A new federal rule opens the door for physicians in California and Texas to take advantage of student loan forgiveness, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.

Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.

But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.

Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.

Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.

The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.

The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.

Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.

Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.

With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.

California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.

Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.

A version of this article appeared on Medscape.com.

A new federal rule opens the door for physicians in California and Texas to take advantage of student loan forgiveness, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.

Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.

But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.

Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.

Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.

The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.

The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.

Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.

Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.

With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.

California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.

Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.

A version of this article appeared on Medscape.com.

A new federal rule opens the door for physicians in California and Texas to take advantage of student loan forgiveness, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.

Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.

But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.

Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.

Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.

The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.

The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.

Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.

Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.

With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.

California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.

Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.

A version of this article appeared on Medscape.com.

A recent Reuters article reported that the manufacturer of the leading antiobesity medication semaglutide (Wegovy) “showers money on U.S. obesity doctors.”

Hello. I’d like to be showered.

According to the article, Novo Nordisk, Wegovy/Ozempic manufacturer, paid medical professionals $25.8 million in “fees and expenses” over a decade.

I think all doctors — who spend a decade of their life in training only to emerge with thousands of dollars in debt — would like to be similarly compensated for their expertise.

Yet, many of us forgo lucrative private practices or industry jobs to work at academic medical centers because we wish to pursue our original mission: To provide the best patient care possible.

Fulfilling this mission in today’s “sickcare” system means being more than a clinician. We become researchers, educators, advocates, mentors, consultants, and advisors. We do so because the system compels us to find other ways to provide quality health care, outside of clinic walls. These ways often include:

• Educating the public through media, social media, or community events.
• Training students, residents, and fellows on the latest medical knowledge.
• Advising industry innovators and entrepreneurs who seek our expertise.

Personally, I engaged in these activities because working 8-5 seeing 20 patients a day wasn’t enough. I wanted to help more people, more quickly. When I was faced with these opportunities, I was excited to say “yes” and never thought to ask for compensation because I didn’t want to seem ungrateful.

Eventually, I learned to ask for compensation.

And then I learned to decide my value.

The Reuters article reports that obesity medicine experts Drs. Lee Kaplan, Donna Ryan, Ania Jastreboff, and Jamy Ard were paid thousands of dollars in consulting fees over a decade. This industry-to-physician relationship should be celebrated because:

• Industries should consult experts in the field.
• These leaders have dedicated decades of their lives to understanding and solving the obesity epidemic.
• This collaboration has resulted in a therapeutic option that is changing lives. 

If there is anything to criticize, it should be:

• The expectation that medical expertise should be free.Wegovy’s manufacturer is worth $403 billion, and the experts are valued at less than 0.1% of that figure.
• The lack of context.
• Some celebrity doctors can earn $300,000 in just one consult. Other medical or surgical specialties are valued at 100 times more than obesity specialists. 
• The false dichotomy.
• Just because money is involved, it doesn’t mean the product is invalid.

Industry and physician relationships have long been examined. Such financial relationships are always disclosed (eg, at conferences, in publications). The Sunshine Act of 2010 and Open Payments provide the necessary transparency for people to decide for themselves whether there were financial incentives or potential conflicts of interest.

We should also take it a step further and ask ourselves: Do conflicts of interest require us to dismiss the end result? In other words, just because the pharmaceutical industry pays these doctors for their time and expertise, does that mean their life’s work is wrong, or that the drug isn’t effective?

In the case of obesity, Wegovy speaks for itself. Remember that the manufacturer stopped advertising. When a disease finally has a treatment, it does not need promoters or salespersons. Just speak to any person with obesity.

Ultimately, I see three main takeaways from Reuters’ reporting:

• The weight loss industry needs more obesity medicine experts. 
• We should value ourselves more.
• When people with resources work with people who have the commitment, knowledge, and experience, we can find a solution that saves lives. 

Dr. Tchang received $5525 in 2022 in consulting fees from Novo Nordisk. She plans to ask for more. She also disclosed ties with Gelesis.

A version of this article appeared on Medscape.com.

A recent Reuters article reported that the manufacturer of the leading antiobesity medication semaglutide (Wegovy) “showers money on U.S. obesity doctors.”

Hello. I’d like to be showered.

According to the article, Novo Nordisk, Wegovy/Ozempic manufacturer, paid medical professionals $25.8 million in “fees and expenses” over a decade.

I think all doctors — who spend a decade of their life in training only to emerge with thousands of dollars in debt — would like to be similarly compensated for their expertise.

Yet, many of us forgo lucrative private practices or industry jobs to work at academic medical centers because we wish to pursue our original mission: To provide the best patient care possible.

Fulfilling this mission in today’s “sickcare” system means being more than a clinician. We become researchers, educators, advocates, mentors, consultants, and advisors. We do so because the system compels us to find other ways to provide quality health care, outside of clinic walls. These ways often include:

• Educating the public through media, social media, or community events.
• Training students, residents, and fellows on the latest medical knowledge.
• Advising industry innovators and entrepreneurs who seek our expertise.

Personally, I engaged in these activities because working 8-5 seeing 20 patients a day wasn’t enough. I wanted to help more people, more quickly. When I was faced with these opportunities, I was excited to say “yes” and never thought to ask for compensation because I didn’t want to seem ungrateful.

Eventually, I learned to ask for compensation.

And then I learned to decide my value.

The Reuters article reports that obesity medicine experts Drs. Lee Kaplan, Donna Ryan, Ania Jastreboff, and Jamy Ard were paid thousands of dollars in consulting fees over a decade. This industry-to-physician relationship should be celebrated because:

• Industries should consult experts in the field.
• These leaders have dedicated decades of their lives to understanding and solving the obesity epidemic.
• This collaboration has resulted in a therapeutic option that is changing lives. 

If there is anything to criticize, it should be:

• The expectation that medical expertise should be free.Wegovy’s manufacturer is worth $403 billion, and the experts are valued at less than 0.1% of that figure.
• The lack of context.
• Some celebrity doctors can earn $300,000 in just one consult. Other medical or surgical specialties are valued at 100 times more than obesity specialists. 
• The false dichotomy.
• Just because money is involved, it doesn’t mean the product is invalid.

Industry and physician relationships have long been examined. Such financial relationships are always disclosed (eg, at conferences, in publications). The Sunshine Act of 2010 and Open Payments provide the necessary transparency for people to decide for themselves whether there were financial incentives or potential conflicts of interest.

We should also take it a step further and ask ourselves: Do conflicts of interest require us to dismiss the end result? In other words, just because the pharmaceutical industry pays these doctors for their time and expertise, does that mean their life’s work is wrong, or that the drug isn’t effective?

In the case of obesity, Wegovy speaks for itself. Remember that the manufacturer stopped advertising. When a disease finally has a treatment, it does not need promoters or salespersons. Just speak to any person with obesity.

Ultimately, I see three main takeaways from Reuters’ reporting:

• The weight loss industry needs more obesity medicine experts. 
• We should value ourselves more.
• When people with resources work with people who have the commitment, knowledge, and experience, we can find a solution that saves lives. 

Dr. Tchang received $5525 in 2022 in consulting fees from Novo Nordisk. She plans to ask for more. She also disclosed ties with Gelesis.

A version of this article appeared on Medscape.com.

A recent Reuters article reported that the manufacturer of the leading antiobesity medication semaglutide (Wegovy) “showers money on U.S. obesity doctors.”

Hello. I’d like to be showered.

According to the article, Novo Nordisk, Wegovy/Ozempic manufacturer, paid medical professionals $25.8 million in “fees and expenses” over a decade.

I think all doctors — who spend a decade of their life in training only to emerge with thousands of dollars in debt — would like to be similarly compensated for their expertise.

Yet, many of us forgo lucrative private practices or industry jobs to work at academic medical centers because we wish to pursue our original mission: To provide the best patient care possible.

Fulfilling this mission in today’s “sickcare” system means being more than a clinician. We become researchers, educators, advocates, mentors, consultants, and advisors. We do so because the system compels us to find other ways to provide quality health care, outside of clinic walls. These ways often include:

• Educating the public through media, social media, or community events.
• Training students, residents, and fellows on the latest medical knowledge.
• Advising industry innovators and entrepreneurs who seek our expertise.

Personally, I engaged in these activities because working 8-5 seeing 20 patients a day wasn’t enough. I wanted to help more people, more quickly. When I was faced with these opportunities, I was excited to say “yes” and never thought to ask for compensation because I didn’t want to seem ungrateful.

Eventually, I learned to ask for compensation.

And then I learned to decide my value.

The Reuters article reports that obesity medicine experts Drs. Lee Kaplan, Donna Ryan, Ania Jastreboff, and Jamy Ard were paid thousands of dollars in consulting fees over a decade. This industry-to-physician relationship should be celebrated because:

• Industries should consult experts in the field.
• These leaders have dedicated decades of their lives to understanding and solving the obesity epidemic.
• This collaboration has resulted in a therapeutic option that is changing lives. 

If there is anything to criticize, it should be:

• The expectation that medical expertise should be free.Wegovy’s manufacturer is worth $403 billion, and the experts are valued at less than 0.1% of that figure.
• The lack of context.
• Some celebrity doctors can earn $300,000 in just one consult. Other medical or surgical specialties are valued at 100 times more than obesity specialists. 
• The false dichotomy.
• Just because money is involved, it doesn’t mean the product is invalid.

Industry and physician relationships have long been examined. Such financial relationships are always disclosed (eg, at conferences, in publications). The Sunshine Act of 2010 and Open Payments provide the necessary transparency for people to decide for themselves whether there were financial incentives or potential conflicts of interest.

We should also take it a step further and ask ourselves: Do conflicts of interest require us to dismiss the end result? In other words, just because the pharmaceutical industry pays these doctors for their time and expertise, does that mean their life’s work is wrong, or that the drug isn’t effective?

In the case of obesity, Wegovy speaks for itself. Remember that the manufacturer stopped advertising. When a disease finally has a treatment, it does not need promoters or salespersons. Just speak to any person with obesity.

Ultimately, I see three main takeaways from Reuters’ reporting:

• The weight loss industry needs more obesity medicine experts. 
• We should value ourselves more.
• When people with resources work with people who have the commitment, knowledge, and experience, we can find a solution that saves lives. 

Dr. Tchang received $5525 in 2022 in consulting fees from Novo Nordisk. She plans to ask for more. She also disclosed ties with Gelesis.

A version of this article appeared on Medscape.com.

A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA). 

However, “this recall is a correction, not a product removal,” according to the FDA. Clinicians do not need to cease using these devices, but they must be mindful of the risks and take the precautions outlined by Olympus.

“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.

The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion. 

On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows: 

“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.” 

To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three: 

• Do not perform high-frequency cauterization while supplying oxygen.
• Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
• Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.

The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
 

Olympus Explains

“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview. 

“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.” 

The products are not being removed, and no labeling changes are being made at this time, she said. 

The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.

“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.

In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws. 

United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.

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

A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA). 

However, “this recall is a correction, not a product removal,” according to the FDA. Clinicians do not need to cease using these devices, but they must be mindful of the risks and take the precautions outlined by Olympus.

“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.

The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion. 

On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows: 

“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.” 

To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three: 

• Do not perform high-frequency cauterization while supplying oxygen.
• Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
• Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.

The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
 

Olympus Explains

“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview. 

“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.” 

The products are not being removed, and no labeling changes are being made at this time, she said. 

The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.

“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.

In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws. 

United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.

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

A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA). 

However, “this recall is a correction, not a product removal,” according to the FDA. Clinicians do not need to cease using these devices, but they must be mindful of the risks and take the precautions outlined by Olympus.

“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.

The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion. 

On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows: 

“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.” 

To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three: 

• Do not perform high-frequency cauterization while supplying oxygen.
• Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
• Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.

