibilities, and in turn, public health experts would get back to their core responsibility – infectious disease preparedness – the role they were initially assigned following Europe’s Black Death during the 14th century. Instead, the world finds itself at a crossroads, with emerging and reemerging infectious disease outbreaks that on the surface appear to arise haphazardly but in reality are the result of decades of reaction and containment policies aimed at putting out fires, not addressing their cause.

Dr. Adalja noted that only when the threat of biological weapons became a reality in the mid-2000s was there a realization that economies of scale could be exploited by merging interests and efforts to develop health security medical countermeasures. For example, it encouraged governments to more closely integrate agencies like the Biomedical Advanced Research and Development Authority and infectious disease research organizations and individuals.

Still, while significant strides have been made in certain areas, the ongoing COVID-19 pandemic has revealed substantial weaknesses remaining in public and private health systems, as well as major gaps in infectious disease preparedness.
 

The role of spillover events

No matter whom you ask, scientists, public health and conservation experts, and infectious disease clinicians all point to one of the most important threats to human health. As Walt Kelly’s Pogo famously put it, “We have met the enemy, and he is us.”

“The reason why these outbreaks of novel infectious diseases are increasingly occurring is because of human-driven environmental change, particularly land use, unsafe practices when raising farmed animals, and commercial wildlife markets,” Neil M. Vora, MD, a physician specializing in pandemic prevention at Conservation International and a former Centers for Disease Control and Prevention epidemic intelligence officer, said in an interview.

In fact, more than 60% of emerging infections and diseases are due to these “spillover events” (zoonotic spillover) that occur when pathogens that commonly circulate in wildlife jump over to new, human hosts.

Several examples come to mind.

COVID-19 may have begun as an enzootic virus from two undetermined animals, using the Huanan Seafood Market as a possible intermediate reservoir, according to a July 26 preprint in the journal Science. 

Likewise, while the Ebola virus was originally attributed to deforestation efforts to create palm oil (which allowed fruit bat carriers to transfer the virus to humans), recent research suggests that bats dwelling in the walls of human dwellings and hospitals are responsible for the 2018 outbreak in the Democratic Republic of Congo. 

(Incidentally, just this week, a new Ebola case was confirmed in Eastern Congo, and it has been genetically linked to the previous outbreak, despite that outbreak having been declared over in early July.)

“When we clear forests, we create opportunities for humans to live alongside the forest edge and displace wildlife. There’s evidence that shows when [these] biodiverse areas are cleared, specialist species that evolved to live in the forests first start to disappear, whereas generalist species – rodents and bats – continue to survive and are able to carry pathogens that can be passed on to humans,” Dr. Vora explained.

So far, China’s outbreak of the novel Langya henipavirus is believed to have spread (either directly or indirectly) by rodents and shrews, according to reports from public health authorities like the European Centre for Disease Prevention and Control, which is currently monitoring the situation. 

Yet, an overreliance on surveillance and containment only perpetuates what Dr. Vora says are cycles of panic and neglect.

“We saw it with Ebola in 2015, in 2016 to 2017 with Zika, you see it with tuberculosis, with sexually transmitted infections, and with COVID. You have policymakers working on solutions, and once they think that they’ve fixed the problem, they’re going to move on to the next crisis.”

It’s also a question of equity.

Reports detailing the reemergence of monkeypox in Nigeria in 2017 were largely ignored, despite the fact that the United States assisted in diagnosing an early case in an 11-year-old boy. At the time, it was clear that the virus was spreading by human-to-human transmission versus animal-to-human transmission, something that had not been seen previously. 

“The current model [is] waiting for pathogens to spill over and then [continuing] to spread signals that rich countries are tolerant of these outbreaks so long as they don’t grow into epidemics or pandemics,” Dr. Vora said.

This model is clearly broken; roughly 5 years after Nigeria reported the resurgence of monkeypox, the United States has more than 14,000 confirmed cases, which represents more than a quarter of the total number of cases reported worldwide. 
 

 

 

Public health on the brink

I’s difficult to imagine a future without outbreaks and more pandemics, and if experts are to be believed, we are ill-prepared. 

“I think that we are in a situation where this is a major threat, and people have become complacent about it,” said Dr. Adalja, who noted that we should be asking ourselves if the “government is actually in a position to be able to respond in a way that we need them to or is [that response] tied up in bureaucracy and inefficiency?”

COVID-19 should have been seen as a wake-up call, and many of those deaths were preventable. “With monkeypox, they’re faltering; it should have been a layup, not a disaster,” he emphasized.

Ellen Eaton, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, also pointed to the reality that by the time COVID-19 reached North America, the United States had already moved away from the model of the public health department as the epicenter of knowledge, education, awareness, and, ironically, public health.

“Thinking about my community, very few people knew the face and name of our local and state health officers,” she told this news organization.  

“There was just this inherent mistrust of these people. If you add in a lot of talking heads, a lot of politicians and messaging from non-experts that countered what was coming out of our public health agencies early, you had this huge disconnect; in the South, it was the perfect storm for vaccine hesitancy.”

At last count, this perfect storm has led to 1.46 million COVID cases and just over 20,000 deaths – many of which were preventable – in Alabama alone. 

“In certain parts of America, we were starting with a broken system with limited resources and few providers,” Dr. Eaton explained.

Dr. Eaton said that a lot of fields, not just medicine and public health, have finite resources that have been stretched to capacity by COVID, and now monkeypox, and wondered what was next as we’re headed into autumn and influenza season. But she also mentioned the tremendous implications of climate change on infectious diseases and community health and wellness.

“There’s a tremendous need to have the ability to survey not just humans but also how the disease burden in our environment that is fluctuating with climate change is going to impact communities in really important ways,” Dr. Eaton said. 
 

Upstream prevention

Dr. Vora said he could not agree more and believes that upstream prevention holds the key. 

“We have to make sure while there’s tension on this issue that the right solutions are implemented,” he said. 

In coming years, postspillover containment strategies – vaccine research and development and strengthening health care surveillance, for example – are likely to become inadequate.

“We saw it with COVID and we are seeing it again with monkeypox,” Dr. Vora said. “We also have to invest further upstream to prevent spillovers in the first place, for example, by addressing deforestation, commercial wildlife markets and trade, [and] infection control when raising farm animals.”

“The thing is, when you invest in those upstream solutions, you are also mitigating climate change and loss of biodiversity. I’m not saying that we should not invest in postspillover containment efforts; we’re never going to contain every spillover. But we also have to invest in prevention,” he added.

In a piece published in Nature, Dr. Vora and his coauthors acknowledge that several international bodies such as the World Health Organization and G7 have invested in initiatives to facilitate coordinated, global responses to climate change, pandemic preparedness, and response. But they point out that these efforts fail to “explicitly address the negative feedback cycle between environmental degradation, wildlife exploitation, and the emergence of pathogens.”

“Environmental conservation is no longer a left-wing fringe issue, it’s moving into public consciousness, and ... it is public health,” Dr. Vora said. “When we destroy nature, we’re destroying our own ability to survive.”

Dr. Adalja, Dr. Vora, and Dr. Eaton report no relevant financial relationships.

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

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Monkeypox. Polio. Covid. A quick glance at the news on any given day seems to indicate that outbreaks, epidemics, and perhaps even pandemics are increasing in frequency.

Granted, these types of events are hardly new; from the plagues of the 5th and 13th centuries to the Spanish flu in the 20th century and SARS-CoV-2 today, they’ve been with us from time immemorial. 

What appears to be different, however, is not their frequency, but their intensity, with research reinforcing that we may be facing unique challenges and smaller windows to intervene as we move forward.

Findings from a modeling study, published in 2021 in Proceedings of the National Academy of Sciences, underscore that without effective intervention, the probability of extreme events like COVID-19 will likely increase threefold in the coming decades.

“The fact is, pandemic preparedness is not something that people have valued or thought of as important, or paid much attention to,” Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, told this news organization.

“It’s all been based on some unusual cluster of cases that were causing severe disease and overwhelming local authorities. So often, like Indiana Jones, somebody got dispatched to deal with an outbreak,” Dr. Adalja said.

In a perfect post-COVID world, government bodies, scientists, clinicians, and others would cross silos to coordinate pandemic prevention, not just preparedness. The public would trust those who carry the title “public health” in their daily responsibilities, and in turn, public health experts would get back to their core responsibility – infectious disease preparedness – the role they were initially assigned following Europe’s Black Death during the 14th century. Instead, the world finds itself at a crossroads, with emerging and reemerging infectious disease outbreaks that on the surface appear to arise haphazardly but in reality are the result of decades of reaction and containment policies aimed at putting out fires, not addressing their cause.

Dr. Adalja noted that only when the threat of biological weapons became a reality in the mid-2000s was there a realization that economies of scale could be exploited by merging interests and efforts to develop health security medical countermeasures. For example, it encouraged governments to more closely integrate agencies like the Biomedical Advanced Research and Development Authority and infectious disease research organizations and individuals.

Still, while significant strides have been made in certain areas, the ongoing COVID-19 pandemic has revealed substantial weaknesses remaining in public and private health systems, as well as major gaps in infectious disease preparedness.
 

The role of spillover events

No matter whom you ask, scientists, public health and conservation experts, and infectious disease clinicians all point to one of the most important threats to human health. As Walt Kelly’s Pogo famously put it, “We have met the enemy, and he is us.”

“The reason why these outbreaks of novel infectious diseases are increasingly occurring is because of human-driven environmental change, particularly land use, unsafe practices when raising farmed animals, and commercial wildlife markets,” Neil M. Vora, MD, a physician specializing in pandemic prevention at Conservation International and a former Centers for Disease Control and Prevention epidemic intelligence officer, said in an interview.

In fact, more than 60% of emerging infections and diseases are due to these “spillover events” (zoonotic spillover) that occur when pathogens that commonly circulate in wildlife jump over to new, human hosts.

Several examples come to mind.

COVID-19 may have begun as an enzootic virus from two undetermined animals, using the Huanan Seafood Market as a possible intermediate reservoir, according to a July 26 preprint in the journal Science. 

Likewise, while the Ebola virus was originally attributed to deforestation efforts to create palm oil (which allowed fruit bat carriers to transfer the virus to humans), recent research suggests that bats dwelling in the walls of human dwellings and hospitals are responsible for the 2018 outbreak in the Democratic Republic of Congo. 

(Incidentally, just this week, a new Ebola case was confirmed in Eastern Congo, and it has been genetically linked to the previous outbreak, despite that outbreak having been declared over in early July.)

“When we clear forests, we create opportunities for humans to live alongside the forest edge and displace wildlife. There’s evidence that shows when [these] biodiverse areas are cleared, specialist species that evolved to live in the forests first start to disappear, whereas generalist species – rodents and bats – continue to survive and are able to carry pathogens that can be passed on to humans,” Dr. Vora explained.

So far, China’s outbreak of the novel Langya henipavirus is believed to have spread (either directly or indirectly) by rodents and shrews, according to reports from public health authorities like the European Centre for Disease Prevention and Control, which is currently monitoring the situation. 

Yet, an overreliance on surveillance and containment only perpetuates what Dr. Vora says are cycles of panic and neglect.

“We saw it with Ebola in 2015, in 2016 to 2017 with Zika, you see it with tuberculosis, with sexually transmitted infections, and with COVID. You have policymakers working on solutions, and once they think that they’ve fixed the problem, they’re going to move on to the next crisis.”

It’s also a question of equity.

Reports detailing the reemergence of monkeypox in Nigeria in 2017 were largely ignored, despite the fact that the United States assisted in diagnosing an early case in an 11-year-old boy. At the time, it was clear that the virus was spreading by human-to-human transmission versus animal-to-human transmission, something that had not been seen previously. 

“The current model [is] waiting for pathogens to spill over and then [continuing] to spread signals that rich countries are tolerant of these outbreaks so long as they don’t grow into epidemics or pandemics,” Dr. Vora said.

This model is clearly broken; roughly 5 years after Nigeria reported the resurgence of monkeypox, the United States has more than 14,000 confirmed cases, which represents more than a quarter of the total number of cases reported worldwide. 
 

 

 

Public health on the brink

I’s difficult to imagine a future without outbreaks and more pandemics, and if experts are to be believed, we are ill-prepared. 

“I think that we are in a situation where this is a major threat, and people have become complacent about it,” said Dr. Adalja, who noted that we should be asking ourselves if the “government is actually in a position to be able to respond in a way that we need them to or is [that response] tied up in bureaucracy and inefficiency?”

COVID-19 should have been seen as a wake-up call, and many of those deaths were preventable. “With monkeypox, they’re faltering; it should have been a layup, not a disaster,” he emphasized.

Ellen Eaton, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, also pointed to the reality that by the time COVID-19 reached North America, the United States had already moved away from the model of the public health department as the epicenter of knowledge, education, awareness, and, ironically, public health.

“Thinking about my community, very few people knew the face and name of our local and state health officers,” she told this news organization.  

“There was just this inherent mistrust of these people. If you add in a lot of talking heads, a lot of politicians and messaging from non-experts that countered what was coming out of our public health agencies early, you had this huge disconnect; in the South, it was the perfect storm for vaccine hesitancy.”

At last count, this perfect storm has led to 1.46 million COVID cases and just over 20,000 deaths – many of which were preventable – in Alabama alone. 

“In certain parts of America, we were starting with a broken system with limited resources and few providers,” Dr. Eaton explained.

Dr. Eaton said that a lot of fields, not just medicine and public health, have finite resources that have been stretched to capacity by COVID, and now monkeypox, and wondered what was next as we’re headed into autumn and influenza season. But she also mentioned the tremendous implications of climate change on infectious diseases and community health and wellness.

“There’s a tremendous need to have the ability to survey not just humans but also how the disease burden in our environment that is fluctuating with climate change is going to impact communities in really important ways,” Dr. Eaton said. 
 

Upstream prevention

Dr. Vora said he could not agree more and believes that upstream prevention holds the key. 

“We have to make sure while there’s tension on this issue that the right solutions are implemented,” he said. 

In coming years, postspillover containment strategies – vaccine research and development and strengthening health care surveillance, for example – are likely to become inadequate.

“We saw it with COVID and we are seeing it again with monkeypox,” Dr. Vora said. “We also have to invest further upstream to prevent spillovers in the first place, for example, by addressing deforestation, commercial wildlife markets and trade, [and] infection control when raising farm animals.”

