Journal of Clinical Outcomes Management

In January 2022, Anthony Arenz, a 51-year-old living in Mesa, Ariz., breathed a small sigh of relief.

The Galleri blood test, which screens for 50 types of cancer, hadn’t detected any positive signs.

It would be welcome news to anyone but especially to a firefighter with a 9% greater risk of developing cancer and a 14% greater risk of dying from it than the average person. The Mesa unit had lost two servicemen to cancer in the past 3 years. Both were more than a decade younger than Mr. Arenz.

When the city of Mesa offered additional free screening – including a full-body MRI – to firefighters over 50, Mr. Arenz initially shrugged it off. With a negative Galleri test in hand, he didn’t want to spend more time dwelling on it.

Still, he began to feel a creeping guilt for skipping a test that many of his fallen colleagues hadn’t been offered. He tried to soothe his anxiety with research. A look through the company’s website didn’t set him at ease. According to Grail Bio, a test result of “no cancer signal detected” does not rule out cancer.

Mr. Arenz booked his free MRI.

The results left him heavy: stage I kidney cancer. The Galleri test had missed it.

Mr. Arenz received his free Galleri test through a cancer screening program funded by the city of Mesa. The program is housed at Vincere Cancer Center in Scottsdale, Ariz. Under the leadership of radiation oncologist and Vincere co-owner Vershalee Shukla, MD, the program currently screens first responders in more than 10 Arizona cities at no cost to them.

Vincere began using Galleri shortly after the test launched for consumers in June 2021. Since then, the first responder program has become the largest commercial user of the test in North America.

But the ability of the Galleri test to identify cancer and, perhaps more importantly, the fallout from erroneous results have been under scrutiny since the test’s launch. The Galleri test, which has not yet been approved by the Food and Drug Administration, is so new that few know what incorrect results look like in practice and how often they might occur.

After running the test on about 2,000 servicemen and servicewomen, Dr. Shukla can offer some insight about the test’s real-world value in a high-risk population.

“Cancer screening is a very complicated issue,” Dr. Shukla said in an interview. “Being honest, the tests are good but are not ready yet [for wider use].”

Mr. Arenz was not the only firefighter who got a surprise after taking a Galleri test.

In nearby Phoenix, 51-year-old firefighter Mike Curtis knew his risk for cancer was high, but he wasn’t that worried. Mr. Curtis had been running into fires since he was 17. His dad, also a firefighter, had died of cancer at age 58.

Mr. Curtis had taken the Vincere Cancer Center up on every free screening service since the program began in late 2018 – well before Dr. Shukla started using Galleri in 2021. His most recent lung CT was clear. But he underwent the Galleri test just to stay vigilant.

His result was a shock. The test detected signs of cancer.

Mr. Curtis decided to tell no one, not even his wife. He’d bear the bad news alone until he was certain.

Dr. Shukla, however, immediately doubted the blood test result. She expedited several follow-up tests. One week, a PET, and CT of the abdomen and pelvis later, her hunch was confirmed. The Galleri test result was wrong, Mr. Curtis did not have cancer.

The price of his peace of mind: an extensive workup with a $4,000 price tag. Fortunately, the bill was covered by the screening program.

Overall, in just over 18 months of using the blood test, Dr. Shukla has only encountered 1 other false positive out of about 2,000 Galleri results.

She also discovered two positive signals for cancer using Galleri that were confirmed with follow-up tests. One was a chordoma, a rare type of bone cancer, and the other was a squamous cell carcinoma of the head and neck. The Galleri test caught both remarkably early, in time for treatment.

For Dr. Shukla, however, false negatives were particularly “horrible.” Mr. Arenz’s was just 1 of 28 cancers that the blood test missed. And because 500 negative tests are yet to be validated, the 28 false negatives may be an underestimate.

In her experience, the binary test result – a simple positive or negative cancer signal – is an oversimplification of risk, she said. It “gives a false perception that you have cancer or you don’t,” although the test itself is not definitive.

Grail senior medical director Whitney Jones, MD, agreed that the test is not meant to be a stand-alone screening test for cancer. The purpose of the Galleri test is to “complement other screenings, not replace them,” Dr. Jones told this news organization.

According to an analysis of Galleri data and Dr. Shukla’s experience, the test’s specificity was over 99%. That means the test successfully minimizes false positives.

But the test’s sensitivity was much lower. From data from first responders, Dr. Shukla determined the sensitivity to be 6.7%. That means the test misses about 93 of every 100 cancers. According to Grail’s latest data from more than 6,300 people older than 50, the test’s sensitivity was 29%.

Specificity and sensitivity are metrics used to credential a test and establish confidence in its ability to detect the target disease. A test with high specificity can correctly identify patients who do not have the condition in question, while a test with high sensitivity can correctly identify patients who do have the disease. But there are trade-offs between sensitivity and specificity. One value is increased at the expense of the other.

It’s normal for a cancer screening test to prioritize specificity, according to Aparna Parikh, MD, an oncologist at Mass General Cancer Center in Boston. In a test like Galleri, which is meant to be an adjunct to other screening modalities, “at least we are seeing a good specificity, which is important, because we don’t want false positives, where the downstream impact on the patient can be high.”

Overall, Dr. Jones said, Grail Bio’s aim is to build a test that’s sensitive enough to catch the most dangerous cancers without inundating the healthcare system with false positives. In addition, Dr. Jones explained, sensitivity varies by cancer type. It tends to be lower for cancers for which other screening modalities are available, as well as for earlier-stage disease.

However, the Galleri sensitivity values are “a little bit scary,” said Ji-Hyun Lee, DrPH, professor of biostatistics at the University of Florida and director of the division of quantitative sciences at the University of Florida Health Cancer Center, both in Gainesville. Dr. Lee, who is not affiliated with Grail, reviewed the company’s publicly available data as well as Dr. Shukla’s data at the request of this news organization.

While there’s no definitive threshold for sensitivity, miss rates as high as 93% and 71% “provide little confidence in the [accuracy of the] test,” Dr. Lee said.

Positive and negative predictive values, however, are more clinically relevant measures of a screening test. These numbers indicate how likely it is that a patient’s results are true and therefore how worried they should be about a positive result and how much they should trust a negative result.

Galleri’s data in the over-50 population and Dr. Shukla’s in first responders suggest the test’s negative predictive value is very high – 98.6% and 98.1%, respectively – which means most people can trust a negative test result.

The positive predictive value, however, was less straightforward. In first responders, Dr. Shukla found that only half of positive Galleri tests were confirmed cases of cancer. And an analysis of Grail’s data found that only 38% of positive Galleri tests – 35 of 92 tests – represented a validated cancer diagnosis.

“In a clinical setting, positive predictive value is more usable for decision-making for the patient,” said Dr. Lee. “Positive predictive value isn’t always high, because everything doesn’t always transfer perfectly to the clinic.” But in the general population, if only 38% of patients with positive Galleri results truly have cancer, the test is “not quite useful to make a decision for the patient or the providers.”

Galleri may also be a costly prospect for patients, no matter the result, cautioned Electra Paskett, PhD, an epidemiologist and cancer screening expert at Ohio State University, Columbus. A positive Galleri test leads to a cascade of follow-up diagnostic tests, which payers may not cover. For a negative result, Galleri recommends that the patient undergo screening again in a year, at an annual cost of $950 plus the cost of any follow-up testing when Galleri does pick something up.

“If a provider wants to offer the Galleri test, all those things need to be made abundantly clear, in my opinion,” Dr. Paskett said.

Following the negative Galleri test, Mr. Arenz’s cancer didn’t slip through the cracks because he received other advanced imaging free of charge. But whether all doctors will go to such lengths to back up Galleri results, even for patients with negative results, is unknown.

A negative result can give patients “a huge false sense of security,” said Dr. Shukla. And if a test is positive, the workup isn’t simple. Chasing cancer, especially one that’s not really there, can be nerve-wracking and expensive.

The question, then, is why perform the Galleri test at all if results require so much validation?

Dr. Parikh explained that a high-risk group such as firefighters represents an ideal-use case for Galleri and other liquid biopsy tests. But she noted that she would be “wary of the ability of the system to manage this test en masse” were the test to be used more widely in the general population.

Dr. Shukla said it’s less about the results she’s getting today and more about making the test more effective for her patients in the future. First responders need a test such as this that can quickly identify multiple cancers. However, to improve the test, Grail needs more data from this high-risk population. That’s what she’s after.

Mr. Curtis doesn’t regret taking the Galleri test. The emotional toll of thinking he had cancer for a few days wasn’t too high a price, in his opinion. It’s part of cancer screening. But he acknowledged that it would have been a much more burdensome experience had he’d been financially responsible for the workup or if he hadn’t had Dr. Shukla to manage his case from start to finish.

Because it was free, Mr. Arenz doesn’t regret undergoing the Galleri test either. But he tells his coworkers to check the site, do their research, and get more screening.

“Any medical center that’s just doing this one test, you just have to be careful,” Dr. Shukla said. “It’s not that easy.”

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

In January 2022, Anthony Arenz, a 51-year-old living in Mesa, Ariz., breathed a small sigh of relief.

The Galleri blood test, which screens for 50 types of cancer, hadn’t detected any positive signs.

It would be welcome news to anyone but especially to a firefighter with a 9% greater risk of developing cancer and a 14% greater risk of dying from it than the average person. The Mesa unit had lost two servicemen to cancer in the past 3 years. Both were more than a decade younger than Mr. Arenz.

When the city of Mesa offered additional free screening – including a full-body MRI – to firefighters over 50, Mr. Arenz initially shrugged it off. With a negative Galleri test in hand, he didn’t want to spend more time dwelling on it.

Still, he began to feel a creeping guilt for skipping a test that many of his fallen colleagues hadn’t been offered. He tried to soothe his anxiety with research. A look through the company’s website didn’t set him at ease. According to Grail Bio, a test result of “no cancer signal detected” does not rule out cancer.

Mr. Arenz booked his free MRI.

The results left him heavy: stage I kidney cancer. The Galleri test had missed it.

Mr. Arenz received his free Galleri test through a cancer screening program funded by the city of Mesa. The program is housed at Vincere Cancer Center in Scottsdale, Ariz. Under the leadership of radiation oncologist and Vincere co-owner Vershalee Shukla, MD, the program currently screens first responders in more than 10 Arizona cities at no cost to them.

Vincere began using Galleri shortly after the test launched for consumers in June 2021. Since then, the first responder program has become the largest commercial user of the test in North America.

But the ability of the Galleri test to identify cancer and, perhaps more importantly, the fallout from erroneous results have been under scrutiny since the test’s launch. The Galleri test, which has not yet been approved by the Food and Drug Administration, is so new that few know what incorrect results look like in practice and how often they might occur.

After running the test on about 2,000 servicemen and servicewomen, Dr. Shukla can offer some insight about the test’s real-world value in a high-risk population.

“Cancer screening is a very complicated issue,” Dr. Shukla said in an interview. “Being honest, the tests are good but are not ready yet [for wider use].”

Mr. Arenz was not the only firefighter who got a surprise after taking a Galleri test.

In nearby Phoenix, 51-year-old firefighter Mike Curtis knew his risk for cancer was high, but he wasn’t that worried. Mr. Curtis had been running into fires since he was 17. His dad, also a firefighter, had died of cancer at age 58.

Mr. Curtis had taken the Vincere Cancer Center up on every free screening service since the program began in late 2018 – well before Dr. Shukla started using Galleri in 2021. His most recent lung CT was clear. But he underwent the Galleri test just to stay vigilant.

His result was a shock. The test detected signs of cancer.

Mr. Curtis decided to tell no one, not even his wife. He’d bear the bad news alone until he was certain.

Dr. Shukla, however, immediately doubted the blood test result. She expedited several follow-up tests. One week, a PET, and CT of the abdomen and pelvis later, her hunch was confirmed. The Galleri test result was wrong, Mr. Curtis did not have cancer.

The price of his peace of mind: an extensive workup with a $4,000 price tag. Fortunately, the bill was covered by the screening program.

Overall, in just over 18 months of using the blood test, Dr. Shukla has only encountered 1 other false positive out of about 2,000 Galleri results.

She also discovered two positive signals for cancer using Galleri that were confirmed with follow-up tests. One was a chordoma, a rare type of bone cancer, and the other was a squamous cell carcinoma of the head and neck. The Galleri test caught both remarkably early, in time for treatment.

For Dr. Shukla, however, false negatives were particularly “horrible.” Mr. Arenz’s was just 1 of 28 cancers that the blood test missed. And because 500 negative tests are yet to be validated, the 28 false negatives may be an underestimate.

In her experience, the binary test result – a simple positive or negative cancer signal – is an oversimplification of risk, she said. It “gives a false perception that you have cancer or you don’t,” although the test itself is not definitive.

Grail senior medical director Whitney Jones, MD, agreed that the test is not meant to be a stand-alone screening test for cancer. The purpose of the Galleri test is to “complement other screenings, not replace them,” Dr. Jones told this news organization.

According to an analysis of Galleri data and Dr. Shukla’s experience, the test’s specificity was over 99%. That means the test successfully minimizes false positives.

But the test’s sensitivity was much lower. From data from first responders, Dr. Shukla determined the sensitivity to be 6.7%. That means the test misses about 93 of every 100 cancers. According to Grail’s latest data from more than 6,300 people older than 50, the test’s sensitivity was 29%.

Specificity and sensitivity are metrics used to credential a test and establish confidence in its ability to detect the target disease. A test with high specificity can correctly identify patients who do not have the condition in question, while a test with high sensitivity can correctly identify patients who do have the disease. But there are trade-offs between sensitivity and specificity. One value is increased at the expense of the other.

It’s normal for a cancer screening test to prioritize specificity, according to Aparna Parikh, MD, an oncologist at Mass General Cancer Center in Boston. In a test like Galleri, which is meant to be an adjunct to other screening modalities, “at least we are seeing a good specificity, which is important, because we don’t want false positives, where the downstream impact on the patient can be high.”

Overall, Dr. Jones said, Grail Bio’s aim is to build a test that’s sensitive enough to catch the most dangerous cancers without inundating the healthcare system with false positives. In addition, Dr. Jones explained, sensitivity varies by cancer type. It tends to be lower for cancers for which other screening modalities are available, as well as for earlier-stage disease.

However, the Galleri sensitivity values are “a little bit scary,” said Ji-Hyun Lee, DrPH, professor of biostatistics at the University of Florida and director of the division of quantitative sciences at the University of Florida Health Cancer Center, both in Gainesville. Dr. Lee, who is not affiliated with Grail, reviewed the company’s publicly available data as well as Dr. Shukla’s data at the request of this news organization.

While there’s no definitive threshold for sensitivity, miss rates as high as 93% and 71% “provide little confidence in the [accuracy of the] test,” Dr. Lee said.

Positive and negative predictive values, however, are more clinically relevant measures of a screening test. These numbers indicate how likely it is that a patient’s results are true and therefore how worried they should be about a positive result and how much they should trust a negative result.

Galleri’s data in the over-50 population and Dr. Shukla’s in first responders suggest the test’s negative predictive value is very high – 98.6% and 98.1%, respectively – which means most people can trust a negative test result.

The positive predictive value, however, was less straightforward. In first responders, Dr. Shukla found that only half of positive Galleri tests were confirmed cases of cancer. And an analysis of Grail’s data found that only 38% of positive Galleri tests – 35 of 92 tests – represented a validated cancer diagnosis.

“In a clinical setting, positive predictive value is more usable for decision-making for the patient,” said Dr. Lee. “Positive predictive value isn’t always high, because everything doesn’t always transfer perfectly to the clinic.” But in the general population, if only 38% of patients with positive Galleri results truly have cancer, the test is “not quite useful to make a decision for the patient or the providers.”

Galleri may also be a costly prospect for patients, no matter the result, cautioned Electra Paskett, PhD, an epidemiologist and cancer screening expert at Ohio State University, Columbus. A positive Galleri test leads to a cascade of follow-up diagnostic tests, which payers may not cover. For a negative result, Galleri recommends that the patient undergo screening again in a year, at an annual cost of $950 plus the cost of any follow-up testing when Galleri does pick something up.

