Each night, while my 2-year-old is having her dinner of macaroni and cheese or chicken nuggets, we video chat with my elderly parents. It used to be that this time was mainly my daughter showing off her newfound fork skills, but lately it has become “elderly parent education hour.”

“Well, we’re trying to decide if we should go to the bridge club,” announced my mother early in the week of March 13th.

“No, mom! Under no circumstances should you go to the bridge club! Social distance! Stay home! If I’ve given up restaurants and babysitters and am sitting here every night holding a phone covered in mac and cheese grease, you can give up the bridge club!”

I am all for keeping my elderly parents as isolated as possible during these pandemic times. I wasn’t alone in my fear that they weren’t taking my advice seriously: My social media feed was subsequently filled with posts from other physicians who had also been educating their parents about the need for social distancing.

Then, just as we were all settling into “social distancing,” on March 20, a debate emerged on the opinion pages of The New York Times that took the argument to the next level: A former professor of mine suggested a move from a policy of “horizontal interdiction” (one that restricts the movement of the entire population, without taking risk into consideration) to a “vertical interdiction” strategy that focuses on sequestering those among us most likely to experience poor outcomes from coronavirus infection (eg, the elderly, people with chronic diseases, and the immunologically compromised).¹

This first piece was followed 2 days later on March 22 by an article from a regular New York Times contributor who called social distancing “groupthink” and then seconded the vertical interdiction proposal.² Both pieces referred to the downturn in the economy as the reason the policy would be an improvement on social distancing; they argued that lost jobs and services would cause less suffering and loss than a policy that required extended isolation of the elderly.

On closer inspection, however, vertical interdiction is different and much scarier than “social distancing.” The words used by the author of the original article gave a clue: “If we were to focus on the especially vulnerable, there would be resources to keep them at home, provide them with needed services and coronavirus testing, and direct our medical system to their early care. I would favor proactive rather than reactive testing.” This was not just a plan to keep my parents from the bridge club. This was a plan for forced quarantine, mandatory testing, and months of isolation. Almost immediately, physicians and policy makers identified feasibility problems with the idea.³ To name a few, it is not clear that the death rate in young people is all that low; even with removing elders from the equation, the demand for hospital and critical care services is rapidly overwhelming supply; testing the “herd immunity” hypothesis in real time with a virus that has a death rate of 1%-3% still runs the risk of causing millions of deaths.

I will add a few more reasons why this idea of vertical interdiction was never feasible: There is no existing structure to facilitate mandatory isolation and quarantine of elders. We have no mechanism for caring for elders who are isolated at home. We cannot rapidly design the digital health monitoring needed. We cannot provide the mobile testing proposed. In the case of seniors who require nursing care, the problems would be even greater. Our recent efforts to protect patients in nursing facilities have proven to be extremely difficult. The greatest problem is finding a way to keep the staff from bringing the virus into the facility (and there are many staff: nutrition services, nursing, patient care technicians, physical therapy, social work). The only possible answer to this issue might mean wearing extensive protective equipment, similar to physicians in Wuhan⁴ (full-head hood plus goggles). Imagine being a patient in this scenario: months of being bathed, dressed, fed, and helped to the bathroom by a person in an isolation suit.

Now, just a few weeks later, with the virus spreading and many nonelders on ventilators, the idea of “elderly sequestration” as it was presented in mid-March feels dated and irrelevant. However, the episode can and should teach us a more important lesson: The idea was fatally flawed not only because it was not feasible but primarily because it was so lacking in compassion.

The lack of compassion was not just related to the fact that patients with end-stage dementia will undoubtedly be confused and frightened when confronted with months of care administered by people in hazmat suits. It is also that the proposed policy, by creating pockets of isolation, felt like a setup for missteps and subsequent rampant infection. My first thought was that these policies would not protect vulnerable elders but hide them from view, causing another situation like the one at Lifecare in Kirkland, Washington, which resulted in more than 35 deaths.⁵ This time, our policies (and not just our carelessness) would be responsible for creating it.