“The thing is, when you invest in those upstream solutions, you are also mitigating climate change and loss of biodiversity. I’m not saying that we should not invest in postspillover containment efforts; we’re never going to contain every spillover. But we also have to invest in prevention,” he added.

In a piece published in Nature, Dr. Vora and his coauthors acknowledge that several international bodies such as the World Health Organization and G7 have invested in initiatives to facilitate coordinated, global responses to climate change, pandemic preparedness, and response. But they point out that these efforts fail to “explicitly address the negative feedback cycle between environmental degradation, wildlife exploitation, and the emergence of pathogens.”

“Environmental conservation is no longer a left-wing fringe issue, it’s moving into public consciousness, and ... it is public health,” Dr. Vora said. “When we destroy nature, we’re destroying our own ability to survive.”

Dr. Adalja, Dr. Vora, and Dr. Eaton report no relevant financial relationships.

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

Monkeypox. Polio. Covid. A quick glance at the news on any given day seems to indicate that outbreaks, epidemics, and perhaps even pandemics are increasing in frequency.

Granted, these types of events are hardly new; from the plagues of the 5th and 13th centuries to the Spanish flu in the 20th century and SARS-CoV-2 today, they’ve been with us from time immemorial. 

What appears to be different, however, is not their frequency, but their intensity, with research reinforcing that we may be facing unique challenges and smaller windows to intervene as we move forward.

Findings from a modeling study, published in 2021 in Proceedings of the National Academy of Sciences, underscore that without effective intervention, the probability of extreme events like COVID-19 will likely increase threefold in the coming decades.

“The fact is, pandemic preparedness is not something that people have valued or thought of as important, or paid much attention to,” Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, told this news organization.

“It’s all been based on some unusual cluster of cases that were causing severe disease and overwhelming local authorities. So often, like Indiana Jones, somebody got dispatched to deal with an outbreak,” Dr. Adalja said.

In a perfect post-COVID world, government bodies, scientists, clinicians, and others would cross silos to coordinate pandemic prevention, not just preparedness. The public would trust those who carry the title “public health” in their daily responsibilities, and in turn, public health experts would get back to their core responsibility – infectious disease preparedness – the role they were initially assigned following Europe’s Black Death during the 14th century. Instead, the world finds itself at a crossroads, with emerging and reemerging infectious disease outbreaks that on the surface appear to arise haphazardly but in reality are the result of decades of reaction and containment policies aimed at putting out fires, not addressing their cause.

Dr. Adalja noted that only when the threat of biological weapons became a reality in the mid-2000s was there a realization that economies of scale could be exploited by merging interests and efforts to develop health security medical countermeasures. For example, it encouraged governments to more closely integrate agencies like the Biomedical Advanced Research and Development Authority and infectious disease research organizations and individuals.

Still, while significant strides have been made in certain areas, the ongoing COVID-19 pandemic has revealed substantial weaknesses remaining in public and private health systems, as well as major gaps in infectious disease preparedness.
 

The role of spillover events

No matter whom you ask, scientists, public health and conservation experts, and infectious disease clinicians all point to one of the most important threats to human health. As Walt Kelly’s Pogo famously put it, “We have met the enemy, and he is us.”

“The reason why these outbreaks of novel infectious diseases are increasingly occurring is because of human-driven environmental change, particularly land use, unsafe practices when raising farmed animals, and commercial wildlife markets,” Neil M. Vora, MD, a physician specializing in pandemic prevention at Conservation International and a former Centers for Disease Control and Prevention epidemic intelligence officer, said in an interview.

In fact, more than 60% of emerging infections and diseases are due to these “spillover events” (zoonotic spillover) that occur when pathogens that commonly circulate in wildlife jump over to new, human hosts.

Several examples come to mind.

COVID-19 may have begun as an enzootic virus from two undetermined animals, using the Huanan Seafood Market as a possible intermediate reservoir, according to a July 26 preprint in the journal Science. 

Likewise, while the Ebola virus was originally attributed to deforestation efforts to create palm oil (which allowed fruit bat carriers to transfer the virus to humans), recent research suggests that bats dwelling in the walls of human dwellings and hospitals are responsible for the 2018 outbreak in the Democratic Republic of Congo. 

(Incidentally, just this week, a new Ebola case was confirmed in Eastern Congo, and it has been genetically linked to the previous outbreak, despite that outbreak having been declared over in early July.)

“When we clear forests, we create opportunities for humans to live alongside the forest edge and displace wildlife. There’s evidence that shows when [these] biodiverse areas are cleared, specialist species that evolved to live in the forests first start to disappear, whereas generalist species – rodents and bats – continue to survive and are able to carry pathogens that can be passed on to humans,” Dr. Vora explained.

So far, China’s outbreak of the novel Langya henipavirus is believed to have spread (either directly or indirectly) by rodents and shrews, according to reports from public health authorities like the European Centre for Disease Prevention and Control, which is currently monitoring the situation. 

Yet, an overreliance on surveillance and containment only perpetuates what Dr. Vora says are cycles of panic and neglect.

“We saw it with Ebola in 2015, in 2016 to 2017 with Zika, you see it with tuberculosis, with sexually transmitted infections, and with COVID. You have policymakers working on solutions, and once they think that they’ve fixed the problem, they’re going to move on to the next crisis.”

It’s also a question of equity.

Reports detailing the reemergence of monkeypox in Nigeria in 2017 were largely ignored, despite the fact that the United States assisted in diagnosing an early case in an 11-year-old boy. At the time, it was clear that the virus was spreading by human-to-human transmission versus animal-to-human transmission, something that had not been seen previously. 

“The current model [is] waiting for pathogens to spill over and then [continuing] to spread signals that rich countries are tolerant of these outbreaks so long as they don’t grow into epidemics or pandemics,” Dr. Vora said.

This model is clearly broken; roughly 5 years after Nigeria reported the resurgence of monkeypox, the United States has more than 14,000 confirmed cases, which represents more than a quarter of the total number of cases reported worldwide. 
 

 

 

Public health on the brink

I’s difficult to imagine a future without outbreaks and more pandemics, and if experts are to be believed, we are ill-prepared. 

“I think that we are in a situation where this is a major threat, and people have become complacent about it,” said Dr. Adalja, who noted that we should be asking ourselves if the “government is actually in a position to be able to respond in a way that we need them to or is [that response] tied up in bureaucracy and inefficiency?”

COVID-19 should have been seen as a wake-up call, and many of those deaths were preventable. “With monkeypox, they’re faltering; it should have been a layup, not a disaster,” he emphasized.

Ellen Eaton, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, also pointed to the reality that by the time COVID-19 reached North America, the United States had already moved away from the model of the public health department as the epicenter of knowledge, education, awareness, and, ironically, public health.

“Thinking about my community, very few people knew the face and name of our local and state health officers,” she told this news organization.  

“There was just this inherent mistrust of these people. If you add in a lot of talking heads, a lot of politicians and messaging from non-experts that countered what was coming out of our public health agencies early, you had this huge disconnect; in the South, it was the perfect storm for vaccine hesitancy.”

At last count, this perfect storm has led to 1.46 million COVID cases and just over 20,000 deaths – many of which were preventable – in Alabama alone. 

“In certain parts of America, we were starting with a broken system with limited resources and few providers,” Dr. Eaton explained.

Dr. Eaton said that a lot of fields, not just medicine and public health, have finite resources that have been stretched to capacity by COVID, and now monkeypox, and wondered what was next as we’re headed into autumn and influenza season. But she also mentioned the tremendous implications of climate change on infectious diseases and community health and wellness.

“There’s a tremendous need to have the ability to survey not just humans but also how the disease burden in our environment that is fluctuating with climate change is going to impact communities in really important ways,” Dr. Eaton said. 
 

Upstream prevention

Dr. Vora said he could not agree more and believes that upstream prevention holds the key. 

“We have to make sure while there’s tension on this issue that the right solutions are implemented,” he said. 

In coming years, postspillover containment strategies – vaccine research and development and strengthening health care surveillance, for example – are likely to become inadequate.

“We saw it with COVID and we are seeing it again with monkeypox,” Dr. Vora said. “We also have to invest further upstream to prevent spillovers in the first place, for example, by addressing deforestation, commercial wildlife markets and trade, [and] infection control when raising farm animals.”

“The thing is, when you invest in those upstream solutions, you are also mitigating climate change and loss of biodiversity. I’m not saying that we should not invest in postspillover containment efforts; we’re never going to contain every spillover. But we also have to invest in prevention,” he added.

In a piece published in Nature, Dr. Vora and his coauthors acknowledge that several international bodies such as the World Health Organization and G7 have invested in initiatives to facilitate coordinated, global responses to climate change, pandemic preparedness, and response. But they point out that these efforts fail to “explicitly address the negative feedback cycle between environmental degradation, wildlife exploitation, and the emergence of pathogens.”

“Environmental conservation is no longer a left-wing fringe issue, it’s moving into public consciousness, and ... it is public health,” Dr. Vora said. “When we destroy nature, we’re destroying our own ability to survive.”

Dr. Adalja, Dr. Vora, and Dr. Eaton report no relevant financial relationships.

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

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Pink Nodule Behind the Ear

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Pink Nodule Behind the Ear

The Diagnosis: Acanthoma Fissuratum

Acanthoma fissuratum is a skin lesion that results from consistent pressure, typically from ill-fitting eyeglass frames.1 The chronic irritation leads to collagen deposition and inflammation that gradually creates the lesion. Many patients never seek care, making incidence figures undeterminable.2 It usually presents as a firm, tender, flesh-colored or pink nodule or plaque with a central indentation from where the frame rests. This indentation splits the lesion in half and classically gives the appearance of a coffee bean.1 The repeated minor trauma at this point of contact also may lead to centralized ulceration, which further blurs the diagnosis to include basal cell carcinoma (BCC).3,4 Although the postauricular groove is the most cited location, lesions also may occur at other contact points of the glasses, such as the lateral aspect of the bridge of the nose and the superior auricular sulcus.5 Acanthoma fissuratum is not limited to the external head. Other etiologies of local trauma and pressure have led to its diagnosis in the upper labioalveolar fold, posterior fourchette of the vulva, penis, and external auditory canal.6-9

The diagnosis of acanthoma fissuratum mainly is clinical; however, due to its similar appearance to BCC and other lesions, a biopsy can be taken to support the diagnosis; a biopsy was not performed in our patient. The main features seen on histopathology include acanthosis, hyperkeratosis, variable parakeratosis, and perivascular nonspecific inflammatory infiltration. The epidermis may reflect the macroscopic frame indentation with central attenuation of the epidermis, which potentially is filled with inflammatory cells or keratin.5

Treatment normally encompasses removing the illfitting frames or fixing the fit, which gradually leads to reduction of the lesion.4,5 This occurred in our patient, who changed eyeglasses and saw an 80% resolution of the lesion in 8 months. Such improvement after removal of a trauma-inducing stimulus would not be seen in malignancies (eg, BCC, squamous cell carcinoma [SCC]), keloids, or cylindromas. If the granulation tissue does not regress or recurs, other potential treatments include excision, intralesional corticosteroids, and electrosurgery.5

Basal cell carcinoma is a common nonmelanoma skin cancer that most often presents on the sun-exposed areas of the head and neck, especially the cheeks, nasolabial folds, and forehead. Although the nodular subtype may clinically appear similar to acanthoma fissuratum, it more typically presents as a pearly papule or nodule with a sharp border, small telangiectases, and potential ulceration.10 Squamous cell carcinoma is another common nonmelanoma skin cancer that often arises in sun-exposed areas, which can include the postauricular area. Although the lesion can be associated with chronic wounds and also can grow vertically, SCC typically has a scalier and more hyperkeratotic surface that can ulcerate.1 A cylindroma is a benign sweat gland tumor that most commonly presents on the head and neck (also known as the turban tumor), though it can develop on the ear. It appears as solitary or multiple nodules that often are flesh colored, red, or blue with a shiny surface.1 Cylindromas are not known to be associated with chronic local trauma or irritation,11 such as wearing ill-fitting eyeglasses. Unlike acanthoma fissuratum, the treatment of cylindromas, BCC, and SCC most often involves excision.1 A keloid presents as a flesh-colored, red, or purple exophytic plaque that is composed of dense dermal tissue and progressively forms after local trauma. Although keloids can spontaneously develop, they commonly form on the ears in susceptible individuals after skin excisions including prior keloid removal, piercings, repairment of auricular traumas, or infections.1 The patient’s coffee bean–like lesion that coincided with wearing new eyeglasses better fits the diagnosis of acanthoma fissuratum than a keloid. Additionally, keloids typically do not regress without treatment. Keloid treatment consists of intralesional steroid injections, occlusive silicone dressings, compression, cryotherapy, radiation, and excisional surgery.1

References
  1. Sand M, Sand D, Brors D, et al. Cutaneous lesions of the external ear. Head Face Med. 2008;4. doi:10.1186/1746-160X-4-2
  2. Orengo I, Robbins K, Marsch A. Pathology of the ear. Semin Plast Surg. 2011;25:279-287. doi:10.1055/s-0031-1288920
  3. Ramroop S. Successful treatment of acanthoma fissuratum with intralesional triamcinolone acetonide. Clin Case Rep. 2020;8:702-703. doi:10.1002/ccr3.2708
  4. Delaney TJ, Stewart TW. Granuloma fissuratum. Br J Dermatol. 1971;84:373-375. doi:10.1111/j.1365-2133.1971.tb14235.x
  5. Deshpande NS, Sen A, Vasudevan B, et al. Acanthoma fissuratum: lest we forget. Indian Dermatol Online J. 2017;8:141-143. doi:10.4103/2229- 5178.202267
  6. Surron RL Jr. A fissured granulomatous lesion of the upper labioalveolar fold. Arch Dermatol Syph. 1932;26:425. doi:10.1001 /archderm.1932.01450030423004
  7. Kennedy CM, Dewdney S, Galask RP. Vulvar granuloma fissuratum: a description of fissuring of the posterior fourchette and the repair. Obstet Gynecol. 2005;105:1018-1023. doi:10.1097/01. AOG.0000158863.70819.53
  8. Lee JL, Lee YB, Cho BK, et al. Acanthoma fissuratum on the penis. Int J Dermatol. 2013;52:382-384. doi:10.1111/j.1365-4632.2011.04903.x
  9. Gonzalez SA, Moore AGN. Acanthoma fissuratum of the outer auditory canal from a hearing aid. J Cutan Pathol. 1989;16:304.
  10. Fania L, Didona D, Morese R, et al. Basal cell carcinoma: from pathophysiology to novel therapeutic approaches. Biomedicines. 2020;8:449. doi:10.3390/biomedicines8110449
  11. Chauhan DS, Guruprasad Y. Dermal cylindroma of the scalp. Natl J Maxillofac Surg. 2012;3:59-61. doi:10.4103/0975-5950.102163
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From the Ohio University Heritage College of Osteopathic Medicine, Dublin. Dr. Trotter also is from the OhioHealth Dermatology Residency Program, Columbus, and is in private practice at Dermatologists of Central States, Canal Winchester, Ohio.