“If a provider wants to offer the Galleri test, all those things need to be made abundantly clear, in my opinion,” Dr. Paskett said.

Following the negative Galleri test, Mr. Arenz’s cancer didn’t slip through the cracks because he received other advanced imaging free of charge. But whether all doctors will go to such lengths to back up Galleri results, even for patients with negative results, is unknown.

A negative result can give patients “a huge false sense of security,” said Dr. Shukla. And if a test is positive, the workup isn’t simple. Chasing cancer, especially one that’s not really there, can be nerve-wracking and expensive.

The question, then, is why perform the Galleri test at all if results require so much validation?

Dr. Parikh explained that a high-risk group such as firefighters represents an ideal-use case for Galleri and other liquid biopsy tests. But she noted that she would be “wary of the ability of the system to manage this test en masse” were the test to be used more widely in the general population.

Dr. Shukla said it’s less about the results she’s getting today and more about making the test more effective for her patients in the future. First responders need a test such as this that can quickly identify multiple cancers. However, to improve the test, Grail needs more data from this high-risk population. That’s what she’s after.

Mr. Curtis doesn’t regret taking the Galleri test. The emotional toll of thinking he had cancer for a few days wasn’t too high a price, in his opinion. It’s part of cancer screening. But he acknowledged that it would have been a much more burdensome experience had he’d been financially responsible for the workup or if he hadn’t had Dr. Shukla to manage his case from start to finish.

Because it was free, Mr. Arenz doesn’t regret undergoing the Galleri test either. But he tells his coworkers to check the site, do their research, and get more screening.

“Any medical center that’s just doing this one test, you just have to be careful,” Dr. Shukla said. “It’s not that easy.”

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

In January 2022, Anthony Arenz, a 51-year-old living in Mesa, Ariz., breathed a small sigh of relief.

The Galleri blood test, which screens for 50 types of cancer, hadn’t detected any positive signs.

It would be welcome news to anyone but especially to a firefighter with a 9% greater risk of developing cancer and a 14% greater risk of dying from it than the average person. The Mesa unit had lost two servicemen to cancer in the past 3 years. Both were more than a decade younger than Mr. Arenz.

When the city of Mesa offered additional free screening – including a full-body MRI – to firefighters over 50, Mr. Arenz initially shrugged it off. With a negative Galleri test in hand, he didn’t want to spend more time dwelling on it.

Still, he began to feel a creeping guilt for skipping a test that many of his fallen colleagues hadn’t been offered. He tried to soothe his anxiety with research. A look through the company’s website didn’t set him at ease. According to Grail Bio, a test result of “no cancer signal detected” does not rule out cancer.

Mr. Arenz booked his free MRI.

The results left him heavy: stage I kidney cancer. The Galleri test had missed it.

Mr. Arenz received his free Galleri test through a cancer screening program funded by the city of Mesa. The program is housed at Vincere Cancer Center in Scottsdale, Ariz. Under the leadership of radiation oncologist and Vincere co-owner Vershalee Shukla, MD, the program currently screens first responders in more than 10 Arizona cities at no cost to them.

Vincere began using Galleri shortly after the test launched for consumers in June 2021. Since then, the first responder program has become the largest commercial user of the test in North America.

But the ability of the Galleri test to identify cancer and, perhaps more importantly, the fallout from erroneous results have been under scrutiny since the test’s launch. The Galleri test, which has not yet been approved by the Food and Drug Administration, is so new that few know what incorrect results look like in practice and how often they might occur.

After running the test on about 2,000 servicemen and servicewomen, Dr. Shukla can offer some insight about the test’s real-world value in a high-risk population.

“Cancer screening is a very complicated issue,” Dr. Shukla said in an interview. “Being honest, the tests are good but are not ready yet [for wider use].”

Mr. Arenz was not the only firefighter who got a surprise after taking a Galleri test.

In nearby Phoenix, 51-year-old firefighter Mike Curtis knew his risk for cancer was high, but he wasn’t that worried. Mr. Curtis had been running into fires since he was 17. His dad, also a firefighter, had died of cancer at age 58.

Mr. Curtis had taken the Vincere Cancer Center up on every free screening service since the program began in late 2018 – well before Dr. Shukla started using Galleri in 2021. His most recent lung CT was clear. But he underwent the Galleri test just to stay vigilant.

His result was a shock. The test detected signs of cancer.

Mr. Curtis decided to tell no one, not even his wife. He’d bear the bad news alone until he was certain.

Dr. Shukla, however, immediately doubted the blood test result. She expedited several follow-up tests. One week, a PET, and CT of the abdomen and pelvis later, her hunch was confirmed. The Galleri test result was wrong, Mr. Curtis did not have cancer.

The price of his peace of mind: an extensive workup with a $4,000 price tag. Fortunately, the bill was covered by the screening program.

Overall, in just over 18 months of using the blood test, Dr. Shukla has only encountered 1 other false positive out of about 2,000 Galleri results.

She also discovered two positive signals for cancer using Galleri that were confirmed with follow-up tests. One was a chordoma, a rare type of bone cancer, and the other was a squamous cell carcinoma of the head and neck. The Galleri test caught both remarkably early, in time for treatment.

For Dr. Shukla, however, false negatives were particularly “horrible.” Mr. Arenz’s was just 1 of 28 cancers that the blood test missed. And because 500 negative tests are yet to be validated, the 28 false negatives may be an underestimate.

In her experience, the binary test result – a simple positive or negative cancer signal – is an oversimplification of risk, she said. It “gives a false perception that you have cancer or you don’t,” although the test itself is not definitive.

Grail senior medical director Whitney Jones, MD, agreed that the test is not meant to be a stand-alone screening test for cancer. The purpose of the Galleri test is to “complement other screenings, not replace them,” Dr. Jones told this news organization.

According to an analysis of Galleri data and Dr. Shukla’s experience, the test’s specificity was over 99%. That means the test successfully minimizes false positives.

But the test’s sensitivity was much lower. From data from first responders, Dr. Shukla determined the sensitivity to be 6.7%. That means the test misses about 93 of every 100 cancers. According to Grail’s latest data from more than 6,300 people older than 50, the test’s sensitivity was 29%.

Specificity and sensitivity are metrics used to credential a test and establish confidence in its ability to detect the target disease. A test with high specificity can correctly identify patients who do not have the condition in question, while a test with high sensitivity can correctly identify patients who do have the disease. But there are trade-offs between sensitivity and specificity. One value is increased at the expense of the other.

It’s normal for a cancer screening test to prioritize specificity, according to Aparna Parikh, MD, an oncologist at Mass General Cancer Center in Boston. In a test like Galleri, which is meant to be an adjunct to other screening modalities, “at least we are seeing a good specificity, which is important, because we don’t want false positives, where the downstream impact on the patient can be high.”

Overall, Dr. Jones said, Grail Bio’s aim is to build a test that’s sensitive enough to catch the most dangerous cancers without inundating the healthcare system with false positives. In addition, Dr. Jones explained, sensitivity varies by cancer type. It tends to be lower for cancers for which other screening modalities are available, as well as for earlier-stage disease.

However, the Galleri sensitivity values are “a little bit scary,” said Ji-Hyun Lee, DrPH, professor of biostatistics at the University of Florida and director of the division of quantitative sciences at the University of Florida Health Cancer Center, both in Gainesville. Dr. Lee, who is not affiliated with Grail, reviewed the company’s publicly available data as well as Dr. Shukla’s data at the request of this news organization.

While there’s no definitive threshold for sensitivity, miss rates as high as 93% and 71% “provide little confidence in the [accuracy of the] test,” Dr. Lee said.

Positive and negative predictive values, however, are more clinically relevant measures of a screening test. These numbers indicate how likely it is that a patient’s results are true and therefore how worried they should be about a positive result and how much they should trust a negative result.

Galleri’s data in the over-50 population and Dr. Shukla’s in first responders suggest the test’s negative predictive value is very high – 98.6% and 98.1%, respectively – which means most people can trust a negative test result.

The positive predictive value, however, was less straightforward. In first responders, Dr. Shukla found that only half of positive Galleri tests were confirmed cases of cancer. And an analysis of Grail’s data found that only 38% of positive Galleri tests – 35 of 92 tests – represented a validated cancer diagnosis.

“In a clinical setting, positive predictive value is more usable for decision-making for the patient,” said Dr. Lee. “Positive predictive value isn’t always high, because everything doesn’t always transfer perfectly to the clinic.” But in the general population, if only 38% of patients with positive Galleri results truly have cancer, the test is “not quite useful to make a decision for the patient or the providers.”

Galleri may also be a costly prospect for patients, no matter the result, cautioned Electra Paskett, PhD, an epidemiologist and cancer screening expert at Ohio State University, Columbus. A positive Galleri test leads to a cascade of follow-up diagnostic tests, which payers may not cover. For a negative result, Galleri recommends that the patient undergo screening again in a year, at an annual cost of $950 plus the cost of any follow-up testing when Galleri does pick something up.

“If a provider wants to offer the Galleri test, all those things need to be made abundantly clear, in my opinion,” Dr. Paskett said.

Following the negative Galleri test, Mr. Arenz’s cancer didn’t slip through the cracks because he received other advanced imaging free of charge. But whether all doctors will go to such lengths to back up Galleri results, even for patients with negative results, is unknown.

A negative result can give patients “a huge false sense of security,” said Dr. Shukla. And if a test is positive, the workup isn’t simple. Chasing cancer, especially one that’s not really there, can be nerve-wracking and expensive.

The question, then, is why perform the Galleri test at all if results require so much validation?

Dr. Parikh explained that a high-risk group such as firefighters represents an ideal-use case for Galleri and other liquid biopsy tests. But she noted that she would be “wary of the ability of the system to manage this test en masse” were the test to be used more widely in the general population.

Dr. Shukla said it’s less about the results she’s getting today and more about making the test more effective for her patients in the future. First responders need a test such as this that can quickly identify multiple cancers. However, to improve the test, Grail needs more data from this high-risk population. That’s what she’s after.

Mr. Curtis doesn’t regret taking the Galleri test. The emotional toll of thinking he had cancer for a few days wasn’t too high a price, in his opinion. It’s part of cancer screening. But he acknowledged that it would have been a much more burdensome experience had he’d been financially responsible for the workup or if he hadn’t had Dr. Shukla to manage his case from start to finish.

Because it was free, Mr. Arenz doesn’t regret undergoing the Galleri test either. But he tells his coworkers to check the site, do their research, and get more screening.

“Any medical center that’s just doing this one test, you just have to be careful,” Dr. Shukla said. “It’s not that easy.”

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

Women across the world face high levels of financial burden from breast cancer, a new systematic review and analysis finds. While the burden of the disease is much higher in less-developed countries, about a third of women in Western nations like the United States say the disease has hurt their financial well-being.

When it comes to financial burden, patients with breast cancer are “a highly vulnerable patient population,” said study coauthor Kavitha Ranganathan, MD, of Brigham and Women’s Hospital, Boston, in an interview. “We need to be both strategic and comprehensive with our approach and use evidence-based methods to come up with these comprehensive solutions,” said Dr. Ranganathan, who noted that she’s hearing more from patients who face monetary hurdles.

The findings were published online in JAMA Network Open.

The researchers believe their analysis is the first to attempt to understand financial toxicity (FT) – excessive financial burden – in breast cancer on a global level. This turned out to be a challenge since there’s no standard way to measure FT.

One approach is to look at financial burden in terms of whether patients are suffering from “catastrophic expenditure,” Dr. Ranganathan said. “That’s what the World Bank and other top health and economic organizations have focused on. It means that the cost of care and – whatever it takes to get care – exceeds 10% of total annual household income.”

Another approach is more subjective and based on patient-reported outcomes, she said: “Are patients having to forgo basic subsistence needs like rent and food?”

For the report, researchers analyzed studies that use both approaches to measure FT from breast cancer. The studies came from high-income countries (n = 24, including 19 from the United States) and middle- and low-income countries (n = 10), and ranged in size from 5 to 2,445 subjects.

The analyzed studies were a range of cross-sectional (n = 26), prospective (n = 7), and retrospective designs (n = 1).

The authors pooled the data from 18 studies and estimated that the rate of patients with FT was 35.3% (14 studies, 27.3%-44.4%) in high-income countries and 78.8% (4 studies, 60.4%-90.0%) in the other countries.

The researchers also conducted a separate pooled analysis of only the U.S. studies (n = 11). It found that 34% (27%-43%) of subjects reported FT. The researchers also conducted a new analysis of Canada-only studies (n = 2) and found that 19% (9%-35%) reported FT.

The researchers weren’t able to provide insight into trends in FT in the United States prior to the period of the studies (2014-2021). But raw numbers suggest the percentage of patients facing financial challenges rose over that time, suggesting a possible increase in burden.

Previous research has suggested that breast cancer poses a higher financial burden than other chronic conditions. “Breast cancer care in particular may be associated with high FT given the need for screening and diagnosis, multidisciplinary care, and longitudinal follow-up,” the researchers write. They add that “notably, gender also affects financial security.”

As for limitations, the researchers report that they only analyzed studies in English, and there was a wide variation in approaches used to analyze FT. The analysis “did not account for different health care systems or control for health care–dedicated gross domestic product,” meaning that there’s no way to know for sure that rates were lower in nations with universal health care.

How could the new findings be useful? “They’re eye-opening for health policymakers. Whenever they see these numbers, they will say, ‘Wow, it is really a problem,’ and they’ll start thinking about solutions,” said study coauthor Rania A. Mekary, PhD, MSc, MSc, of Massachusetts College of Pharmacy and Health Sciences in Boston. “When you give them evidence-based data, then they will take it more seriously.”

The researchers call for interventions in several areas including education about early diagnosis and treatment of breast cancer, expansion of health care coverage, programs to help with nonmedical costs, and better resources for breast cancer care.

In an interview, Mary C. Politi, PhD, of Washington University, St. Louis, said the new report is useful “because it examines financial hardship internationally. Some people wonder whether financial hardship is a U.S. problem because of our health care system, which often relies on insurance and a lot of cost-sharing between insurance and patients. However, financial toxicity is prevalent across countries.”

And, she said, “the study is also useful because it encourages us to measure financial hardship and burden in a more uniform way so we can better compare and pool studies.”

Dr. Politi noted that there are ways to help patients now. “Most hospitals and health centers have staff who can talk to patients about their bills. Sometimes, a payment plan can be set up to space out payments,” she said. “Health care teams can try to consolidate care for patients on the same day to reduce parking expenses or time off for work or child care. Sometimes, changing to less expensive but effective generic medications is an option.”

The study authors received support from the National Cancer Institute, the United Nations Institute for Training and Research, the Global Surgery Foundation, the Harvard Global Health Institute, the Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan and Dr. Mekary report no disclosures. One coauthor reported a patent (BREAST-Q) and codevelopment of QPROMS, owned by Memorial Sloan Kettering Cancer Center. Another author reports salary support from Blue Cross Blue Shield of Michigan through the collaborative quality initiative known as Michigan Social Health Interventions to Eliminate Disparities. Dr. Politi has no disclosures.

Women across the world face high levels of financial burden from breast cancer, a new systematic review and analysis finds. While the burden of the disease is much higher in less-developed countries, about a third of women in Western nations like the United States say the disease has hurt their financial well-being.

When it comes to financial burden, patients with breast cancer are “a highly vulnerable patient population,” said study coauthor Kavitha Ranganathan, MD, of Brigham and Women’s Hospital, Boston, in an interview. “We need to be both strategic and comprehensive with our approach and use evidence-based methods to come up with these comprehensive solutions,” said Dr. Ranganathan, who noted that she’s hearing more from patients who face monetary hurdles.

The findings were published online in JAMA Network Open.

The researchers believe their analysis is the first to attempt to understand financial toxicity (FT) – excessive financial burden – in breast cancer on a global level. This turned out to be a challenge since there’s no standard way to measure FT.

One approach is to look at financial burden in terms of whether patients are suffering from “catastrophic expenditure,” Dr. Ranganathan said. “That’s what the World Bank and other top health and economic organizations have focused on. It means that the cost of care and – whatever it takes to get care – exceeds 10% of total annual household income.”