The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
 

Olympus Explains

“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview. 

“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.” 

The products are not being removed, and no labeling changes are being made at this time, she said. 

The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.

“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.

In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws. 

United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.

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

This transcript has been edited for clarity.

Sandra Fryhofer, MD, highlights updates in the 2024 Advisory Committee on Immunization Practices (ACIP) Adult Immunization Schedule.

The biggest change for 2024 is that you don’t need to wait till January 1, 2024, for these schedules go into effect. Both schedules were published and became available in November 2023 and became effective immediately. They include ACIP recommendations approved by the Centers for Disease Control and Prevention (CDC) director through October 23, 2023.

Subsequent recommendations (before publication of the 2025 schedule) will be added to the addendum, a new Step 5, Section 5 in the schedule. The addendum should make Affordable Care Act (ACA)–compliant insurance plans cover ACIP-recommended immunizations sooner.

This year’s schedule includes more vaccines with new recommendations and new color code keys for the schedule’s vaccine tables. The newest vaccine additions to the 2024 schedule include respiratory syncytial virus (RSV) vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of the updated COVID vaccine (both mRNA and protein-based adjuvanted versions).

These are listed on the cover page (in alphabetical order) by name, abbreviation, and trade name. Vaccine-specific details can be found in the (Step 3) Notes section, also organized alphabetically.
 

The Tables

Step 1 is Table 1: Vaccinations by Age. Step 2 is Table 2: Vaccinations by Medical Conditions or Other Indications. The table names haven’t changed. However, their color code legends have been adjusted and refined. Also, the legends for the some of the same colors are not the same for both tables.

The order of and conditions covered in the columns on Table 2 have been reorganized.

Even for vaccines whose recommendations have not changed, the color code keys reflecting the recommendations have changed. For this reason, the 2024 version of Table 2 looks very different from the 2023 version. Also, much of the wording on overlays has been removed, which means you have to rely more heavily on the Notes section.

The color brown has been introduced on Table 2 to spotlight groups and conditions that require recurrent revaccination:

• Give Tdap in each and every pregnancy at 27-36 weeks.
• Revaccinate people living with HIV with MenACWY every 5 years.
• Revaccinate those with asplenia and/or complement deficiency with MenACWY every 5 years and MenB every 2-3 years.
• Stem cell transplant recipients need three doses of Hib.

Vaccine order is the same on both tables.

The rows for 2023-2024 formulations of COVID and flu vaccines are at the top of both tables are coded yellow, meaning everyone needs a dose of both vaccines.

Both tables have added a row for RSV vaccines and mpox vaccines.
 

Notes Section

The notes have been edited for clarity and reveal who needs what and when and include special vaccine-specific sections for special circumstances.

COVID vaccines. The COVID vaccine note embraces the updated 2023-2024 formula. Everyone aged 6 months or older needs a dose of the updated COVID vaccine. Specifics of who needs what (and when) depend on what they have already received, as well as their immune status. Detailed recommendations for both mRNA and protein-based adjuvanted versions are included in the notes.

RSV vaccines. The notes also give vital details about RSV vaccines for pregnant people and for older adults. There are two RSV vaccines. Both are preF RSV vaccines. They’re identified by trade names for clarity. Arexvy contains an adjuvant. Abrysvo does not contain an adjuvant. The RSV vaccine note explains that only Abyrsvo (the vaccine without the adjuvant) can be given to pregnant people, only at 32-36 weeks, and only to those whose baby would be born during RSV season.

ACIP recommends a dose of either vaccine for adults aged 60 or older, under shared clinical decision-making (meaning you and your patients have to discuss and decide). The notes link to additional guidance for making that decision.

Mpox vaccines. For the mpox vaccine, all adults in any age group at increased risk of getting mpox should get a two-dose series of the vaccine. The mpox vaccine notes include a list of mpox risk factors.
 

Other Features of the 2024 Adult Immunization Schedule

The schedule has useful links to helpful information:

• Vaccine information statements
• Complete ACIP recommendations
• CDC’s General Best Practice Guidelines for Immunizations.
• VAERS (CDC’s Vaccine Adverse Event Reporting System)

A new “Additional Information” section in the Notes links to:

• Travel vaccination requirements
• Best practices guidelines for vaccinating persons with immunodeficiency
• The National Vaccine Injury Compensation program (for resolving any vaccine injury claims)

The cover page has links to:

• CDC’s vaccine app
• QR code to access the schedule online.

With all these tools literally at your fingertips, there’s no reason not to know which vaccines your patients need and when. The challenge now is making it happen: getting those needed vaccines into arms.

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

This transcript has been edited for clarity.

Sandra Fryhofer, MD, highlights updates in the 2024 Advisory Committee on Immunization Practices (ACIP) Adult Immunization Schedule.

The biggest change for 2024 is that you don’t need to wait till January 1, 2024, for these schedules go into effect. Both schedules were published and became available in November 2023 and became effective immediately. They include ACIP recommendations approved by the Centers for Disease Control and Prevention (CDC) director through October 23, 2023.

Subsequent recommendations (before publication of the 2025 schedule) will be added to the addendum, a new Step 5, Section 5 in the schedule. The addendum should make Affordable Care Act (ACA)–compliant insurance plans cover ACIP-recommended immunizations sooner.

This year’s schedule includes more vaccines with new recommendations and new color code keys for the schedule’s vaccine tables. The newest vaccine additions to the 2024 schedule include respiratory syncytial virus (RSV) vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of the updated COVID vaccine (both mRNA and protein-based adjuvanted versions).

These are listed on the cover page (in alphabetical order) by name, abbreviation, and trade name. Vaccine-specific details can be found in the (Step 3) Notes section, also organized alphabetically.
 

The Tables

Step 1 is Table 1: Vaccinations by Age. Step 2 is Table 2: Vaccinations by Medical Conditions or Other Indications. The table names haven’t changed. However, their color code legends have been adjusted and refined. Also, the legends for the some of the same colors are not the same for both tables.

The order of and conditions covered in the columns on Table 2 have been reorganized.

Even for vaccines whose recommendations have not changed, the color code keys reflecting the recommendations have changed. For this reason, the 2024 version of Table 2 looks very different from the 2023 version. Also, much of the wording on overlays has been removed, which means you have to rely more heavily on the Notes section.

The color brown has been introduced on Table 2 to spotlight groups and conditions that require recurrent revaccination:

• Give Tdap in each and every pregnancy at 27-36 weeks.
• Revaccinate people living with HIV with MenACWY every 5 years.
• Revaccinate those with asplenia and/or complement deficiency with MenACWY every 5 years and MenB every 2-3 years.
• Stem cell transplant recipients need three doses of Hib.

Vaccine order is the same on both tables.

The rows for 2023-2024 formulations of COVID and flu vaccines are at the top of both tables are coded yellow, meaning everyone needs a dose of both vaccines.

Both tables have added a row for RSV vaccines and mpox vaccines.
 

Notes Section

The notes have been edited for clarity and reveal who needs what and when and include special vaccine-specific sections for special circumstances.

COVID vaccines. The COVID vaccine note embraces the updated 2023-2024 formula. Everyone aged 6 months or older needs a dose of the updated COVID vaccine. Specifics of who needs what (and when) depend on what they have already received, as well as their immune status. Detailed recommendations for both mRNA and protein-based adjuvanted versions are included in the notes.

RSV vaccines. The notes also give vital details about RSV vaccines for pregnant people and for older adults. There are two RSV vaccines. Both are preF RSV vaccines. They’re identified by trade names for clarity. Arexvy contains an adjuvant. Abrysvo does not contain an adjuvant. The RSV vaccine note explains that only Abyrsvo (the vaccine without the adjuvant) can be given to pregnant people, only at 32-36 weeks, and only to those whose baby would be born during RSV season.

ACIP recommends a dose of either vaccine for adults aged 60 or older, under shared clinical decision-making (meaning you and your patients have to discuss and decide). The notes link to additional guidance for making that decision.

Mpox vaccines. For the mpox vaccine, all adults in any age group at increased risk of getting mpox should get a two-dose series of the vaccine. The mpox vaccine notes include a list of mpox risk factors.
 

Other Features of the 2024 Adult Immunization Schedule

The schedule has useful links to helpful information:

• Vaccine information statements
• Complete ACIP recommendations
• CDC’s General Best Practice Guidelines for Immunizations.
• VAERS (CDC’s Vaccine Adverse Event Reporting System)

A new “Additional Information” section in the Notes links to:

• Travel vaccination requirements
• Best practices guidelines for vaccinating persons with immunodeficiency
• The National Vaccine Injury Compensation program (for resolving any vaccine injury claims)

The cover page has links to:

• CDC’s vaccine app
• QR code to access the schedule online.

With all these tools literally at your fingertips, there’s no reason not to know which vaccines your patients need and when. The challenge now is making it happen: getting those needed vaccines into arms.

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

This transcript has been edited for clarity.

Sandra Fryhofer, MD, highlights updates in the 2024 Advisory Committee on Immunization Practices (ACIP) Adult Immunization Schedule.

The biggest change for 2024 is that you don’t need to wait till January 1, 2024, for these schedules go into effect. Both schedules were published and became available in November 2023 and became effective immediately. They include ACIP recommendations approved by the Centers for Disease Control and Prevention (CDC) director through October 23, 2023.

Subsequent recommendations (before publication of the 2025 schedule) will be added to the addendum, a new Step 5, Section 5 in the schedule. The addendum should make Affordable Care Act (ACA)–compliant insurance plans cover ACIP-recommended immunizations sooner.

This year’s schedule includes more vaccines with new recommendations and new color code keys for the schedule’s vaccine tables. The newest vaccine additions to the 2024 schedule include respiratory syncytial virus (RSV) vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of the updated COVID vaccine (both mRNA and protein-based adjuvanted versions).

These are listed on the cover page (in alphabetical order) by name, abbreviation, and trade name. Vaccine-specific details can be found in the (Step 3) Notes section, also organized alphabetically.
 

The Tables

Step 1 is Table 1: Vaccinations by Age. Step 2 is Table 2: Vaccinations by Medical Conditions or Other Indications. The table names haven’t changed. However, their color code legends have been adjusted and refined. Also, the legends for the some of the same colors are not the same for both tables.

The order of and conditions covered in the columns on Table 2 have been reorganized.

Even for vaccines whose recommendations have not changed, the color code keys reflecting the recommendations have changed. For this reason, the 2024 version of Table 2 looks very different from the 2023 version. Also, much of the wording on overlays has been removed, which means you have to rely more heavily on the Notes section.

The color brown has been introduced on Table 2 to spotlight groups and conditions that require recurrent revaccination:

• Give Tdap in each and every pregnancy at 27-36 weeks.
• Revaccinate people living with HIV with MenACWY every 5 years.
• Revaccinate those with asplenia and/or complement deficiency with MenACWY every 5 years and MenB every 2-3 years.
• Stem cell transplant recipients need three doses of Hib.

Vaccine order is the same on both tables.

The rows for 2023-2024 formulations of COVID and flu vaccines are at the top of both tables are coded yellow, meaning everyone needs a dose of both vaccines.

Both tables have added a row for RSV vaccines and mpox vaccines.
 

Notes Section

The notes have been edited for clarity and reveal who needs what and when and include special vaccine-specific sections for special circumstances.

COVID vaccines. The COVID vaccine note embraces the updated 2023-2024 formula. Everyone aged 6 months or older needs a dose of the updated COVID vaccine. Specifics of who needs what (and when) depend on what they have already received, as well as their immune status. Detailed recommendations for both mRNA and protein-based adjuvanted versions are included in the notes.