While writing this article, sadly, such a thing has happened, just miles from my home. The Soldiers Home in Holyoke, Massachusetts, is a skilled nursing facility that has generally been very highly regarded by veterans and their families. Unfortunately, a lack of responsiveness to the current pandemic, including failure to provide protective equipment, failure to remove symptomatic staff from frontline care, and a lack of transparency about symptomatic staff and patients has resulted in a scandal and a tragedy.⁶ Over 5 days at the end of March, eight veterans died of coronavirus without patients being sent to hospitals and without the cases being reported to either Massachusetts or local officials. Many other patients in the facility also tested positive for coronavirus, as did staff members. While this incident was not driven by a vertical interdiction policy, it was the result of actions taken to isolate and sequester elders from the community. The worst (and most symbolic) injustice was the fact that, because of rules about disposing of bodies with coronavirus (and possibly to cover up the incompetence that led to the deaths), the bodies of deceased veterans were piled into a refrigeration truck sitting in the parking lot of the facility as the tragedy unfolded.

This is a defining moment for physicians, for the healthcare system, and for our society. I am so proud of my colleagues who have stepped up, shown up, worn their (sometimes improvised) personal protective equipment and kept seeing patients because it is our job and it is part of the contract we entered into when we became physicians. Our policy choices in this moment are just as important, and it is not our ability to “get the economy started again” but our sacrifices now (or lack thereof) that will be remembered for a hundred years. Choosing patients over profit, compassion over callousness, are important not just for controlling hospital volumes and reserving intensive care unit beds, but also for preserving our professional integrity and saving our humanity.

Each night, while my 2-year-old is having her dinner of macaroni and cheese or chicken nuggets, we video chat with my elderly parents. It used to be that this time was mainly my daughter showing off her newfound fork skills, but lately it has become “elderly parent education hour.”

“Well, we’re trying to decide if we should go to the bridge club,” announced my mother early in the week of March 13th.

“No, mom! Under no circumstances should you go to the bridge club! Social distance! Stay home! If I’ve given up restaurants and babysitters and am sitting here every night holding a phone covered in mac and cheese grease, you can give up the bridge club!”

I am all for keeping my elderly parents as isolated as possible during these pandemic times. I wasn’t alone in my fear that they weren’t taking my advice seriously: My social media feed was subsequently filled with posts from other physicians who had also been educating their parents about the need for social distancing.

Then, just as we were all settling into “social distancing,” on March 20, a debate emerged on the opinion pages of The New York Times that took the argument to the next level: A former professor of mine suggested a move from a policy of “horizontal interdiction” (one that restricts the movement of the entire population, without taking risk into consideration) to a “vertical interdiction” strategy that focuses on sequestering those among us most likely to experience poor outcomes from coronavirus infection (eg, the elderly, people with chronic diseases, and the immunologically compromised).¹

This first piece was followed 2 days later on March 22 by an article from a regular New York Times contributor who called social distancing “groupthink” and then seconded the vertical interdiction proposal.² Both pieces referred to the downturn in the economy as the reason the policy would be an improvement on social distancing; they argued that lost jobs and services would cause less suffering and loss than a policy that required extended isolation of the elderly.

On closer inspection, however, vertical interdiction is different and much scarier than “social distancing.” The words used by the author of the original article gave a clue: “If we were to focus on the especially vulnerable, there would be resources to keep them at home, provide them with needed services and coronavirus testing, and direct our medical system to their early care. I would favor proactive rather than reactive testing.” This was not just a plan to keep my parents from the bridge club. This was a plan for forced quarantine, mandatory testing, and months of isolation. Almost immediately, physicians and policy makers identified feasibility problems with the idea.³ To name a few, it is not clear that the death rate in young people is all that low; even with removing elders from the equation, the demand for hospital and critical care services is rapidly overwhelming supply; testing the “herd immunity” hypothesis in real time with a virus that has a death rate of 1%-3% still runs the risk of causing millions of deaths.

I will add a few more reasons why this idea of vertical interdiction was never feasible: There is no existing structure to facilitate mandatory isolation and quarantine of elders. We have no mechanism for caring for elders who are isolated at home. We cannot rapidly design the digital health monitoring needed. We cannot provide the mobile testing proposed. In the case of seniors who require nursing care, the problems would be even greater. Our recent efforts to protect patients in nursing facilities have proven to be extremely difficult. The greatest problem is finding a way to keep the staff from bringing the virus into the facility (and there are many staff: nutrition services, nursing, patient care technicians, physical therapy, social work). The only possible answer to this issue might mean wearing extensive protective equipment, similar to physicians in Wuhan⁴ (full-head hood plus goggles). Imagine being a patient in this scenario: months of being bathed, dressed, fed, and helped to the bathroom by a person in an isolation suit.