Another approach is more subjective and based on patient-reported outcomes, she said: “Are patients having to forgo basic subsistence needs like rent and food?”

For the report, researchers analyzed studies that use both approaches to measure FT from breast cancer. The studies came from high-income countries (n = 24, including 19 from the United States) and middle- and low-income countries (n = 10), and ranged in size from 5 to 2,445 subjects.

The analyzed studies were a range of cross-sectional (n = 26), prospective (n = 7), and retrospective designs (n = 1).

The authors pooled the data from 18 studies and estimated that the rate of patients with FT was 35.3% (14 studies, 27.3%-44.4%) in high-income countries and 78.8% (4 studies, 60.4%-90.0%) in the other countries.

The researchers also conducted a separate pooled analysis of only the U.S. studies (n = 11). It found that 34% (27%-43%) of subjects reported FT. The researchers also conducted a new analysis of Canada-only studies (n = 2) and found that 19% (9%-35%) reported FT.

The researchers weren’t able to provide insight into trends in FT in the United States prior to the period of the studies (2014-2021). But raw numbers suggest the percentage of patients facing financial challenges rose over that time, suggesting a possible increase in burden.

Previous research has suggested that breast cancer poses a higher financial burden than other chronic conditions. “Breast cancer care in particular may be associated with high FT given the need for screening and diagnosis, multidisciplinary care, and longitudinal follow-up,” the researchers write. They add that “notably, gender also affects financial security.”

As for limitations, the researchers report that they only analyzed studies in English, and there was a wide variation in approaches used to analyze FT. The analysis “did not account for different health care systems or control for health care–dedicated gross domestic product,” meaning that there’s no way to know for sure that rates were lower in nations with universal health care.

How could the new findings be useful? “They’re eye-opening for health policymakers. Whenever they see these numbers, they will say, ‘Wow, it is really a problem,’ and they’ll start thinking about solutions,” said study coauthor Rania A. Mekary, PhD, MSc, MSc, of Massachusetts College of Pharmacy and Health Sciences in Boston. “When you give them evidence-based data, then they will take it more seriously.”

The researchers call for interventions in several areas including education about early diagnosis and treatment of breast cancer, expansion of health care coverage, programs to help with nonmedical costs, and better resources for breast cancer care.

In an interview, Mary C. Politi, PhD, of Washington University, St. Louis, said the new report is useful “because it examines financial hardship internationally. Some people wonder whether financial hardship is a U.S. problem because of our health care system, which often relies on insurance and a lot of cost-sharing between insurance and patients. However, financial toxicity is prevalent across countries.”

And, she said, “the study is also useful because it encourages us to measure financial hardship and burden in a more uniform way so we can better compare and pool studies.”

Dr. Politi noted that there are ways to help patients now. “Most hospitals and health centers have staff who can talk to patients about their bills. Sometimes, a payment plan can be set up to space out payments,” she said. “Health care teams can try to consolidate care for patients on the same day to reduce parking expenses or time off for work or child care. Sometimes, changing to less expensive but effective generic medications is an option.”

The study authors received support from the National Cancer Institute, the United Nations Institute for Training and Research, the Global Surgery Foundation, the Harvard Global Health Institute, the Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan and Dr. Mekary report no disclosures. One coauthor reported a patent (BREAST-Q) and codevelopment of QPROMS, owned by Memorial Sloan Kettering Cancer Center. Another author reports salary support from Blue Cross Blue Shield of Michigan through the collaborative quality initiative known as Michigan Social Health Interventions to Eliminate Disparities. Dr. Politi has no disclosures.

Women across the world face high levels of financial burden from breast cancer, a new systematic review and analysis finds. While the burden of the disease is much higher in less-developed countries, about a third of women in Western nations like the United States say the disease has hurt their financial well-being.

When it comes to financial burden, patients with breast cancer are “a highly vulnerable patient population,” said study coauthor Kavitha Ranganathan, MD, of Brigham and Women’s Hospital, Boston, in an interview. “We need to be both strategic and comprehensive with our approach and use evidence-based methods to come up with these comprehensive solutions,” said Dr. Ranganathan, who noted that she’s hearing more from patients who face monetary hurdles.

The findings were published online in JAMA Network Open.

The researchers believe their analysis is the first to attempt to understand financial toxicity (FT) – excessive financial burden – in breast cancer on a global level. This turned out to be a challenge since there’s no standard way to measure FT.

One approach is to look at financial burden in terms of whether patients are suffering from “catastrophic expenditure,” Dr. Ranganathan said. “That’s what the World Bank and other top health and economic organizations have focused on. It means that the cost of care and – whatever it takes to get care – exceeds 10% of total annual household income.”

Another approach is more subjective and based on patient-reported outcomes, she said: “Are patients having to forgo basic subsistence needs like rent and food?”

For the report, researchers analyzed studies that use both approaches to measure FT from breast cancer. The studies came from high-income countries (n = 24, including 19 from the United States) and middle- and low-income countries (n = 10), and ranged in size from 5 to 2,445 subjects.

The analyzed studies were a range of cross-sectional (n = 26), prospective (n = 7), and retrospective designs (n = 1).

The authors pooled the data from 18 studies and estimated that the rate of patients with FT was 35.3% (14 studies, 27.3%-44.4%) in high-income countries and 78.8% (4 studies, 60.4%-90.0%) in the other countries.

The researchers also conducted a separate pooled analysis of only the U.S. studies (n = 11). It found that 34% (27%-43%) of subjects reported FT. The researchers also conducted a new analysis of Canada-only studies (n = 2) and found that 19% (9%-35%) reported FT.

The researchers weren’t able to provide insight into trends in FT in the United States prior to the period of the studies (2014-2021). But raw numbers suggest the percentage of patients facing financial challenges rose over that time, suggesting a possible increase in burden.

Previous research has suggested that breast cancer poses a higher financial burden than other chronic conditions. “Breast cancer care in particular may be associated with high FT given the need for screening and diagnosis, multidisciplinary care, and longitudinal follow-up,” the researchers write. They add that “notably, gender also affects financial security.”

As for limitations, the researchers report that they only analyzed studies in English, and there was a wide variation in approaches used to analyze FT. The analysis “did not account for different health care systems or control for health care–dedicated gross domestic product,” meaning that there’s no way to know for sure that rates were lower in nations with universal health care.

How could the new findings be useful? “They’re eye-opening for health policymakers. Whenever they see these numbers, they will say, ‘Wow, it is really a problem,’ and they’ll start thinking about solutions,” said study coauthor Rania A. Mekary, PhD, MSc, MSc, of Massachusetts College of Pharmacy and Health Sciences in Boston. “When you give them evidence-based data, then they will take it more seriously.”

The researchers call for interventions in several areas including education about early diagnosis and treatment of breast cancer, expansion of health care coverage, programs to help with nonmedical costs, and better resources for breast cancer care.

In an interview, Mary C. Politi, PhD, of Washington University, St. Louis, said the new report is useful “because it examines financial hardship internationally. Some people wonder whether financial hardship is a U.S. problem because of our health care system, which often relies on insurance and a lot of cost-sharing between insurance and patients. However, financial toxicity is prevalent across countries.”

And, she said, “the study is also useful because it encourages us to measure financial hardship and burden in a more uniform way so we can better compare and pool studies.”

Dr. Politi noted that there are ways to help patients now. “Most hospitals and health centers have staff who can talk to patients about their bills. Sometimes, a payment plan can be set up to space out payments,” she said. “Health care teams can try to consolidate care for patients on the same day to reduce parking expenses or time off for work or child care. Sometimes, changing to less expensive but effective generic medications is an option.”

The study authors received support from the National Cancer Institute, the United Nations Institute for Training and Research, the Global Surgery Foundation, the Harvard Global Health Institute, the Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan and Dr. Mekary report no disclosures. One coauthor reported a patent (BREAST-Q) and codevelopment of QPROMS, owned by Memorial Sloan Kettering Cancer Center. Another author reports salary support from Blue Cross Blue Shield of Michigan through the collaborative quality initiative known as Michigan Social Health Interventions to Eliminate Disparities. Dr. Politi has no disclosures.

Continuous glucose monitoring (CGM) is gaining ground with both patients and providers because of an array of driving forces, including broadening eligibility, insulin price caps, public awareness, and an increasing number of educational initiatives for doctors.

While professional organizations aim to familiarize doctors with this relatively new technology, more patients are learning independently that finger sticks may be optional, leading them to request CGM from their provider, according to Neil Skolnik, MD.

Overview of online resources and navigating coverage

The latest learning resource on CGM for physicians comes from the American Academy of Family Physicians in the form of a new online educational hub with a 2-credit, ACCME-accredited course. It offers comprehensive guidance for employing CGM in daily practice. Topics include both medical and practical considerations, from interpretation of curves and glucose goal-setting to choosing a device and navigating coverage.

The AAFP’s new offering joins a growing number of similar educational efforts launched over the past few years by the Association of Diabetes Care & Education Specialists, the American Pharmacists Association, the American Diabetes Association, and the American Association of Clinical Endocrinologists.

Checking for coverage is a key first step when considering CGM for a particular patient, Dr. Jones said, noting that CGM, like any new form of care, presents unique challenges with coding and claims that must be overcome to get reimbursed.

“No margin, no mission,” Dr. Jones said. “If you are not able to pay your bills, you can’t be available for your patients. Our goal at the AAFP is to make sure that physicians get this knowledge [about reimbursement].”

To this end, the AAFP’s new online educational hub and the guide provided by APhA present CGM eligibility criteria for various patient groups, including those with Medicare, Medicaid, private insurance, and without coverage.

Medicare criteria include a diagnosis of diabetes, treatment with three or more daily administrations of insulin or continuous infusion via a pump, frequent adjustment to insulin treatment based on glucose readings, and presentation for diabetes in the past 6 months.

Once these requirements are clearly documented in the patient’s record, providers need to write the script, complete a certificate of medical necessity, and choose a supplier. Medicare covers CGM as a durable medical equipment benefit instead of a pharmacy benefit, according to the AAFP and APhA.

Exact coverage criteria and reimbursement processes for non-Medicare patients follow similar paths, although details vary by state and insurer, so personalized investigation is required.

When exploring coverage, the AAFP recommends paying attention to information needed for prior authorization, the patient’s diabetes type and age, and other medical requirements, such as minimum number of daily finger sticks or insulin doses per day.

Looking ahead, Dr. Jones predicted that authorization obstacles stemming from short-term cost concerns are going to fade as long-term savings are uncovered.

“I think pharmacy benefit managers and payers are going to recognize that we have better patient compliance, and that continuous glucose monitoring is going to bring the cost of care down and decrease the rate of hospitalizations,” Dr. Jones said. “So I think they’re going to be willing to pay clinicians to engage in this more readily over time.”

Patients who fail to qualify for personal CGM can still benefit from professional CGM, in which they borrow necessary equipment on a short-term basis. This avenue typically requires minimal or no insurance authorization. In addition, providers have the “opportunity to cover/exceed expenses by enhancing revenue with separately billable procedures, which can be billed in addition to [evaluation and management] if done on same day,” according to the AAFP guide, which goes on to provide appropriate codes.
 

Learning CGM through first-hand experience

Getting started with CGM can be intimidating for providers, Dr. Skolnik said, although he offered some reassurance, suggesting that the learning process may be more forgiving than prescribing a new drug for the first time.

“I think the best way to figure out CGM is to prescribe it to a couple of patients and learn with them,” Dr. Skolnik said. “You can’t do that with medicines. With medicines, you need to know what you’re doing before you choose who to give a medicine to.”

Courtesy Dr. Neil Skolnik

Encouraging patients to start CGM

Like providers, patients may also be intimidated by CGM, Dr. Jones said, typically because they don’t know how it works, or it seems complicated. Fortunately, he said, these fears are easily overcome when patients learn that they don’t need to stick themselves, record any of their readings, or really do anything at all for the first few weeks.

“You don’t even worry about it,” Dr. Jones tells his patients, who typically feel “more in control and engaged in their own care” after experiencing CGM for themselves.

Dr. Jones speaks from both professional and personal experience. A member of his family recently started CGM after being discharged from the hospital, and the benefits have been significant for everyone involved.

“I see how effectively we can control [my family member’s] blood pressure and insulin requirements, as opposed to several months ago when we didn’t have it,” Dr. Jones said. “So I’m giving it to you from two perspectives: one, of the clinician who knows, intellectually, what should go on, and two, experientially, from a family trying to take care of someone they love.”

Dr. Skolnik disclosed relationships with AstraZeneca, Teva, Lilly, Boehringer Ingelheim, Sanofi, GSK, Bayer, Genentech, Abbott, Idorsia, Merck, Novartis, Heartland, and Novo Nordisk. Dr Jones disclosed no relevant conflicts of interest.

Continuous glucose monitoring (CGM) is gaining ground with both patients and providers because of an array of driving forces, including broadening eligibility, insulin price caps, public awareness, and an increasing number of educational initiatives for doctors.

While professional organizations aim to familiarize doctors with this relatively new technology, more patients are learning independently that finger sticks may be optional, leading them to request CGM from their provider, according to Neil Skolnik, MD.

Overview of online resources and navigating coverage

The latest learning resource on CGM for physicians comes from the American Academy of Family Physicians in the form of a new online educational hub with a 2-credit, ACCME-accredited course. It offers comprehensive guidance for employing CGM in daily practice. Topics include both medical and practical considerations, from interpretation of curves and glucose goal-setting to choosing a device and navigating coverage.

The AAFP’s new offering joins a growing number of similar educational efforts launched over the past few years by the Association of Diabetes Care & Education Specialists, the American Pharmacists Association, the American Diabetes Association, and the American Association of Clinical Endocrinologists.

Checking for coverage is a key first step when considering CGM for a particular patient, Dr. Jones said, noting that CGM, like any new form of care, presents unique challenges with coding and claims that must be overcome to get reimbursed.

“No margin, no mission,” Dr. Jones said. “If you are not able to pay your bills, you can’t be available for your patients. Our goal at the AAFP is to make sure that physicians get this knowledge [about reimbursement].”

To this end, the AAFP’s new online educational hub and the guide provided by APhA present CGM eligibility criteria for various patient groups, including those with Medicare, Medicaid, private insurance, and without coverage.

Medicare criteria include a diagnosis of diabetes, treatment with three or more daily administrations of insulin or continuous infusion via a pump, frequent adjustment to insulin treatment based on glucose readings, and presentation for diabetes in the past 6 months.

Once these requirements are clearly documented in the patient’s record, providers need to write the script, complete a certificate of medical necessity, and choose a supplier. Medicare covers CGM as a durable medical equipment benefit instead of a pharmacy benefit, according to the AAFP and APhA.

Exact coverage criteria and reimbursement processes for non-Medicare patients follow similar paths, although details vary by state and insurer, so personalized investigation is required.

When exploring coverage, the AAFP recommends paying attention to information needed for prior authorization, the patient’s diabetes type and age, and other medical requirements, such as minimum number of daily finger sticks or insulin doses per day.

Looking ahead, Dr. Jones predicted that authorization obstacles stemming from short-term cost concerns are going to fade as long-term savings are uncovered.

“I think pharmacy benefit managers and payers are going to recognize that we have better patient compliance, and that continuous glucose monitoring is going to bring the cost of care down and decrease the rate of hospitalizations,” Dr. Jones said. “So I think they’re going to be willing to pay clinicians to engage in this more readily over time.”

Patients who fail to qualify for personal CGM can still benefit from professional CGM, in which they borrow necessary equipment on a short-term basis. This avenue typically requires minimal or no insurance authorization. In addition, providers have the “opportunity to cover/exceed expenses by enhancing revenue with separately billable procedures, which can be billed in addition to [evaluation and management] if done on same day,” according to the AAFP guide, which goes on to provide appropriate codes.
 

Learning CGM through first-hand experience

Getting started with CGM can be intimidating for providers, Dr. Skolnik said, although he offered some reassurance, suggesting that the learning process may be more forgiving than prescribing a new drug for the first time.