RSV vaccines. The notes also give vital details about RSV vaccines for pregnant people and for older adults. There are two RSV vaccines. Both are preF RSV vaccines. They’re identified by trade names for clarity. Arexvy contains an adjuvant. Abrysvo does not contain an adjuvant. The RSV vaccine note explains that only Abyrsvo (the vaccine without the adjuvant) can be given to pregnant people, only at 32-36 weeks, and only to those whose baby would be born during RSV season.

ACIP recommends a dose of either vaccine for adults aged 60 or older, under shared clinical decision-making (meaning you and your patients have to discuss and decide). The notes link to additional guidance for making that decision.

Mpox vaccines. For the mpox vaccine, all adults in any age group at increased risk of getting mpox should get a two-dose series of the vaccine. The mpox vaccine notes include a list of mpox risk factors.
 

Other Features of the 2024 Adult Immunization Schedule

The schedule has useful links to helpful information:

• Vaccine information statements
• Complete ACIP recommendations
• CDC’s General Best Practice Guidelines for Immunizations.
• VAERS (CDC’s Vaccine Adverse Event Reporting System)

A new “Additional Information” section in the Notes links to:

• Travel vaccination requirements
• Best practices guidelines for vaccinating persons with immunodeficiency
• The National Vaccine Injury Compensation program (for resolving any vaccine injury claims)

The cover page has links to:

• CDC’s vaccine app
• QR code to access the schedule online.

With all these tools literally at your fingertips, there’s no reason not to know which vaccines your patients need and when. The challenge now is making it happen: getting those needed vaccines into arms.

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

Young women diagnosed with breast cancer have been shown to experience higher rates of symptoms that may adversely affect quality of life (QOL), including depression, weight gain, vasomotor symptoms, and sexual dysfunction; they may also have a harder time managing these issues.³ Chemotherapy-related amenorrhea (CRA) is one of the side effects of breast cancer treatment that can affect premenopausal women, and is associated with both patient- (age, body mass index) and treatment-related (regimen, duration) factors.⁴ A study analyzing data derived from the prospective, longitudinal Cancer Toxicities Study included 1636 premenopausal women ≤ 50 years of age with stage I-III breast cancer treated with chemotherapy but not receiving ovarian suppression (Kabirian et al). A total of 83.0% of women reported CRA at year 1, 72.5% at year 2, and 66.1% at year 4. A higher likelihood of CRA was observed for women of older age vs those age 18-34 years (adjusted odds ratio [aOR] for 35-39 years 1.84; 40-44 years 5.90; and ≥ 45 years 21.29; P < .001 for all), those who received adjuvant tamoxifen (aOR 1.97; P < .001), and those who had hot flashes at baseline (aOR 1.83; P = .01). In the QOL analysis, 57.1% reported no recovery of menses. Persistent CRA was associated with worse insomnia, more systemic therapy–related adverse effects, and worse sexual functioning. These findings highlight the importance of identifying and discussing CRA with our patients, as this can have both physical and psychological effects in the survivorship setting.

The phase 3 KEYNOTE-522 trial has established immunotherapy plus an anthracycline-based chemotherapy backbone for the treatment of stage II-III triple-negative breast cancer (TNBC), with improvements in pathologic complete response (pCR) rates and survival outcomes.⁵ This regimen can present tolerance issues in clinical practice, and rare risks for cardiotoxicity and secondary hematologic malignancies are also relevant to consider. Furthermore, some patients may not be candidates for anthracycline-based treatment due to prior receipt of a drug in this class or cardiac comorbidities. De-escalation strategies are desired to lessen toxicity and maintain (or improve) outcomes. An open-label phase 2 trial (NeoPACT) investigated the efficacy of neoadjuvant carboplatin (AUC 6), docetaxel (75 mg/m²), and pembrolizumab (200 mg) every 21 days for six cycles among 115 patients with stage I-III TNBC (Sharma et al). The overall pCR and residual cancer burden (RCB 0+1) rates were 58% (95% CI 48%-67%) and 69% (95% CI 60%-78%), respectively. Estimated 3-year event-free survival was 86% (95% CI 77%-95%) in all patients, 98% in those with a pCR, and 68% in those with residual disease. This study also demonstrated a positive association of immune biomarkers and pathologic response. The most common grade ≥ 3 treatment-related adverse events were diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%). The phase 3 SCARLET (Shorter Anthracycline-Free Chemoimmunotherapy Adapted to Pathologic Response in Early TNBC) trial is comparing the NeoPACT regimen with the standard KEYNOTE-522 regimen in early-stage TNBC and will be critical to further defining this treatment space.⁶ Presently, considering the described efficacy outcomes with the NeoPACT regimen, this regimen would be very reasonable to consider in patients who are not candidates for an anthracycline. Future prospective evaluation of immune biomarkers and additional predictors of response will also be valuable to further individualize treatment for our patients.

Additional References

1. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
2. Partridge AH, Niman SM, Ruggeri M, et al, for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
3. Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: A systematic review. J Natl Cancer Inst. 2012;104:386-405. doi: 10.1093/jnci/djr541
4. Turnbull AK, Patel S, Martinez-Perez C, et al. Risk of chemotherapy-related amenorrhoea (CRA) in premenopausal women undergoing chemotherapy for early stage breast cancer. Breast Cancer Res Treat. 2021;186:237-245. doi: 10.1007/s10549-020-05951-5
5. Schmid P, Cortes J, Dent R, et al; KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567. doi: 10.1056/NEJMoa2112651
6. US National Cancer Institute, Cancer Therapy Evaluation Program. Shorter anthracycline-free chemoimmunotherapy adapted to pathological response in early TNBC (SCARLET); SWOG S2212. Source

Young women diagnosed with breast cancer have been shown to experience higher rates of symptoms that may adversely affect quality of life (QOL), including depression, weight gain, vasomotor symptoms, and sexual dysfunction; they may also have a harder time managing these issues.³ Chemotherapy-related amenorrhea (CRA) is one of the side effects of breast cancer treatment that can affect premenopausal women, and is associated with both patient- (age, body mass index) and treatment-related (regimen, duration) factors.⁴ A study analyzing data derived from the prospective, longitudinal Cancer Toxicities Study included 1636 premenopausal women ≤ 50 years of age with stage I-III breast cancer treated with chemotherapy but not receiving ovarian suppression (Kabirian et al). A total of 83.0% of women reported CRA at year 1, 72.5% at year 2, and 66.1% at year 4. A higher likelihood of CRA was observed for women of older age vs those age 18-34 years (adjusted odds ratio [aOR] for 35-39 years 1.84; 40-44 years 5.90; and ≥ 45 years 21.29; P < .001 for all), those who received adjuvant tamoxifen (aOR 1.97; P < .001), and those who had hot flashes at baseline (aOR 1.83; P = .01). In the QOL analysis, 57.1% reported no recovery of menses. Persistent CRA was associated with worse insomnia, more systemic therapy–related adverse effects, and worse sexual functioning. These findings highlight the importance of identifying and discussing CRA with our patients, as this can have both physical and psychological effects in the survivorship setting.

The phase 3 KEYNOTE-522 trial has established immunotherapy plus an anthracycline-based chemotherapy backbone for the treatment of stage II-III triple-negative breast cancer (TNBC), with improvements in pathologic complete response (pCR) rates and survival outcomes.⁵ This regimen can present tolerance issues in clinical practice, and rare risks for cardiotoxicity and secondary hematologic malignancies are also relevant to consider. Furthermore, some patients may not be candidates for anthracycline-based treatment due to prior receipt of a drug in this class or cardiac comorbidities. De-escalation strategies are desired to lessen toxicity and maintain (or improve) outcomes. An open-label phase 2 trial (NeoPACT) investigated the efficacy of neoadjuvant carboplatin (AUC 6), docetaxel (75 mg/m²), and pembrolizumab (200 mg) every 21 days for six cycles among 115 patients with stage I-III TNBC (Sharma et al). The overall pCR and residual cancer burden (RCB 0+1) rates were 58% (95% CI 48%-67%) and 69% (95% CI 60%-78%), respectively. Estimated 3-year event-free survival was 86% (95% CI 77%-95%) in all patients, 98% in those with a pCR, and 68% in those with residual disease. This study also demonstrated a positive association of immune biomarkers and pathologic response. The most common grade ≥ 3 treatment-related adverse events were diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%). The phase 3 SCARLET (Shorter Anthracycline-Free Chemoimmunotherapy Adapted to Pathologic Response in Early TNBC) trial is comparing the NeoPACT regimen with the standard KEYNOTE-522 regimen in early-stage TNBC and will be critical to further defining this treatment space.⁶ Presently, considering the described efficacy outcomes with the NeoPACT regimen, this regimen would be very reasonable to consider in patients who are not candidates for an anthracycline. Future prospective evaluation of immune biomarkers and additional predictors of response will also be valuable to further individualize treatment for our patients.

Additional References

1. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
2. Partridge AH, Niman SM, Ruggeri M, et al, for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
3. Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: A systematic review. J Natl Cancer Inst. 2012;104:386-405. doi: 10.1093/jnci/djr541
4. Turnbull AK, Patel S, Martinez-Perez C, et al. Risk of chemotherapy-related amenorrhoea (CRA) in premenopausal women undergoing chemotherapy for early stage breast cancer. Breast Cancer Res Treat. 2021;186:237-245. doi: 10.1007/s10549-020-05951-5
5. Schmid P, Cortes J, Dent R, et al; KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567. doi: 10.1056/NEJMoa2112651
6. US National Cancer Institute, Cancer Therapy Evaluation Program. Shorter anthracycline-free chemoimmunotherapy adapted to pathological response in early TNBC (SCARLET); SWOG S2212. Source

Young women diagnosed with breast cancer have been shown to experience higher rates of symptoms that may adversely affect quality of life (QOL), including depression, weight gain, vasomotor symptoms, and sexual dysfunction; they may also have a harder time managing these issues.³ Chemotherapy-related amenorrhea (CRA) is one of the side effects of breast cancer treatment that can affect premenopausal women, and is associated with both patient- (age, body mass index) and treatment-related (regimen, duration) factors.⁴ A study analyzing data derived from the prospective, longitudinal Cancer Toxicities Study included 1636 premenopausal women ≤ 50 years of age with stage I-III breast cancer treated with chemotherapy but not receiving ovarian suppression (Kabirian et al). A total of 83.0% of women reported CRA at year 1, 72.5% at year 2, and 66.1% at year 4. A higher likelihood of CRA was observed for women of older age vs those age 18-34 years (adjusted odds ratio [aOR] for 35-39 years 1.84; 40-44 years 5.90; and ≥ 45 years 21.29; P < .001 for all), those who received adjuvant tamoxifen (aOR 1.97; P < .001), and those who had hot flashes at baseline (aOR 1.83; P = .01). In the QOL analysis, 57.1% reported no recovery of menses. Persistent CRA was associated with worse insomnia, more systemic therapy–related adverse effects, and worse sexual functioning. These findings highlight the importance of identifying and discussing CRA with our patients, as this can have both physical and psychological effects in the survivorship setting.