Now, just a few weeks later, with the virus spreading and many nonelders on ventilators, the idea of “elderly sequestration” as it was presented in mid-March feels dated and irrelevant. However, the episode can and should teach us a more important lesson: The idea was fatally flawed not only because it was not feasible but primarily because it was so lacking in compassion.

The lack of compassion was not just related to the fact that patients with end-stage dementia will undoubtedly be confused and frightened when confronted with months of care administered by people in hazmat suits. It is also that the proposed policy, by creating pockets of isolation, felt like a setup for missteps and subsequent rampant infection. My first thought was that these policies would not protect vulnerable elders but hide them from view, causing another situation like the one at Lifecare in Kirkland, Washington, which resulted in more than 35 deaths.⁵ This time, our policies (and not just our carelessness) would be responsible for creating it.

While writing this article, sadly, such a thing has happened, just miles from my home. The Soldiers Home in Holyoke, Massachusetts, is a skilled nursing facility that has generally been very highly regarded by veterans and their families. Unfortunately, a lack of responsiveness to the current pandemic, including failure to provide protective equipment, failure to remove symptomatic staff from frontline care, and a lack of transparency about symptomatic staff and patients has resulted in a scandal and a tragedy.⁶ Over 5 days at the end of March, eight veterans died of coronavirus without patients being sent to hospitals and without the cases being reported to either Massachusetts or local officials. Many other patients in the facility also tested positive for coronavirus, as did staff members. While this incident was not driven by a vertical interdiction policy, it was the result of actions taken to isolate and sequester elders from the community. The worst (and most symbolic) injustice was the fact that, because of rules about disposing of bodies with coronavirus (and possibly to cover up the incompetence that led to the deaths), the bodies of deceased veterans were piled into a refrigeration truck sitting in the parking lot of the facility as the tragedy unfolded.

This is a defining moment for physicians, for the healthcare system, and for our society. I am so proud of my colleagues who have stepped up, shown up, worn their (sometimes improvised) personal protective equipment and kept seeing patients because it is our job and it is part of the contract we entered into when we became physicians. Our policy choices in this moment are just as important, and it is not our ability to “get the economy started again” but our sacrifices now (or lack thereof) that will be remembered for a hundred years. Choosing patients over profit, compassion over callousness, are important not just for controlling hospital volumes and reserving intensive care unit beds, but also for preserving our professional integrity and saving our humanity.

Each night, while my 2-year-old is having her dinner of macaroni and cheese or chicken nuggets, we video chat with my elderly parents. It used to be that this time was mainly my daughter showing off her newfound fork skills, but lately it has become “elderly parent education hour.”

“Well, we’re trying to decide if we should go to the bridge club,” announced my mother early in the week of March 13th.

“No, mom! Under no circumstances should you go to the bridge club! Social distance! Stay home! If I’ve given up restaurants and babysitters and am sitting here every night holding a phone covered in mac and cheese grease, you can give up the bridge club!”

I am all for keeping my elderly parents as isolated as possible during these pandemic times. I wasn’t alone in my fear that they weren’t taking my advice seriously: My social media feed was subsequently filled with posts from other physicians who had also been educating their parents about the need for social distancing.

Then, just as we were all settling into “social distancing,” on March 20, a debate emerged on the opinion pages of The New York Times that took the argument to the next level: A former professor of mine suggested a move from a policy of “horizontal interdiction” (one that restricts the movement of the entire population, without taking risk into consideration) to a “vertical interdiction” strategy that focuses on sequestering those among us most likely to experience poor outcomes from coronavirus infection (eg, the elderly, people with chronic diseases, and the immunologically compromised).¹

This first piece was followed 2 days later on March 22 by an article from a regular New York Times contributor who called social distancing “groupthink” and then seconded the vertical interdiction proposal.² Both pieces referred to the downturn in the economy as the reason the policy would be an improvement on social distancing; they argued that lost jobs and services would cause less suffering and loss than a policy that required extended isolation of the elderly.

On closer inspection, however, vertical interdiction is different and much scarier than “social distancing.” The words used by the author of the original article gave a clue: “If we were to focus on the especially vulnerable, there would be resources to keep them at home, provide them with needed services and coronavirus testing, and direct our medical system to their early care. I would favor proactive rather than reactive testing.” This was not just a plan to keep my parents from the bridge club. This was a plan for forced quarantine, mandatory testing, and months of isolation. Almost immediately, physicians and policy makers identified feasibility problems with the idea.³ To name a few, it is not clear that the death rate in young people is all that low; even with removing elders from the equation, the demand for hospital and critical care services is rapidly overwhelming supply; testing the “herd immunity” hypothesis in real time with a virus that has a death rate of 1%-3% still runs the risk of causing millions of deaths.