“I think the best way to figure out CGM is to prescribe it to a couple of patients and learn with them,” Dr. Skolnik said. “You can’t do that with medicines. With medicines, you need to know what you’re doing before you choose who to give a medicine to.”

Courtesy Dr. Neil Skolnik

Encouraging patients to start CGM

Like providers, patients may also be intimidated by CGM, Dr. Jones said, typically because they don’t know how it works, or it seems complicated. Fortunately, he said, these fears are easily overcome when patients learn that they don’t need to stick themselves, record any of their readings, or really do anything at all for the first few weeks.

“You don’t even worry about it,” Dr. Jones tells his patients, who typically feel “more in control and engaged in their own care” after experiencing CGM for themselves.

Dr. Jones speaks from both professional and personal experience. A member of his family recently started CGM after being discharged from the hospital, and the benefits have been significant for everyone involved.

“I see how effectively we can control [my family member’s] blood pressure and insulin requirements, as opposed to several months ago when we didn’t have it,” Dr. Jones said. “So I’m giving it to you from two perspectives: one, of the clinician who knows, intellectually, what should go on, and two, experientially, from a family trying to take care of someone they love.”

Dr. Skolnik disclosed relationships with AstraZeneca, Teva, Lilly, Boehringer Ingelheim, Sanofi, GSK, Bayer, Genentech, Abbott, Idorsia, Merck, Novartis, Heartland, and Novo Nordisk. Dr Jones disclosed no relevant conflicts of interest.

Continuous glucose monitoring (CGM) is gaining ground with both patients and providers because of an array of driving forces, including broadening eligibility, insulin price caps, public awareness, and an increasing number of educational initiatives for doctors.

While professional organizations aim to familiarize doctors with this relatively new technology, more patients are learning independently that finger sticks may be optional, leading them to request CGM from their provider, according to Neil Skolnik, MD.

Overview of online resources and navigating coverage

The latest learning resource on CGM for physicians comes from the American Academy of Family Physicians in the form of a new online educational hub with a 2-credit, ACCME-accredited course. It offers comprehensive guidance for employing CGM in daily practice. Topics include both medical and practical considerations, from interpretation of curves and glucose goal-setting to choosing a device and navigating coverage.

The AAFP’s new offering joins a growing number of similar educational efforts launched over the past few years by the Association of Diabetes Care & Education Specialists, the American Pharmacists Association, the American Diabetes Association, and the American Association of Clinical Endocrinologists.

Checking for coverage is a key first step when considering CGM for a particular patient, Dr. Jones said, noting that CGM, like any new form of care, presents unique challenges with coding and claims that must be overcome to get reimbursed.

“No margin, no mission,” Dr. Jones said. “If you are not able to pay your bills, you can’t be available for your patients. Our goal at the AAFP is to make sure that physicians get this knowledge [about reimbursement].”

To this end, the AAFP’s new online educational hub and the guide provided by APhA present CGM eligibility criteria for various patient groups, including those with Medicare, Medicaid, private insurance, and without coverage.

Medicare criteria include a diagnosis of diabetes, treatment with three or more daily administrations of insulin or continuous infusion via a pump, frequent adjustment to insulin treatment based on glucose readings, and presentation for diabetes in the past 6 months.

Once these requirements are clearly documented in the patient’s record, providers need to write the script, complete a certificate of medical necessity, and choose a supplier. Medicare covers CGM as a durable medical equipment benefit instead of a pharmacy benefit, according to the AAFP and APhA.

Exact coverage criteria and reimbursement processes for non-Medicare patients follow similar paths, although details vary by state and insurer, so personalized investigation is required.

When exploring coverage, the AAFP recommends paying attention to information needed for prior authorization, the patient’s diabetes type and age, and other medical requirements, such as minimum number of daily finger sticks or insulin doses per day.

Looking ahead, Dr. Jones predicted that authorization obstacles stemming from short-term cost concerns are going to fade as long-term savings are uncovered.

“I think pharmacy benefit managers and payers are going to recognize that we have better patient compliance, and that continuous glucose monitoring is going to bring the cost of care down and decrease the rate of hospitalizations,” Dr. Jones said. “So I think they’re going to be willing to pay clinicians to engage in this more readily over time.”

Patients who fail to qualify for personal CGM can still benefit from professional CGM, in which they borrow necessary equipment on a short-term basis. This avenue typically requires minimal or no insurance authorization. In addition, providers have the “opportunity to cover/exceed expenses by enhancing revenue with separately billable procedures, which can be billed in addition to [evaluation and management] if done on same day,” according to the AAFP guide, which goes on to provide appropriate codes.
 

Learning CGM through first-hand experience

Getting started with CGM can be intimidating for providers, Dr. Skolnik said, although he offered some reassurance, suggesting that the learning process may be more forgiving than prescribing a new drug for the first time.

“I think the best way to figure out CGM is to prescribe it to a couple of patients and learn with them,” Dr. Skolnik said. “You can’t do that with medicines. With medicines, you need to know what you’re doing before you choose who to give a medicine to.”

Courtesy Dr. Neil Skolnik

Encouraging patients to start CGM

Like providers, patients may also be intimidated by CGM, Dr. Jones said, typically because they don’t know how it works, or it seems complicated. Fortunately, he said, these fears are easily overcome when patients learn that they don’t need to stick themselves, record any of their readings, or really do anything at all for the first few weeks.

“You don’t even worry about it,” Dr. Jones tells his patients, who typically feel “more in control and engaged in their own care” after experiencing CGM for themselves.

Dr. Jones speaks from both professional and personal experience. A member of his family recently started CGM after being discharged from the hospital, and the benefits have been significant for everyone involved.

“I see how effectively we can control [my family member’s] blood pressure and insulin requirements, as opposed to several months ago when we didn’t have it,” Dr. Jones said. “So I’m giving it to you from two perspectives: one, of the clinician who knows, intellectually, what should go on, and two, experientially, from a family trying to take care of someone they love.”

Dr. Skolnik disclosed relationships with AstraZeneca, Teva, Lilly, Boehringer Ingelheim, Sanofi, GSK, Bayer, Genentech, Abbott, Idorsia, Merck, Novartis, Heartland, and Novo Nordisk. Dr Jones disclosed no relevant conflicts of interest.

On June 14, 2017, just before noon, a doctor made an incision near a patient’s groin. Kari Kirk, a representative for the world’s largest medical device company, Medtronic, looked on and began texting her colleague a play-by-play.

“Fixing both legs from the ankles,” she wrote.

It was a fairly common procedure at the Robert J. Dole Veterans Affairs Medical Center in Wichita, Kansas, performed to treat blockages in the leg vessels.

Within reach were an array of Medtronic products: tubes with blades attached to shave hardened deposits off of artery walls; stents to widen blood vessels; balloons coated with therapeutic drugs.

Each time a doctor puts a foreign device in someone’s body, it carries a risk of complication, which can include clots or even require amputation. So medical experts, research and even Medtronic’s own device instructions urge doctors to use as few as are necessary.

But, as revealed in Kirk’s text messages, this doctor took an aggressive approach.

“Just used 12 [drug-coated balloons]!!” Kirk texted her colleague.

“Does that mean I owe u $$,” he responded.

“Thats what I’m thinking!!!” she said. “And now 14 balloons?!”

“but only one stent so far??”

“So far!”

As the texting continued, her colleague replied, “U are going to want to start going to the VA all the time.”

The messages, recently unsealed in an ongoing whistleblower lawsuit, give a window into the way money and medicine mingle in the booming business of peripheral artery disease, a condition that afflicts 6.5 million Americans over age 40 and is caused when fatty plaque builds up in arteries, blocking blood flow to the legs.

Representatives from companies are often present during vascular procedures to guide doctors on how to use their complex devices. This kind of access has the potential to influence treatment plans, as companies and their representatives profit when more of their product is used.

The suit, filed in 2017 by a sales representative for a competing medical device firm, alleges an illegal kickback scheme between Medtronic and hospital employees. According to the complaint and documents released in the suit, between 2011 and 2018, VA health care workers received steakhouse dinners, Apple electronics, and NASCAR tickets, and in turn, Medtronic secured a lucrative contract with the hospital. Meanwhile, the company’s representatives allegedly “groomed and trained” physicians at the facility, who then deployed the company’s devices even when it was not medically indicated.

Independently from the whistleblower suit, internal investigators at the Wichita facility have also examined the treatment patterns of its vascular patients in recent years and found numerous cases where medical devices were used excessively. While it’s not uncommon to deploy several devices, a medical expert on the investigation team found that the VA doctors sometimes used more than 15 at a time – one used 33 – deviating from the standard of care.

“It is unconscionable – there can be no valid medically acceptable basis to cram so many devices into a human being,” wrote attorneys representing the whistleblower in legal filings from January 2023. “This is not medical treatment. This is abuse.”

Dr. Kim Hodgson, former president of the Society for Vascular Surgery and an expert retained by the plaintiff, said the findings of the internal review of patient data raise “a high level of concern regarding necessity of treatment provided,” according to case documents.

Medtronic declined to respond to ProPublica’s questions, citing the ongoing litigation. “These allegations are false and Medtronic is defending against these claims in court,” said Boua Xiong, a spokesperson for the company. Medtronic representative Kirk declined to respond to ProPublica’s request for comment.

The hospital investigation found that amputations increased sixfold in the same time frame as the procedures in question, according to internal emails, but made no conclusion about whether those two things were connected. ProPublica reached out to the VA to ask whether any patients had been harmed.

The VA is “conducting an extensive review of patient care” at the Kansas hospital, “including the number of devices used on patients – to make sure that Veterans were not harmed by any procedures,” press secretary Terrence Hayes said in a statement. So far, the VA’s investigation has found no “quality of care issues,” he said, and the investigation will continue “until every Veteran’s case has been reviewed.” (Read the full statement here.) Neither the department nor the hospital has taken formal action against the medical providers, Hayes said.

The medical group that had a contract with the VA for vascular interventions, Wichita Radiological Group, did not respond to ProPublica’s requests for comment, nor did the doctors named in the suit: Dr. Shaun Gonda, Dr. Bret Winblad, and Dr. Kermit Rust. It is unclear from the case documents which doctors conducted which procedures. Eric Barth, an attorney for the medical group, denied the allegations in recent legal filings, calling the claims “baseless” and the lawsuit a “witch hunt.”

The lawsuit comes amid growing concern about one of these procedures – atherectomies – after researchers and doctors have uncovered patterns of excessive and inappropriate use. Recent research has found that this procedure, a common but costly treatment to shave or laser plaque from blood vessels, is not more effective than cheaper alternatives and may even be associated with a higher risk of complications including amputation. In recent years, several doctors and clinics have been investigated for allegedly taking advantage of Medicare’s reimbursement rates, and one study found that many doctors are resorting to atherectomies in the earliest stages of peripheral artery disease, against best practices that urge noninvasive treatment.

“Atherectomy is important in certain settings. But it’s being used in a way that is entirely inappropriate and it’s largely driven by the incentive structure,” said Dr. Caitlin Hicks, the lead author of the study and an associate professor of surgery at Johns Hopkins University School of Medicine.

Although different payment structures govern the care of veterans, the whistleblower lawsuit alleges that outside physicians, paid hourly by the Dole VA, were motivated to conduct longer and more complex procedures that would earn them higher payment.

Under different circumstances, the patient in the procedure room on that summer day could have been done after 2 hours.

But, 150 minutes in, those Medtronic representatives were still texting. At that point, more than 15 of their vascular devices had been used, including stents, balloons, and those for atherectomy.

“Long case!” Kirk’s colleague texted. “Is it looking ok??”

“It is,” she said. “Thought we were done a few times! Now he’s going back in to cut again!”

A little while later, she texted: “....17!”

He texted back [with laughing emoticons].

Hospital leaders had been scrutinizing the use of these procedures at the Dole VA for years.

In 2017, shortly after Rick Ament was hired to lead the facility, he noticed something was amiss. While the longtime hospital administrator was poring over the finances, he was alarmed to discover that the relatively small Dole VA had one of the most expensive cardiac programs in the country. As Ament dug deeper, he realized vascular interventions were the reason.

“It just did not make sense that the acuity level of our patients would generate such extreme cost variances from the norm,” he testified in December, in a deposition for the whistleblower case. “It was so significant, we needed to get to the bottom of it.”

Ament, a second generation Air Force veteran, quietly assembled a task force to investigate why the facility had purchased so many medical devices for these procedures. After they examined inventory records, calculating the total number of medical devices and the cost of devices per patient, they grew concerned.

“We were more expensive than, I believe it was, the top 10 hospitals in the VA combined,” he said. “My feeling was that we either had very, very bad providers or we had product walking out the door.”

Ament enlisted experts from other VA hospitals to help his team investigate, including an administrative officer who could understand finances and a respected interventional radiologist who could examine records. The task force gathered a list of patients from 2016 to 2018, according to internal emails, and analyzed their medical charts.

According to internal VA documents released through the whistleblower suit, the review found a number of clinical failings: Evidence-based medicine had not been followed in the majority of cases reviewed. Procedures were over-aggressive, treating lesions that should have been left alone. And there was a total disregard for established best practices for treating peripheral artery disease.

One of the experts on the investigative team explained to Ament that while it was not uncommon for doctors to use a couple of devices in one intervention, the total number of devices in many of the procedures at his facility went into the double digits, sometimes five times the expected amount.

In one encounter, a doctor deployed 33 devices in one procedure – 3 atherectomy devices, 9 stents, and 21 balloons.

This use of devices was exorbitant, Ament came to understand. “I want to say the term ‘egregious’ was used,” he testified. “It was kind of like validation, but I really wish I was wrong.”

“Did it make you concerned for patient care?” a lawyer asked during the deposition.

“It did,” Ament replied.

A member of his task force pulled data for veterans who had leg amputations due to vascular disease. Over 5 years, the number of veterans who had amputations increased, from about 6 in 2013 to 38 in 2018, according to internal emails released in the suit. The VA did not respond to ProPublica’s questions about the rise in amputations or whether it was due to complications from the procedures.

Even though Ament testified in December 2022 that he became aware of the excessive use of devices during his investigation that began about 5 years ago, neither he nor the VA have publicly acknowledged these findings outside of the lawsuit. It is unclear whether VA representatives informed the patients whose records were reviewed about their findings. ProPublica reached out to more than half a dozen veteran community groups in the Wichita area and none were aware of the investigation nor the allegations of overuse of vascular procedures at the facility.

The VA says that if its ongoing review finds instances of substandard care, it will reach out to affected patients and inform them about possible complications and benefits they may be entitled to. The press secretary said the review will take several months. Ament declined to respond to ProPublica’s questions, citing the ongoing case.

In 2018, Ament turned over his findings to the criminal division of the VA’s Office of Inspector General. He also shut down interventional radiology procedures at the facility’s catheter lab.

Federal agents separately opened an investigation into the same unit in the facility, looking into allegations of kickbacks.

More than 40 pages of expense reports from Medtronic, revealed in the whistleblower case, show sales representatives treating Dole health care workers to hundreds of meals over several years – lunches at Dempsey’s Biscuit Co.; business meals at the Scotch & Sirloin steakhouse; dinner at Chester’s Chophouse & Wine Bar, price per attendee: $122.39.

Federal agents obtained the receipts.

“Robert J. Dole VAMC employees may have received improper gratuities, in the forms of paid lunches, dinners, etc., from sales representatives from Medtronic,” Nathen Howard, a special agent in the VA OIG, wrote in an investigation memo from February 2019.

This kind of relationship could violate VA policy, which forbids federal employees from receiving any gifts, including meals, from people who do business or seek to do business with a federal institution. For health care workers, violating this policy could have serious implications for patients. Numerous studies have shown that even modest industry-sponsored gifts, including meals, may influence prescribing or treatment behavior of health care professionals.

The agents opened their investigation into kickbacks at the Wichita facility in response to the whistleblower lawsuit, which was filed by Thomas Schroeder in 2017. The VA OIG would not confirm or deny whether it was continuing to investigate kickbacks at the facility. The VA did not directly answer ProPublica’s questions about kickbacks at the Dole VA, but it said that every employee must complete an annual ethics training, which covers gift rules.