The authors report no conflict of interest.

Correspondence: Ryan Jay, DO, OhioHealth Riverside Methodist Hospital, 3535 Olentangy River Rd, Columbus, OH 43214 ([email protected]).

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From the Ohio University Heritage College of Osteopathic Medicine, Dublin. Dr. Trotter also is from the OhioHealth Dermatology Residency Program, Columbus, and is in private practice at Dermatologists of Central States, Canal Winchester, Ohio.

The authors report no conflict of interest.

Correspondence: Ryan Jay, DO, OhioHealth Riverside Methodist Hospital, 3535 Olentangy River Rd, Columbus, OH 43214 ([email protected]).

Author and Disclosure Information

From the Ohio University Heritage College of Osteopathic Medicine, Dublin. Dr. Trotter also is from the OhioHealth Dermatology Residency Program, Columbus, and is in private practice at Dermatologists of Central States, Canal Winchester, Ohio.

The authors report no conflict of interest.

Correspondence: Ryan Jay, DO, OhioHealth Riverside Methodist Hospital, 3535 Olentangy River Rd, Columbus, OH 43214 ([email protected]).

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The Diagnosis: Acanthoma Fissuratum

Acanthoma fissuratum is a skin lesion that results from consistent pressure, typically from ill-fitting eyeglass frames.1 The chronic irritation leads to collagen deposition and inflammation that gradually creates the lesion. Many patients never seek care, making incidence figures undeterminable.2 It usually presents as a firm, tender, flesh-colored or pink nodule or plaque with a central indentation from where the frame rests. This indentation splits the lesion in half and classically gives the appearance of a coffee bean.1 The repeated minor trauma at this point of contact also may lead to centralized ulceration, which further blurs the diagnosis to include basal cell carcinoma (BCC).3,4 Although the postauricular groove is the most cited location, lesions also may occur at other contact points of the glasses, such as the lateral aspect of the bridge of the nose and the superior auricular sulcus.5 Acanthoma fissuratum is not limited to the external head. Other etiologies of local trauma and pressure have led to its diagnosis in the upper labioalveolar fold, posterior fourchette of the vulva, penis, and external auditory canal.6-9

The diagnosis of acanthoma fissuratum mainly is clinical; however, due to its similar appearance to BCC and other lesions, a biopsy can be taken to support the diagnosis; a biopsy was not performed in our patient. The main features seen on histopathology include acanthosis, hyperkeratosis, variable parakeratosis, and perivascular nonspecific inflammatory infiltration. The epidermis may reflect the macroscopic frame indentation with central attenuation of the epidermis, which potentially is filled with inflammatory cells or keratin.5

Treatment normally encompasses removing the illfitting frames or fixing the fit, which gradually leads to reduction of the lesion.4,5 This occurred in our patient, who changed eyeglasses and saw an 80% resolution of the lesion in 8 months. Such improvement after removal of a trauma-inducing stimulus would not be seen in malignancies (eg, BCC, squamous cell carcinoma [SCC]), keloids, or cylindromas. If the granulation tissue does not regress or recurs, other potential treatments include excision, intralesional corticosteroids, and electrosurgery.5

Basal cell carcinoma is a common nonmelanoma skin cancer that most often presents on the sun-exposed areas of the head and neck, especially the cheeks, nasolabial folds, and forehead. Although the nodular subtype may clinically appear similar to acanthoma fissuratum, it more typically presents as a pearly papule or nodule with a sharp border, small telangiectases, and potential ulceration.10 Squamous cell carcinoma is another common nonmelanoma skin cancer that often arises in sun-exposed areas, which can include the postauricular area. Although the lesion can be associated with chronic wounds and also can grow vertically, SCC typically has a scalier and more hyperkeratotic surface that can ulcerate.1 A cylindroma is a benign sweat gland tumor that most commonly presents on the head and neck (also known as the turban tumor), though it can develop on the ear. It appears as solitary or multiple nodules that often are flesh colored, red, or blue with a shiny surface.1 Cylindromas are not known to be associated with chronic local trauma or irritation,11 such as wearing ill-fitting eyeglasses. Unlike acanthoma fissuratum, the treatment of cylindromas, BCC, and SCC most often involves excision.1 A keloid presents as a flesh-colored, red, or purple exophytic plaque that is composed of dense dermal tissue and progressively forms after local trauma. Although keloids can spontaneously develop, they commonly form on the ears in susceptible individuals after skin excisions including prior keloid removal, piercings, repairment of auricular traumas, or infections.1 The patient’s coffee bean–like lesion that coincided with wearing new eyeglasses better fits the diagnosis of acanthoma fissuratum than a keloid. Additionally, keloids typically do not regress without treatment. Keloid treatment consists of intralesional steroid injections, occlusive silicone dressings, compression, cryotherapy, radiation, and excisional surgery.1

The Diagnosis: Acanthoma Fissuratum

Acanthoma fissuratum is a skin lesion that results from consistent pressure, typically from ill-fitting eyeglass frames.1 The chronic irritation leads to collagen deposition and inflammation that gradually creates the lesion. Many patients never seek care, making incidence figures undeterminable.2 It usually presents as a firm, tender, flesh-colored or pink nodule or plaque with a central indentation from where the frame rests. This indentation splits the lesion in half and classically gives the appearance of a coffee bean.1 The repeated minor trauma at this point of contact also may lead to centralized ulceration, which further blurs the diagnosis to include basal cell carcinoma (BCC).3,4 Although the postauricular groove is the most cited location, lesions also may occur at other contact points of the glasses, such as the lateral aspect of the bridge of the nose and the superior auricular sulcus.5 Acanthoma fissuratum is not limited to the external head. Other etiologies of local trauma and pressure have led to its diagnosis in the upper labioalveolar fold, posterior fourchette of the vulva, penis, and external auditory canal.6-9

The diagnosis of acanthoma fissuratum mainly is clinical; however, due to its similar appearance to BCC and other lesions, a biopsy can be taken to support the diagnosis; a biopsy was not performed in our patient. The main features seen on histopathology include acanthosis, hyperkeratosis, variable parakeratosis, and perivascular nonspecific inflammatory infiltration. The epidermis may reflect the macroscopic frame indentation with central attenuation of the epidermis, which potentially is filled with inflammatory cells or keratin.5

Treatment normally encompasses removing the illfitting frames or fixing the fit, which gradually leads to reduction of the lesion.4,5 This occurred in our patient, who changed eyeglasses and saw an 80% resolution of the lesion in 8 months. Such improvement after removal of a trauma-inducing stimulus would not be seen in malignancies (eg, BCC, squamous cell carcinoma [SCC]), keloids, or cylindromas. If the granulation tissue does not regress or recurs, other potential treatments include excision, intralesional corticosteroids, and electrosurgery.5

Basal cell carcinoma is a common nonmelanoma skin cancer that most often presents on the sun-exposed areas of the head and neck, especially the cheeks, nasolabial folds, and forehead. Although the nodular subtype may clinically appear similar to acanthoma fissuratum, it more typically presents as a pearly papule or nodule with a sharp border, small telangiectases, and potential ulceration.10 Squamous cell carcinoma is another common nonmelanoma skin cancer that often arises in sun-exposed areas, which can include the postauricular area. Although the lesion can be associated with chronic wounds and also can grow vertically, SCC typically has a scalier and more hyperkeratotic surface that can ulcerate.1 A cylindroma is a benign sweat gland tumor that most commonly presents on the head and neck (also known as the turban tumor), though it can develop on the ear. It appears as solitary or multiple nodules that often are flesh colored, red, or blue with a shiny surface.1 Cylindromas are not known to be associated with chronic local trauma or irritation,11 such as wearing ill-fitting eyeglasses. Unlike acanthoma fissuratum, the treatment of cylindromas, BCC, and SCC most often involves excision.1 A keloid presents as a flesh-colored, red, or purple exophytic plaque that is composed of dense dermal tissue and progressively forms after local trauma. Although keloids can spontaneously develop, they commonly form on the ears in susceptible individuals after skin excisions including prior keloid removal, piercings, repairment of auricular traumas, or infections.1 The patient’s coffee bean–like lesion that coincided with wearing new eyeglasses better fits the diagnosis of acanthoma fissuratum than a keloid. Additionally, keloids typically do not regress without treatment. Keloid treatment consists of intralesional steroid injections, occlusive silicone dressings, compression, cryotherapy, radiation, and excisional surgery.1

References
  1. Sand M, Sand D, Brors D, et al. Cutaneous lesions of the external ear. Head Face Med. 2008;4. doi:10.1186/1746-160X-4-2
  2. Orengo I, Robbins K, Marsch A. Pathology of the ear. Semin Plast Surg. 2011;25:279-287. doi:10.1055/s-0031-1288920
  3. Ramroop S. Successful treatment of acanthoma fissuratum with intralesional triamcinolone acetonide. Clin Case Rep. 2020;8:702-703. doi:10.1002/ccr3.2708
  4. Delaney TJ, Stewart TW. Granuloma fissuratum. Br J Dermatol. 1971;84:373-375. doi:10.1111/j.1365-2133.1971.tb14235.x
  5. Deshpande NS, Sen A, Vasudevan B, et al. Acanthoma fissuratum: lest we forget. Indian Dermatol Online J. 2017;8:141-143. doi:10.4103/2229- 5178.202267
  6. Surron RL Jr. A fissured granulomatous lesion of the upper labioalveolar fold. Arch Dermatol Syph. 1932;26:425. doi:10.1001 /archderm.1932.01450030423004
  7. Kennedy CM, Dewdney S, Galask RP. Vulvar granuloma fissuratum: a description of fissuring of the posterior fourchette and the repair. Obstet Gynecol. 2005;105:1018-1023. doi:10.1097/01. AOG.0000158863.70819.53
  8. Lee JL, Lee YB, Cho BK, et al. Acanthoma fissuratum on the penis. Int J Dermatol. 2013;52:382-384. doi:10.1111/j.1365-4632.2011.04903.x
  9. Gonzalez SA, Moore AGN. Acanthoma fissuratum of the outer auditory canal from a hearing aid. J Cutan Pathol. 1989;16:304.
  10. Fania L, Didona D, Morese R, et al. Basal cell carcinoma: from pathophysiology to novel therapeutic approaches. Biomedicines. 2020;8:449. doi:10.3390/biomedicines8110449
  11. Chauhan DS, Guruprasad Y. Dermal cylindroma of the scalp. Natl J Maxillofac Surg. 2012;3:59-61. doi:10.4103/0975-5950.102163
References
  1. Sand M, Sand D, Brors D, et al. Cutaneous lesions of the external ear. Head Face Med. 2008;4. doi:10.1186/1746-160X-4-2
  2. Orengo I, Robbins K, Marsch A. Pathology of the ear. Semin Plast Surg. 2011;25:279-287. doi:10.1055/s-0031-1288920
  3. Ramroop S. Successful treatment of acanthoma fissuratum with intralesional triamcinolone acetonide. Clin Case Rep. 2020;8:702-703. doi:10.1002/ccr3.2708
  4. Delaney TJ, Stewart TW. Granuloma fissuratum. Br J Dermatol. 1971;84:373-375. doi:10.1111/j.1365-2133.1971.tb14235.x
  5. Deshpande NS, Sen A, Vasudevan B, et al. Acanthoma fissuratum: lest we forget. Indian Dermatol Online J. 2017;8:141-143. doi:10.4103/2229- 5178.202267
  6. Surron RL Jr. A fissured granulomatous lesion of the upper labioalveolar fold. Arch Dermatol Syph. 1932;26:425. doi:10.1001 /archderm.1932.01450030423004
  7. Kennedy CM, Dewdney S, Galask RP. Vulvar granuloma fissuratum: a description of fissuring of the posterior fourchette and the repair. Obstet Gynecol. 2005;105:1018-1023. doi:10.1097/01. AOG.0000158863.70819.53
  8. Lee JL, Lee YB, Cho BK, et al. Acanthoma fissuratum on the penis. Int J Dermatol. 2013;52:382-384. doi:10.1111/j.1365-4632.2011.04903.x
  9. Gonzalez SA, Moore AGN. Acanthoma fissuratum of the outer auditory canal from a hearing aid. J Cutan Pathol. 1989;16:304.
  10. Fania L, Didona D, Morese R, et al. Basal cell carcinoma: from pathophysiology to novel therapeutic approaches. Biomedicines. 2020;8:449. doi:10.3390/biomedicines8110449
  11. Chauhan DS, Guruprasad Y. Dermal cylindroma of the scalp. Natl J Maxillofac Surg. 2012;3:59-61. doi:10.4103/0975-5950.102163
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A 62-year-old man presented to the dermatology office with a 1.5-cm, pink, rubbery nodule behind the left ear that sometimes was tender. He stated that the lesion gradually grew in size over the last 2 years, and it developed after he was fitted for new glasses.

Pink nodule behind the ear

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Children and COVID: New cases fall again, ED rates rebound for some

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New COVID-19 cases in children declined for a second consecutive week, even as emergency department visit rates started rising for those aged 12-15 years.

The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.

That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.

There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
 

Weekly cases fall below 80,000

New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).



The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.

Most younger children still not vaccinated

Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.

Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.

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New COVID-19 cases in children declined for a second consecutive week, even as emergency department visit rates started rising for those aged 12-15 years.

The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.

That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.

There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
 

Weekly cases fall below 80,000

New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).



The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.