I will add a few more reasons why this idea of vertical interdiction was never feasible: There is no existing structure to facilitate mandatory isolation and quarantine of elders. We have no mechanism for caring for elders who are isolated at home. We cannot rapidly design the digital health monitoring needed. We cannot provide the mobile testing proposed. In the case of seniors who require nursing care, the problems would be even greater. Our recent efforts to protect patients in nursing facilities have proven to be extremely difficult. The greatest problem is finding a way to keep the staff from bringing the virus into the facility (and there are many staff: nutrition services, nursing, patient care technicians, physical therapy, social work). The only possible answer to this issue might mean wearing extensive protective equipment, similar to physicians in Wuhan⁴ (full-head hood plus goggles). Imagine being a patient in this scenario: months of being bathed, dressed, fed, and helped to the bathroom by a person in an isolation suit.

Now, just a few weeks later, with the virus spreading and many nonelders on ventilators, the idea of “elderly sequestration” as it was presented in mid-March feels dated and irrelevant. However, the episode can and should teach us a more important lesson: The idea was fatally flawed not only because it was not feasible but primarily because it was so lacking in compassion.

The lack of compassion was not just related to the fact that patients with end-stage dementia will undoubtedly be confused and frightened when confronted with months of care administered by people in hazmat suits. It is also that the proposed policy, by creating pockets of isolation, felt like a setup for missteps and subsequent rampant infection. My first thought was that these policies would not protect vulnerable elders but hide them from view, causing another situation like the one at Lifecare in Kirkland, Washington, which resulted in more than 35 deaths.⁵ This time, our policies (and not just our carelessness) would be responsible for creating it.

While writing this article, sadly, such a thing has happened, just miles from my home. The Soldiers Home in Holyoke, Massachusetts, is a skilled nursing facility that has generally been very highly regarded by veterans and their families. Unfortunately, a lack of responsiveness to the current pandemic, including failure to provide protective equipment, failure to remove symptomatic staff from frontline care, and a lack of transparency about symptomatic staff and patients has resulted in a scandal and a tragedy.⁶ Over 5 days at the end of March, eight veterans died of coronavirus without patients being sent to hospitals and without the cases being reported to either Massachusetts or local officials. Many other patients in the facility also tested positive for coronavirus, as did staff members. While this incident was not driven by a vertical interdiction policy, it was the result of actions taken to isolate and sequester elders from the community. The worst (and most symbolic) injustice was the fact that, because of rules about disposing of bodies with coronavirus (and possibly to cover up the incompetence that led to the deaths), the bodies of deceased veterans were piled into a refrigeration truck sitting in the parking lot of the facility as the tragedy unfolded.

This is a defining moment for physicians, for the healthcare system, and for our society. I am so proud of my colleagues who have stepped up, shown up, worn their (sometimes improvised) personal protective equipment and kept seeing patients because it is our job and it is part of the contract we entered into when we became physicians. Our policy choices in this moment are just as important, and it is not our ability to “get the economy started again” but our sacrifices now (or lack thereof) that will be remembered for a hundred years. Choosing patients over profit, compassion over callousness, are important not just for controlling hospital volumes and reserving intensive care unit beds, but also for preserving our professional integrity and saving our humanity.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

“All VA facilities are equipped with essential items and supplies, and we are continually monitoring the status of those items to ensure a robust supply chain,” US Department of Veterans Affairs (VA) Press Secretary Christina Noel insisted on April 14th. The problem? The Wall Street Journal had just reported that internal VA memos detailing concerns about shortages in personal protective equipment (PPE), including memos saying PPE rationing had begun, were circulating at the highest levels. Top VA officials, including Secretary Robert Wilkie, had been briefed several times on systemwide shortages, the memos indicated.

The department had about 2 weeks’ worth of masks on hand, the Journal said, according to a briefing made to Congress several days earlier.

One April 7, 2020 memo noted that the “United States is experiencing challenges procuring adequate supplies of [facemasks and N95 respirators] to protect Veterans Health Administration (VHA) staff” and suggested limiting access to PPE. “Mask supply levels in VHA do not support providing masks to all other employees not working directly with COVID-19 infected veterans,” the memo noted. The memo also recommended that one mask per day for health care workers involved in “screening program activities” and taking care of “COVID-19 positive patients not undergoing high risk procedures.” Even employees “performing high risk procedures or activities on suspect or confirmed COVID19 patients,” were recommended to “wear an N95 respirator for extended use with multiple COVID-19 patients.”