In recent years, Medtronic has settled a handful of other cases that have alleged kickbacks between company representatives and health care professionals.

In 2018, Medtronic’s subsidiary Covidien paid $13 million to settle claims with the U.S. Department of Justice that it paid kickbacks to health care institutions that used its mechanical blood clot devices. In 2019, the same subsidiary paid $17 million to resolve allegations that it provided in-kind marketing support to doctors using its vein products. And in 2020, Medtronic paid more than $8 million to settle claims that representatives had paid kickbacks to a neurosurgeon, including scores of lavish meals at a restaurant that the doctor owned, to induce him to purchase the company’s medication pumps.

Schroeder’s lawsuit is not the first time Medtronic’s vascular devices were named in an alleged kickback scheme. In early 2015, Medtronic acquired Covidien, and shortly after the merger, its subsidiary ev3 Inc. agreed to pay $1.25 million to resolve allegations that it had paid doctors who were “high volume users” of its atherectomy devices to act as evangelists for the company, and had provided physicians with company shares to participate in clinical trials for their tools.

The whistleblower in this earlier case, a former sales representative for the company, also alleged that the subsidiary was gaming Medicare’s payment system. Hospitals were often hesitant to conduct atherectomy procedures because of the low reimbursement rates. According to the suit, sales representatives encouraged doctors to admit patients for longer stays to reap greater reimbursements and make a profit, even though such stays were often not medically indicated.

“Medical device makers that try to boost their profits by causing patients to be admitted for unnecessary and expensive inpatient hospital stays will be held accountable,” special agent Thomas O’Donnell, from the Office of Inspector General at the U.S. Department of Health and Human Services, said in a press release for the settlement. “Both patients and taxpayers deserve to have medical decisions made based on what is medically appropriate.”

Medtronic spokesperson Xiong said that in each case, the company “cooperated fully with the DOJ to resolve its concerns and, where wrongdoing was found, took appropriate remedial action.”

Seton Hall Law School professor Jacob Elberg, a former assistant U.S. attorney for the District of New Jersey who led its health care and government fraud unit, is concerned by the frequency of such settlements in the last 2 decades. “There are, at this point, real questions as to whether the sanctions imposed by DOJ are sufficient to deter wrongdoing and to lead to meaningful change, especially within the medical device industry.”

Although the Department of Justice has declined to intervene in the lawsuit involving the Dole VA at this time, the case is ongoing and further depositions with Medtronic sales representatives and a former VA employee are scheduled for this month.

VA employees and doctors named in the suit declined to comment or did not respond to ProPublica’s questions about the alleged kickbacks and whether sales representatives may have influenced veterans’ treatment plans. In interviews with federal investigators, according to released transcripts, several of the employees who were questioned denied receiving frequent meals from sales representatives, contradicting Medtronic’s expense reports.

Their statements also stand in contrast to Medtronic representative Kari Kirk’s final text messages during that procedure in June 2017, which ultimately lasted more than 3 hours.

“Now u done??” her colleague asked.

“Just finished,” she texted. “Running to get them lunch!”

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

On June 14, 2017, just before noon, a doctor made an incision near a patient’s groin. Kari Kirk, a representative for the world’s largest medical device company, Medtronic, looked on and began texting her colleague a play-by-play.

“Fixing both legs from the ankles,” she wrote.

It was a fairly common procedure at the Robert J. Dole Veterans Affairs Medical Center in Wichita, Kansas, performed to treat blockages in the leg vessels.

Within reach were an array of Medtronic products: tubes with blades attached to shave hardened deposits off of artery walls; stents to widen blood vessels; balloons coated with therapeutic drugs.

Each time a doctor puts a foreign device in someone’s body, it carries a risk of complication, which can include clots or even require amputation. So medical experts, research and even Medtronic’s own device instructions urge doctors to use as few as are necessary.

But, as revealed in Kirk’s text messages, this doctor took an aggressive approach.

“Just used 12 [drug-coated balloons]!!” Kirk texted her colleague.

“Does that mean I owe u $$,” he responded.

“Thats what I’m thinking!!!” she said. “And now 14 balloons?!”

“but only one stent so far??”

“So far!”

As the texting continued, her colleague replied, “U are going to want to start going to the VA all the time.”

The messages, recently unsealed in an ongoing whistleblower lawsuit, give a window into the way money and medicine mingle in the booming business of peripheral artery disease, a condition that afflicts 6.5 million Americans over age 40 and is caused when fatty plaque builds up in arteries, blocking blood flow to the legs.

Representatives from companies are often present during vascular procedures to guide doctors on how to use their complex devices. This kind of access has the potential to influence treatment plans, as companies and their representatives profit when more of their product is used.

The suit, filed in 2017 by a sales representative for a competing medical device firm, alleges an illegal kickback scheme between Medtronic and hospital employees. According to the complaint and documents released in the suit, between 2011 and 2018, VA health care workers received steakhouse dinners, Apple electronics, and NASCAR tickets, and in turn, Medtronic secured a lucrative contract with the hospital. Meanwhile, the company’s representatives allegedly “groomed and trained” physicians at the facility, who then deployed the company’s devices even when it was not medically indicated.

Independently from the whistleblower suit, internal investigators at the Wichita facility have also examined the treatment patterns of its vascular patients in recent years and found numerous cases where medical devices were used excessively. While it’s not uncommon to deploy several devices, a medical expert on the investigation team found that the VA doctors sometimes used more than 15 at a time – one used 33 – deviating from the standard of care.

“It is unconscionable – there can be no valid medically acceptable basis to cram so many devices into a human being,” wrote attorneys representing the whistleblower in legal filings from January 2023. “This is not medical treatment. This is abuse.”

Dr. Kim Hodgson, former president of the Society for Vascular Surgery and an expert retained by the plaintiff, said the findings of the internal review of patient data raise “a high level of concern regarding necessity of treatment provided,” according to case documents.

Medtronic declined to respond to ProPublica’s questions, citing the ongoing litigation. “These allegations are false and Medtronic is defending against these claims in court,” said Boua Xiong, a spokesperson for the company. Medtronic representative Kirk declined to respond to ProPublica’s request for comment.

The hospital investigation found that amputations increased sixfold in the same time frame as the procedures in question, according to internal emails, but made no conclusion about whether those two things were connected. ProPublica reached out to the VA to ask whether any patients had been harmed.

The VA is “conducting an extensive review of patient care” at the Kansas hospital, “including the number of devices used on patients – to make sure that Veterans were not harmed by any procedures,” press secretary Terrence Hayes said in a statement. So far, the VA’s investigation has found no “quality of care issues,” he said, and the investigation will continue “until every Veteran’s case has been reviewed.” (Read the full statement here.) Neither the department nor the hospital has taken formal action against the medical providers, Hayes said.

The medical group that had a contract with the VA for vascular interventions, Wichita Radiological Group, did not respond to ProPublica’s requests for comment, nor did the doctors named in the suit: Dr. Shaun Gonda, Dr. Bret Winblad, and Dr. Kermit Rust. It is unclear from the case documents which doctors conducted which procedures. Eric Barth, an attorney for the medical group, denied the allegations in recent legal filings, calling the claims “baseless” and the lawsuit a “witch hunt.”

The lawsuit comes amid growing concern about one of these procedures – atherectomies – after researchers and doctors have uncovered patterns of excessive and inappropriate use. Recent research has found that this procedure, a common but costly treatment to shave or laser plaque from blood vessels, is not more effective than cheaper alternatives and may even be associated with a higher risk of complications including amputation. In recent years, several doctors and clinics have been investigated for allegedly taking advantage of Medicare’s reimbursement rates, and one study found that many doctors are resorting to atherectomies in the earliest stages of peripheral artery disease, against best practices that urge noninvasive treatment.

“Atherectomy is important in certain settings. But it’s being used in a way that is entirely inappropriate and it’s largely driven by the incentive structure,” said Dr. Caitlin Hicks, the lead author of the study and an associate professor of surgery at Johns Hopkins University School of Medicine.

Although different payment structures govern the care of veterans, the whistleblower lawsuit alleges that outside physicians, paid hourly by the Dole VA, were motivated to conduct longer and more complex procedures that would earn them higher payment.

Under different circumstances, the patient in the procedure room on that summer day could have been done after 2 hours.

But, 150 minutes in, those Medtronic representatives were still texting. At that point, more than 15 of their vascular devices had been used, including stents, balloons, and those for atherectomy.

“Long case!” Kirk’s colleague texted. “Is it looking ok??”

“It is,” she said. “Thought we were done a few times! Now he’s going back in to cut again!”

A little while later, she texted: “....17!”

He texted back [with laughing emoticons].

Hospital leaders had been scrutinizing the use of these procedures at the Dole VA for years.

In 2017, shortly after Rick Ament was hired to lead the facility, he noticed something was amiss. While the longtime hospital administrator was poring over the finances, he was alarmed to discover that the relatively small Dole VA had one of the most expensive cardiac programs in the country. As Ament dug deeper, he realized vascular interventions were the reason.

“It just did not make sense that the acuity level of our patients would generate such extreme cost variances from the norm,” he testified in December, in a deposition for the whistleblower case. “It was so significant, we needed to get to the bottom of it.”

Ament, a second generation Air Force veteran, quietly assembled a task force to investigate why the facility had purchased so many medical devices for these procedures. After they examined inventory records, calculating the total number of medical devices and the cost of devices per patient, they grew concerned.

“We were more expensive than, I believe it was, the top 10 hospitals in the VA combined,” he said. “My feeling was that we either had very, very bad providers or we had product walking out the door.”

Ament enlisted experts from other VA hospitals to help his team investigate, including an administrative officer who could understand finances and a respected interventional radiologist who could examine records. The task force gathered a list of patients from 2016 to 2018, according to internal emails, and analyzed their medical charts.

According to internal VA documents released through the whistleblower suit, the review found a number of clinical failings: Evidence-based medicine had not been followed in the majority of cases reviewed. Procedures were over-aggressive, treating lesions that should have been left alone. And there was a total disregard for established best practices for treating peripheral artery disease.

One of the experts on the investigative team explained to Ament that while it was not uncommon for doctors to use a couple of devices in one intervention, the total number of devices in many of the procedures at his facility went into the double digits, sometimes five times the expected amount.

In one encounter, a doctor deployed 33 devices in one procedure – 3 atherectomy devices, 9 stents, and 21 balloons.

This use of devices was exorbitant, Ament came to understand. “I want to say the term ‘egregious’ was used,” he testified. “It was kind of like validation, but I really wish I was wrong.”

“Did it make you concerned for patient care?” a lawyer asked during the deposition.

“It did,” Ament replied.

A member of his task force pulled data for veterans who had leg amputations due to vascular disease. Over 5 years, the number of veterans who had amputations increased, from about 6 in 2013 to 38 in 2018, according to internal emails released in the suit. The VA did not respond to ProPublica’s questions about the rise in amputations or whether it was due to complications from the procedures.

Even though Ament testified in December 2022 that he became aware of the excessive use of devices during his investigation that began about 5 years ago, neither he nor the VA have publicly acknowledged these findings outside of the lawsuit. It is unclear whether VA representatives informed the patients whose records were reviewed about their findings. ProPublica reached out to more than half a dozen veteran community groups in the Wichita area and none were aware of the investigation nor the allegations of overuse of vascular procedures at the facility.

The VA says that if its ongoing review finds instances of substandard care, it will reach out to affected patients and inform them about possible complications and benefits they may be entitled to. The press secretary said the review will take several months. Ament declined to respond to ProPublica’s questions, citing the ongoing case.

In 2018, Ament turned over his findings to the criminal division of the VA’s Office of Inspector General. He also shut down interventional radiology procedures at the facility’s catheter lab.

Federal agents separately opened an investigation into the same unit in the facility, looking into allegations of kickbacks.

More than 40 pages of expense reports from Medtronic, revealed in the whistleblower case, show sales representatives treating Dole health care workers to hundreds of meals over several years – lunches at Dempsey’s Biscuit Co.; business meals at the Scotch & Sirloin steakhouse; dinner at Chester’s Chophouse & Wine Bar, price per attendee: $122.39.

Federal agents obtained the receipts.

“Robert J. Dole VAMC employees may have received improper gratuities, in the forms of paid lunches, dinners, etc., from sales representatives from Medtronic,” Nathen Howard, a special agent in the VA OIG, wrote in an investigation memo from February 2019.

This kind of relationship could violate VA policy, which forbids federal employees from receiving any gifts, including meals, from people who do business or seek to do business with a federal institution. For health care workers, violating this policy could have serious implications for patients. Numerous studies have shown that even modest industry-sponsored gifts, including meals, may influence prescribing or treatment behavior of health care professionals.

The agents opened their investigation into kickbacks at the Wichita facility in response to the whistleblower lawsuit, which was filed by Thomas Schroeder in 2017. The VA OIG would not confirm or deny whether it was continuing to investigate kickbacks at the facility. The VA did not directly answer ProPublica’s questions about kickbacks at the Dole VA, but it said that every employee must complete an annual ethics training, which covers gift rules.

In recent years, Medtronic has settled a handful of other cases that have alleged kickbacks between company representatives and health care professionals.

In 2018, Medtronic’s subsidiary Covidien paid $13 million to settle claims with the U.S. Department of Justice that it paid kickbacks to health care institutions that used its mechanical blood clot devices. In 2019, the same subsidiary paid $17 million to resolve allegations that it provided in-kind marketing support to doctors using its vein products. And in 2020, Medtronic paid more than $8 million to settle claims that representatives had paid kickbacks to a neurosurgeon, including scores of lavish meals at a restaurant that the doctor owned, to induce him to purchase the company’s medication pumps.

Schroeder’s lawsuit is not the first time Medtronic’s vascular devices were named in an alleged kickback scheme. In early 2015, Medtronic acquired Covidien, and shortly after the merger, its subsidiary ev3 Inc. agreed to pay $1.25 million to resolve allegations that it had paid doctors who were “high volume users” of its atherectomy devices to act as evangelists for the company, and had provided physicians with company shares to participate in clinical trials for their tools.

The whistleblower in this earlier case, a former sales representative for the company, also alleged that the subsidiary was gaming Medicare’s payment system. Hospitals were often hesitant to conduct atherectomy procedures because of the low reimbursement rates. According to the suit, sales representatives encouraged doctors to admit patients for longer stays to reap greater reimbursements and make a profit, even though such stays were often not medically indicated.

“Medical device makers that try to boost their profits by causing patients to be admitted for unnecessary and expensive inpatient hospital stays will be held accountable,” special agent Thomas O’Donnell, from the Office of Inspector General at the U.S. Department of Health and Human Services, said in a press release for the settlement. “Both patients and taxpayers deserve to have medical decisions made based on what is medically appropriate.”

Medtronic spokesperson Xiong said that in each case, the company “cooperated fully with the DOJ to resolve its concerns and, where wrongdoing was found, took appropriate remedial action.”

Seton Hall Law School professor Jacob Elberg, a former assistant U.S. attorney for the District of New Jersey who led its health care and government fraud unit, is concerned by the frequency of such settlements in the last 2 decades. “There are, at this point, real questions as to whether the sanctions imposed by DOJ are sufficient to deter wrongdoing and to lead to meaningful change, especially within the medical device industry.”

Although the Department of Justice has declined to intervene in the lawsuit involving the Dole VA at this time, the case is ongoing and further depositions with Medtronic sales representatives and a former VA employee are scheduled for this month.

VA employees and doctors named in the suit declined to comment or did not respond to ProPublica’s questions about the alleged kickbacks and whether sales representatives may have influenced veterans’ treatment plans. In interviews with federal investigators, according to released transcripts, several of the employees who were questioned denied receiving frequent meals from sales representatives, contradicting Medtronic’s expense reports.

Their statements also stand in contrast to Medtronic representative Kari Kirk’s final text messages during that procedure in June 2017, which ultimately lasted more than 3 hours.

“Now u done??” her colleague asked.

“Just finished,” she texted. “Running to get them lunch!”

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

On June 14, 2017, just before noon, a doctor made an incision near a patient’s groin. Kari Kirk, a representative for the world’s largest medical device company, Medtronic, looked on and began texting her colleague a play-by-play.