Most younger children still not vaccinated

Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.

Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.

New COVID-19 cases in children declined for a second consecutive week, even as emergency department visit rates started rising for those aged 12-15 years.

The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.

That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.

There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
 

Weekly cases fall below 80,000

New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).



The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.

Most younger children still not vaccinated

Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.

Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.

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Incomplete recovery common 6 months after mild TBI

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More than half of patients with mild traumatic brain injury (TBI) and a negative head CT scan have not recovered completely 6 months after sustaining their injury, new data from the TRACK-TBI study shows.

“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.

“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.

The findings were published online in JAMA Network Open.

The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.

Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).

Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.

Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.

The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.

The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.

“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.

The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.

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

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More than half of patients with mild traumatic brain injury (TBI) and a negative head CT scan have not recovered completely 6 months after sustaining their injury, new data from the TRACK-TBI study shows.

“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.

“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.

The findings were published online in JAMA Network Open.

The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.

Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).

Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.

Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.

The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.

The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.

“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.

The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.

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

More than half of patients with mild traumatic brain injury (TBI) and a negative head CT scan have not recovered completely 6 months after sustaining their injury, new data from the TRACK-TBI study shows.

“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.

“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.

The findings were published online in JAMA Network Open.

The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.

Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).

Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.

Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.

The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.

The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.

“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.

The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.

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

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Patients with cancer get valuable second opinion for free

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Halfway through her first round of chemotherapy, with hair falling out, weight down, and her brain in a fog, Carolyn Hackett sat down for a Zoom meeting with a team of oncologists.

She didn’t even want a second opinion, but a friend had insisted that she get one, and she had agreed for the sake of their friendship.

But that Zoom meeting likely saved her life. The team of five specialists who had been reviewing her case for a week explained that she had been misdiagnosed. The original pathologist was mistaken. She didn’t have Hodgkin lymphoma; her cancer was really non-Hodgkin T-cell lymphoma. And the chemotherapy regimen she was in the middle of would do nothing to stop it.

The panel of doctors who populated Hackett’s computer screen during that December 2020 Zoom call were all volunteers with an organization called thesecondopinion, based in San Francisco.

The group, organized in 1969, currently offers free second opinions to at least three California patients with cancer each week. Patients meet for an average of 30-40 minutes – though there is really no limit – with a panel of doctors who have expertise in their specific case.

More than 70 cancer-related specialists, both current and retired, make up the roster of volunteers. A paid staffer rounds up a patient’s medical records, imaging and pathology slides. And a team of four to five doctors spends a week reviewing each case.

Then they meet directly with the patient and their doctor to answer questions and deliver their consensus.

Ms. Hackett was in disbelief after her meeting with thesecondopinion. Her diagnosis had gone from bad to worse, but the new information had changed her life. Without it, she would have surely continued chemotherapy and died.

On top of the new acccurate diagnosis, Ms. Hackett said it was a relief and reassurance when the team of volunteer doctors honored and included her oncologist. “I’m a nurse,” she said, and so she knows through experience that medicine comes with egos and frequent risk of lawsuits. But the team from thesecondopinion never criticized her doctor – after all, it wasn’t his mistake anyway – nor did they suggest legal action. Instead, they immediately included him as part of the team and sent him a letter detailing the panel concensus, she said, which made her feel safe.
 

Second opinions are big business

Medical second opinions are a large and growing industry projected to be worth more than $9.7 billion by 2027. There are already many services across the United States and worldwide devoted to providing second opinions specifically for patients with cancer.

“And rightly so,” says Alan Venook, MD, a professor of medicine at UCSF with experience and expertise in gastrointestinal malignancies who was approached for comment but is not associated with thesecondopinion. Cancer is an increasingly a sub-specialized area, and every patient should get a second opinion, he said in an interview.

What is unique to an appointment with thesecondopinion, however, is the price tag – $0.

By comparison, a virtual second opinion at the Cleveland Clinic comes at a flat rate of $1,850, and at the Dana-Farber Cancer Institute, Boston, the cost is $2,400.

At UCSF, a second opinion from Dr. Venook and his colleagues will cost patients a couple thousand dollars out-of-pocket, he said. “Many patients don’t have the luxury of paying for a second opinion,” he said.
 

More than looking for misdiagnosis

Research shows that getting a second opinion can significantly change the course of a patient’s disease and treatment. A 2017 study by the Mayo Clinic found that at their institution, around 22% of second opinions changed the diagnosis, and 66% of patients received a refined or redefined diagnosis.

However, a misdiagnosis – such the case presented by Ms. Hackett – is a rare occurrence at thesecondopinion, said Howard Kleckner, MD, a medical oncologist and the organization’s medical director.

“We aren’t in the business to look for mistakes,” he said.

More often, thesecondopinion panels are about clarifying and helping patients understand the disease and options they have.”People with cancer need to make a peace with it and make peace with the treatment,” Dr. Kleckner said.

He estimates that 90% of the patients that come to the group already have the right diagnosis and treatment plan because, he says, there are “very good doctors in the state and in the Bay Area in particular.”

And even in the case of the remaining 10% of patients whose second opinion differs from their first, it’s largely a case of differences in the staging the disease or treatment options, Dr. Kleckner said.

“We aren’t coming up with brilliant suggestions. Often we are agreeing with what’s already been said,” said David Lakes, MD, a retired medical oncologist who has been volunteering with thesecondopinion for more than 30 years. “But we often see people understand for the first time.”

Both Dr. Kleckner and Dr. Lakes say that the organization attracts a certain kind of doctor, who tends to be an excellent communicator and really cares about helping the patients.

Many of these doctors are retired, but they want to keep doing the work, and they understand which pieces of information are most important for patients to know, Dr. Kleckner told this news organization. They are also willing to do this kind of work even when they won’t get paid, Dr. Kleckner said.

Part of that comes with gray hair and storied careers, Dr. Lakes added. “Retired people have experience and judgment and communication skills that a lot of younger doctors don’t have,” he commented. They often have more experience with some of the tough stuff, like exploring the goals of treatment, discontinuing treatment, and end-of-life care, and they also have more time to engage patients on their emotional health, he said.

Dr. Venook said that the services provided free-of-charge by these volunteers is “laudable,” and their thorough review of all the diagnostic information is “to their credit.” But he questions whether every second opinion provided by the organization is an expert one, since the doctors are no longer practicing. Oncology is a particularly fast-moving field, with many new developments and novel drugs launched in recent years.

“Second opinions are incredibly helpful but [have] to be [provided] by a knowledgeable expert who gets all the details and gives it serious thought,” Dr. Venook said.

Dr. Lakes says that he is constantly evaluating whether he is entitled to keep offering second opinions when he isn’t practicing; so far the answer remains a yes. Although he now has to spend more time researching treatment options like biologics, he still feels adept at engaging with patients and helping patients understand where they are in their illness and the potential benefits of fourth- or fifth-line treatments.

Another strength of thesecondopinion model lies in numbers. Most of the time second opinions are given by one doctor, Dr. Kleckner pointed out. In contrast, thesecondopinion provides the patient with access to a whole team of specialists.

“Sometimes people on the panels don’t completely agree,” Dr. Lakes said. So, before meeting with the patient on Zoom, the doctors review the case together for about half an hour and come up with a consensus. This way there’s no mixed messaging and as little anxiety for the patient as possible, he said.

The fact that patients have direct access to the panel of experts who review their cases is unique in itself, Dr. Kleckner said.

Many hospitals have tumor boards, but they are reserved for physicians, he pointed out. Patients get to hear the board’s opinion secondhand through their primary doctor or oncologist.

But at thesecondopinion, the patient gets to engage with the doctors directly. There is time to review up to four questions that the patient has submitted before the meeting and also time for any additional questions that may have arisen during the course of the meeting.

In oncology, and medicine in general, patients are often shuffled from one specialist to another, Dr. Lakes said. But often, there is no one who takes a steps back to see the whole picture.

That’s part of what thesecondopinion offers, he said. “We have the time, the experience, and no skin in the game. We can think about [the cases] in an intellectual way without feeling like we are in the hot seat or in charge.”

Thanks to her second opinion, Ms. Hackett was able to get connected with an oncologist in San Francisco who specializes in the type of cancer she actually had. She went on to receive nine rounds of a monoclonal antibody treatment formulated for her specific cancer. She is now in remission 6 months after finishing that therapy.

Scans in late July showed that she was cancer-free and doing really well. “I’m so grateful to them. I’m so impressed with thesecondopinion, I can’t believe it,” she said. “I’m alive because of them.”

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

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Halfway through her first round of chemotherapy, with hair falling out, weight down, and her brain in a fog, Carolyn Hackett sat down for a Zoom meeting with a team of oncologists.

She didn’t even want a second opinion, but a friend had insisted that she get one, and she had agreed for the sake of their friendship.

But that Zoom meeting likely saved her life. The team of five specialists who had been reviewing her case for a week explained that she had been misdiagnosed. The original pathologist was mistaken. She didn’t have Hodgkin lymphoma; her cancer was really non-Hodgkin T-cell lymphoma. And the chemotherapy regimen she was in the middle of would do nothing to stop it.

The panel of doctors who populated Hackett’s computer screen during that December 2020 Zoom call were all volunteers with an organization called thesecondopinion, based in San Francisco.

The group, organized in 1969, currently offers free second opinions to at least three California patients with cancer each week. Patients meet for an average of 30-40 minutes – though there is really no limit – with a panel of doctors who have expertise in their specific case.

More than 70 cancer-related specialists, both current and retired, make up the roster of volunteers. A paid staffer rounds up a patient’s medical records, imaging and pathology slides. And a team of four to five doctors spends a week reviewing each case.

Then they meet directly with the patient and their doctor to answer questions and deliver their consensus.

Ms. Hackett was in disbelief after her meeting with thesecondopinion. Her diagnosis had gone from bad to worse, but the new information had changed her life. Without it, she would have surely continued chemotherapy and died.

On top of the new acccurate diagnosis, Ms. Hackett said it was a relief and reassurance when the team of volunteer doctors honored and included her oncologist. “I’m a nurse,” she said, and so she knows through experience that medicine comes with egos and frequent risk of lawsuits. But the team from thesecondopinion never criticized her doctor – after all, it wasn’t his mistake anyway – nor did they suggest legal action. Instead, they immediately included him as part of the team and sent him a letter detailing the panel concensus, she said, which made her feel safe.
 

Second opinions are big business

Medical second opinions are a large and growing industry projected to be worth more than $9.7 billion by 2027. There are already many services across the United States and worldwide devoted to providing second opinions specifically for patients with cancer.

“And rightly so,” says Alan Venook, MD, a professor of medicine at UCSF with experience and expertise in gastrointestinal malignancies who was approached for comment but is not associated with thesecondopinion. Cancer is an increasingly a sub-specialized area, and every patient should get a second opinion, he said in an interview.

What is unique to an appointment with thesecondopinion, however, is the price tag – $0.

By comparison, a virtual second opinion at the Cleveland Clinic comes at a flat rate of $1,850, and at the Dana-Farber Cancer Institute, Boston, the cost is $2,400.

At UCSF, a second opinion from Dr. Venook and his colleagues will cost patients a couple thousand dollars out-of-pocket, he said. “Many patients don’t have the luxury of paying for a second opinion,” he said.
 

More than looking for misdiagnosis

Research shows that getting a second opinion can significantly change the course of a patient’s disease and treatment. A 2017 study by the Mayo Clinic found that at their institution, around 22% of second opinions changed the diagnosis, and 66% of patients received a refined or redefined diagnosis.

However, a misdiagnosis – such the case presented by Ms. Hackett – is a rare occurrence at thesecondopinion, said Howard Kleckner, MD, a medical oncologist and the organization’s medical director.

“We aren’t in the business to look for mistakes,” he said.

More often, thesecondopinion panels are about clarifying and helping patients understand the disease and options they have.”People with cancer need to make a peace with it and make peace with the treatment,” Dr. Kleckner said.

He estimates that 90% of the patients that come to the group already have the right diagnosis and treatment plan because, he says, there are “very good doctors in the state and in the Bay Area in particular.”

And even in the case of the remaining 10% of patients whose second opinion differs from their first, it’s largely a case of differences in the staging the disease or treatment options, Dr. Kleckner said.

“We aren’t coming up with brilliant suggestions. Often we are agreeing with what’s already been said,” said David Lakes, MD, a retired medical oncologist who has been volunteering with thesecondopinion for more than 30 years. “But we often see people understand for the first time.”

Both Dr. Kleckner and Dr. Lakes say that the organization attracts a certain kind of doctor, who tends to be an excellent communicator and really cares about helping the patients.

Many of these doctors are retired, but they want to keep doing the work, and they understand which pieces of information are most important for patients to know, Dr. Kleckner told this news organization. They are also willing to do this kind of work even when they won’t get paid, Dr. Kleckner said.

Part of that comes with gray hair and storied careers, Dr. Lakes added. “Retired people have experience and judgment and communication skills that a lot of younger doctors don’t have,” he commented. They often have more experience with some of the tough stuff, like exploring the goals of treatment, discontinuing treatment, and end-of-life care, and they also have more time to engage patients on their emotional health, he said.

Dr. Venook said that the services provided free-of-charge by these volunteers is “laudable,” and their thorough review of all the diagnostic information is “to their credit.” But he questions whether every second opinion provided by the organization is an expert one, since the doctors are no longer practicing. Oncology is a particularly fast-moving field, with many new developments and novel drugs launched in recent years.

“Second opinions are incredibly helpful but [have] to be [provided] by a knowledgeable expert who gets all the details and gives it serious thought,” Dr. Venook said.

Dr. Lakes says that he is constantly evaluating whether he is entitled to keep offering second opinions when he isn’t practicing; so far the answer remains a yes. Although he now has to spend more time researching treatment options like biologics, he still feels adept at engaging with patients and helping patients understand where they are in their illness and the potential benefits of fourth- or fifth-line treatments.

Another strength of thesecondopinion model lies in numbers. Most of the time second opinions are given by one doctor, Dr. Kleckner pointed out. In contrast, thesecondopinion provides the patient with access to a whole team of specialists.

“Sometimes people on the panels don’t completely agree,” Dr. Lakes said. So, before meeting with the patient on Zoom, the doctors review the case together for about half an hour and come up with a consensus. This way there’s no mixed messaging and as little anxiety for the patient as possible, he said.