Secretary Wilkie conceded to the Wall Street Journal that,  “[W]e don’t have the supplies that we would have in an optimal situation, we have the supplies that we need as the [CDC] prescribes.”

The VA COVID-19 National Summary reported 5,468 positive cases of COVID-19 and 339 inpatient deaths on April 20. Although the rate of infection for veterans remains low—just .06% of veterans in the VHA system have tested positive—the 6.2% rate of death is higher than the US rate (4.6%) and nearly as high as the global rate. More than 1,600 employees at the VHA have tested positive for COVID-19, according to the VA, and 14 medical center employees had died of complications due to the virus.

The VA now appears to be increasing the number of health workers allotted protective masks. In an April 15 email, Executive in Charge Richard A. Stone, MD, sought to reassure VHA employees. “VA always had a contingency supply of PPE,” Stone explained. “However, when this crisis started to face every healthcare organization in the nation, it became more difficult to project our incoming supply chain. For this reason, and out of an abundance of caution, we implemented austerity measures to ensure that every person working with COVID-19 patients had the equipment they needed.”

According to Stone, the VA is now more confident in its supply chain. Under his direction “all employees in a community living center, spinal cord injury unit or inpatient mental health unit will receive one mask a day to support their duties. We will continue providing N95 masks to those directly in contact with COVID-19-positive patients.”

“Your safety is the most important thing to us – we need to protect you,” Stone insisted. “I give you my word that we are doing everything to help you continue to take care of our Veterans.

“All VA facilities are equipped with essential items and supplies, and we are continually monitoring the status of those items to ensure a robust supply chain,” US Department of Veterans Affairs (VA) Press Secretary Christina Noel insisted on April 14th. The problem? The Wall Street Journal had just reported that internal VA memos detailing concerns about shortages in personal protective equipment (PPE), including memos saying PPE rationing had begun, were circulating at the highest levels. Top VA officials, including Secretary Robert Wilkie, had been briefed several times on systemwide shortages, the memos indicated.

The department had about 2 weeks’ worth of masks on hand, the Journal said, according to a briefing made to Congress several days earlier.

One April 7, 2020 memo noted that the “United States is experiencing challenges procuring adequate supplies of [facemasks and N95 respirators] to protect Veterans Health Administration (VHA) staff” and suggested limiting access to PPE. “Mask supply levels in VHA do not support providing masks to all other employees not working directly with COVID-19 infected veterans,” the memo noted. The memo also recommended that one mask per day for health care workers involved in “screening program activities” and taking care of “COVID-19 positive patients not undergoing high risk procedures.” Even employees “performing high risk procedures or activities on suspect or confirmed COVID19 patients,” were recommended to “wear an N95 respirator for extended use with multiple COVID-19 patients.”

Secretary Wilkie conceded to the Wall Street Journal that,  “[W]e don’t have the supplies that we would have in an optimal situation, we have the supplies that we need as the [CDC] prescribes.”

The VA COVID-19 National Summary reported 5,468 positive cases of COVID-19 and 339 inpatient deaths on April 20. Although the rate of infection for veterans remains low—just .06% of veterans in the VHA system have tested positive—the 6.2% rate of death is higher than the US rate (4.6%) and nearly as high as the global rate. More than 1,600 employees at the VHA have tested positive for COVID-19, according to the VA, and 14 medical center employees had died of complications due to the virus.

The VA now appears to be increasing the number of health workers allotted protective masks. In an April 15 email, Executive in Charge Richard A. Stone, MD, sought to reassure VHA employees. “VA always had a contingency supply of PPE,” Stone explained. “However, when this crisis started to face every healthcare organization in the nation, it became more difficult to project our incoming supply chain. For this reason, and out of an abundance of caution, we implemented austerity measures to ensure that every person working with COVID-19 patients had the equipment they needed.”

According to Stone, the VA is now more confident in its supply chain. Under his direction “all employees in a community living center, spinal cord injury unit or inpatient mental health unit will receive one mask a day to support their duties. We will continue providing N95 masks to those directly in contact with COVID-19-positive patients.”

“Your safety is the most important thing to us – we need to protect you,” Stone insisted. “I give you my word that we are doing everything to help you continue to take care of our Veterans.