“Fixing both legs from the ankles,” she wrote.

It was a fairly common procedure at the Robert J. Dole Veterans Affairs Medical Center in Wichita, Kansas, performed to treat blockages in the leg vessels.

Within reach were an array of Medtronic products: tubes with blades attached to shave hardened deposits off of artery walls; stents to widen blood vessels; balloons coated with therapeutic drugs.

Each time a doctor puts a foreign device in someone’s body, it carries a risk of complication, which can include clots or even require amputation. So medical experts, research and even Medtronic’s own device instructions urge doctors to use as few as are necessary.

But, as revealed in Kirk’s text messages, this doctor took an aggressive approach.

“Just used 12 [drug-coated balloons]!!” Kirk texted her colleague.

“Does that mean I owe u $$,” he responded.

“Thats what I’m thinking!!!” she said. “And now 14 balloons?!”

“but only one stent so far??”

“So far!”

As the texting continued, her colleague replied, “U are going to want to start going to the VA all the time.”

The messages, recently unsealed in an ongoing whistleblower lawsuit, give a window into the way money and medicine mingle in the booming business of peripheral artery disease, a condition that afflicts 6.5 million Americans over age 40 and is caused when fatty plaque builds up in arteries, blocking blood flow to the legs.

Representatives from companies are often present during vascular procedures to guide doctors on how to use their complex devices. This kind of access has the potential to influence treatment plans, as companies and their representatives profit when more of their product is used.

The suit, filed in 2017 by a sales representative for a competing medical device firm, alleges an illegal kickback scheme between Medtronic and hospital employees. According to the complaint and documents released in the suit, between 2011 and 2018, VA health care workers received steakhouse dinners, Apple electronics, and NASCAR tickets, and in turn, Medtronic secured a lucrative contract with the hospital. Meanwhile, the company’s representatives allegedly “groomed and trained” physicians at the facility, who then deployed the company’s devices even when it was not medically indicated.

Independently from the whistleblower suit, internal investigators at the Wichita facility have also examined the treatment patterns of its vascular patients in recent years and found numerous cases where medical devices were used excessively. While it’s not uncommon to deploy several devices, a medical expert on the investigation team found that the VA doctors sometimes used more than 15 at a time – one used 33 – deviating from the standard of care.

“It is unconscionable – there can be no valid medically acceptable basis to cram so many devices into a human being,” wrote attorneys representing the whistleblower in legal filings from January 2023. “This is not medical treatment. This is abuse.”

Dr. Kim Hodgson, former president of the Society for Vascular Surgery and an expert retained by the plaintiff, said the findings of the internal review of patient data raise “a high level of concern regarding necessity of treatment provided,” according to case documents.

Medtronic declined to respond to ProPublica’s questions, citing the ongoing litigation. “These allegations are false and Medtronic is defending against these claims in court,” said Boua Xiong, a spokesperson for the company. Medtronic representative Kirk declined to respond to ProPublica’s request for comment.

The hospital investigation found that amputations increased sixfold in the same time frame as the procedures in question, according to internal emails, but made no conclusion about whether those two things were connected. ProPublica reached out to the VA to ask whether any patients had been harmed.

The VA is “conducting an extensive review of patient care” at the Kansas hospital, “including the number of devices used on patients – to make sure that Veterans were not harmed by any procedures,” press secretary Terrence Hayes said in a statement. So far, the VA’s investigation has found no “quality of care issues,” he said, and the investigation will continue “until every Veteran’s case has been reviewed.” (Read the full statement here.) Neither the department nor the hospital has taken formal action against the medical providers, Hayes said.

The medical group that had a contract with the VA for vascular interventions, Wichita Radiological Group, did not respond to ProPublica’s requests for comment, nor did the doctors named in the suit: Dr. Shaun Gonda, Dr. Bret Winblad, and Dr. Kermit Rust. It is unclear from the case documents which doctors conducted which procedures. Eric Barth, an attorney for the medical group, denied the allegations in recent legal filings, calling the claims “baseless” and the lawsuit a “witch hunt.”

The lawsuit comes amid growing concern about one of these procedures – atherectomies – after researchers and doctors have uncovered patterns of excessive and inappropriate use. Recent research has found that this procedure, a common but costly treatment to shave or laser plaque from blood vessels, is not more effective than cheaper alternatives and may even be associated with a higher risk of complications including amputation. In recent years, several doctors and clinics have been investigated for allegedly taking advantage of Medicare’s reimbursement rates, and one study found that many doctors are resorting to atherectomies in the earliest stages of peripheral artery disease, against best practices that urge noninvasive treatment.

“Atherectomy is important in certain settings. But it’s being used in a way that is entirely inappropriate and it’s largely driven by the incentive structure,” said Dr. Caitlin Hicks, the lead author of the study and an associate professor of surgery at Johns Hopkins University School of Medicine.

Although different payment structures govern the care of veterans, the whistleblower lawsuit alleges that outside physicians, paid hourly by the Dole VA, were motivated to conduct longer and more complex procedures that would earn them higher payment.

Under different circumstances, the patient in the procedure room on that summer day could have been done after 2 hours.

But, 150 minutes in, those Medtronic representatives were still texting. At that point, more than 15 of their vascular devices had been used, including stents, balloons, and those for atherectomy.

“Long case!” Kirk’s colleague texted. “Is it looking ok??”

“It is,” she said. “Thought we were done a few times! Now he’s going back in to cut again!”

A little while later, she texted: “....17!”

He texted back [with laughing emoticons].

Hospital leaders had been scrutinizing the use of these procedures at the Dole VA for years.

In 2017, shortly after Rick Ament was hired to lead the facility, he noticed something was amiss. While the longtime hospital administrator was poring over the finances, he was alarmed to discover that the relatively small Dole VA had one of the most expensive cardiac programs in the country. As Ament dug deeper, he realized vascular interventions were the reason.

“It just did not make sense that the acuity level of our patients would generate such extreme cost variances from the norm,” he testified in December, in a deposition for the whistleblower case. “It was so significant, we needed to get to the bottom of it.”

Ament, a second generation Air Force veteran, quietly assembled a task force to investigate why the facility had purchased so many medical devices for these procedures. After they examined inventory records, calculating the total number of medical devices and the cost of devices per patient, they grew concerned.

“We were more expensive than, I believe it was, the top 10 hospitals in the VA combined,” he said. “My feeling was that we either had very, very bad providers or we had product walking out the door.”

Ament enlisted experts from other VA hospitals to help his team investigate, including an administrative officer who could understand finances and a respected interventional radiologist who could examine records. The task force gathered a list of patients from 2016 to 2018, according to internal emails, and analyzed their medical charts.

According to internal VA documents released through the whistleblower suit, the review found a number of clinical failings: Evidence-based medicine had not been followed in the majority of cases reviewed. Procedures were over-aggressive, treating lesions that should have been left alone. And there was a total disregard for established best practices for treating peripheral artery disease.

One of the experts on the investigative team explained to Ament that while it was not uncommon for doctors to use a couple of devices in one intervention, the total number of devices in many of the procedures at his facility went into the double digits, sometimes five times the expected amount.

In one encounter, a doctor deployed 33 devices in one procedure – 3 atherectomy devices, 9 stents, and 21 balloons.

This use of devices was exorbitant, Ament came to understand. “I want to say the term ‘egregious’ was used,” he testified. “It was kind of like validation, but I really wish I was wrong.”

“Did it make you concerned for patient care?” a lawyer asked during the deposition.

“It did,” Ament replied.

A member of his task force pulled data for veterans who had leg amputations due to vascular disease. Over 5 years, the number of veterans who had amputations increased, from about 6 in 2013 to 38 in 2018, according to internal emails released in the suit. The VA did not respond to ProPublica’s questions about the rise in amputations or whether it was due to complications from the procedures.

Even though Ament testified in December 2022 that he became aware of the excessive use of devices during his investigation that began about 5 years ago, neither he nor the VA have publicly acknowledged these findings outside of the lawsuit. It is unclear whether VA representatives informed the patients whose records were reviewed about their findings. ProPublica reached out to more than half a dozen veteran community groups in the Wichita area and none were aware of the investigation nor the allegations of overuse of vascular procedures at the facility.

The VA says that if its ongoing review finds instances of substandard care, it will reach out to affected patients and inform them about possible complications and benefits they may be entitled to. The press secretary said the review will take several months. Ament declined to respond to ProPublica’s questions, citing the ongoing case.

In 2018, Ament turned over his findings to the criminal division of the VA’s Office of Inspector General. He also shut down interventional radiology procedures at the facility’s catheter lab.

Federal agents separately opened an investigation into the same unit in the facility, looking into allegations of kickbacks.

More than 40 pages of expense reports from Medtronic, revealed in the whistleblower case, show sales representatives treating Dole health care workers to hundreds of meals over several years – lunches at Dempsey’s Biscuit Co.; business meals at the Scotch & Sirloin steakhouse; dinner at Chester’s Chophouse & Wine Bar, price per attendee: $122.39.

Federal agents obtained the receipts.

“Robert J. Dole VAMC employees may have received improper gratuities, in the forms of paid lunches, dinners, etc., from sales representatives from Medtronic,” Nathen Howard, a special agent in the VA OIG, wrote in an investigation memo from February 2019.

This kind of relationship could violate VA policy, which forbids federal employees from receiving any gifts, including meals, from people who do business or seek to do business with a federal institution. For health care workers, violating this policy could have serious implications for patients. Numerous studies have shown that even modest industry-sponsored gifts, including meals, may influence prescribing or treatment behavior of health care professionals.

The agents opened their investigation into kickbacks at the Wichita facility in response to the whistleblower lawsuit, which was filed by Thomas Schroeder in 2017. The VA OIG would not confirm or deny whether it was continuing to investigate kickbacks at the facility. The VA did not directly answer ProPublica’s questions about kickbacks at the Dole VA, but it said that every employee must complete an annual ethics training, which covers gift rules.

In recent years, Medtronic has settled a handful of other cases that have alleged kickbacks between company representatives and health care professionals.

In 2018, Medtronic’s subsidiary Covidien paid $13 million to settle claims with the U.S. Department of Justice that it paid kickbacks to health care institutions that used its mechanical blood clot devices. In 2019, the same subsidiary paid $17 million to resolve allegations that it provided in-kind marketing support to doctors using its vein products. And in 2020, Medtronic paid more than $8 million to settle claims that representatives had paid kickbacks to a neurosurgeon, including scores of lavish meals at a restaurant that the doctor owned, to induce him to purchase the company’s medication pumps.

Schroeder’s lawsuit is not the first time Medtronic’s vascular devices were named in an alleged kickback scheme. In early 2015, Medtronic acquired Covidien, and shortly after the merger, its subsidiary ev3 Inc. agreed to pay $1.25 million to resolve allegations that it had paid doctors who were “high volume users” of its atherectomy devices to act as evangelists for the company, and had provided physicians with company shares to participate in clinical trials for their tools.

The whistleblower in this earlier case, a former sales representative for the company, also alleged that the subsidiary was gaming Medicare’s payment system. Hospitals were often hesitant to conduct atherectomy procedures because of the low reimbursement rates. According to the suit, sales representatives encouraged doctors to admit patients for longer stays to reap greater reimbursements and make a profit, even though such stays were often not medically indicated.

“Medical device makers that try to boost their profits by causing patients to be admitted for unnecessary and expensive inpatient hospital stays will be held accountable,” special agent Thomas O’Donnell, from the Office of Inspector General at the U.S. Department of Health and Human Services, said in a press release for the settlement. “Both patients and taxpayers deserve to have medical decisions made based on what is medically appropriate.”

Medtronic spokesperson Xiong said that in each case, the company “cooperated fully with the DOJ to resolve its concerns and, where wrongdoing was found, took appropriate remedial action.”

Seton Hall Law School professor Jacob Elberg, a former assistant U.S. attorney for the District of New Jersey who led its health care and government fraud unit, is concerned by the frequency of such settlements in the last 2 decades. “There are, at this point, real questions as to whether the sanctions imposed by DOJ are sufficient to deter wrongdoing and to lead to meaningful change, especially within the medical device industry.”

Although the Department of Justice has declined to intervene in the lawsuit involving the Dole VA at this time, the case is ongoing and further depositions with Medtronic sales representatives and a former VA employee are scheduled for this month.

VA employees and doctors named in the suit declined to comment or did not respond to ProPublica’s questions about the alleged kickbacks and whether sales representatives may have influenced veterans’ treatment plans. In interviews with federal investigators, according to released transcripts, several of the employees who were questioned denied receiving frequent meals from sales representatives, contradicting Medtronic’s expense reports.

Their statements also stand in contrast to Medtronic representative Kari Kirk’s final text messages during that procedure in June 2017, which ultimately lasted more than 3 hours.

“Now u done??” her colleague asked.

“Just finished,” she texted. “Running to get them lunch!”

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A strategy for the treatment of tuberculosis involving just an 8-week treatment regimen – along with close posttreatment monitoring and treatment extension if needed – shows potential as an effective alternative to the standard 24-week regimen.

“We found that if we use the strategy of a bedaquiline-linezolid five-drug regimen for 8 weeks and then followed patients for 96 weeks, [the regimen] was noninferior, clinically, to the standard regimen in terms of the number of people alive, free of TB disease, and not on treatment,” said lead author Nicholas Paton, MD, of the National University of Singapore, in a press conference held during the Conference on Retroviruses & Opportunistic Infections.

“The total time on treatment was reduced by half – instead of 160 days, it was 85 days for the total duration.”

Commenting on the study, which was published concurrently in the New England Journal of Medicine, Richard E. Chaisson, MD, noted that, although more needs to be understood, the high number of responses is nevertheless encouraging.

“Clinicians will not feel comfortable with the short regimens at this point, but it is remarkable that so many patients did well with shorter treatments,” Dr. Chaisson, who is a professor of medicine, epidemiology, and international health and director of the Johns Hopkins University Center for Tuberculosis Research, Baltimore, said in an interview.

Importantly, the study should help push forward “future studies [that] will stratify patients according to their likelihood of responding to shorter treatments,” he said.

The current global standard for TB treatment, practiced for 4 decades, has been a 6-month rifampin-based regimen. Although the regimen performs well, curing more than 95% of cases in clinical trials, in real-world practice, the prolonged duration can be problematic, with issues of nonadherence and loss of patients to follow-up.

Previous research has shown that shorter regimens have potential, with some studies showing as many as 85% of patients cured with 3- and 4-month regimens, and some promising 2-month regimens showing efficacy specifically for those with smear-negative TB.

These efforts suggest that “the current 6-month regimen may lead to overtreatment in the majority of persons in order to prevent relapse in a minority of persons,” the authors asserted.
 

TRUNCATE-TB

To investigate a suitable shorter-term alternative, the authors conducted the phase 2-3, prospective, open-label TRUNCATE-TB trial, in which 674 patients with rifampin-susceptible pulmonary TB were enrolled at 18 sites in Asia and Africa.

The patients were randomly assigned to receive either the standard treatment regimen (rifampin and isoniazid for 24 weeks with pyrazinamide and ethambutol for the first 8 weeks; n = 181), or one of four novel five-drug regimens to be administered over 8 weeks, along with extended treatment for persistent clinical disease of up to 12 weeks, if needed, and a plan for retreatment in the case of relapse (n = 493).

Two of the regimens were dropped because of logistic criteria; the two remaining shorter-course groups included in the study involved either high-dose rifampin plus linezolid or bedaquiline plus linezolid, each combined with isoniazid, pyrazinamide, and ethambutol.

Of the patients, 62% were male, and four withdrew or were lost to follow-up by the end of the study at a final follow-up at week 96.

Among patients assigned to the 8-week regimens, 80% stopped at exactly 8 weeks, while 9% wound up having extended treatment to 10 weeks and 3% were extended to 12 weeks.

For the primary endpoint, a composite of death, ongoing treatment, or active disease at week 96, the rate was lowest in the standard 24-week therapy group, occurring in 7 of 181 patients (3.9%), compared with 21 of 184 patients (11.4%) in the rifampin plus linezolid group (adjusted difference, 7.4 percentage points, which did not meet noninferiority criterion), and 11 of 189 (5.8%) in the group in the bedaquiline plus linezolid group (adjusted difference, 0.8 percentage points, meeting noninferiority criterion).