The fact that patients have direct access to the panel of experts who review their cases is unique in itself, Dr. Kleckner said.

Many hospitals have tumor boards, but they are reserved for physicians, he pointed out. Patients get to hear the board’s opinion secondhand through their primary doctor or oncologist.

But at thesecondopinion, the patient gets to engage with the doctors directly. There is time to review up to four questions that the patient has submitted before the meeting and also time for any additional questions that may have arisen during the course of the meeting.

In oncology, and medicine in general, patients are often shuffled from one specialist to another, Dr. Lakes said. But often, there is no one who takes a steps back to see the whole picture.

That’s part of what thesecondopinion offers, he said. “We have the time, the experience, and no skin in the game. We can think about [the cases] in an intellectual way without feeling like we are in the hot seat or in charge.”

Thanks to her second opinion, Ms. Hackett was able to get connected with an oncologist in San Francisco who specializes in the type of cancer she actually had. She went on to receive nine rounds of a monoclonal antibody treatment formulated for her specific cancer. She is now in remission 6 months after finishing that therapy.

Scans in late July showed that she was cancer-free and doing really well. “I’m so grateful to them. I’m so impressed with thesecondopinion, I can’t believe it,” she said. “I’m alive because of them.”

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

 

Halfway through her first round of chemotherapy, with hair falling out, weight down, and her brain in a fog, Carolyn Hackett sat down for a Zoom meeting with a team of oncologists.

She didn’t even want a second opinion, but a friend had insisted that she get one, and she had agreed for the sake of their friendship.

But that Zoom meeting likely saved her life. The team of five specialists who had been reviewing her case for a week explained that she had been misdiagnosed. The original pathologist was mistaken. She didn’t have Hodgkin lymphoma; her cancer was really non-Hodgkin T-cell lymphoma. And the chemotherapy regimen she was in the middle of would do nothing to stop it.

The panel of doctors who populated Hackett’s computer screen during that December 2020 Zoom call were all volunteers with an organization called thesecondopinion, based in San Francisco.

The group, organized in 1969, currently offers free second opinions to at least three California patients with cancer each week. Patients meet for an average of 30-40 minutes – though there is really no limit – with a panel of doctors who have expertise in their specific case.

More than 70 cancer-related specialists, both current and retired, make up the roster of volunteers. A paid staffer rounds up a patient’s medical records, imaging and pathology slides. And a team of four to five doctors spends a week reviewing each case.

Then they meet directly with the patient and their doctor to answer questions and deliver their consensus.

Ms. Hackett was in disbelief after her meeting with thesecondopinion. Her diagnosis had gone from bad to worse, but the new information had changed her life. Without it, she would have surely continued chemotherapy and died.

On top of the new acccurate diagnosis, Ms. Hackett said it was a relief and reassurance when the team of volunteer doctors honored and included her oncologist. “I’m a nurse,” she said, and so she knows through experience that medicine comes with egos and frequent risk of lawsuits. But the team from thesecondopinion never criticized her doctor – after all, it wasn’t his mistake anyway – nor did they suggest legal action. Instead, they immediately included him as part of the team and sent him a letter detailing the panel concensus, she said, which made her feel safe.
 

Second opinions are big business

Medical second opinions are a large and growing industry projected to be worth more than $9.7 billion by 2027. There are already many services across the United States and worldwide devoted to providing second opinions specifically for patients with cancer.

“And rightly so,” says Alan Venook, MD, a professor of medicine at UCSF with experience and expertise in gastrointestinal malignancies who was approached for comment but is not associated with thesecondopinion. Cancer is an increasingly a sub-specialized area, and every patient should get a second opinion, he said in an interview.

What is unique to an appointment with thesecondopinion, however, is the price tag – $0.

By comparison, a virtual second opinion at the Cleveland Clinic comes at a flat rate of $1,850, and at the Dana-Farber Cancer Institute, Boston, the cost is $2,400.

At UCSF, a second opinion from Dr. Venook and his colleagues will cost patients a couple thousand dollars out-of-pocket, he said. “Many patients don’t have the luxury of paying for a second opinion,” he said.
 

More than looking for misdiagnosis

Research shows that getting a second opinion can significantly change the course of a patient’s disease and treatment. A 2017 study by the Mayo Clinic found that at their institution, around 22% of second opinions changed the diagnosis, and 66% of patients received a refined or redefined diagnosis.

However, a misdiagnosis – such the case presented by Ms. Hackett – is a rare occurrence at thesecondopinion, said Howard Kleckner, MD, a medical oncologist and the organization’s medical director.

“We aren’t in the business to look for mistakes,” he said.

More often, thesecondopinion panels are about clarifying and helping patients understand the disease and options they have.”People with cancer need to make a peace with it and make peace with the treatment,” Dr. Kleckner said.

He estimates that 90% of the patients that come to the group already have the right diagnosis and treatment plan because, he says, there are “very good doctors in the state and in the Bay Area in particular.”

And even in the case of the remaining 10% of patients whose second opinion differs from their first, it’s largely a case of differences in the staging the disease or treatment options, Dr. Kleckner said.

“We aren’t coming up with brilliant suggestions. Often we are agreeing with what’s already been said,” said David Lakes, MD, a retired medical oncologist who has been volunteering with thesecondopinion for more than 30 years. “But we often see people understand for the first time.”

Both Dr. Kleckner and Dr. Lakes say that the organization attracts a certain kind of doctor, who tends to be an excellent communicator and really cares about helping the patients.

Many of these doctors are retired, but they want to keep doing the work, and they understand which pieces of information are most important for patients to know, Dr. Kleckner told this news organization. They are also willing to do this kind of work even when they won’t get paid, Dr. Kleckner said.

Part of that comes with gray hair and storied careers, Dr. Lakes added. “Retired people have experience and judgment and communication skills that a lot of younger doctors don’t have,” he commented. They often have more experience with some of the tough stuff, like exploring the goals of treatment, discontinuing treatment, and end-of-life care, and they also have more time to engage patients on their emotional health, he said.

Dr. Venook said that the services provided free-of-charge by these volunteers is “laudable,” and their thorough review of all the diagnostic information is “to their credit.” But he questions whether every second opinion provided by the organization is an expert one, since the doctors are no longer practicing. Oncology is a particularly fast-moving field, with many new developments and novel drugs launched in recent years.

“Second opinions are incredibly helpful but [have] to be [provided] by a knowledgeable expert who gets all the details and gives it serious thought,” Dr. Venook said.

Dr. Lakes says that he is constantly evaluating whether he is entitled to keep offering second opinions when he isn’t practicing; so far the answer remains a yes. Although he now has to spend more time researching treatment options like biologics, he still feels adept at engaging with patients and helping patients understand where they are in their illness and the potential benefits of fourth- or fifth-line treatments.

Another strength of thesecondopinion model lies in numbers. Most of the time second opinions are given by one doctor, Dr. Kleckner pointed out. In contrast, thesecondopinion provides the patient with access to a whole team of specialists.

“Sometimes people on the panels don’t completely agree,” Dr. Lakes said. So, before meeting with the patient on Zoom, the doctors review the case together for about half an hour and come up with a consensus. This way there’s no mixed messaging and as little anxiety for the patient as possible, he said.

The fact that patients have direct access to the panel of experts who review their cases is unique in itself, Dr. Kleckner said.

Many hospitals have tumor boards, but they are reserved for physicians, he pointed out. Patients get to hear the board’s opinion secondhand through their primary doctor or oncologist.

But at thesecondopinion, the patient gets to engage with the doctors directly. There is time to review up to four questions that the patient has submitted before the meeting and also time for any additional questions that may have arisen during the course of the meeting.

In oncology, and medicine in general, patients are often shuffled from one specialist to another, Dr. Lakes said. But often, there is no one who takes a steps back to see the whole picture.

That’s part of what thesecondopinion offers, he said. “We have the time, the experience, and no skin in the game. We can think about [the cases] in an intellectual way without feeling like we are in the hot seat or in charge.”

Thanks to her second opinion, Ms. Hackett was able to get connected with an oncologist in San Francisco who specializes in the type of cancer she actually had. She went on to receive nine rounds of a monoclonal antibody treatment formulated for her specific cancer. She is now in remission 6 months after finishing that therapy.

Scans in late July showed that she was cancer-free and doing really well. “I’m so grateful to them. I’m so impressed with thesecondopinion, I can’t believe it,” she said. “I’m alive because of them.”

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

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Will monkeypox be the ‘syphilis of the 21st century’?

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France is boosting its vaccination campaign in response to the increase in cases of monkeypox. After a sluggish start, newly appointed French health minister François Braun has announced the release of 42,000 vaccine doses. At the same time, medical students will be able to lend a helping hand at vaccination sites. However, some experts have criticized the measures taken as being too lax to combat what the World Health Organization has designated a global health emergency.

For Benjamin Davido, MD, MSc, PhD, an infectious disease specialist at the Raymond-Poincaré Hospital (Paris Public Hospital Trust, AP-HP, Garches region), the risks of this disease have been minimized and the measures taken are not adequate, despite the ready availability of the tools needed to manage the epidemic. We must remain alert to the risks posed by this monkeypox epidemic, which seems different from the sporadic outbreaks that usually crop up in Central and West Africa, he said. Dr. Davido recently shared his opinions in an interview.

Question: What do you think about the monkeypox vaccination campaign currently underway in France?

Dr. Davido: It doesn’t go far enough, and I am surprised by the lack of a concrete and specific objective. The effects of the disease are being minimized, and we seem to be in limbo. It seems we have to wait until the fire is out of control before we can call the fire department. We should have been more reactive and taken a more drastic approach from the get-go. In France, as in other countries affected by this epidemic, we are still, unfortunately, in a phase of observation, reassuring ourselves that this will surely not become another pandemic, as that would be really bad luck.

Yet we find ourselves in an unprecedented situation: We have known about the disease in question for a long time, the target population has been identified, and we have a vaccine immediately available. So, we have all the tools and knowledge acquired from the COVID-19 pandemic at our disposal, yet we are choosing to wait and see. We have clearly underestimated the risks of failing after a stalled start to the vaccination campaign.

Question: What exactly are the risks, in your opinion?  Should we already be worried about how the epidemic is progressing?

Dr. Davido: The situation is definitely worrying. I personally am convinced that this disease will be the syphilis of the 21st century. Although the risk is low, it is not beyond the bounds of possibility that this could be the start of a new pandemic. For the time being, its spread is limited to at-risk populations, mainly men who have sex with other men and who have multiple partners, which accounts for around 300,000 people in France. However, the risk for heterosexuals must not be minimized; we must not forget that this disease can also be transmitted through contact with an infected person and by respiratory droplets from people living in the same household. There have been recent cases of women and children infected with monkeypox. If monkeypox starts to spread in the community, rather than being a sexually transmitted infection, the epidemic could spread to the rest of the population. With the rise in cases, scientists are also concerned about transmission to animals. Monkeypox could become endemic like it is in Africa, where rodents are the main reservoir of the virus.

Question: What do we know about the dynamics of this epidemic?  What can be done to effectively improve the situation?

Dr. Davido: Experience gained from African countries affected by monkeypox, as well as from the spate of cases that occurred in the United States in 2003, has shown us that the epidemic can be controlled once the cases have been contained. It is hoped that further waves of the epidemic can be avoided, providing the monkeypox vaccine achieves its objectives.

But we need to give ourselves the means to do so. The expansion of the vaccination program to the most at-risk populations in early July was the right decision. We have seen that ring vaccination targeting close-contact cases does not work with monkeypox. The current problem is that this vaccine is nearly exclusively restricted to hospital settings. We are making the same mistakes as [we did] at the start of the COVID-19 epidemic. We don’t have the right infrastructure in place for this vaccination program. We need to get doctors, paramedics, pharmacists, etc., involved. And cut back on the red tape. After embracing digital procedures during COVID-19, we find ourselves having to complete paper copies of documents for every single person attending a vaccination site. It just doesn’t make sense!

Question: You highlighted the lack of a clear objective with this vaccination campaign. What should we be aiming for?

Dr. Davido: During the COVID-19 vaccination campaign, there was a set number of people to be vaccinated within a given time frame. The approach demanded a fast pace and a desired outcome. Yes, it was an ambitious target from the get-go, but it was one that we stuck to. Currently, no figure, no target, has been set for the monkeypox vaccination program. Ideally, we would have completed the vaccination campaign before the start of the new school year to limit new infections.

As it stands now, only 10% of the target population has received the vaccine. There is talk of the summer period not being favorable. Yet I remember that last year, the COVID-19 vaccination program was strengthened in the middle of August. If the monkeypox vaccination campaign is not given a boost by the end of the summer, we run the risk of encouraging transmission of the virus between close contacts when different groups mix after being on holiday at the start of the new school year. I think that, first and foremost, we must make general practitioners aware of the disease and train them in how to diagnose it so that patients can be isolated and vaccinated as quickly as possible.

Question: There has also been talk of increasing the set 28-day period between the two doses, or even getting rid of it entirely. Would this perhaps lead to better vaccine uptake?

Dr. Davido: The United Kingdom has chosen to give a single dose and recommends a second dose after exposure. I am not sure that this is the best strategy. Although the efficacy data are still limited, the results are not as good after a single dose. According to initial data from the French National Agency for the Safety of Medicines and Health Products (the ANSM), the rate of seroconversion after one dose rises from 10% to 56% on D28 in healthy volunteers, but is between 77% and 89% 2 weeks after the second dose administered on D28.

So, the second dose is needed, especially as immunological memory seems to drop 2 years after the first injection. The U.S. Centers for Disease Control and Prevention proposes leaving 35 days between the two doses. I think this is a reasonable time frame. So, delaying the second dose makes administration of the first dose even easier because the second often fell in the middle of the holiday period and so we also save precious doses. If the time between doses is longer, we risk vaccinated individuals becoming lax and possibly being tempted to skip the “optional” booster or simply forgetting about it.

Question: Are people who have already had the smallpox vaccine better protected against monkeypox?

Dr. Davido: The efficacy of this vaccine against monkeypox is not perfect on a very long-term basis and, to be honest, we don’t really know the level of protection afforded by first-generation vaccines after 20 years. We must not forget that 20% of people infected with monkeypox were vaccinated against smallpox before mandatory vaccination for this disease was abolished [Editor’s note: The requirement of an initial dose of smallpox vaccine was lifted in 1979, once smallpox had been eradicated].