“All VA facilities are equipped with essential items and supplies, and we are continually monitoring the status of those items to ensure a robust supply chain,” US Department of Veterans Affairs (VA) Press Secretary Christina Noel insisted on April 14th. The problem? The Wall Street Journal had just reported that internal VA memos detailing concerns about shortages in personal protective equipment (PPE), including memos saying PPE rationing had begun, were circulating at the highest levels. Top VA officials, including Secretary Robert Wilkie, had been briefed several times on systemwide shortages, the memos indicated.

The department had about 2 weeks’ worth of masks on hand, the Journal said, according to a briefing made to Congress several days earlier.

One April 7, 2020 memo noted that the “United States is experiencing challenges procuring adequate supplies of [facemasks and N95 respirators] to protect Veterans Health Administration (VHA) staff” and suggested limiting access to PPE. “Mask supply levels in VHA do not support providing masks to all other employees not working directly with COVID-19 infected veterans,” the memo noted. The memo also recommended that one mask per day for health care workers involved in “screening program activities” and taking care of “COVID-19 positive patients not undergoing high risk procedures.” Even employees “performing high risk procedures or activities on suspect or confirmed COVID19 patients,” were recommended to “wear an N95 respirator for extended use with multiple COVID-19 patients.”

Secretary Wilkie conceded to the Wall Street Journal that,  “[W]e don’t have the supplies that we would have in an optimal situation, we have the supplies that we need as the [CDC] prescribes.”

The VA COVID-19 National Summary reported 5,468 positive cases of COVID-19 and 339 inpatient deaths on April 20. Although the rate of infection for veterans remains low—just .06% of veterans in the VHA system have tested positive—the 6.2% rate of death is higher than the US rate (4.6%) and nearly as high as the global rate. More than 1,600 employees at the VHA have tested positive for COVID-19, according to the VA, and 14 medical center employees had died of complications due to the virus.

The VA now appears to be increasing the number of health workers allotted protective masks. In an April 15 email, Executive in Charge Richard A. Stone, MD, sought to reassure VHA employees. “VA always had a contingency supply of PPE,” Stone explained. “However, when this crisis started to face every healthcare organization in the nation, it became more difficult to project our incoming supply chain. For this reason, and out of an abundance of caution, we implemented austerity measures to ensure that every person working with COVID-19 patients had the equipment they needed.”

According to Stone, the VA is now more confident in its supply chain. Under his direction “all employees in a community living center, spinal cord injury unit or inpatient mental health unit will receive one mask a day to support their duties. We will continue providing N95 masks to those directly in contact with COVID-19-positive patients.”

“Your safety is the most important thing to us – we need to protect you,” Stone insisted. “I give you my word that we are doing everything to help you continue to take care of our Veterans.

As I write, I must admit this message is different than the one I’d envisioned sharing with you weeks ago. I anticipated updating you on meetings and collaborations with sister societies, new educational offerings, and how the Bologna World Congress and Annual Meeting plans were progressing, but activities at CHEST – and our sense of priority – have evolved along with those of our global community.

Pulmonary and critical care providers are now at the forefront of health care. Our patients, and now the greater public, are relying on our efforts and those of our teams. Amid this crisis, there is a renewed appreciation for the work all of you do; and with it, an opportunity for CHEST to lead and help ensure that the profession and our systems emerge stronger.

Back in February, we held the program committee meeting for the Annual Meeting with over 1000 submissions. It is astounding how the program came together over just a few days thanks to the preemptive work done by Chair, Dr. Victor Test, and, Co-Chair, Dr. Christopher Carroll, and all of the curricular groups, program committee members, and staff putting in so much work prior to the face-to-face meeting. Also during February, CHEST leadership held the Forum of International Respiratory Societies’ (FIRS) strategic planning meeting. The main outcome is a plan to engage a lobbyist to represent the worldwide respiratory societies in the WHO in Geneva on universal topics such as air pollution and now, unfortunately, COVID-19. CHEST was represented at the Society of Critical Care Medicine (SCCM) Congress where we heard late-breaking information as the pandemic was beginning to unfold. We met with the Critical Care Societies Collaborative (CCSC), which is composed of representatives from CHEST, SCCM, the American Thoracic Society (ATS), and the American Association of Critical-Care Nurses (AACN). We had an opportunity to meet with the European Society of Intensive Care Medicine (ESICM) and initiate discussions toward future collaboration.