The phase 3 KEYNOTE-522 trial has established immunotherapy plus an anthracycline-based chemotherapy backbone for the treatment of stage II-III triple-negative breast cancer (TNBC), with improvements in pathologic complete response (pCR) rates and survival outcomes.⁵ This regimen can present tolerance issues in clinical practice, and rare risks for cardiotoxicity and secondary hematologic malignancies are also relevant to consider. Furthermore, some patients may not be candidates for anthracycline-based treatment due to prior receipt of a drug in this class or cardiac comorbidities. De-escalation strategies are desired to lessen toxicity and maintain (or improve) outcomes. An open-label phase 2 trial (NeoPACT) investigated the efficacy of neoadjuvant carboplatin (AUC 6), docetaxel (75 mg/m²), and pembrolizumab (200 mg) every 21 days for six cycles among 115 patients with stage I-III TNBC (Sharma et al). The overall pCR and residual cancer burden (RCB 0+1) rates were 58% (95% CI 48%-67%) and 69% (95% CI 60%-78%), respectively. Estimated 3-year event-free survival was 86% (95% CI 77%-95%) in all patients, 98% in those with a pCR, and 68% in those with residual disease. This study also demonstrated a positive association of immune biomarkers and pathologic response. The most common grade ≥ 3 treatment-related adverse events were diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%). The phase 3 SCARLET (Shorter Anthracycline-Free Chemoimmunotherapy Adapted to Pathologic Response in Early TNBC) trial is comparing the NeoPACT regimen with the standard KEYNOTE-522 regimen in early-stage TNBC and will be critical to further defining this treatment space.⁶ Presently, considering the described efficacy outcomes with the NeoPACT regimen, this regimen would be very reasonable to consider in patients who are not candidates for an anthracycline. Future prospective evaluation of immune biomarkers and additional predictors of response will also be valuable to further individualize treatment for our patients.

Additional References

1. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
2. Partridge AH, Niman SM, Ruggeri M, et al, for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
3. Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: A systematic review. J Natl Cancer Inst. 2012;104:386-405. doi: 10.1093/jnci/djr541
4. Turnbull AK, Patel S, Martinez-Perez C, et al. Risk of chemotherapy-related amenorrhoea (CRA) in premenopausal women undergoing chemotherapy for early stage breast cancer. Breast Cancer Res Treat. 2021;186:237-245. doi: 10.1007/s10549-020-05951-5
5. Schmid P, Cortes J, Dent R, et al; KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567. doi: 10.1056/NEJMoa2112651
6. US National Cancer Institute, Cancer Therapy Evaluation Program. Shorter anthracycline-free chemoimmunotherapy adapted to pathological response in early TNBC (SCARLET); SWOG S2212. Source

Treatment of enthesitis can be challenging. Head-to-head clinical trials using clinical enthesitis indices have indicated that TNF inhibitors and IL-17 inhibitors have similar efficacy in treating enthesitis. However, clinically determined enthesitis may not be true inflammatory enthesitis. Ultrasonography-confirmed enthesitis probably reflects true enthesitis. Therefore, Elliot and colleagues conducted an observational study that compared the change in MAdrid Sonographic Enthesitis Index (MASEI) at 16 weeks of treatment with either TNF inhibitors or secukinumab. They observed that the mean reduction in MASEI that assesses both active and chronic entheseal disease was not significantly different with TNF inhibitors vs secukinumab treatment. However, TNF inhibitors were significantly more effective than secukinumab when only active entheseal lesions were considered. Thus, TNF inhibitors may be more effective for active enthesitis; randomized trials using ultrasonographic enthesitis indices comparing the two treatments are required.

Serum drug levels have previously been shown to be associated with response to bDMARD therapy, but use of drug-level measurement is not routine in rheumatology practice. Moreover, trough levels are emphasized and may not often be feasible to obtain. Curry and colleagues investigated the relationship between serum non-trough drug levels (SDL) and treatment response at 3 months in patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97). They demonstrated that patients with higher etanercept SDL or higher adalimumab SDL were significantly more likely to be responders. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and nonresponders with ~50% specificity and > 60% sensitivity. However, the area under the receiver operating characteristic curves were only about 65%; thus, the ability of SDL to discriminate between responders and nonresponders is low.

Treatment of enthesitis can be challenging. Head-to-head clinical trials using clinical enthesitis indices have indicated that TNF inhibitors and IL-17 inhibitors have similar efficacy in treating enthesitis. However, clinically determined enthesitis may not be true inflammatory enthesitis. Ultrasonography-confirmed enthesitis probably reflects true enthesitis. Therefore, Elliot and colleagues conducted an observational study that compared the change in MAdrid Sonographic Enthesitis Index (MASEI) at 16 weeks of treatment with either TNF inhibitors or secukinumab. They observed that the mean reduction in MASEI that assesses both active and chronic entheseal disease was not significantly different with TNF inhibitors vs secukinumab treatment. However, TNF inhibitors were significantly more effective than secukinumab when only active entheseal lesions were considered. Thus, TNF inhibitors may be more effective for active enthesitis; randomized trials using ultrasonographic enthesitis indices comparing the two treatments are required.

Serum drug levels have previously been shown to be associated with response to bDMARD therapy, but use of drug-level measurement is not routine in rheumatology practice. Moreover, trough levels are emphasized and may not often be feasible to obtain. Curry and colleagues investigated the relationship between serum non-trough drug levels (SDL) and treatment response at 3 months in patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97). They demonstrated that patients with higher etanercept SDL or higher adalimumab SDL were significantly more likely to be responders. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and nonresponders with ~50% specificity and > 60% sensitivity. However, the area under the receiver operating characteristic curves were only about 65%; thus, the ability of SDL to discriminate between responders and nonresponders is low.

Treatment of enthesitis can be challenging. Head-to-head clinical trials using clinical enthesitis indices have indicated that TNF inhibitors and IL-17 inhibitors have similar efficacy in treating enthesitis. However, clinically determined enthesitis may not be true inflammatory enthesitis. Ultrasonography-confirmed enthesitis probably reflects true enthesitis. Therefore, Elliot and colleagues conducted an observational study that compared the change in MAdrid Sonographic Enthesitis Index (MASEI) at 16 weeks of treatment with either TNF inhibitors or secukinumab. They observed that the mean reduction in MASEI that assesses both active and chronic entheseal disease was not significantly different with TNF inhibitors vs secukinumab treatment. However, TNF inhibitors were significantly more effective than secukinumab when only active entheseal lesions were considered. Thus, TNF inhibitors may be more effective for active enthesitis; randomized trials using ultrasonographic enthesitis indices comparing the two treatments are required.

Serum drug levels have previously been shown to be associated with response to bDMARD therapy, but use of drug-level measurement is not routine in rheumatology practice. Moreover, trough levels are emphasized and may not often be feasible to obtain. Curry and colleagues investigated the relationship between serum non-trough drug levels (SDL) and treatment response at 3 months in patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97). They demonstrated that patients with higher etanercept SDL or higher adalimumab SDL were significantly more likely to be responders. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and nonresponders with ~50% specificity and > 60% sensitivity. However, the area under the receiver operating characteristic curves were only about 65%; thus, the ability of SDL to discriminate between responders and nonresponders is low.

The COVID-19 pandemic may no longer be a global public health emergency, but millions continue to struggle with the aftermath: Long COVID. New research and clinical anecdotes suggest that certain individuals are more likely to be afflicted by the condition, nearly 4 years after the virus emerged. 

People with a history of allergies, anxiety or depression, arthritis, and autoimmune diseases and women are among those who appear more vulnerable to developing long COVID, said doctors who specialize in treating the condition.

Many patients with long COVID struggle with debilitating fatigue, brain fog, and cognitive impairment. The condition is also characterized by a catalog of other symptoms that may be difficult to recognize as long COVID, experts said. That’s especially true when patients may not mention seemingly unrelated information, such as underlying health conditions that might make them more vulnerable. This makes screening for certain conditions and investigating every symptom especially important. 

The severity of a patient’s initial infection is not the only determining factor for developing long COVID, experts said.

“Don’t judge the person based on how sick they were initially,” said Mark Bayley, MD, medical director of the Toronto Rehabilitation Institute at University Health Network and a professor with the Temerty Faculty of Medicine at the University of Toronto. “You have to evaluate every symptom as best you can to make sure you’re not missing anything else.” 

Someone who only had a bad cough or felt really unwell for just a few days and recovered but started feeling rotten again later — “that’s the person that we are seeing for long COVID,” said Dr. Bayley. 

While patients who become severely sick and require hospitalization have a higher risk of developing long COVID, this group size is small compared with the much larger number of people infected overall. As a result, despite the lower risk, those who only become mild to moderately sick make up the vast majority of patients in long COVID clinics. 

A small Northwestern Medicine study found that 41% of patients with long COVID never tested positive for COVID-19 but were found to have antibodies that indicated exposure to the virus. 

Doctors treating patients with long COVID should consider several risk factors, specialists said. They include:

• A history of asthma, eczema, or allergies
• Signs of autonomic nervous system dysfunction
• Preexisting immune system issues
• Chronic infections
• Diabetes
• Being slightly overweight
• A preexisting history of anxiety or depression
• Joint hypermobility ( being “double-jointed” with pain and other symptoms)

Screening for Allergies

Alba Azola, MD, assistant professor of Physical Medicine and Rehabilitation at Johns Hopkins Medicine, said a history of asthma, allergies, and eczema and an onset of new food allergies may be an important factor in long COVID that doctors should consider when evaluating at-risk patients.

It is important to identify this subgroup of patients because they respond to antihistamines and mast cell stabilizers, which not only relieve their allergy symptoms but may also help improve overall fatigue and their tolerance for basic activities like standing, Dr. Azola said.

A recently published systemic review of prospective cohort studies on long COVID also found that patients with preexisting allergic conditions like asthma or rhinitis may be linked to a higher risk of developing long COVID. The authors cautioned, however, that the evidence for the link is uncertain and more rigorous research is needed.

“It stands to reason that if your immune system tends to be a bit hyperactive that triggering it with a virus will make it worse,” said Dr. Bayley.


 

Signs of Dysautonomia, Joint Hypermobility

Patients should also be screened for signs and symptoms of dysautonomia, or autonomic nervous system disorder, such as postural orthostatic tachycardia syndrome (POTS) or another type of autonomic dysfunction, doctors said.

“There’s a whole list because the autonomic nervous system involves every part of your body, every system,” Dr. Azola said.

Issues with standing, vision, digestion, urination, and bowel movement, for example, appear to be multisystemic problems but may all be linked to autonomic dysfunction, she explained.

Patients who have POTS usually experience a worsening of symptoms after COVID infection, Dr. Azola said, adding that some patients may have even assumed their pre-COVID symptoms of POTS were normal. 

She also screens for joint hypermobility or hypermobile Ehlers-Danlos syndrome, which affects connective tissue. Research has long shown a relationship between autonomic dysfunction, mast cell activation syndrome (repeated severe allergy symptoms that affect multiple systems), and the presence of hypermobility, Dr. Azola said. She added that gentle physical therapy can be helpful for patients with hypermobility issues.

Previous studies before and during the pandemic have also found that a substantial subset of patients with myalgic encephalomyelitis/chronic fatigue syndrome, which shares many similarities with long COVID, also have connective tissue/hypermobility disorders.
 

Depression, Anxiety, and Female Patients

People with a preexisting history of anxiety or depression also appear to be at a higher risk for long COVID, Dr. Bayley said, noting that patients with these conditions appear more vulnerable to brain fog and other difficulties brought on by COVID infection. Earlier research found biochemical evidence of brain inflammation that correlates with symptoms of anxiety in patients with long COVID.

“We know that depression is related to neurotransmitters like adrenaline and serotonin,” Dr. Bayley said. “The chronic inflammation that’s associated with COVID — this will make people feel more depressed because they’re not getting the neurotransmitters in their brain releasing at the right times.”

It may also put patients at a risk for anxiety due to fears of post-exertional malaise (PEM), where symptoms worsen after even very minor physical or mental exertion and can last days or weeks.

“You can see how that leads to a bit of a vicious cycle,” said Dr. Bayley, explaining that the cycle of fear and avoidance makes patients less active and deconditioned. But he added that learning to manage their activity can actually help mitigate PEM due to the anti-inflammatory effects of exercise, its positive impact on mood, and benefits to the immune and cardiovascular systems. 

Meanwhile, a number of epidemiologic studies have found a higher prevalence of long COVID among women. Perimenopausal and menopausal women in particular appeared more prone, and at least one study reported that women under 50 years were five times more likely to develop post-COVID symptoms than men.