The mean total duration of treatment through week 96 in the standard treatment group was 180 days versus 106 days in the rifampin–linezolid group, and 85 days in the bedaquiline-linezolid group.

The results were consistent across multiple subgroups defined according to baseline characteristics, including some that could be linked to severe disease and a high risk for relapse.

In terms of safety, there were no significant differences between the groups in terms of grade 3 or 4 adverse events.

Of note, only two patients (1.1%) in the bedaquiline plus linezolid group acquired a resistance, which Dr. Paton said was “encouraging,” because of concerns about resistance to that drug.
 

‘Unfavorable’ composite also evaluated

In an updated analysis of the study that Dr. Paton presented at the meeting, the authors looked at a revised “unfavorable” primary outcome – a composite including treatment failure, relapse, death, or nonattendance at week 96 without evidence of prior disease clearance.

The rate remained lowest in the standard 24-week therapy group (3.9%) versus 25% in the rifampin plus linezolid group, and 13.8% in the bedaquiline plus linezolid group.

Though the lower rate with the standard treatment was expected, Dr. Paton said the results nevertheless hold promise, at least for some patients, for successful treatment with the 8-week bedaquiline plus linezolid strategy.

“What the trial has told us is that even with that 13.8% relapse rate, we can manage patients within this strategy and people can do fine at the end, because with some simple clinical biomarkers, we can pick the people who may have a high chance of achieving a cure.”

Dr. Chaisson expressed concern over the higher unfavorable rates, but said the results help pave the way for refining a workable-shorter term strategy.

“TRUNCATE-TB did find that most patients could be successfully treated in 2 months with the novel regimen of bedaquiline plus linezolid, but the failure rate was still unacceptably high,” he said. 

“This regimen will not be widely adapted at this point, but additional analyses may identify subsets of patients who will do well with shorter regimens, and future studies will stratify patients according to their likelihood of responding to shorter treatments.”

The authors of an accompanying editorial further commented that the benefits of a shorter treatment strategy could very well outweigh possible shortcomings.

“Treatment algorithms such as that used in the TRUNCATE-TB trial are fundamental to tuberculosis control,” wrote Véronique Dartois, PhD, Center for Discovery and Innovation, Nutley, N.J., and Eric J. Rubin, MD, PhD, the editor-in-chief of NEJM. “Although implementing them could be a challenge, any added burden might be offset by reduced costs, better adherence, and increased patient satisfaction. Thus, for tuberculosis, a strategy might be more than just a regimen.”

The good news, as summed up by CROI vice-chair Landon Myer, MD, PhD, in the press conference, is that “we’re moving closer and closer to the holy grail of a short, efficacious regimen for TB treatment. We’re getting there slowly, but we’re getting there.”

The study received grant funding from the Singapore National Medical Research Council; a grant from the Department of Health and Social Care; the Foreign, Commonwealth, and Development Office; the Medical Research Council; and Wellcome Trust; as well as a grant from the UK Research and Innovation Medical Research Council. Dr. Dartois reported no relevant financial relationships. Dr. Chaisson had no disclosures to report.

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

A strategy for the treatment of tuberculosis involving just an 8-week treatment regimen – along with close posttreatment monitoring and treatment extension if needed – shows potential as an effective alternative to the standard 24-week regimen.

“We found that if we use the strategy of a bedaquiline-linezolid five-drug regimen for 8 weeks and then followed patients for 96 weeks, [the regimen] was noninferior, clinically, to the standard regimen in terms of the number of people alive, free of TB disease, and not on treatment,” said lead author Nicholas Paton, MD, of the National University of Singapore, in a press conference held during the Conference on Retroviruses & Opportunistic Infections.

“The total time on treatment was reduced by half – instead of 160 days, it was 85 days for the total duration.”

Commenting on the study, which was published concurrently in the New England Journal of Medicine, Richard E. Chaisson, MD, noted that, although more needs to be understood, the high number of responses is nevertheless encouraging.

“Clinicians will not feel comfortable with the short regimens at this point, but it is remarkable that so many patients did well with shorter treatments,” Dr. Chaisson, who is a professor of medicine, epidemiology, and international health and director of the Johns Hopkins University Center for Tuberculosis Research, Baltimore, said in an interview.

Importantly, the study should help push forward “future studies [that] will stratify patients according to their likelihood of responding to shorter treatments,” he said.

The current global standard for TB treatment, practiced for 4 decades, has been a 6-month rifampin-based regimen. Although the regimen performs well, curing more than 95% of cases in clinical trials, in real-world practice, the prolonged duration can be problematic, with issues of nonadherence and loss of patients to follow-up.

Previous research has shown that shorter regimens have potential, with some studies showing as many as 85% of patients cured with 3- and 4-month regimens, and some promising 2-month regimens showing efficacy specifically for those with smear-negative TB.

These efforts suggest that “the current 6-month regimen may lead to overtreatment in the majority of persons in order to prevent relapse in a minority of persons,” the authors asserted.
 

TRUNCATE-TB

To investigate a suitable shorter-term alternative, the authors conducted the phase 2-3, prospective, open-label TRUNCATE-TB trial, in which 674 patients with rifampin-susceptible pulmonary TB were enrolled at 18 sites in Asia and Africa.

The patients were randomly assigned to receive either the standard treatment regimen (rifampin and isoniazid for 24 weeks with pyrazinamide and ethambutol for the first 8 weeks; n = 181), or one of four novel five-drug regimens to be administered over 8 weeks, along with extended treatment for persistent clinical disease of up to 12 weeks, if needed, and a plan for retreatment in the case of relapse (n = 493).

Two of the regimens were dropped because of logistic criteria; the two remaining shorter-course groups included in the study involved either high-dose rifampin plus linezolid or bedaquiline plus linezolid, each combined with isoniazid, pyrazinamide, and ethambutol.

Of the patients, 62% were male, and four withdrew or were lost to follow-up by the end of the study at a final follow-up at week 96.

Among patients assigned to the 8-week regimens, 80% stopped at exactly 8 weeks, while 9% wound up having extended treatment to 10 weeks and 3% were extended to 12 weeks.

For the primary endpoint, a composite of death, ongoing treatment, or active disease at week 96, the rate was lowest in the standard 24-week therapy group, occurring in 7 of 181 patients (3.9%), compared with 21 of 184 patients (11.4%) in the rifampin plus linezolid group (adjusted difference, 7.4 percentage points, which did not meet noninferiority criterion), and 11 of 189 (5.8%) in the group in the bedaquiline plus linezolid group (adjusted difference, 0.8 percentage points, meeting noninferiority criterion).

The mean total duration of treatment through week 96 in the standard treatment group was 180 days versus 106 days in the rifampin–linezolid group, and 85 days in the bedaquiline-linezolid group.

The results were consistent across multiple subgroups defined according to baseline characteristics, including some that could be linked to severe disease and a high risk for relapse.

In terms of safety, there were no significant differences between the groups in terms of grade 3 or 4 adverse events.

Of note, only two patients (1.1%) in the bedaquiline plus linezolid group acquired a resistance, which Dr. Paton said was “encouraging,” because of concerns about resistance to that drug.
 

‘Unfavorable’ composite also evaluated

In an updated analysis of the study that Dr. Paton presented at the meeting, the authors looked at a revised “unfavorable” primary outcome – a composite including treatment failure, relapse, death, or nonattendance at week 96 without evidence of prior disease clearance.

The rate remained lowest in the standard 24-week therapy group (3.9%) versus 25% in the rifampin plus linezolid group, and 13.8% in the bedaquiline plus linezolid group.

Though the lower rate with the standard treatment was expected, Dr. Paton said the results nevertheless hold promise, at least for some patients, for successful treatment with the 8-week bedaquiline plus linezolid strategy.

“What the trial has told us is that even with that 13.8% relapse rate, we can manage patients within this strategy and people can do fine at the end, because with some simple clinical biomarkers, we can pick the people who may have a high chance of achieving a cure.”

Dr. Chaisson expressed concern over the higher unfavorable rates, but said the results help pave the way for refining a workable-shorter term strategy.

“TRUNCATE-TB did find that most patients could be successfully treated in 2 months with the novel regimen of bedaquiline plus linezolid, but the failure rate was still unacceptably high,” he said. 

“This regimen will not be widely adapted at this point, but additional analyses may identify subsets of patients who will do well with shorter regimens, and future studies will stratify patients according to their likelihood of responding to shorter treatments.”

The authors of an accompanying editorial further commented that the benefits of a shorter treatment strategy could very well outweigh possible shortcomings.

“Treatment algorithms such as that used in the TRUNCATE-TB trial are fundamental to tuberculosis control,” wrote Véronique Dartois, PhD, Center for Discovery and Innovation, Nutley, N.J., and Eric J. Rubin, MD, PhD, the editor-in-chief of NEJM. “Although implementing them could be a challenge, any added burden might be offset by reduced costs, better adherence, and increased patient satisfaction. Thus, for tuberculosis, a strategy might be more than just a regimen.”

The good news, as summed up by CROI vice-chair Landon Myer, MD, PhD, in the press conference, is that “we’re moving closer and closer to the holy grail of a short, efficacious regimen for TB treatment. We’re getting there slowly, but we’re getting there.”

The study received grant funding from the Singapore National Medical Research Council; a grant from the Department of Health and Social Care; the Foreign, Commonwealth, and Development Office; the Medical Research Council; and Wellcome Trust; as well as a grant from the UK Research and Innovation Medical Research Council. Dr. Dartois reported no relevant financial relationships. Dr. Chaisson had no disclosures to report.

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

A strategy for the treatment of tuberculosis involving just an 8-week treatment regimen – along with close posttreatment monitoring and treatment extension if needed – shows potential as an effective alternative to the standard 24-week regimen.

“We found that if we use the strategy of a bedaquiline-linezolid five-drug regimen for 8 weeks and then followed patients for 96 weeks, [the regimen] was noninferior, clinically, to the standard regimen in terms of the number of people alive, free of TB disease, and not on treatment,” said lead author Nicholas Paton, MD, of the National University of Singapore, in a press conference held during the Conference on Retroviruses & Opportunistic Infections.

“The total time on treatment was reduced by half – instead of 160 days, it was 85 days for the total duration.”

Commenting on the study, which was published concurrently in the New England Journal of Medicine, Richard E. Chaisson, MD, noted that, although more needs to be understood, the high number of responses is nevertheless encouraging.

“Clinicians will not feel comfortable with the short regimens at this point, but it is remarkable that so many patients did well with shorter treatments,” Dr. Chaisson, who is a professor of medicine, epidemiology, and international health and director of the Johns Hopkins University Center for Tuberculosis Research, Baltimore, said in an interview.

Importantly, the study should help push forward “future studies [that] will stratify patients according to their likelihood of responding to shorter treatments,” he said.

The current global standard for TB treatment, practiced for 4 decades, has been a 6-month rifampin-based regimen. Although the regimen performs well, curing more than 95% of cases in clinical trials, in real-world practice, the prolonged duration can be problematic, with issues of nonadherence and loss of patients to follow-up.

Previous research has shown that shorter regimens have potential, with some studies showing as many as 85% of patients cured with 3- and 4-month regimens, and some promising 2-month regimens showing efficacy specifically for those with smear-negative TB.

These efforts suggest that “the current 6-month regimen may lead to overtreatment in the majority of persons in order to prevent relapse in a minority of persons,” the authors asserted.
 

TRUNCATE-TB

To investigate a suitable shorter-term alternative, the authors conducted the phase 2-3, prospective, open-label TRUNCATE-TB trial, in which 674 patients with rifampin-susceptible pulmonary TB were enrolled at 18 sites in Asia and Africa.

The patients were randomly assigned to receive either the standard treatment regimen (rifampin and isoniazid for 24 weeks with pyrazinamide and ethambutol for the first 8 weeks; n = 181), or one of four novel five-drug regimens to be administered over 8 weeks, along with extended treatment for persistent clinical disease of up to 12 weeks, if needed, and a plan for retreatment in the case of relapse (n = 493).

Two of the regimens were dropped because of logistic criteria; the two remaining shorter-course groups included in the study involved either high-dose rifampin plus linezolid or bedaquiline plus linezolid, each combined with isoniazid, pyrazinamide, and ethambutol.

Of the patients, 62% were male, and four withdrew or were lost to follow-up by the end of the study at a final follow-up at week 96.

Among patients assigned to the 8-week regimens, 80% stopped at exactly 8 weeks, while 9% wound up having extended treatment to 10 weeks and 3% were extended to 12 weeks.

For the primary endpoint, a composite of death, ongoing treatment, or active disease at week 96, the rate was lowest in the standard 24-week therapy group, occurring in 7 of 181 patients (3.9%), compared with 21 of 184 patients (11.4%) in the rifampin plus linezolid group (adjusted difference, 7.4 percentage points, which did not meet noninferiority criterion), and 11 of 189 (5.8%) in the group in the bedaquiline plus linezolid group (adjusted difference, 0.8 percentage points, meeting noninferiority criterion).

The mean total duration of treatment through week 96 in the standard treatment group was 180 days versus 106 days in the rifampin–linezolid group, and 85 days in the bedaquiline-linezolid group.

The results were consistent across multiple subgroups defined according to baseline characteristics, including some that could be linked to severe disease and a high risk for relapse.

In terms of safety, there were no significant differences between the groups in terms of grade 3 or 4 adverse events.

Of note, only two patients (1.1%) in the bedaquiline plus linezolid group acquired a resistance, which Dr. Paton said was “encouraging,” because of concerns about resistance to that drug.
 

‘Unfavorable’ composite also evaluated

In an updated analysis of the study that Dr. Paton presented at the meeting, the authors looked at a revised “unfavorable” primary outcome – a composite including treatment failure, relapse, death, or nonattendance at week 96 without evidence of prior disease clearance.

The rate remained lowest in the standard 24-week therapy group (3.9%) versus 25% in the rifampin plus linezolid group, and 13.8% in the bedaquiline plus linezolid group.

Though the lower rate with the standard treatment was expected, Dr. Paton said the results nevertheless hold promise, at least for some patients, for successful treatment with the 8-week bedaquiline plus linezolid strategy.

“What the trial has told us is that even with that 13.8% relapse rate, we can manage patients within this strategy and people can do fine at the end, because with some simple clinical biomarkers, we can pick the people who may have a high chance of achieving a cure.”

Dr. Chaisson expressed concern over the higher unfavorable rates, but said the results help pave the way for refining a workable-shorter term strategy.

“TRUNCATE-TB did find that most patients could be successfully treated in 2 months with the novel regimen of bedaquiline plus linezolid, but the failure rate was still unacceptably high,” he said. 

“This regimen will not be widely adapted at this point, but additional analyses may identify subsets of patients who will do well with shorter regimens, and future studies will stratify patients according to their likelihood of responding to shorter treatments.”

The authors of an accompanying editorial further commented that the benefits of a shorter treatment strategy could very well outweigh possible shortcomings.

“Treatment algorithms such as that used in the TRUNCATE-TB trial are fundamental to tuberculosis control,” wrote Véronique Dartois, PhD, Center for Discovery and Innovation, Nutley, N.J., and Eric J. Rubin, MD, PhD, the editor-in-chief of NEJM. “Although implementing them could be a challenge, any added burden might be offset by reduced costs, better adherence, and increased patient satisfaction. Thus, for tuberculosis, a strategy might be more than just a regimen.”

The good news, as summed up by CROI vice-chair Landon Myer, MD, PhD, in the press conference, is that “we’re moving closer and closer to the holy grail of a short, efficacious regimen for TB treatment. We’re getting there slowly, but we’re getting there.”

The study received grant funding from the Singapore National Medical Research Council; a grant from the Department of Health and Social Care; the Foreign, Commonwealth, and Development Office; the Medical Research Council; and Wellcome Trust; as well as a grant from the UK Research and Innovation Medical Research Council. Dr. Dartois reported no relevant financial relationships. Dr. Chaisson had no disclosures to report.