It is hoped that, as a minimum, this vaccine protects against serious illness. Yet in my department, we regularly see severe cases of monkeypox with widespread lesions in the over 45s, who are said to be vaccinated against smallpox.

Question: By comparison, is it likely that a third-generation vaccine would afford better protection against severe illness?

Dr. Davido: We still don’t have enough data or hindsight to assess the real-world impact of third-generation vaccines. This vaccine has a better tolerance profile than its predecessors, but we currently don’t know if it protects against severe forms of monkeypox. We also need to learn more about the disease causing the current epidemic, since it seems different from the sporadic outbreaks that usually crop up in Central and West Africa. The lesions seen are notably milder. The WHO has given this vaccine an efficacy level of 85% against infection by the monkeypox virus, but we must remain cautious: This figure is based on data from Africa. The epidemic in which we find ourselves is not the same. Overall, we must be wary of overly optimistic rhetoric around this new epidemic.

A version of this article appeared on Medscape.com. The article was translated from the Medscape French edition.

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France is boosting its vaccination campaign in response to the increase in cases of monkeypox. After a sluggish start, newly appointed French health minister François Braun has announced the release of 42,000 vaccine doses. At the same time, medical students will be able to lend a helping hand at vaccination sites. However, some experts have criticized the measures taken as being too lax to combat what the World Health Organization has designated a global health emergency.

For Benjamin Davido, MD, MSc, PhD, an infectious disease specialist at the Raymond-Poincaré Hospital (Paris Public Hospital Trust, AP-HP, Garches region), the risks of this disease have been minimized and the measures taken are not adequate, despite the ready availability of the tools needed to manage the epidemic. We must remain alert to the risks posed by this monkeypox epidemic, which seems different from the sporadic outbreaks that usually crop up in Central and West Africa, he said. Dr. Davido recently shared his opinions in an interview.

Question: What do you think about the monkeypox vaccination campaign currently underway in France?

Dr. Davido: It doesn’t go far enough, and I am surprised by the lack of a concrete and specific objective. The effects of the disease are being minimized, and we seem to be in limbo. It seems we have to wait until the fire is out of control before we can call the fire department. We should have been more reactive and taken a more drastic approach from the get-go. In France, as in other countries affected by this epidemic, we are still, unfortunately, in a phase of observation, reassuring ourselves that this will surely not become another pandemic, as that would be really bad luck.

Yet we find ourselves in an unprecedented situation: We have known about the disease in question for a long time, the target population has been identified, and we have a vaccine immediately available. So, we have all the tools and knowledge acquired from the COVID-19 pandemic at our disposal, yet we are choosing to wait and see. We have clearly underestimated the risks of failing after a stalled start to the vaccination campaign.

Question: What exactly are the risks, in your opinion?  Should we already be worried about how the epidemic is progressing?

Dr. Davido: The situation is definitely worrying. I personally am convinced that this disease will be the syphilis of the 21st century. Although the risk is low, it is not beyond the bounds of possibility that this could be the start of a new pandemic. For the time being, its spread is limited to at-risk populations, mainly men who have sex with other men and who have multiple partners, which accounts for around 300,000 people in France. However, the risk for heterosexuals must not be minimized; we must not forget that this disease can also be transmitted through contact with an infected person and by respiratory droplets from people living in the same household. There have been recent cases of women and children infected with monkeypox. If monkeypox starts to spread in the community, rather than being a sexually transmitted infection, the epidemic could spread to the rest of the population. With the rise in cases, scientists are also concerned about transmission to animals. Monkeypox could become endemic like it is in Africa, where rodents are the main reservoir of the virus.

Question: What do we know about the dynamics of this epidemic?  What can be done to effectively improve the situation?

Dr. Davido: Experience gained from African countries affected by monkeypox, as well as from the spate of cases that occurred in the United States in 2003, has shown us that the epidemic can be controlled once the cases have been contained. It is hoped that further waves of the epidemic can be avoided, providing the monkeypox vaccine achieves its objectives.

But we need to give ourselves the means to do so. The expansion of the vaccination program to the most at-risk populations in early July was the right decision. We have seen that ring vaccination targeting close-contact cases does not work with monkeypox. The current problem is that this vaccine is nearly exclusively restricted to hospital settings. We are making the same mistakes as [we did] at the start of the COVID-19 epidemic. We don’t have the right infrastructure in place for this vaccination program. We need to get doctors, paramedics, pharmacists, etc., involved. And cut back on the red tape. After embracing digital procedures during COVID-19, we find ourselves having to complete paper copies of documents for every single person attending a vaccination site. It just doesn’t make sense!

Question: You highlighted the lack of a clear objective with this vaccination campaign. What should we be aiming for?

Dr. Davido: During the COVID-19 vaccination campaign, there was a set number of people to be vaccinated within a given time frame. The approach demanded a fast pace and a desired outcome. Yes, it was an ambitious target from the get-go, but it was one that we stuck to. Currently, no figure, no target, has been set for the monkeypox vaccination program. Ideally, we would have completed the vaccination campaign before the start of the new school year to limit new infections.

As it stands now, only 10% of the target population has received the vaccine. There is talk of the summer period not being favorable. Yet I remember that last year, the COVID-19 vaccination program was strengthened in the middle of August. If the monkeypox vaccination campaign is not given a boost by the end of the summer, we run the risk of encouraging transmission of the virus between close contacts when different groups mix after being on holiday at the start of the new school year. I think that, first and foremost, we must make general practitioners aware of the disease and train them in how to diagnose it so that patients can be isolated and vaccinated as quickly as possible.

Question: There has also been talk of increasing the set 28-day period between the two doses, or even getting rid of it entirely. Would this perhaps lead to better vaccine uptake?

Dr. Davido: The United Kingdom has chosen to give a single dose and recommends a second dose after exposure. I am not sure that this is the best strategy. Although the efficacy data are still limited, the results are not as good after a single dose. According to initial data from the French National Agency for the Safety of Medicines and Health Products (the ANSM), the rate of seroconversion after one dose rises from 10% to 56% on D28 in healthy volunteers, but is between 77% and 89% 2 weeks after the second dose administered on D28.

So, the second dose is needed, especially as immunological memory seems to drop 2 years after the first injection. The U.S. Centers for Disease Control and Prevention proposes leaving 35 days between the two doses. I think this is a reasonable time frame. So, delaying the second dose makes administration of the first dose even easier because the second often fell in the middle of the holiday period and so we also save precious doses. If the time between doses is longer, we risk vaccinated individuals becoming lax and possibly being tempted to skip the “optional” booster or simply forgetting about it.

Question: Are people who have already had the smallpox vaccine better protected against monkeypox?

Dr. Davido: The efficacy of this vaccine against monkeypox is not perfect on a very long-term basis and, to be honest, we don’t really know the level of protection afforded by first-generation vaccines after 20 years. We must not forget that 20% of people infected with monkeypox were vaccinated against smallpox before mandatory vaccination for this disease was abolished [Editor’s note: The requirement of an initial dose of smallpox vaccine was lifted in 1979, once smallpox had been eradicated].

It is hoped that, as a minimum, this vaccine protects against serious illness. Yet in my department, we regularly see severe cases of monkeypox with widespread lesions in the over 45s, who are said to be vaccinated against smallpox.

Question: By comparison, is it likely that a third-generation vaccine would afford better protection against severe illness?

Dr. Davido: We still don’t have enough data or hindsight to assess the real-world impact of third-generation vaccines. This vaccine has a better tolerance profile than its predecessors, but we currently don’t know if it protects against severe forms of monkeypox. We also need to learn more about the disease causing the current epidemic, since it seems different from the sporadic outbreaks that usually crop up in Central and West Africa. The lesions seen are notably milder. The WHO has given this vaccine an efficacy level of 85% against infection by the monkeypox virus, but we must remain cautious: This figure is based on data from Africa. The epidemic in which we find ourselves is not the same. Overall, we must be wary of overly optimistic rhetoric around this new epidemic.

A version of this article appeared on Medscape.com. The article was translated from the Medscape French edition.

 

France is boosting its vaccination campaign in response to the increase in cases of monkeypox. After a sluggish start, newly appointed French health minister François Braun has announced the release of 42,000 vaccine doses. At the same time, medical students will be able to lend a helping hand at vaccination sites. However, some experts have criticized the measures taken as being too lax to combat what the World Health Organization has designated a global health emergency.

For Benjamin Davido, MD, MSc, PhD, an infectious disease specialist at the Raymond-Poincaré Hospital (Paris Public Hospital Trust, AP-HP, Garches region), the risks of this disease have been minimized and the measures taken are not adequate, despite the ready availability of the tools needed to manage the epidemic. We must remain alert to the risks posed by this monkeypox epidemic, which seems different from the sporadic outbreaks that usually crop up in Central and West Africa, he said. Dr. Davido recently shared his opinions in an interview.

Question: What do you think about the monkeypox vaccination campaign currently underway in France?

Dr. Davido: It doesn’t go far enough, and I am surprised by the lack of a concrete and specific objective. The effects of the disease are being minimized, and we seem to be in limbo. It seems we have to wait until the fire is out of control before we can call the fire department. We should have been more reactive and taken a more drastic approach from the get-go. In France, as in other countries affected by this epidemic, we are still, unfortunately, in a phase of observation, reassuring ourselves that this will surely not become another pandemic, as that would be really bad luck.

Yet we find ourselves in an unprecedented situation: We have known about the disease in question for a long time, the target population has been identified, and we have a vaccine immediately available. So, we have all the tools and knowledge acquired from the COVID-19 pandemic at our disposal, yet we are choosing to wait and see. We have clearly underestimated the risks of failing after a stalled start to the vaccination campaign.

Question: What exactly are the risks, in your opinion?  Should we already be worried about how the epidemic is progressing?

Dr. Davido: The situation is definitely worrying. I personally am convinced that this disease will be the syphilis of the 21st century. Although the risk is low, it is not beyond the bounds of possibility that this could be the start of a new pandemic. For the time being, its spread is limited to at-risk populations, mainly men who have sex with other men and who have multiple partners, which accounts for around 300,000 people in France. However, the risk for heterosexuals must not be minimized; we must not forget that this disease can also be transmitted through contact with an infected person and by respiratory droplets from people living in the same household. There have been recent cases of women and children infected with monkeypox. If monkeypox starts to spread in the community, rather than being a sexually transmitted infection, the epidemic could spread to the rest of the population. With the rise in cases, scientists are also concerned about transmission to animals. Monkeypox could become endemic like it is in Africa, where rodents are the main reservoir of the virus.

Question: What do we know about the dynamics of this epidemic?  What can be done to effectively improve the situation?

Dr. Davido: Experience gained from African countries affected by monkeypox, as well as from the spate of cases that occurred in the United States in 2003, has shown us that the epidemic can be controlled once the cases have been contained. It is hoped that further waves of the epidemic can be avoided, providing the monkeypox vaccine achieves its objectives.

But we need to give ourselves the means to do so. The expansion of the vaccination program to the most at-risk populations in early July was the right decision. We have seen that ring vaccination targeting close-contact cases does not work with monkeypox. The current problem is that this vaccine is nearly exclusively restricted to hospital settings. We are making the same mistakes as [we did] at the start of the COVID-19 epidemic. We don’t have the right infrastructure in place for this vaccination program. We need to get doctors, paramedics, pharmacists, etc., involved. And cut back on the red tape. After embracing digital procedures during COVID-19, we find ourselves having to complete paper copies of documents for every single person attending a vaccination site. It just doesn’t make sense!

Question: You highlighted the lack of a clear objective with this vaccination campaign. What should we be aiming for?

Dr. Davido: During the COVID-19 vaccination campaign, there was a set number of people to be vaccinated within a given time frame. The approach demanded a fast pace and a desired outcome. Yes, it was an ambitious target from the get-go, but it was one that we stuck to. Currently, no figure, no target, has been set for the monkeypox vaccination program. Ideally, we would have completed the vaccination campaign before the start of the new school year to limit new infections.

As it stands now, only 10% of the target population has received the vaccine. There is talk of the summer period not being favorable. Yet I remember that last year, the COVID-19 vaccination program was strengthened in the middle of August. If the monkeypox vaccination campaign is not given a boost by the end of the summer, we run the risk of encouraging transmission of the virus between close contacts when different groups mix after being on holiday at the start of the new school year. I think that, first and foremost, we must make general practitioners aware of the disease and train them in how to diagnose it so that patients can be isolated and vaccinated as quickly as possible.

Question: There has also been talk of increasing the set 28-day period between the two doses, or even getting rid of it entirely. Would this perhaps lead to better vaccine uptake?

Dr. Davido: The United Kingdom has chosen to give a single dose and recommends a second dose after exposure. I am not sure that this is the best strategy. Although the efficacy data are still limited, the results are not as good after a single dose. According to initial data from the French National Agency for the Safety of Medicines and Health Products (the ANSM), the rate of seroconversion after one dose rises from 10% to 56% on D28 in healthy volunteers, but is between 77% and 89% 2 weeks after the second dose administered on D28.

So, the second dose is needed, especially as immunological memory seems to drop 2 years after the first injection. The U.S. Centers for Disease Control and Prevention proposes leaving 35 days between the two doses. I think this is a reasonable time frame. So, delaying the second dose makes administration of the first dose even easier because the second often fell in the middle of the holiday period and so we also save precious doses. If the time between doses is longer, we risk vaccinated individuals becoming lax and possibly being tempted to skip the “optional” booster or simply forgetting about it.

Question: Are people who have already had the smallpox vaccine better protected against monkeypox?

Dr. Davido: The efficacy of this vaccine against monkeypox is not perfect on a very long-term basis and, to be honest, we don’t really know the level of protection afforded by first-generation vaccines after 20 years. We must not forget that 20% of people infected with monkeypox were vaccinated against smallpox before mandatory vaccination for this disease was abolished [Editor’s note: The requirement of an initial dose of smallpox vaccine was lifted in 1979, once smallpox had been eradicated].

It is hoped that, as a minimum, this vaccine protects against serious illness. Yet in my department, we regularly see severe cases of monkeypox with widespread lesions in the over 45s, who are said to be vaccinated against smallpox.