A recent small UK study that focused on COVID-19 hospitalizations found that women who had lower levels of inflammatory biomarkers at admission were more likely to experience certain long-term symptoms like muscle ache, low mood and anxiety, adding to earlier research linking female patients, long COVID, and neuropsychiatric symptoms. 


 

History of Immune Dysfunction, Diabetes, Elevated Body Mass Index (BMI)

Immune dysfunction, a history of recurrent infections, or chronic sinus infections are also common among patients under Dr. Azola and her team’s care. Those who have arthritis or other autoimmune diseases such as lupus also appear more vulnerable, Dr. Bayley said, along with patients who have diabetes or a little overweight.

Recent research out of the University of Queensland found that being overweight can negatively affect the body’s immune response to the SARS-CoV-2 virus. Blood samples collected 13 months after infection, for example, found that individuals with a higher BMI had lower antibody activity and a reduced percentage of relevant B cells that help build antibodies to fight the virus. Being overweight did not affect the antibody response to the COVID-19 vaccines, however, giving further support for vaccination over infection-induced immunity as an important protective factor, researchers said.
 

Narrowing the Information Gap

The latest Centers for Centers for Disease Control and Prevention’s Household Pulse Survey estimates that 14% of all American adults have had long COVID at some point, with more than 5% of the entire adult population currently experiencing long COVID. With millions of Americans affected, experts and advocates highlight the importance of bridging the knowledge gap with primary care doctors. 

Long COVID specialists said understanding these connections helps guide treatment plans and manage symptoms, such as finding the right medications, improving tolerance, optimizing sleep, applying cognitive strategies for brain fog, dietary changes, respiratory exercises to help with shortness of breath, and finding the fine line between what causes PEM and what doesn’t. 

“Whenever you see a disease like this one, you always have to ask yourself, is there an alternative way of looking at this that might explain what we’re seeing?” said Dr. Bayley. “It remains to be said that all bets are still open and that we need to continue to be very broad thinking about this.”

A version of this article appeared on Medscape.com.

The COVID-19 pandemic may no longer be a global public health emergency, but millions continue to struggle with the aftermath: Long COVID. New research and clinical anecdotes suggest that certain individuals are more likely to be afflicted by the condition, nearly 4 years after the virus emerged. 

People with a history of allergies, anxiety or depression, arthritis, and autoimmune diseases and women are among those who appear more vulnerable to developing long COVID, said doctors who specialize in treating the condition.

Many patients with long COVID struggle with debilitating fatigue, brain fog, and cognitive impairment. The condition is also characterized by a catalog of other symptoms that may be difficult to recognize as long COVID, experts said. That’s especially true when patients may not mention seemingly unrelated information, such as underlying health conditions that might make them more vulnerable. This makes screening for certain conditions and investigating every symptom especially important. 

The severity of a patient’s initial infection is not the only determining factor for developing long COVID, experts said.

“Don’t judge the person based on how sick they were initially,” said Mark Bayley, MD, medical director of the Toronto Rehabilitation Institute at University Health Network and a professor with the Temerty Faculty of Medicine at the University of Toronto. “You have to evaluate every symptom as best you can to make sure you’re not missing anything else.” 

Someone who only had a bad cough or felt really unwell for just a few days and recovered but started feeling rotten again later — “that’s the person that we are seeing for long COVID,” said Dr. Bayley. 

While patients who become severely sick and require hospitalization have a higher risk of developing long COVID, this group size is small compared with the much larger number of people infected overall. As a result, despite the lower risk, those who only become mild to moderately sick make up the vast majority of patients in long COVID clinics. 

A small Northwestern Medicine study found that 41% of patients with long COVID never tested positive for COVID-19 but were found to have antibodies that indicated exposure to the virus. 

Doctors treating patients with long COVID should consider several risk factors, specialists said. They include:

• A history of asthma, eczema, or allergies
• Signs of autonomic nervous system dysfunction
• Preexisting immune system issues
• Chronic infections
• Diabetes
• Being slightly overweight
• A preexisting history of anxiety or depression
• Joint hypermobility ( being “double-jointed” with pain and other symptoms)

Screening for Allergies

Alba Azola, MD, assistant professor of Physical Medicine and Rehabilitation at Johns Hopkins Medicine, said a history of asthma, allergies, and eczema and an onset of new food allergies may be an important factor in long COVID that doctors should consider when evaluating at-risk patients.

It is important to identify this subgroup of patients because they respond to antihistamines and mast cell stabilizers, which not only relieve their allergy symptoms but may also help improve overall fatigue and their tolerance for basic activities like standing, Dr. Azola said.

A recently published systemic review of prospective cohort studies on long COVID also found that patients with preexisting allergic conditions like asthma or rhinitis may be linked to a higher risk of developing long COVID. The authors cautioned, however, that the evidence for the link is uncertain and more rigorous research is needed.

“It stands to reason that if your immune system tends to be a bit hyperactive that triggering it with a virus will make it worse,” said Dr. Bayley.


 

Signs of Dysautonomia, Joint Hypermobility

Patients should also be screened for signs and symptoms of dysautonomia, or autonomic nervous system disorder, such as postural orthostatic tachycardia syndrome (POTS) or another type of autonomic dysfunction, doctors said.

“There’s a whole list because the autonomic nervous system involves every part of your body, every system,” Dr. Azola said.

Issues with standing, vision, digestion, urination, and bowel movement, for example, appear to be multisystemic problems but may all be linked to autonomic dysfunction, she explained.

Patients who have POTS usually experience a worsening of symptoms after COVID infection, Dr. Azola said, adding that some patients may have even assumed their pre-COVID symptoms of POTS were normal. 

She also screens for joint hypermobility or hypermobile Ehlers-Danlos syndrome, which affects connective tissue. Research has long shown a relationship between autonomic dysfunction, mast cell activation syndrome (repeated severe allergy symptoms that affect multiple systems), and the presence of hypermobility, Dr. Azola said. She added that gentle physical therapy can be helpful for patients with hypermobility issues.

Previous studies before and during the pandemic have also found that a substantial subset of patients with myalgic encephalomyelitis/chronic fatigue syndrome, which shares many similarities with long COVID, also have connective tissue/hypermobility disorders.
 

Depression, Anxiety, and Female Patients

People with a preexisting history of anxiety or depression also appear to be at a higher risk for long COVID, Dr. Bayley said, noting that patients with these conditions appear more vulnerable to brain fog and other difficulties brought on by COVID infection. Earlier research found biochemical evidence of brain inflammation that correlates with symptoms of anxiety in patients with long COVID.

“We know that depression is related to neurotransmitters like adrenaline and serotonin,” Dr. Bayley said. “The chronic inflammation that’s associated with COVID — this will make people feel more depressed because they’re not getting the neurotransmitters in their brain releasing at the right times.”

It may also put patients at a risk for anxiety due to fears of post-exertional malaise (PEM), where symptoms worsen after even very minor physical or mental exertion and can last days or weeks.

“You can see how that leads to a bit of a vicious cycle,” said Dr. Bayley, explaining that the cycle of fear and avoidance makes patients less active and deconditioned. But he added that learning to manage their activity can actually help mitigate PEM due to the anti-inflammatory effects of exercise, its positive impact on mood, and benefits to the immune and cardiovascular systems. 

Meanwhile, a number of epidemiologic studies have found a higher prevalence of long COVID among women. Perimenopausal and menopausal women in particular appeared more prone, and at least one study reported that women under 50 years were five times more likely to develop post-COVID symptoms than men.

A recent small UK study that focused on COVID-19 hospitalizations found that women who had lower levels of inflammatory biomarkers at admission were more likely to experience certain long-term symptoms like muscle ache, low mood and anxiety, adding to earlier research linking female patients, long COVID, and neuropsychiatric symptoms. 


 

History of Immune Dysfunction, Diabetes, Elevated Body Mass Index (BMI)

Immune dysfunction, a history of recurrent infections, or chronic sinus infections are also common among patients under Dr. Azola and her team’s care. Those who have arthritis or other autoimmune diseases such as lupus also appear more vulnerable, Dr. Bayley said, along with patients who have diabetes or a little overweight.

Recent research out of the University of Queensland found that being overweight can negatively affect the body’s immune response to the SARS-CoV-2 virus. Blood samples collected 13 months after infection, for example, found that individuals with a higher BMI had lower antibody activity and a reduced percentage of relevant B cells that help build antibodies to fight the virus. Being overweight did not affect the antibody response to the COVID-19 vaccines, however, giving further support for vaccination over infection-induced immunity as an important protective factor, researchers said.
 

Narrowing the Information Gap

The latest Centers for Centers for Disease Control and Prevention’s Household Pulse Survey estimates that 14% of all American adults have had long COVID at some point, with more than 5% of the entire adult population currently experiencing long COVID. With millions of Americans affected, experts and advocates highlight the importance of bridging the knowledge gap with primary care doctors. 

Long COVID specialists said understanding these connections helps guide treatment plans and manage symptoms, such as finding the right medications, improving tolerance, optimizing sleep, applying cognitive strategies for brain fog, dietary changes, respiratory exercises to help with shortness of breath, and finding the fine line between what causes PEM and what doesn’t. 

“Whenever you see a disease like this one, you always have to ask yourself, is there an alternative way of looking at this that might explain what we’re seeing?” said Dr. Bayley. “It remains to be said that all bets are still open and that we need to continue to be very broad thinking about this.”

A version of this article appeared on Medscape.com.

The COVID-19 pandemic may no longer be a global public health emergency, but millions continue to struggle with the aftermath: Long COVID. New research and clinical anecdotes suggest that certain individuals are more likely to be afflicted by the condition, nearly 4 years after the virus emerged. 

People with a history of allergies, anxiety or depression, arthritis, and autoimmune diseases and women are among those who appear more vulnerable to developing long COVID, said doctors who specialize in treating the condition.

Many patients with long COVID struggle with debilitating fatigue, brain fog, and cognitive impairment. The condition is also characterized by a catalog of other symptoms that may be difficult to recognize as long COVID, experts said. That’s especially true when patients may not mention seemingly unrelated information, such as underlying health conditions that might make them more vulnerable. This makes screening for certain conditions and investigating every symptom especially important. 

The severity of a patient’s initial infection is not the only determining factor for developing long COVID, experts said.

“Don’t judge the person based on how sick they were initially,” said Mark Bayley, MD, medical director of the Toronto Rehabilitation Institute at University Health Network and a professor with the Temerty Faculty of Medicine at the University of Toronto. “You have to evaluate every symptom as best you can to make sure you’re not missing anything else.” 

Someone who only had a bad cough or felt really unwell for just a few days and recovered but started feeling rotten again later — “that’s the person that we are seeing for long COVID,” said Dr. Bayley. 

While patients who become severely sick and require hospitalization have a higher risk of developing long COVID, this group size is small compared with the much larger number of people infected overall. As a result, despite the lower risk, those who only become mild to moderately sick make up the vast majority of patients in long COVID clinics. 

A small Northwestern Medicine study found that 41% of patients with long COVID never tested positive for COVID-19 but were found to have antibodies that indicated exposure to the virus. 

Doctors treating patients with long COVID should consider several risk factors, specialists said. They include:

• A history of asthma, eczema, or allergies
• Signs of autonomic nervous system dysfunction
• Preexisting immune system issues
• Chronic infections
• Diabetes
• Being slightly overweight
• A preexisting history of anxiety or depression
• Joint hypermobility ( being “double-jointed” with pain and other symptoms)

Screening for Allergies

Alba Azola, MD, assistant professor of Physical Medicine and Rehabilitation at Johns Hopkins Medicine, said a history of asthma, allergies, and eczema and an onset of new food allergies may be an important factor in long COVID that doctors should consider when evaluating at-risk patients.