In early March, as COVID-19 began to interfere with in-person meetings, we participated virtually in the NAMDRC meeting, and finalized our commitment to formally joining forces under the umbrella of CHEST to better serve our members in the area of advocacy. To this end, a new standing CHEST committee was founded, consisting of members from the former NAMRDC Board and members from the CHEST Board of Regents and Board of Trustees and chaired by Dr. Neil Freedman and Dr. Jim Lamberti. We look forward to hosting advocacy sessions during our October meeting, and going forward, our Spring Leadership Meeting will be combined with the former NAMDRC meeting to allow our leaders to participate in advocacy efforts. We will continue to publish the Washington Watchline, bringing important news on efforts to enhance access to care and our ability to deliver it effectively. Our spring leadership meetings, board meetings, and committee meetings in early April were held virtually in light of the pandemic.

Since March, CHEST has been heavily immersed in COVID-19 preparation with new plans for alternate methods of educational delivery, new business models, and curtailment of travel on both our home fronts and on the CHEST front. Zoom and like platforms are now my best friend! Our daily vocabulary now includes an abundance of caution, surge, sheltering in place, quarantine, social distancing, flattening the curve, tele-medicine, and don and doff, and we close e-mails, texts, and phone calls with Stay Safe! I established a COVID task force led by Dr. Steve Simpson (CHEST President-Elect) and with representation from the Critical Care, Chest Infections, and Disaster Response and Global Health NetWorks. They have been meeting weekly with the goals of disseminating and distilling COVID-related materials for the busy practitioner with links to the specific article or statement along with the BLUF (Bottom Line Up Front). I’m sure you were able to see and hear some of the reports by Dr. Mangala Narasimhan and others on the front lines in New York, on the CHEST website, 60 Minutes, and CNN. CHEST held a two-part webinar with our Chinese colleagues who shared their COVID experiences with us. These relationships were in part built from the PCCM Fellowship Training program we conducted with Chinese physicians, led by Dr. Darcy Marciniuk and Dr. Chen Wang under the guidance of Dr. Renli Qiao, and with the help of the late Dr. Mark Rosen, Dr. Jack Buckley, and myself. CHEST has posted a webinar on point of care ultrasound testing in the setting of COVID since many units are now using more POCUS instead of standard imaging for the critically ill. We have also posted some of our board review lectures on demand for those who want to brush up on their critical care skills and knowledge.

CHEST, unfortunately, had to reschedule the Bologna meeting due to the tragic situation in Italy and plans to reconvene the meeting June 24-26 of 2021. As of now, CHEST 2020 in Chicago is a go, but, of course, we will monitor that situation carefully. We have extended the deadline for abstracts and case reports to June 1, 2020, given the ongoing crisis. The team is busy planning for standalone and complementary online offerings to ensure seamless delivery of critical education in formats that cater easily to our newly formed habits.

CHEST staff have been working from home due to the Illinois shelter in place order but continue to work tremendously hard. They are implementing new areas to the website in an effort to improve the user experience by making information easier to find and more timely. In the publishing space, Dr. Peter Mazzone and the journal team have been receiving hundreds of COVID-related publications, which they have been reviewing and expediting for publication where appropriate. There will also be additional podcasts coming from our journal. The guidelines group has been working on shorter expert panel statements in the setting of rapidly changing evidence. And, to keep us all well, there are opportunities to share our personal feelings and experiences with treating those with COVID in video format on the website and across CHEST social media channels. The CHEST and the CHEST Foundation have initiated a new microgrants program and have reached out to over 150 ILD and COPD support groups across the country to offer them the opportunity to apply for a max $2,500 grant. So far, 7seven groups have requested support. These grants go directly to patients and caregivers and provide needed relief through provision of:

1. Groceries

2. Gift cards

3. Medical supplies (including PPE for patients)

4. Technology needed to communicate with their community and HCPs

5. Household supplies, cleaning supplies

In an attempt to assist our colleagues in New York City, a call went out for volunteers at the end of March and has resulted in over 200 volunteers and more than 400 inquiries from our members. Bravo!!! We want to thank our sister societies for joining our efforts during this time to help all of our respective members and, ultimately, those patients stricken with this terrible illness. As I don and doff my COVID gear, I hope you are all safe and well in this time of unprecedented change in our lives. I look forward to my next report in a few months, hopefully on a happier note.

Stay safe!