Question: By comparison, is it likely that a third-generation vaccine would afford better protection against severe illness?

Dr. Davido: We still don’t have enough data or hindsight to assess the real-world impact of third-generation vaccines. This vaccine has a better tolerance profile than its predecessors, but we currently don’t know if it protects against severe forms of monkeypox. We also need to learn more about the disease causing the current epidemic, since it seems different from the sporadic outbreaks that usually crop up in Central and West Africa. The lesions seen are notably milder. The WHO has given this vaccine an efficacy level of 85% against infection by the monkeypox virus, but we must remain cautious: This figure is based on data from Africa. The epidemic in which we find ourselves is not the same. Overall, we must be wary of overly optimistic rhetoric around this new epidemic.

A version of this article appeared on Medscape.com. The article was translated from the Medscape French edition.

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‘I missed it’: Coping with medical error

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Thursday night

It was 9 o’clock at night when my phone rang. I didn’t recognize the number but decided to answer it anyway. It was my doctor.

Dr. M. Chase Levesque

“Chase, I got your labs back and you have a critically low level. I spoke with someone at the hospital, I think I know what is happening, but I need you to go to the pharmacy right now and get a medicine.” She explained further and as I listened electric currents ran through my thighs until I could barely feel my legs.

“I’m so sorry, Chase. I missed it. It was low the last time we did your labs 9 months ago, and I missed it.”

In disbelief, I continued to listen as she instructed me about the next steps I was to take and prepared me for what was to come the next day.

“If you notice any changes overnight, go straight to the ED.”

My chest tingled and I could barely breathe. My mind struggled to comprehend what was happening. I looked at my husband sitting close by on the couch. He looked concerned. I tuned back in and heard her say: “Is your husband there? Can I talk to him?”

“Yes,” is all I could manage, and I handed him the phone. I sat while he listened and asked his questions. My breathing came back under my control, my legs felt wiry, and restlessness set in. “I have to get out of here,” I thought. “I have to go and pick up this medicine.”
 

Monday afternoon

I am sitting across from a PGY3 resident I have been treating since his intern year, as part of his treatment plan for managing a chronic mental illness that began in medical school. Earlier in the day, I received an urgent message from him requesting an emergency appointment.

Within a few minutes of sitting down, the story from his weekend call shift tumbled out of him. His speech became pressured, and his eyes welled with tears as he recounted in detail the steps he had taken to care for a very sick patient overnight.

“I missed it.” The dam broke and he sat sobbing in front of me, his body trembling.

I sat silently across from him. Willing him to breathe.

In time, his breathing came back under his control, and he slowly regained his composure. He continued: “I got the imaging, and I missed a bleed.”
 

Failure and shame

I can recall memorable moments from my training when I came to understand that what I initially perceived to be a mistake was instead part of the work. An example from our practice involves a patient whom I was comanaging with her primary care provider (PCP). She was not doing well following a critical work event. When I met with her after the event, she admitted having thoughts of suicide, refused a voluntary inpatient admission, and would not have met criteria for an involuntary admission. My hands were tied.

Together we created a plan to keep her safe, which included paging her PCP after hours if needed. I told her PCP before leaving that night that he might hear from her and that if she reached out, she would require hospitalization.

I arrived at work the following day, and her PCP shared with me that our patient had overdosed on medication, paged him, and was admitted to the unit.

He seemed forlorn.

I was both relieved by the news and confused by his reaction. I had hoped that she would choose a higher level of care than what we could provide her as an outpatient. I said: “This is good. She followed the plan.”

Her overdose was, of course, not part of the plan. She was struggling with several internal conflicts, including having mixed feelings about coming into the hospital; but, when the critical moment happened and she was faced with a decision to call for help or possibly die, she chose to call her PCP and have him paged as we had talked about.

I looked at her PCP. “You helped get her to where she needed to be.”

In the years of working side by side with medically trained colleagues, I have time and again needed to reframe for them that what they perceive to be a “failure” or a “crisis” is often a catalyst for change. The patient I comanaged with the PCP was a highly skilled caregiver and, as such, had been having a hard time asking for help. The hospitalization that her PCP facilitated allowed her to receive the care she needed and created an opportunity for family and friends to show up for her. Their support fed her, and she only made gains from that point on.

My training had taught me that respecting a patient’s autonomy was of the utmost importance. This instills confidence in patients as the authority in their lives. For a clinician to do this, a certain amount of helplessness must be tolerated. As I became better at identifying these moments of helplessness, feelings of failure and shame transformed.
 

Medical error

Sitting across from the PGY3 resident who I had met with weekly for the past 3 years, I thought about his error.

I thought about my phone call 4 nights earlier. My doctor was called at home by a lab technician, who never met their patients but was simply following protocol and alerted my doctor to the worsening number that she should have been aware of 9 months earlier.

Just like my doctor’s lapse of attention, my patient’s error was not a moment of helplessness to be tolerated. These were mistakes, and there was no way around it.

“People make mistakes.” I said simply.

We sat silently for a time.

I don’t remember who broke the silence. The conversation that followed was centered on our humanity and our capability for both compassion and fallibility. Afterward, I wondered who my doctor confided in and hoped she had a similar conversation.

Dr. Levesque is a clinical psychologist and clinical assistant professor of psychiatry at the Geisel School of Medicine at Dartmouth, Hanover, N.H., where she also serves on the Committee for a Respectful Learning Environment.

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

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Thursday night

It was 9 o’clock at night when my phone rang. I didn’t recognize the number but decided to answer it anyway. It was my doctor.

Dr. M. Chase Levesque

“Chase, I got your labs back and you have a critically low level. I spoke with someone at the hospital, I think I know what is happening, but I need you to go to the pharmacy right now and get a medicine.” She explained further and as I listened electric currents ran through my thighs until I could barely feel my legs.

“I’m so sorry, Chase. I missed it. It was low the last time we did your labs 9 months ago, and I missed it.”

In disbelief, I continued to listen as she instructed me about the next steps I was to take and prepared me for what was to come the next day.

“If you notice any changes overnight, go straight to the ED.”

My chest tingled and I could barely breathe. My mind struggled to comprehend what was happening. I looked at my husband sitting close by on the couch. He looked concerned. I tuned back in and heard her say: “Is your husband there? Can I talk to him?”

“Yes,” is all I could manage, and I handed him the phone. I sat while he listened and asked his questions. My breathing came back under my control, my legs felt wiry, and restlessness set in. “I have to get out of here,” I thought. “I have to go and pick up this medicine.”
 

Monday afternoon

I am sitting across from a PGY3 resident I have been treating since his intern year, as part of his treatment plan for managing a chronic mental illness that began in medical school. Earlier in the day, I received an urgent message from him requesting an emergency appointment.

Within a few minutes of sitting down, the story from his weekend call shift tumbled out of him. His speech became pressured, and his eyes welled with tears as he recounted in detail the steps he had taken to care for a very sick patient overnight.

“I missed it.” The dam broke and he sat sobbing in front of me, his body trembling.

I sat silently across from him. Willing him to breathe.

In time, his breathing came back under his control, and he slowly regained his composure. He continued: “I got the imaging, and I missed a bleed.”
 

Failure and shame

I can recall memorable moments from my training when I came to understand that what I initially perceived to be a mistake was instead part of the work. An example from our practice involves a patient whom I was comanaging with her primary care provider (PCP). She was not doing well following a critical work event. When I met with her after the event, she admitted having thoughts of suicide, refused a voluntary inpatient admission, and would not have met criteria for an involuntary admission. My hands were tied.

Together we created a plan to keep her safe, which included paging her PCP after hours if needed. I told her PCP before leaving that night that he might hear from her and that if she reached out, she would require hospitalization.

I arrived at work the following day, and her PCP shared with me that our patient had overdosed on medication, paged him, and was admitted to the unit.

He seemed forlorn.

I was both relieved by the news and confused by his reaction. I had hoped that she would choose a higher level of care than what we could provide her as an outpatient. I said: “This is good. She followed the plan.”

Her overdose was, of course, not part of the plan. She was struggling with several internal conflicts, including having mixed feelings about coming into the hospital; but, when the critical moment happened and she was faced with a decision to call for help or possibly die, she chose to call her PCP and have him paged as we had talked about.

I looked at her PCP. “You helped get her to where she needed to be.”

In the years of working side by side with medically trained colleagues, I have time and again needed to reframe for them that what they perceive to be a “failure” or a “crisis” is often a catalyst for change. The patient I comanaged with the PCP was a highly skilled caregiver and, as such, had been having a hard time asking for help. The hospitalization that her PCP facilitated allowed her to receive the care she needed and created an opportunity for family and friends to show up for her. Their support fed her, and she only made gains from that point on.

My training had taught me that respecting a patient’s autonomy was of the utmost importance. This instills confidence in patients as the authority in their lives. For a clinician to do this, a certain amount of helplessness must be tolerated. As I became better at identifying these moments of helplessness, feelings of failure and shame transformed.
 

Medical error

Sitting across from the PGY3 resident who I had met with weekly for the past 3 years, I thought about his error.

I thought about my phone call 4 nights earlier. My doctor was called at home by a lab technician, who never met their patients but was simply following protocol and alerted my doctor to the worsening number that she should have been aware of 9 months earlier.

Just like my doctor’s lapse of attention, my patient’s error was not a moment of helplessness to be tolerated. These were mistakes, and there was no way around it.

“People make mistakes.” I said simply.

We sat silently for a time.

I don’t remember who broke the silence. The conversation that followed was centered on our humanity and our capability for both compassion and fallibility. Afterward, I wondered who my doctor confided in and hoped she had a similar conversation.

Dr. Levesque is a clinical psychologist and clinical assistant professor of psychiatry at the Geisel School of Medicine at Dartmouth, Hanover, N.H., where she also serves on the Committee for a Respectful Learning Environment.

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

 

Thursday night

It was 9 o’clock at night when my phone rang. I didn’t recognize the number but decided to answer it anyway. It was my doctor.

Dr. M. Chase Levesque

“Chase, I got your labs back and you have a critically low level. I spoke with someone at the hospital, I think I know what is happening, but I need you to go to the pharmacy right now and get a medicine.” She explained further and as I listened electric currents ran through my thighs until I could barely feel my legs.

“I’m so sorry, Chase. I missed it. It was low the last time we did your labs 9 months ago, and I missed it.”

In disbelief, I continued to listen as she instructed me about the next steps I was to take and prepared me for what was to come the next day.

“If you notice any changes overnight, go straight to the ED.”

My chest tingled and I could barely breathe. My mind struggled to comprehend what was happening. I looked at my husband sitting close by on the couch. He looked concerned. I tuned back in and heard her say: “Is your husband there? Can I talk to him?”

“Yes,” is all I could manage, and I handed him the phone. I sat while he listened and asked his questions. My breathing came back under my control, my legs felt wiry, and restlessness set in. “I have to get out of here,” I thought. “I have to go and pick up this medicine.”
 

Monday afternoon

I am sitting across from a PGY3 resident I have been treating since his intern year, as part of his treatment plan for managing a chronic mental illness that began in medical school. Earlier in the day, I received an urgent message from him requesting an emergency appointment.

Within a few minutes of sitting down, the story from his weekend call shift tumbled out of him. His speech became pressured, and his eyes welled with tears as he recounted in detail the steps he had taken to care for a very sick patient overnight.

“I missed it.” The dam broke and he sat sobbing in front of me, his body trembling.

I sat silently across from him. Willing him to breathe.

In time, his breathing came back under his control, and he slowly regained his composure. He continued: “I got the imaging, and I missed a bleed.”
 

Failure and shame

I can recall memorable moments from my training when I came to understand that what I initially perceived to be a mistake was instead part of the work. An example from our practice involves a patient whom I was comanaging with her primary care provider (PCP). She was not doing well following a critical work event. When I met with her after the event, she admitted having thoughts of suicide, refused a voluntary inpatient admission, and would not have met criteria for an involuntary admission. My hands were tied.

Together we created a plan to keep her safe, which included paging her PCP after hours if needed. I told her PCP before leaving that night that he might hear from her and that if she reached out, she would require hospitalization.

I arrived at work the following day, and her PCP shared with me that our patient had overdosed on medication, paged him, and was admitted to the unit.

He seemed forlorn.

I was both relieved by the news and confused by his reaction. I had hoped that she would choose a higher level of care than what we could provide her as an outpatient. I said: “This is good. She followed the plan.”

Her overdose was, of course, not part of the plan. She was struggling with several internal conflicts, including having mixed feelings about coming into the hospital; but, when the critical moment happened and she was faced with a decision to call for help or possibly die, she chose to call her PCP and have him paged as we had talked about.

I looked at her PCP. “You helped get her to where she needed to be.”

In the years of working side by side with medically trained colleagues, I have time and again needed to reframe for them that what they perceive to be a “failure” or a “crisis” is often a catalyst for change. The patient I comanaged with the PCP was a highly skilled caregiver and, as such, had been having a hard time asking for help. The hospitalization that her PCP facilitated allowed her to receive the care she needed and created an opportunity for family and friends to show up for her. Their support fed her, and she only made gains from that point on.

My training had taught me that respecting a patient’s autonomy was of the utmost importance. This instills confidence in patients as the authority in their lives. For a clinician to do this, a certain amount of helplessness must be tolerated. As I became better at identifying these moments of helplessness, feelings of failure and shame transformed.
 

Medical error

Sitting across from the PGY3 resident who I had met with weekly for the past 3 years, I thought about his error.

I thought about my phone call 4 nights earlier. My doctor was called at home by a lab technician, who never met their patients but was simply following protocol and alerted my doctor to the worsening number that she should have been aware of 9 months earlier.

Just like my doctor’s lapse of attention, my patient’s error was not a moment of helplessness to be tolerated. These were mistakes, and there was no way around it.

“People make mistakes.” I said simply.

We sat silently for a time.

I don’t remember who broke the silence. The conversation that followed was centered on our humanity and our capability for both compassion and fallibility. Afterward, I wondered who my doctor confided in and hoped she had a similar conversation.

Dr. Levesque is a clinical psychologist and clinical assistant professor of psychiatry at the Geisel School of Medicine at Dartmouth, Hanover, N.H., where she also serves on the Committee for a Respectful Learning Environment.