It is important to identify this subgroup of patients because they respond to antihistamines and mast cell stabilizers, which not only relieve their allergy symptoms but may also help improve overall fatigue and their tolerance for basic activities like standing, Dr. Azola said.

A recently published systemic review of prospective cohort studies on long COVID also found that patients with preexisting allergic conditions like asthma or rhinitis may be linked to a higher risk of developing long COVID. The authors cautioned, however, that the evidence for the link is uncertain and more rigorous research is needed.

“It stands to reason that if your immune system tends to be a bit hyperactive that triggering it with a virus will make it worse,” said Dr. Bayley.


 

Signs of Dysautonomia, Joint Hypermobility

Patients should also be screened for signs and symptoms of dysautonomia, or autonomic nervous system disorder, such as postural orthostatic tachycardia syndrome (POTS) or another type of autonomic dysfunction, doctors said.

“There’s a whole list because the autonomic nervous system involves every part of your body, every system,” Dr. Azola said.

Issues with standing, vision, digestion, urination, and bowel movement, for example, appear to be multisystemic problems but may all be linked to autonomic dysfunction, she explained.

Patients who have POTS usually experience a worsening of symptoms after COVID infection, Dr. Azola said, adding that some patients may have even assumed their pre-COVID symptoms of POTS were normal. 

She also screens for joint hypermobility or hypermobile Ehlers-Danlos syndrome, which affects connective tissue. Research has long shown a relationship between autonomic dysfunction, mast cell activation syndrome (repeated severe allergy symptoms that affect multiple systems), and the presence of hypermobility, Dr. Azola said. She added that gentle physical therapy can be helpful for patients with hypermobility issues.

Previous studies before and during the pandemic have also found that a substantial subset of patients with myalgic encephalomyelitis/chronic fatigue syndrome, which shares many similarities with long COVID, also have connective tissue/hypermobility disorders.
 

Depression, Anxiety, and Female Patients

People with a preexisting history of anxiety or depression also appear to be at a higher risk for long COVID, Dr. Bayley said, noting that patients with these conditions appear more vulnerable to brain fog and other difficulties brought on by COVID infection. Earlier research found biochemical evidence of brain inflammation that correlates with symptoms of anxiety in patients with long COVID.

“We know that depression is related to neurotransmitters like adrenaline and serotonin,” Dr. Bayley said. “The chronic inflammation that’s associated with COVID — this will make people feel more depressed because they’re not getting the neurotransmitters in their brain releasing at the right times.”

It may also put patients at a risk for anxiety due to fears of post-exertional malaise (PEM), where symptoms worsen after even very minor physical or mental exertion and can last days or weeks.

“You can see how that leads to a bit of a vicious cycle,” said Dr. Bayley, explaining that the cycle of fear and avoidance makes patients less active and deconditioned. But he added that learning to manage their activity can actually help mitigate PEM due to the anti-inflammatory effects of exercise, its positive impact on mood, and benefits to the immune and cardiovascular systems. 

Meanwhile, a number of epidemiologic studies have found a higher prevalence of long COVID among women. Perimenopausal and menopausal women in particular appeared more prone, and at least one study reported that women under 50 years were five times more likely to develop post-COVID symptoms than men.

A recent small UK study that focused on COVID-19 hospitalizations found that women who had lower levels of inflammatory biomarkers at admission were more likely to experience certain long-term symptoms like muscle ache, low mood and anxiety, adding to earlier research linking female patients, long COVID, and neuropsychiatric symptoms. 


 

History of Immune Dysfunction, Diabetes, Elevated Body Mass Index (BMI)

Immune dysfunction, a history of recurrent infections, or chronic sinus infections are also common among patients under Dr. Azola and her team’s care. Those who have arthritis or other autoimmune diseases such as lupus also appear more vulnerable, Dr. Bayley said, along with patients who have diabetes or a little overweight.

Recent research out of the University of Queensland found that being overweight can negatively affect the body’s immune response to the SARS-CoV-2 virus. Blood samples collected 13 months after infection, for example, found that individuals with a higher BMI had lower antibody activity and a reduced percentage of relevant B cells that help build antibodies to fight the virus. Being overweight did not affect the antibody response to the COVID-19 vaccines, however, giving further support for vaccination over infection-induced immunity as an important protective factor, researchers said.
 

Narrowing the Information Gap

The latest Centers for Centers for Disease Control and Prevention’s Household Pulse Survey estimates that 14% of all American adults have had long COVID at some point, with more than 5% of the entire adult population currently experiencing long COVID. With millions of Americans affected, experts and advocates highlight the importance of bridging the knowledge gap with primary care doctors. 

Long COVID specialists said understanding these connections helps guide treatment plans and manage symptoms, such as finding the right medications, improving tolerance, optimizing sleep, applying cognitive strategies for brain fog, dietary changes, respiratory exercises to help with shortness of breath, and finding the fine line between what causes PEM and what doesn’t. 

“Whenever you see a disease like this one, you always have to ask yourself, is there an alternative way of looking at this that might explain what we’re seeing?” said Dr. Bayley. “It remains to be said that all bets are still open and that we need to continue to be very broad thinking about this.”

A version of this article appeared on Medscape.com.

For smokers, deaths with a cardiovascular or cancer-related cause, or ones that can be attributed to a respiratory disease such as chronic obstructive pulmonary disease, are significantly more common than for nonsmokers. It is widely recognized that stopping smoking leads to a reduction in mortality risk. To make reliable statements on the timeline of this reduction, researchers analyzed interview data and death rates from 438,015 adult US citizens from 1997 to the end of 2019.

The analyses show that it takes 30 years for the mortality risk of ex-smokers to resemble that of people who never regularly smoked. Blake Thomson, PhD, and Fahrad Islami, MD, PhD, both members of the Department of Surveillance and Health Equity Science of the American Cancer Society in Atlanta, Georgia, published their results as a research letter in JAMA Internal Medicine.
 

After Smoking Cessation

Overall, 11,860 cardiovascular, 10,935 cancer-related, and 2,060 respiratory-related deaths were considered from over 5 million patient years. Taken from these figures, the mortality risks of continuous smokers were 2.3 times (cardiovascular), 3.4 times (cancer-related), and 13.3 times (respiratory-related) higher than those of continuous nonsmokers.

Within 10 years of stopping smoking, the following occurred:

• The cardiovascular mortality risk fell by 1.47 times, compared with nonsmokers (by 36% compared with smokers).
• The cancer-related mortality risk fell by 2.13 times, compared with nonsmokers (by 47% compared with smokers).
• The respiratory-related mortality risk fell by 6.35 times, compared with nonsmokers (by 43% compared with smokers).

In the second decade after stopping smoking, the risk dropped even further. The researchers observed the following trends:

• The cardiovascular mortality risk fell by 1.26 times.
• The cancer-related mortality risk fell by 1.59 times.
• The respiratory-related mortality risk fell by 3.63 times — each time compared with nonsmokers.

During the third decade after stopping smoking, the risk continued to decrease. The trends were as follows:

• The cardiovascular mortality risk fell by 1.07 times.
• The cancer-related mortality risk fell by 1.34 times.
• The respiratory-related mortality risk fell by 2.34 times, compared with nonsmokers.

30 Years Later

Only after more than 30 years of not smoking was the cardiovascular-related mortality risk 0.96 and, therefore, no longer significant. Compared with nonsmokers, the cancer-related mortality risk was 1.16, and the respiratory-related mortality risk was 1.31.

Therefore, former smokers can reduce their cardiovascular mortality risk by 100%, the cancer-related by 93%, and the respiratory-related mortality risk by 97%.

The result reinforces earlier analyses on the reduction in mortality risks by stopping smoking, with fewer participants. Smokers, therefore, benefit more the longer that they can refrain from using tobacco. “The earlier in life that smoking is given up, the better,” the authors wrote. But even in the first 10 years, the mortality risks examined decreased by a statistically significant 36% (cardiovascular) to 47% (cancer-related).
 

An Underestimation?

One disadvantage of the study is that the participants’ data were collected using personal questionnaires. For this reason, participants may have reported their tobacco consumption as being lower than it was, particularly because these questionnaires are often answered in hindsight, the authors pointed out.

In addition, some of the participants who reported stopping smoking completely may have only reduced their consumption. However, both circumstances would cause the results of the analysis to be even clearer, compared with reality, and therefore better.

This article was translated from the Medscape German edition.

A version of this article appeared on Medscape.com.

For smokers, deaths with a cardiovascular or cancer-related cause, or ones that can be attributed to a respiratory disease such as chronic obstructive pulmonary disease, are significantly more common than for nonsmokers. It is widely recognized that stopping smoking leads to a reduction in mortality risk. To make reliable statements on the timeline of this reduction, researchers analyzed interview data and death rates from 438,015 adult US citizens from 1997 to the end of 2019.

The analyses show that it takes 30 years for the mortality risk of ex-smokers to resemble that of people who never regularly smoked. Blake Thomson, PhD, and Fahrad Islami, MD, PhD, both members of the Department of Surveillance and Health Equity Science of the American Cancer Society in Atlanta, Georgia, published their results as a research letter in JAMA Internal Medicine.
 

After Smoking Cessation

Overall, 11,860 cardiovascular, 10,935 cancer-related, and 2,060 respiratory-related deaths were considered from over 5 million patient years. Taken from these figures, the mortality risks of continuous smokers were 2.3 times (cardiovascular), 3.4 times (cancer-related), and 13.3 times (respiratory-related) higher than those of continuous nonsmokers.

Within 10 years of stopping smoking, the following occurred:

• The cardiovascular mortality risk fell by 1.47 times, compared with nonsmokers (by 36% compared with smokers).
• The cancer-related mortality risk fell by 2.13 times, compared with nonsmokers (by 47% compared with smokers).
• The respiratory-related mortality risk fell by 6.35 times, compared with nonsmokers (by 43% compared with smokers).

In the second decade after stopping smoking, the risk dropped even further. The researchers observed the following trends:

• The cardiovascular mortality risk fell by 1.26 times.
• The cancer-related mortality risk fell by 1.59 times.
• The respiratory-related mortality risk fell by 3.63 times — each time compared with nonsmokers.

During the third decade after stopping smoking, the risk continued to decrease. The trends were as follows:

• The cardiovascular mortality risk fell by 1.07 times.
• The cancer-related mortality risk fell by 1.34 times.
• The respiratory-related mortality risk fell by 2.34 times, compared with nonsmokers.

30 Years Later

Only after more than 30 years of not smoking was the cardiovascular-related mortality risk 0.96 and, therefore, no longer significant. Compared with nonsmokers, the cancer-related mortality risk was 1.16, and the respiratory-related mortality risk was 1.31.

Therefore, former smokers can reduce their cardiovascular mortality risk by 100%, the cancer-related by 93%, and the respiratory-related mortality risk by 97%.

The result reinforces earlier analyses on the reduction in mortality risks by stopping smoking, with fewer participants. Smokers, therefore, benefit more the longer that they can refrain from using tobacco. “The earlier in life that smoking is given up, the better,” the authors wrote. But even in the first 10 years, the mortality risks examined decreased by a statistically significant 36% (cardiovascular) to 47% (cancer-related).
 

An Underestimation?

One disadvantage of the study is that the participants’ data were collected using personal questionnaires. For this reason, participants may have reported their tobacco consumption as being lower than it was, particularly because these questionnaires are often answered in hindsight, the authors pointed out.

In addition, some of the participants who reported stopping smoking completely may have only reduced their consumption. However, both circumstances would cause the results of the analysis to be even clearer, compared with reality, and therefore better.

This article was translated from the Medscape German edition.

A version of this article appeared on Medscape.com.