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

The natural immunity provided by a COVID infection protects a person against severe illness on a par with two doses of mRNA vaccine, a new study says. 

People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet. 

The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported. 

But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.

They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied. 

The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News. 

“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”

The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.

This was the largest meta-analysis of immunity following infection to date, NBC News reports.

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

The natural immunity provided by a COVID infection protects a person against severe illness on a par with two doses of mRNA vaccine, a new study says. 

People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet. 

The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported. 

But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.

They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied. 

The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News. 

“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”

The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.

This was the largest meta-analysis of immunity following infection to date, NBC News reports.

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

The natural immunity provided by a COVID infection protects a person against severe illness on a par with two doses of mRNA vaccine, a new study says. 

People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet. 

The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported. 

But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.

They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied. 

The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News. 

“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”

The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.

This was the largest meta-analysis of immunity following infection to date, NBC News reports.

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

Approximately one in four patients with untreated COVID-19 experience symptom relapse, while almost one in three exhibits relapse of viral load, a recent study finds.

These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.

“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.

To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).

From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.

“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.

Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.

The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.

Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.

This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.

This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
 

Paxlovid may not be to blame for COVID-19 rebound

“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.

Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.

“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
 

Longer antiviral therapy deserves investigation

This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.

“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.

This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.

“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”

That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,

“We need further study of longer-term therapies,” he said.

An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.

“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”

While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.

The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.

Approximately one in four patients with untreated COVID-19 experience symptom relapse, while almost one in three exhibits relapse of viral load, a recent study finds.

These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.

“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.

To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).

From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.

“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.

Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.

The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.

Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.

This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.

This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
 

Paxlovid may not be to blame for COVID-19 rebound

“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.

Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.

“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
 

Longer antiviral therapy deserves investigation

This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.

“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.

This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.

“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”

That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,

“We need further study of longer-term therapies,” he said.

An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.

“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”

While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.

The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.

Approximately one in four patients with untreated COVID-19 experience symptom relapse, while almost one in three exhibits relapse of viral load, a recent study finds.

These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.

“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.

To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).

From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.

“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.

Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.

The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.

Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.

This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.

This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
 

Paxlovid may not be to blame for COVID-19 rebound

“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.

Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.

“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
 

Longer antiviral therapy deserves investigation

This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.

“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.

This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.

“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”

That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,

“We need further study of longer-term therapies,” he said.

An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.

“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”

While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.

The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.

A diagnostic workup for pulmonary embolism (PE) should be performed in all patients with recent onset of exertional dyspnea, according to the authors of an article published in the Journal of Thrombosis and Haemostasis. That conclusion emerged from an analysis of PE prevalence in 417 patients with recent marked exertional dyspnea performing previously well-tolerated physical activities.

Exertional dyspnea is a frequently encountered complaint in clinical practice. Missteps in both diagnosis and early management, however, have been found to be prevalent in emergency department practices. PE diagnosis can be delayed or altogether missed through nonspecific clinical manifestations or the absence of typical signs and symptoms, with a complicated clinical course or mortality as a consequence, stated the researchers. Also, failure to diagnose PE is a common malpractice allegation.

Noting that the prevalence of PE among patients with dyspnea on exertion has not been reported, the authors hypothesized: “PE might be a frequent underlying condition in patients presenting for care complaining of marked dyspnea on exertion of recent onset.”

In a multicenter prospective, cross-sectional study among 14 university or hospital centers in Italy, patients who were referred for outpatient evaluation with recent (< 1 month) dyspnea on exertion with a severity of 3 or 4 on the modified Medical Research Council dyspnea scale were potentially eligible for the study. Prior deep-vein thrombosis (DVT), PE, and use of therapeutic anticoagulation were among exclusion criteria. All patients aged 75 years or younger with recent (< 1 month) marked exertional dyspnea had a systematic workup for PE, irrespective of concomitant signs or symptoms of venous thromboembolism and alternative explanations for dyspnea. The main study outcome was prevalence of PE in the entire cohort of patients with recent marked dyspnea on exertion.

When about 400 patients had been enrolled after an interim analysis in which the preestablished stopping rule (if the lower limit of the 95% confidence interval of the prevalence of PE exceeds 20%) was met, the study was prematurely terminated. PE was found, after exclusion of 134 patients based on low PE clinical probability and normal D-dimer, in 134 (47.3%) of the remaining 283 patients. The overall PE prevalence was 32.1% (95% confidence interval, 27.8-36.8).

PE was present in 40 of 204 (19.6%) patients without other findings suspicious for PE and in 94 of 213 patients (44.1%) with PE-suspicious findings. PE involved a main pulmonary artery in 37% and multiple lobes in 87% of the patients.

The researchers pointed out that, while the prevalence of PE was highest (44%) in patients who had concomitant signs or symptoms suspicious of PE or underlying DVT, PE was detected in almost 20% of patients without concomitant PE signs and symptoms. Also, the detected pulmonary emboli were deemed significant.

“Our findings suggest that, regardless of the diagnostic algorithm in use, physicians should rule in or out PE in patients who solely report recent onset of marked dyspnea on exertion,” they concluded.

Agreeing with the authors’ conclusions, Mary Jo S. Farmer, MD, PhD, of the department of medicine at University of Massachusetts, Worcester, stated in an interview, “The results of the current study support a diagnostic workup for pulmonary embolus in all patients with recent onset of exertional dyspnea.” She added, “Pulmonary emboli detected were significant as almost all were segmental or more proximal emboli involving multiple lobes. The observed overall prevalence of pulmonary embolus of 32% may seem high when compared with the low prevalence of 7%-13% reported in other studies of patients with suspected pulmonary embolus. However, the prevalence of pulmonary embolus among emergency department cohorts in European countries is generally higher, as is the diagnostic yield from [CT pulmonary angiogram] compared to North American countries. This could be explained by differences in applied thresholds for suspicion of pulmonary embolus. The incidence of COVID-19 and association with thrombosis was not reported.

“It has been reported that nonspecific clinical manifestations and absence of typical signs and symptoms can result in delay in diagnosis of pulmonary embolus or result in pulmonary embolus being missed, an unfortunate situation that could result in malpractice allegation.” Dr. Farmer concluded.

Among limitations of the study, the authors noted that their results are not applicable to patients older than 75 years or patients with chronic (more than 1 month) symptoms of dyspnea or less severe dyspnea (modified Medical Research Council dyspnea score of 2 or lower). Also, no attempt to stratify the clinical relevance of PE was made.

The study was funded by the Arianna Foundation on Anticoagulation, Bologna, Italy. The authors reported that they had no potential conflicts. Dr. Farmer also declared she had no relevant conflicts.

A diagnostic workup for pulmonary embolism (PE) should be performed in all patients with recent onset of exertional dyspnea, according to the authors of an article published in the Journal of Thrombosis and Haemostasis. That conclusion emerged from an analysis of PE prevalence in 417 patients with recent marked exertional dyspnea performing previously well-tolerated physical activities.

Exertional dyspnea is a frequently encountered complaint in clinical practice. Missteps in both diagnosis and early management, however, have been found to be prevalent in emergency department practices. PE diagnosis can be delayed or altogether missed through nonspecific clinical manifestations or the absence of typical signs and symptoms, with a complicated clinical course or mortality as a consequence, stated the researchers. Also, failure to diagnose PE is a common malpractice allegation.

Noting that the prevalence of PE among patients with dyspnea on exertion has not been reported, the authors hypothesized: “PE might be a frequent underlying condition in patients presenting for care complaining of marked dyspnea on exertion of recent onset.”

In a multicenter prospective, cross-sectional study among 14 university or hospital centers in Italy, patients who were referred for outpatient evaluation with recent (< 1 month) dyspnea on exertion with a severity of 3 or 4 on the modified Medical Research Council dyspnea scale were potentially eligible for the study. Prior deep-vein thrombosis (DVT), PE, and use of therapeutic anticoagulation were among exclusion criteria. All patients aged 75 years or younger with recent (< 1 month) marked exertional dyspnea had a systematic workup for PE, irrespective of concomitant signs or symptoms of venous thromboembolism and alternative explanations for dyspnea. The main study outcome was prevalence of PE in the entire cohort of patients with recent marked dyspnea on exertion.

When about 400 patients had been enrolled after an interim analysis in which the preestablished stopping rule (if the lower limit of the 95% confidence interval of the prevalence of PE exceeds 20%) was met, the study was prematurely terminated. PE was found, after exclusion of 134 patients based on low PE clinical probability and normal D-dimer, in 134 (47.3%) of the remaining 283 patients. The overall PE prevalence was 32.1% (95% confidence interval, 27.8-36.8).

PE was present in 40 of 204 (19.6%) patients without other findings suspicious for PE and in 94 of 213 patients (44.1%) with PE-suspicious findings. PE involved a main pulmonary artery in 37% and multiple lobes in 87% of the patients.

The researchers pointed out that, while the prevalence of PE was highest (44%) in patients who had concomitant signs or symptoms suspicious of PE or underlying DVT, PE was detected in almost 20% of patients without concomitant PE signs and symptoms. Also, the detected pulmonary emboli were deemed significant.

“Our findings suggest that, regardless of the diagnostic algorithm in use, physicians should rule in or out PE in patients who solely report recent onset of marked dyspnea on exertion,” they concluded.

Agreeing with the authors’ conclusions, Mary Jo S. Farmer, MD, PhD, of the department of medicine at University of Massachusetts, Worcester, stated in an interview, “The results of the current study support a diagnostic workup for pulmonary embolus in all patients with recent onset of exertional dyspnea.” She added, “Pulmonary emboli detected were significant as almost all were segmental or more proximal emboli involving multiple lobes. The observed overall prevalence of pulmonary embolus of 32% may seem high when compared with the low prevalence of 7%-13% reported in other studies of patients with suspected pulmonary embolus. However, the prevalence of pulmonary embolus among emergency department cohorts in European countries is generally higher, as is the diagnostic yield from [CT pulmonary angiogram] compared to North American countries. This could be explained by differences in applied thresholds for suspicion of pulmonary embolus. The incidence of COVID-19 and association with thrombosis was not reported.

“It has been reported that nonspecific clinical manifestations and absence of typical signs and symptoms can result in delay in diagnosis of pulmonary embolus or result in pulmonary embolus being missed, an unfortunate situation that could result in malpractice allegation.” Dr. Farmer concluded.

Among limitations of the study, the authors noted that their results are not applicable to patients older than 75 years or patients with chronic (more than 1 month) symptoms of dyspnea or less severe dyspnea (modified Medical Research Council dyspnea score of 2 or lower). Also, no attempt to stratify the clinical relevance of PE was made.

The study was funded by the Arianna Foundation on Anticoagulation, Bologna, Italy. The authors reported that they had no potential conflicts. Dr. Farmer also declared she had no relevant conflicts.

A diagnostic workup for pulmonary embolism (PE) should be performed in all patients with recent onset of exertional dyspnea, according to the authors of an article published in the Journal of Thrombosis and Haemostasis. That conclusion emerged from an analysis of PE prevalence in 417 patients with recent marked exertional dyspnea performing previously well-tolerated physical activities.

Exertional dyspnea is a frequently encountered complaint in clinical practice. Missteps in both diagnosis and early management, however, have been found to be prevalent in emergency department practices. PE diagnosis can be delayed or altogether missed through nonspecific clinical manifestations or the absence of typical signs and symptoms, with a complicated clinical course or mortality as a consequence, stated the researchers. Also, failure to diagnose PE is a common malpractice allegation.

Noting that the prevalence of PE among patients with dyspnea on exertion has not been reported, the authors hypothesized: “PE might be a frequent underlying condition in patients presenting for care complaining of marked dyspnea on exertion of recent onset.”

In a multicenter prospective, cross-sectional study among 14 university or hospital centers in Italy, patients who were referred for outpatient evaluation with recent (< 1 month) dyspnea on exertion with a severity of 3 or 4 on the modified Medical Research Council dyspnea scale were potentially eligible for the study. Prior deep-vein thrombosis (DVT), PE, and use of therapeutic anticoagulation were among exclusion criteria. All patients aged 75 years or younger with recent (< 1 month) marked exertional dyspnea had a systematic workup for PE, irrespective of concomitant signs or symptoms of venous thromboembolism and alternative explanations for dyspnea. The main study outcome was prevalence of PE in the entire cohort of patients with recent marked dyspnea on exertion.

When about 400 patients had been enrolled after an interim analysis in which the preestablished stopping rule (if the lower limit of the 95% confidence interval of the prevalence of PE exceeds 20%) was met, the study was prematurely terminated. PE was found, after exclusion of 134 patients based on low PE clinical probability and normal D-dimer, in 134 (47.3%) of the remaining 283 patients. The overall PE prevalence was 32.1% (95% confidence interval, 27.8-36.8).

PE was present in 40 of 204 (19.6%) patients without other findings suspicious for PE and in 94 of 213 patients (44.1%) with PE-suspicious findings. PE involved a main pulmonary artery in 37% and multiple lobes in 87% of the patients.

The researchers pointed out that, while the prevalence of PE was highest (44%) in patients who had concomitant signs or symptoms suspicious of PE or underlying DVT, PE was detected in almost 20% of patients without concomitant PE signs and symptoms. Also, the detected pulmonary emboli were deemed significant.

“Our findings suggest that, regardless of the diagnostic algorithm in use, physicians should rule in or out PE in patients who solely report recent onset of marked dyspnea on exertion,” they concluded.

Agreeing with the authors’ conclusions, Mary Jo S. Farmer, MD, PhD, of the department of medicine at University of Massachusetts, Worcester, stated in an interview, “The results of the current study support a diagnostic workup for pulmonary embolus in all patients with recent onset of exertional dyspnea.” She added, “Pulmonary emboli detected were significant as almost all were segmental or more proximal emboli involving multiple lobes. The observed overall prevalence of pulmonary embolus of 32% may seem high when compared with the low prevalence of 7%-13% reported in other studies of patients with suspected pulmonary embolus. However, the prevalence of pulmonary embolus among emergency department cohorts in European countries is generally higher, as is the diagnostic yield from [CT pulmonary angiogram] compared to North American countries. This could be explained by differences in applied thresholds for suspicion of pulmonary embolus. The incidence of COVID-19 and association with thrombosis was not reported.

“It has been reported that nonspecific clinical manifestations and absence of typical signs and symptoms can result in delay in diagnosis of pulmonary embolus or result in pulmonary embolus being missed, an unfortunate situation that could result in malpractice allegation.” Dr. Farmer concluded.

Among limitations of the study, the authors noted that their results are not applicable to patients older than 75 years or patients with chronic (more than 1 month) symptoms of dyspnea or less severe dyspnea (modified Medical Research Council dyspnea score of 2 or lower). Also, no attempt to stratify the clinical relevance of PE was made.

The study was funded by the Arianna Foundation on Anticoagulation, Bologna, Italy. The authors reported that they had no potential conflicts. Dr. Farmer also declared she had no relevant conflicts.

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

This transcript has been edited for clarity.

Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany. Today, I would like to discuss what happened in neurology in the past month.
 

Treatment of tension-type headache

I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.

A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.

The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.

In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
 

Headache after COVID-19

The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.

SSRIs during COVID-19 infection

The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.

Preventing dementia with antihypertensive treatment

The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.

Antiplatelet therapy

The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.

Regular exercise in Parkinson’s disease

The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.

Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany. Today, I would like to discuss what happened in neurology in the past month.
 

Treatment of tension-type headache

I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.

A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.

The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.

In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
 

Headache after COVID-19

The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.

SSRIs during COVID-19 infection

The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.

Preventing dementia with antihypertensive treatment

The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.

Antiplatelet therapy

The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.

Regular exercise in Parkinson’s disease

The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.

Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany. Today, I would like to discuss what happened in neurology in the past month.
 

Treatment of tension-type headache

I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.

A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.

The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.

In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
 

Headache after COVID-19

The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.

SSRIs during COVID-19 infection

The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.

Preventing dementia with antihypertensive treatment

The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.

Antiplatelet therapy

The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.

Regular exercise in Parkinson’s disease

The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.

Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.