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

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Regular physical activity may fight infection, illness from COVID: Study

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New research suggests that regular physical activity can help lower the risk of COVID-19 infection and its severity, with a weekly tally of 150 minutes of moderate, or 75 minutes of vigorous, physical activity affording the best protection.

Our findings highlight the protective effects of engaging in sufficient physical activity as a public health strategy, with potential benefits to reduce the risk of severe COVID-19,” say Antonio García-Hermoso, PhD, Public University of Navarra, Pamplona, Spain, and colleagues.

“Regular physical activity seemed to be related to a lower risk of COVID-19 infection, Dr. García-Hermoso said in an interview. “There is evidence that regular physical activity might contribute to a more effective immune response, providing enhanced protective immunity to infections, which could explain the relationship between exercise consistency with COVID-19 infection.”

Regular exercise may also help to boost the body’s anti-inflammatory responses, as well as cardiorespiratory and muscular fitness, all of which may explain its beneficial effects on COVID-19 severity, the researchers say.

The study was published online in the British Journal of Sports Medicine.
 

Strong protection from COVID?

A growing body of evidence suggests that increased physical activity may modulate the course of COVID-19 infection and reduce the risk of poor outcomes. The new analysis is the first to systematically evaluate and pool data on the effect of regular physical activity on COVID-19 outcomes.

The findings are based on data from 16 studies with over 1.8 million adults (53% women, mean age 53 years).

Individuals who included regular physical activity in their weekly routine had an 11% lower risk for infection with SARS-CoV-2 (hazard ratio, 0.89; 95% confidence interval, 0.84-0.95), compared with inactive peers.

The physically active adults also had a 36% (HR, 0.64; 95% CI, 0.54-0.76) lower risk of being hospitalized, a 44% (HR, 0.66; 95% CI, 0.58-0.77) lower risk for severe COVID-19 illness, and a 43% (HR, 0.57; 95% CI, 0.46-0.71) lower risk of dying from COVID-19 than their inactive peers.

The greatest protective effect occurs with achieving at least 500 metabolic equivalent of task (MET) minutes per week of physical activity – equivalent to 150 minutes of moderate-intensity or 75 min of vigorous-intensity physical activity per week – with no added benefit beyond this level.

The researchers caution that the analysis included observational studies, differing study designs, subjective assessments of physical activity levels, and concerned only the Beta and Delta variants of SARS-CoV-2, not Omicron.

Despite these limitations, the researchers say their findings “may help guide physicians and health care policymakers in making recommendations and developing guidelines with respect to the degree of physical activity that can help reduce the risk of infectivity, hospitalization, severity, and mortality of COVID-19 at both the individual and the population level, especially in high-risk patients.”
 

Helpful, but not a panacea

Reached for comment, Sean Heffron, MD, a preventive cardiologist and assistant professor of medicine at NYU Langone Health, New York, said the study “supports the well-established nonlinear association of increasing physical activity with adverse outcomes from a diverse array of diseases, including infectious diseases, such as COVID-19.”

The observation is not particularly surprising, he said.

“It is as I would suspect. They compiled data from a large number of studies published over the past several years that all had consistent findings,” Dr. Heffron said.

“The take-away from a public health standpoint is that being physically active improves health in myriad ways. That being said, it is not a panacea, so additional measures (masking, vaccinations, etc.) are important for everyone,” he said.

Also weighing in, Joseph Herrera, DO, chair of the department of rehabilitation for Mount Sinai Health System, New York, said, “If you are physically fit, your body is more resilient and better prepared to handle the stressors of COVID or any other disease process.”

For now, however, the question of whether physical fitness is actually protective against COVID remains unclear. “I’m just not sure right now,” Dr. Herrera said in an interview.

He said he has treated athletes in professional sports – including the National Football League and Major League Baseball – and some of them have had long COVID and have not returned to play. “These are athletes at the peak of fitness and their career.”

Nonetheless, Dr. Herrera said a good public health message in general is to stay fit or get fit.

“That’s something I preach all the time,” he told this news organization.

Dr. García-Hermoso agreed. “In contrast to the vast majority of drugs, exercise is free of adverse effects. It’s time to consider exercise as medicine. It’s never too late to start being physically active.”

The study had no specific funding. Dr. García-Hermoso, Dr. Heffron, and Dr. Herrera have reported no relevant financial relationships.

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

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New research suggests that regular physical activity can help lower the risk of COVID-19 infection and its severity, with a weekly tally of 150 minutes of moderate, or 75 minutes of vigorous, physical activity affording the best protection.

Our findings highlight the protective effects of engaging in sufficient physical activity as a public health strategy, with potential benefits to reduce the risk of severe COVID-19,” say Antonio García-Hermoso, PhD, Public University of Navarra, Pamplona, Spain, and colleagues.

“Regular physical activity seemed to be related to a lower risk of COVID-19 infection, Dr. García-Hermoso said in an interview. “There is evidence that regular physical activity might contribute to a more effective immune response, providing enhanced protective immunity to infections, which could explain the relationship between exercise consistency with COVID-19 infection.”

Regular exercise may also help to boost the body’s anti-inflammatory responses, as well as cardiorespiratory and muscular fitness, all of which may explain its beneficial effects on COVID-19 severity, the researchers say.

The study was published online in the British Journal of Sports Medicine.
 

Strong protection from COVID?

A growing body of evidence suggests that increased physical activity may modulate the course of COVID-19 infection and reduce the risk of poor outcomes. The new analysis is the first to systematically evaluate and pool data on the effect of regular physical activity on COVID-19 outcomes.

The findings are based on data from 16 studies with over 1.8 million adults (53% women, mean age 53 years).

Individuals who included regular physical activity in their weekly routine had an 11% lower risk for infection with SARS-CoV-2 (hazard ratio, 0.89; 95% confidence interval, 0.84-0.95), compared with inactive peers.

The physically active adults also had a 36% (HR, 0.64; 95% CI, 0.54-0.76) lower risk of being hospitalized, a 44% (HR, 0.66; 95% CI, 0.58-0.77) lower risk for severe COVID-19 illness, and a 43% (HR, 0.57; 95% CI, 0.46-0.71) lower risk of dying from COVID-19 than their inactive peers.

The greatest protective effect occurs with achieving at least 500 metabolic equivalent of task (MET) minutes per week of physical activity – equivalent to 150 minutes of moderate-intensity or 75 min of vigorous-intensity physical activity per week – with no added benefit beyond this level.

The researchers caution that the analysis included observational studies, differing study designs, subjective assessments of physical activity levels, and concerned only the Beta and Delta variants of SARS-CoV-2, not Omicron.

Despite these limitations, the researchers say their findings “may help guide physicians and health care policymakers in making recommendations and developing guidelines with respect to the degree of physical activity that can help reduce the risk of infectivity, hospitalization, severity, and mortality of COVID-19 at both the individual and the population level, especially in high-risk patients.”
 

Helpful, but not a panacea

Reached for comment, Sean Heffron, MD, a preventive cardiologist and assistant professor of medicine at NYU Langone Health, New York, said the study “supports the well-established nonlinear association of increasing physical activity with adverse outcomes from a diverse array of diseases, including infectious diseases, such as COVID-19.”

The observation is not particularly surprising, he said.

“It is as I would suspect. They compiled data from a large number of studies published over the past several years that all had consistent findings,” Dr. Heffron said.

“The take-away from a public health standpoint is that being physically active improves health in myriad ways. That being said, it is not a panacea, so additional measures (masking, vaccinations, etc.) are important for everyone,” he said.

Also weighing in, Joseph Herrera, DO, chair of the department of rehabilitation for Mount Sinai Health System, New York, said, “If you are physically fit, your body is more resilient and better prepared to handle the stressors of COVID or any other disease process.”

For now, however, the question of whether physical fitness is actually protective against COVID remains unclear. “I’m just not sure right now,” Dr. Herrera said in an interview.

He said he has treated athletes in professional sports – including the National Football League and Major League Baseball – and some of them have had long COVID and have not returned to play. “These are athletes at the peak of fitness and their career.”

Nonetheless, Dr. Herrera said a good public health message in general is to stay fit or get fit.

“That’s something I preach all the time,” he told this news organization.

Dr. García-Hermoso agreed. “In contrast to the vast majority of drugs, exercise is free of adverse effects. It’s time to consider exercise as medicine. It’s never too late to start being physically active.”

The study had no specific funding. Dr. García-Hermoso, Dr. Heffron, and Dr. Herrera have reported no relevant financial relationships.

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

New research suggests that regular physical activity can help lower the risk of COVID-19 infection and its severity, with a weekly tally of 150 minutes of moderate, or 75 minutes of vigorous, physical activity affording the best protection.

Our findings highlight the protective effects of engaging in sufficient physical activity as a public health strategy, with potential benefits to reduce the risk of severe COVID-19,” say Antonio García-Hermoso, PhD, Public University of Navarra, Pamplona, Spain, and colleagues.

“Regular physical activity seemed to be related to a lower risk of COVID-19 infection, Dr. García-Hermoso said in an interview. “There is evidence that regular physical activity might contribute to a more effective immune response, providing enhanced protective immunity to infections, which could explain the relationship between exercise consistency with COVID-19 infection.”

Regular exercise may also help to boost the body’s anti-inflammatory responses, as well as cardiorespiratory and muscular fitness, all of which may explain its beneficial effects on COVID-19 severity, the researchers say.

The study was published online in the British Journal of Sports Medicine.
 

Strong protection from COVID?

A growing body of evidence suggests that increased physical activity may modulate the course of COVID-19 infection and reduce the risk of poor outcomes. The new analysis is the first to systematically evaluate and pool data on the effect of regular physical activity on COVID-19 outcomes.

The findings are based on data from 16 studies with over 1.8 million adults (53% women, mean age 53 years).

Individuals who included regular physical activity in their weekly routine had an 11% lower risk for infection with SARS-CoV-2 (hazard ratio, 0.89; 95% confidence interval, 0.84-0.95), compared with inactive peers.

The physically active adults also had a 36% (HR, 0.64; 95% CI, 0.54-0.76) lower risk of being hospitalized, a 44% (HR, 0.66; 95% CI, 0.58-0.77) lower risk for severe COVID-19 illness, and a 43% (HR, 0.57; 95% CI, 0.46-0.71) lower risk of dying from COVID-19 than their inactive peers.

The greatest protective effect occurs with achieving at least 500 metabolic equivalent of task (MET) minutes per week of physical activity – equivalent to 150 minutes of moderate-intensity or 75 min of vigorous-intensity physical activity per week – with no added benefit beyond this level.

The researchers caution that the analysis included observational studies, differing study designs, subjective assessments of physical activity levels, and concerned only the Beta and Delta variants of SARS-CoV-2, not Omicron.

Despite these limitations, the researchers say their findings “may help guide physicians and health care policymakers in making recommendations and developing guidelines with respect to the degree of physical activity that can help reduce the risk of infectivity, hospitalization, severity, and mortality of COVID-19 at both the individual and the population level, especially in high-risk patients.”
 

Helpful, but not a panacea

Reached for comment, Sean Heffron, MD, a preventive cardiologist and assistant professor of medicine at NYU Langone Health, New York, said the study “supports the well-established nonlinear association of increasing physical activity with adverse outcomes from a diverse array of diseases, including infectious diseases, such as COVID-19.”

The observation is not particularly surprising, he said.

“It is as I would suspect. They compiled data from a large number of studies published over the past several years that all had consistent findings,” Dr. Heffron said.

“The take-away from a public health standpoint is that being physically active improves health in myriad ways. That being said, it is not a panacea, so additional measures (masking, vaccinations, etc.) are important for everyone,” he said.

Also weighing in, Joseph Herrera, DO, chair of the department of rehabilitation for Mount Sinai Health System, New York, said, “If you are physically fit, your body is more resilient and better prepared to handle the stressors of COVID or any other disease process.”

For now, however, the question of whether physical fitness is actually protective against COVID remains unclear. “I’m just not sure right now,” Dr. Herrera said in an interview.

He said he has treated athletes in professional sports – including the National Football League and Major League Baseball – and some of them have had long COVID and have not returned to play. “These are athletes at the peak of fitness and their career.”

Nonetheless, Dr. Herrera said a good public health message in general is to stay fit or get fit.

“That’s something I preach all the time,” he told this news organization.

Dr. García-Hermoso agreed. “In contrast to the vast majority of drugs, exercise is free of adverse effects. It’s time to consider exercise as medicine. It’s never too late to start being physically active.”

The study had no specific funding. Dr. García-Hermoso, Dr. Heffron, and Dr. Herrera have reported no relevant financial relationships.

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

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Monkeypox virus found in asymptomatic people

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Researchers in France have discovered monkeypox virus in anal samples of men with no symptoms of the disease, advancing the possibility that asymptomatic carriers may be hidden drivers of the global outbreak.

The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.

It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”

In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”

Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.

That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
 

Research methods

For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.

During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.

The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.

In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.

At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
 

Clinical implications of findings are uncertain

Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.

Dr. Monica Gandhi

Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”

Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.

She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”

However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
 

 

 

Non-vaccine interventions are also needed

Other experts stressed the need for nonvaccine interventions.

In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.

Dr. Aileen Marty

Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.

Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”

Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”

Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.

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Researchers in France have discovered monkeypox virus in anal samples of men with no symptoms of the disease, advancing the possibility that asymptomatic carriers may be hidden drivers of the global outbreak.

The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.

It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”

In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”

Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.

That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
 

Research methods

For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.

During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.

The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.

In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.

At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
 

Clinical implications of findings are uncertain

Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.

Dr. Monica Gandhi

Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”

Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.

She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”

However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
 

 

 

Non-vaccine interventions are also needed

Other experts stressed the need for nonvaccine interventions.

In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.

Dr. Aileen Marty

Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.

Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”

Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”

Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.

Researchers in France have discovered monkeypox virus in anal samples of men with no symptoms of the disease, advancing the possibility that asymptomatic carriers may be hidden drivers of the global outbreak.

The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.

It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”

In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”

Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.

That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
 

Research methods

For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.

During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.

The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.

In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.

At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
 

Clinical implications of findings are uncertain

Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.

Dr. Monica Gandhi

Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”

Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.

She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”

However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
 

 

 

Non-vaccine interventions are also needed

Other experts stressed the need for nonvaccine interventions.

In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.

Dr. Aileen Marty

Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.

Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”

Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”

Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.

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