For smokers, deaths with a cardiovascular or cancer-related cause, or ones that can be attributed to a respiratory disease such as chronic obstructive pulmonary disease, are significantly more common than for nonsmokers. It is widely recognized that stopping smoking leads to a reduction in mortality risk. To make reliable statements on the timeline of this reduction, researchers analyzed interview data and death rates from 438,015 adult US citizens from 1997 to the end of 2019.

The analyses show that it takes 30 years for the mortality risk of ex-smokers to resemble that of people who never regularly smoked. Blake Thomson, PhD, and Fahrad Islami, MD, PhD, both members of the Department of Surveillance and Health Equity Science of the American Cancer Society in Atlanta, Georgia, published their results as a research letter in JAMA Internal Medicine.
 

After Smoking Cessation

Overall, 11,860 cardiovascular, 10,935 cancer-related, and 2,060 respiratory-related deaths were considered from over 5 million patient years. Taken from these figures, the mortality risks of continuous smokers were 2.3 times (cardiovascular), 3.4 times (cancer-related), and 13.3 times (respiratory-related) higher than those of continuous nonsmokers.

Within 10 years of stopping smoking, the following occurred:

• The cardiovascular mortality risk fell by 1.47 times, compared with nonsmokers (by 36% compared with smokers).
• The cancer-related mortality risk fell by 2.13 times, compared with nonsmokers (by 47% compared with smokers).
• The respiratory-related mortality risk fell by 6.35 times, compared with nonsmokers (by 43% compared with smokers).

In the second decade after stopping smoking, the risk dropped even further. The researchers observed the following trends:

• The cardiovascular mortality risk fell by 1.26 times.
• The cancer-related mortality risk fell by 1.59 times.
• The respiratory-related mortality risk fell by 3.63 times — each time compared with nonsmokers.

During the third decade after stopping smoking, the risk continued to decrease. The trends were as follows:

• The cardiovascular mortality risk fell by 1.07 times.
• The cancer-related mortality risk fell by 1.34 times.
• The respiratory-related mortality risk fell by 2.34 times, compared with nonsmokers.

30 Years Later

Only after more than 30 years of not smoking was the cardiovascular-related mortality risk 0.96 and, therefore, no longer significant. Compared with nonsmokers, the cancer-related mortality risk was 1.16, and the respiratory-related mortality risk was 1.31.

Therefore, former smokers can reduce their cardiovascular mortality risk by 100%, the cancer-related by 93%, and the respiratory-related mortality risk by 97%.

The result reinforces earlier analyses on the reduction in mortality risks by stopping smoking, with fewer participants. Smokers, therefore, benefit more the longer that they can refrain from using tobacco. “The earlier in life that smoking is given up, the better,” the authors wrote. But even in the first 10 years, the mortality risks examined decreased by a statistically significant 36% (cardiovascular) to 47% (cancer-related).
 

An Underestimation?

One disadvantage of the study is that the participants’ data were collected using personal questionnaires. For this reason, participants may have reported their tobacco consumption as being lower than it was, particularly because these questionnaires are often answered in hindsight, the authors pointed out.

In addition, some of the participants who reported stopping smoking completely may have only reduced their consumption. However, both circumstances would cause the results of the analysis to be even clearer, compared with reality, and therefore better.

This article was translated from the Medscape German edition.

A version of this article appeared on Medscape.com.

With so many treatment options available for atopic dermatitis (AD) and more in the pipeline, one common question Raj Chovatiya, MD, PhD, hears from his fellow dermatologists is: How do I choose the right therapy for my patients?

“There isn’t going to be a one-size-fits-all approach, and it may be impossible to differentiate, given that these agents are not likely to be studied head-to-head,” Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference.

Dr. Chovatiya

He shared a list of factors to consider when engaged in shared decision-making with patients about their AD treatment options. These include:

• Severity of disease (mild vs moderate vs severe).
• Extent of disease (low vs high body surface area).
• Rapidity of drug onset (hours vs days vs weeks).
• Depth of response based on different endpoints such as itch and number of lesions.
• Long-term efficacy (durability on treatment vs off treatment).
• Adverse events (cutaneous vs systemic).
• Black box warnings (present vs absent).
• Tolerance (selective areas vs the entire skin).
• Vehicle (ointment vs cream).
• Patient preference. “This may be the biggest driver; what do patients want?” Dr. Chovatiya said.
• Access to the drug. Is it easily obtainable for the patient?

He concluded his remarks by posing a question to attendees: “Are we closer to living in a topical steroid–free world for AD? Is that what we want?” he asked. “I wholeheartedly say that’s what we’ve been working toward all these years, and we should keep up the good fight. We have more data for targeted therapy to treat very specific disease with very specific outcomes and endpoints, because I think that’s [what] we all dream about in dermatology.”

Dr. Chovatiya disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies.

With so many treatment options available for atopic dermatitis (AD) and more in the pipeline, one common question Raj Chovatiya, MD, PhD, hears from his fellow dermatologists is: How do I choose the right therapy for my patients?

“There isn’t going to be a one-size-fits-all approach, and it may be impossible to differentiate, given that these agents are not likely to be studied head-to-head,” Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference.

Dr. Chovatiya

He shared a list of factors to consider when engaged in shared decision-making with patients about their AD treatment options. These include:

• Severity of disease (mild vs moderate vs severe).
• Extent of disease (low vs high body surface area).
• Rapidity of drug onset (hours vs days vs weeks).
• Depth of response based on different endpoints such as itch and number of lesions.
• Long-term efficacy (durability on treatment vs off treatment).
• Adverse events (cutaneous vs systemic).
• Black box warnings (present vs absent).
• Tolerance (selective areas vs the entire skin).
• Vehicle (ointment vs cream).
• Patient preference. “This may be the biggest driver; what do patients want?” Dr. Chovatiya said.
• Access to the drug. Is it easily obtainable for the patient?

He concluded his remarks by posing a question to attendees: “Are we closer to living in a topical steroid–free world for AD? Is that what we want?” he asked. “I wholeheartedly say that’s what we’ve been working toward all these years, and we should keep up the good fight. We have more data for targeted therapy to treat very specific disease with very specific outcomes and endpoints, because I think that’s [what] we all dream about in dermatology.”

Dr. Chovatiya disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies.

With so many treatment options available for atopic dermatitis (AD) and more in the pipeline, one common question Raj Chovatiya, MD, PhD, hears from his fellow dermatologists is: How do I choose the right therapy for my patients?

“There isn’t going to be a one-size-fits-all approach, and it may be impossible to differentiate, given that these agents are not likely to be studied head-to-head,” Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference.

Dr. Chovatiya

He shared a list of factors to consider when engaged in shared decision-making with patients about their AD treatment options. These include:

• Severity of disease (mild vs moderate vs severe).
• Extent of disease (low vs high body surface area).
• Rapidity of drug onset (hours vs days vs weeks).
• Depth of response based on different endpoints such as itch and number of lesions.
• Long-term efficacy (durability on treatment vs off treatment).
• Adverse events (cutaneous vs systemic).
• Black box warnings (present vs absent).
• Tolerance (selective areas vs the entire skin).
• Vehicle (ointment vs cream).
• Patient preference. “This may be the biggest driver; what do patients want?” Dr. Chovatiya said.
• Access to the drug. Is it easily obtainable for the patient?

He concluded his remarks by posing a question to attendees: “Are we closer to living in a topical steroid–free world for AD? Is that what we want?” he asked. “I wholeheartedly say that’s what we’ve been working toward all these years, and we should keep up the good fight. We have more data for targeted therapy to treat very specific disease with very specific outcomes and endpoints, because I think that’s [what] we all dream about in dermatology.”

Dr. Chovatiya disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies.

Continuous positive airway pressure (CPAP) is first-line therapy for sleep-related breathing disorders (SRBDs). Obstructive sleep apnea (OSA) is the major player in the SRBDs space, with a prevalence approaching 100% in adult men using current diagnostic criteria. Patients with OSA and comorbid cardiovascular disease (CVD) are diagnosed with OSA syndrome, and CPAP is prescribed. Primary care physicians and cardiologists are quick to refer patients with CVD to sleep docs to see whether CPAP can improve CVD-related outcomes.

What the Studies Show

There’s a problem though. CPAP doesn’t seem to improve CVD-related outcomes. In some cases, it’s even harmful. Let’s do a quick review. In 2005, the CANPAP study found CPAP didn’t improve a composite CVD outcome that included mortality. A post hoc analysis found that it actually increased mortality if central apneas weren’t eliminated. The post hoc analysis also found benefit when central apneas were eliminated, but for all-comers, CPAP didn’t improve outcomes. Strike one.

Enter adaptive servo-ventilation (ASV). If CANPAP showed that success depended on eliminating central apneas, why not use ASV for all patients with CVD and central apneas or Cheyne-Stokes respirations? ASV eliminates central apneas and Cheyne-Stokes. Well, that didn’t work either. The randomized, controlled SERVE-HF trial, published in 2015, showed that ASV increases all-cause and CVD-specific mortality. Oops. That’s two trials showing that CPAP and ASV can increase mortality in patients with heart failure. Strike two.

Alright. But that’s heart failure. What about hypertension or coronary artery disease (CAD)? Shouldn’t such patients be treated with CPAP to reduce CVD risk? After all, there’s all those surrogate outcomes data for CPAP — it improves vascular tone and lowers catecholamines and all that stuff. Doesn’t it lower blood pressure too? Surely CPAP benefits patients with CVD who don’t have heart failure, right?

Not really. The RICCADSA study, published in 2016, found that CPAP didn’t reduce a composite of CVD outcomes in patients with newly revascularized CAD. The SAVE trial published the same year had a similar design with similar results. CPAP did not improve CVD-related outcomes. Most recently, the ISAACC study was negative. That’s three negative randomized controlled trials in less than 5 years showing CPAP doesn’t affect CVD-related outcomes in high-risk populations with known disease. Strike three?

CPAP provides no benefit for CVD and possible harm when treating heart failure. Surely CPAP is useful for patients with hypertension. Let’s see. The American Academy of Sleep Medicine (AASM) conducted meta-analyses for the guideline it produced recommending CPAP for patients with comorbid hypertension. They note that 24-hour blood pressure measurements are best correlated with outcomes. CPAP did lead to significant 24-hour blood pressure reduction, but guess how large it was? For systolic blood pressure, it was 1.5 mm Hg; for diastolic pressure, it was 1.6 mm Hg. That’s it.

How did the AASM summarize and interpret the above data in their 2019 guidelines for prescribing CPAP? Although covered in their detailed review, both heart failure and CVD are left out of their primary recommendations . They do provide a conditional recommendation for prescribing CPAP to patients with comorbid hypertension that states, “The majority of well-informed patients would choose the intervention over no treatment.” Really? If you were told that CPAP provides less reduction in blood pressure than dietary changes and/or medications, would you choose to wear it or take a pill once a day? Remember, you have to take the pill anyway to get your blood pressure to target unless your pressure is only 1.5-1.6 mm Hg above normal. Where does one find patients who are anxious to wear a mask to bed for minimal benefit and a 20% copay? I’ve yet to meet one.

As always, the pressure pushers are undeterred by inconvenient evidence. A secondary analysis of adherent patients in RICCADSA resorts to the “bait and switch” that’s propped up CPAP enthusiasts for decades: Compare adherent patients versus those who are not (or those who refuse treatment) to prove benefit. The flaws to this approach are obvious. First, performing a post hoc analysis that reintroduces all of the confounding that plagues existing CPAP data negates the benefits of randomization, fancy statistics notwithstanding. Second, it belies the reality that in well-controlled, well-conducted randomized trials where patients get far more support than those in the community (and sometimes are preselected for adherence), a majority simply won’t use CPAP . Excluding the nonadherent or comparing them with the adherent is the epitome of selection bias.

The editorial accompanying the ISAACC study is a tour de force in CPAP apologies. The apnea-hypopnea index (AHI) isn’t the right metric — this one’s invoked often. Never mind that the very premise that OSA causes CVD is from observational data based on the AHI. If you abandon the AHI, don’t you lose your justification for prospective trials targeting CVD with CPAP?

Even better, in an argument fit for a Twitter ban, the author suggests that patients in ISAACC, SAVE, and RICCADSA couldn’t benefit because they already have CVD. The very concept, refuted by decades of secondary prevention research in cardiology, implies that CPAP should be used for primary prevention. Only a sleep researcher could spin a negative study into an expansion of CPAP indications. Others in the AASM have made similar proposals.

Final Thoughts

The sleep field lacks unblinded realists capable of choosing wisely. A little therapeutic underconfidence is warranted. Diseases and therapies will always have champions. Prudence and restraint? Not so much. The AASM could summarize the CPAP literature in a single recommendation: “If your patient is sleepy, CPAP might help them feel better if their disease is moderate or severe.” All other indications are soft.

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

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Maryland, and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington, DC. He covers a  wide range of topics in pulmonary, critical care, and sleep medicine .

Continuous positive airway pressure (CPAP) is first-line therapy for sleep-related breathing disorders (SRBDs). Obstructive sleep apnea (OSA) is the major player in the SRBDs space, with a prevalence approaching 100% in adult men using current diagnostic criteria. Patients with OSA and comorbid cardiovascular disease (CVD) are diagnosed with OSA syndrome, and CPAP is prescribed. Primary care physicians and cardiologists are quick to refer patients with CVD to sleep docs to see whether CPAP can improve CVD-related outcomes.

What the Studies Show

There’s a problem though. CPAP doesn’t seem to improve CVD-related outcomes. In some cases, it’s even harmful. Let’s do a quick review. In 2005, the CANPAP study found CPAP didn’t improve a composite CVD outcome that included mortality. A post hoc analysis found that it actually increased mortality if central apneas weren’t eliminated. The post hoc analysis also found benefit when central apneas were eliminated, but for all-comers, CPAP didn’t improve outcomes. Strike one.

Enter adaptive servo-ventilation (ASV). If CANPAP showed that success depended on eliminating central apneas, why not use ASV for all patients with CVD and central apneas or Cheyne-Stokes respirations? ASV eliminates central apneas and Cheyne-Stokes. Well, that didn’t work either. The randomized, controlled SERVE-HF trial, published in 2015, showed that ASV increases all-cause and CVD-specific mortality. Oops. That’s two trials showing that CPAP and ASV can increase mortality in patients with heart failure. Strike two.

Alright. But that’s heart failure. What about hypertension or coronary artery disease (CAD)? Shouldn’t such patients be treated with CPAP to reduce CVD risk? After all, there’s all those surrogate outcomes data for CPAP — it improves vascular tone and lowers catecholamines and all that stuff. Doesn’t it lower blood pressure too? Surely CPAP benefits patients with CVD who don’t have heart failure, right?

Not really. The RICCADSA study, published in 2016, found that CPAP didn’t reduce a composite of CVD outcomes in patients with newly revascularized CAD. The SAVE trial published the same year had a similar design with similar results. CPAP did not improve CVD-related outcomes. Most recently, the ISAACC study was negative. That’s three negative randomized controlled trials in less than 5 years showing CPAP doesn’t affect CVD-related outcomes in high-risk populations with known disease. Strike three?

CPAP provides no benefit for CVD and possible harm when treating heart failure. Surely CPAP is useful for patients with hypertension. Let’s see. The American Academy of Sleep Medicine (AASM) conducted meta-analyses for the guideline it produced recommending CPAP for patients with comorbid hypertension. They note that 24-hour blood pressure measurements are best correlated with outcomes. CPAP did lead to significant 24-hour blood pressure reduction, but guess how large it was? For systolic blood pressure, it was 1.5 mm Hg; for diastolic pressure, it was 1.6 mm Hg. That’s it.

How did the AASM summarize and interpret the above data in their 2019 guidelines for prescribing CPAP? Although covered in their detailed review, both heart failure and CVD are left out of their primary recommendations . They do provide a conditional recommendation for prescribing CPAP to patients with comorbid hypertension that states, “The majority of well-informed patients would choose the intervention over no treatment.” Really? If you were told that CPAP provides less reduction in blood pressure than dietary changes and/or medications, would you choose to wear it or take a pill once a day? Remember, you have to take the pill anyway to get your blood pressure to target unless your pressure is only 1.5-1.6 mm Hg above normal. Where does one find patients who are anxious to wear a mask to bed for minimal benefit and a 20% copay? I’ve yet to meet one.

As always, the pressure pushers are undeterred by inconvenient evidence. A secondary analysis of adherent patients in RICCADSA resorts to the “bait and switch” that’s propped up CPAP enthusiasts for decades: Compare adherent patients versus those who are not (or those who refuse treatment) to prove benefit. The flaws to this approach are obvious. First, performing a post hoc analysis that reintroduces all of the confounding that plagues existing CPAP data negates the benefits of randomization, fancy statistics notwithstanding. Second, it belies the reality that in well-controlled, well-conducted randomized trials where patients get far more support than those in the community (and sometimes are preselected for adherence), a majority simply won’t use CPAP . Excluding the nonadherent or comparing them with the adherent is the epitome of selection bias.

The editorial accompanying the ISAACC study is a tour de force in CPAP apologies. The apnea-hypopnea index (AHI) isn’t the right metric — this one’s invoked often. Never mind that the very premise that OSA causes CVD is from observational data based on the AHI. If you abandon the AHI, don’t you lose your justification for prospective trials targeting CVD with CPAP?

Even better, in an argument fit for a Twitter ban, the author suggests that patients in ISAACC, SAVE, and RICCADSA couldn’t benefit because they already have CVD. The very concept, refuted by decades of secondary prevention research in cardiology, implies that CPAP should be used for primary prevention. Only a sleep researcher could spin a negative study into an expansion of CPAP indications. Others in the AASM have made similar proposals.

Final Thoughts

The sleep field lacks unblinded realists capable of choosing wisely. A little therapeutic underconfidence is warranted. Diseases and therapies will always have champions. Prudence and restraint? Not so much. The AASM could summarize the CPAP literature in a single recommendation: “If your patient is sleepy, CPAP might help them feel better if their disease is moderate or severe.” All other indications are soft.

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

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Maryland, and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington, DC. He covers a  wide range of topics in pulmonary, critical care, and sleep medicine .

Continuous positive airway pressure (CPAP) is first-line therapy for sleep-related breathing disorders (SRBDs). Obstructive sleep apnea (OSA) is the major player in the SRBDs space, with a prevalence approaching 100% in adult men using current diagnostic criteria. Patients with OSA and comorbid cardiovascular disease (CVD) are diagnosed with OSA syndrome, and CPAP is prescribed. Primary care physicians and cardiologists are quick to refer patients with CVD to sleep docs to see whether CPAP can improve CVD-related outcomes.

What the Studies Show

There’s a problem though. CPAP doesn’t seem to improve CVD-related outcomes. In some cases, it’s even harmful. Let’s do a quick review. In 2005, the CANPAP study found CPAP didn’t improve a composite CVD outcome that included mortality. A post hoc analysis found that it actually increased mortality if central apneas weren’t eliminated. The post hoc analysis also found benefit when central apneas were eliminated, but for all-comers, CPAP didn’t improve outcomes. Strike one.

Enter adaptive servo-ventilation (ASV). If CANPAP showed that success depended on eliminating central apneas, why not use ASV for all patients with CVD and central apneas or Cheyne-Stokes respirations? ASV eliminates central apneas and Cheyne-Stokes. Well, that didn’t work either. The randomized, controlled SERVE-HF trial, published in 2015, showed that ASV increases all-cause and CVD-specific mortality. Oops. That’s two trials showing that CPAP and ASV can increase mortality in patients with heart failure. Strike two.

Alright. But that’s heart failure. What about hypertension or coronary artery disease (CAD)? Shouldn’t such patients be treated with CPAP to reduce CVD risk? After all, there’s all those surrogate outcomes data for CPAP — it improves vascular tone and lowers catecholamines and all that stuff. Doesn’t it lower blood pressure too? Surely CPAP benefits patients with CVD who don’t have heart failure, right?

Not really. The RICCADSA study, published in 2016, found that CPAP didn’t reduce a composite of CVD outcomes in patients with newly revascularized CAD. The SAVE trial published the same year had a similar design with similar results. CPAP did not improve CVD-related outcomes. Most recently, the ISAACC study was negative. That’s three negative randomized controlled trials in less than 5 years showing CPAP doesn’t affect CVD-related outcomes in high-risk populations with known disease. Strike three?

CPAP provides no benefit for CVD and possible harm when treating heart failure. Surely CPAP is useful for patients with hypertension. Let’s see. The American Academy of Sleep Medicine (AASM) conducted meta-analyses for the guideline it produced recommending CPAP for patients with comorbid hypertension. They note that 24-hour blood pressure measurements are best correlated with outcomes. CPAP did lead to significant 24-hour blood pressure reduction, but guess how large it was? For systolic blood pressure, it was 1.5 mm Hg; for diastolic pressure, it was 1.6 mm Hg. That’s it.

How did the AASM summarize and interpret the above data in their 2019 guidelines for prescribing CPAP? Although covered in their detailed review, both heart failure and CVD are left out of their primary recommendations . They do provide a conditional recommendation for prescribing CPAP to patients with comorbid hypertension that states, “The majority of well-informed patients would choose the intervention over no treatment.” Really? If you were told that CPAP provides less reduction in blood pressure than dietary changes and/or medications, would you choose to wear it or take a pill once a day? Remember, you have to take the pill anyway to get your blood pressure to target unless your pressure is only 1.5-1.6 mm Hg above normal. Where does one find patients who are anxious to wear a mask to bed for minimal benefit and a 20% copay? I’ve yet to meet one.

As always, the pressure pushers are undeterred by inconvenient evidence. A secondary analysis of adherent patients in RICCADSA resorts to the “bait and switch” that’s propped up CPAP enthusiasts for decades: Compare adherent patients versus those who are not (or those who refuse treatment) to prove benefit. The flaws to this approach are obvious. First, performing a post hoc analysis that reintroduces all of the confounding that plagues existing CPAP data negates the benefits of randomization, fancy statistics notwithstanding. Second, it belies the reality that in well-controlled, well-conducted randomized trials where patients get far more support than those in the community (and sometimes are preselected for adherence), a majority simply won’t use CPAP . Excluding the nonadherent or comparing them with the adherent is the epitome of selection bias.

The editorial accompanying the ISAACC study is a tour de force in CPAP apologies. The apnea-hypopnea index (AHI) isn’t the right metric — this one’s invoked often. Never mind that the very premise that OSA causes CVD is from observational data based on the AHI. If you abandon the AHI, don’t you lose your justification for prospective trials targeting CVD with CPAP?

Even better, in an argument fit for a Twitter ban, the author suggests that patients in ISAACC, SAVE, and RICCADSA couldn’t benefit because they already have CVD. The very concept, refuted by decades of secondary prevention research in cardiology, implies that CPAP should be used for primary prevention. Only a sleep researcher could spin a negative study into an expansion of CPAP indications. Others in the AASM have made similar proposals.

Final Thoughts

The sleep field lacks unblinded realists capable of choosing wisely. A little therapeutic underconfidence is warranted. Diseases and therapies will always have champions. Prudence and restraint? Not so much. The AASM could summarize the CPAP literature in a single recommendation: “If your patient is sleepy, CPAP might help them feel better if their disease is moderate or severe.” All other indications are soft.

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

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Maryland, and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington, DC. He covers a  wide range of topics in pulmonary, critical care, and sleep medicine .