Stephanie

As I write, I must admit this message is different than the one I’d envisioned sharing with you weeks ago. I anticipated updating you on meetings and collaborations with sister societies, new educational offerings, and how the Bologna World Congress and Annual Meeting plans were progressing, but activities at CHEST – and our sense of priority – have evolved along with those of our global community.

Pulmonary and critical care providers are now at the forefront of health care. Our patients, and now the greater public, are relying on our efforts and those of our teams. Amid this crisis, there is a renewed appreciation for the work all of you do; and with it, an opportunity for CHEST to lead and help ensure that the profession and our systems emerge stronger.

Back in February, we held the program committee meeting for the Annual Meeting with over 1000 submissions. It is astounding how the program came together over just a few days thanks to the preemptive work done by Chair, Dr. Victor Test, and, Co-Chair, Dr. Christopher Carroll, and all of the curricular groups, program committee members, and staff putting in so much work prior to the face-to-face meeting. Also during February, CHEST leadership held the Forum of International Respiratory Societies’ (FIRS) strategic planning meeting. The main outcome is a plan to engage a lobbyist to represent the worldwide respiratory societies in the WHO in Geneva on universal topics such as air pollution and now, unfortunately, COVID-19. CHEST was represented at the Society of Critical Care Medicine (SCCM) Congress where we heard late-breaking information as the pandemic was beginning to unfold. We met with the Critical Care Societies Collaborative (CCSC), which is composed of representatives from CHEST, SCCM, the American Thoracic Society (ATS), and the American Association of Critical-Care Nurses (AACN). We had an opportunity to meet with the European Society of Intensive Care Medicine (ESICM) and initiate discussions toward future collaboration.

In early March, as COVID-19 began to interfere with in-person meetings, we participated virtually in the NAMDRC meeting, and finalized our commitment to formally joining forces under the umbrella of CHEST to better serve our members in the area of advocacy. To this end, a new standing CHEST committee was founded, consisting of members from the former NAMRDC Board and members from the CHEST Board of Regents and Board of Trustees and chaired by Dr. Neil Freedman and Dr. Jim Lamberti. We look forward to hosting advocacy sessions during our October meeting, and going forward, our Spring Leadership Meeting will be combined with the former NAMDRC meeting to allow our leaders to participate in advocacy efforts. We will continue to publish the Washington Watchline, bringing important news on efforts to enhance access to care and our ability to deliver it effectively. Our spring leadership meetings, board meetings, and committee meetings in early April were held virtually in light of the pandemic.

Since March, CHEST has been heavily immersed in COVID-19 preparation with new plans for alternate methods of educational delivery, new business models, and curtailment of travel on both our home fronts and on the CHEST front. Zoom and like platforms are now my best friend! Our daily vocabulary now includes an abundance of caution, surge, sheltering in place, quarantine, social distancing, flattening the curve, tele-medicine, and don and doff, and we close e-mails, texts, and phone calls with Stay Safe! I established a COVID task force led by Dr. Steve Simpson (CHEST President-Elect) and with representation from the Critical Care, Chest Infections, and Disaster Response and Global Health NetWorks. They have been meeting weekly with the goals of disseminating and distilling COVID-related materials for the busy practitioner with links to the specific article or statement along with the BLUF (Bottom Line Up Front). I’m sure you were able to see and hear some of the reports by Dr. Mangala Narasimhan and others on the front lines in New York, on the CHEST website, 60 Minutes, and CNN. CHEST held a two-part webinar with our Chinese colleagues who shared their COVID experiences with us. These relationships were in part built from the PCCM Fellowship Training program we conducted with Chinese physicians, led by Dr. Darcy Marciniuk and Dr. Chen Wang under the guidance of Dr. Renli Qiao, and with the help of the late Dr. Mark Rosen, Dr. Jack Buckley, and myself. CHEST has posted a webinar on point of care ultrasound testing in the setting of COVID since many units are now using more POCUS instead of standard imaging for the critically ill. We have also posted some of our board review lectures on demand for those who want to brush up on their critical care skills and knowledge.

CHEST, unfortunately, had to reschedule the Bologna meeting due to the tragic situation in Italy and plans to reconvene the meeting June 24-26 of 2021. As of now, CHEST 2020 in Chicago is a go, but, of course, we will monitor that situation carefully. We have extended the deadline for abstracts and case reports to June 1, 2020, given the ongoing crisis. The team is busy planning for standalone and complementary online offerings to ensure seamless delivery of critical education in formats that cater easily to our newly formed habits.

CHEST staff have been working from home due to the Illinois shelter in place order but continue to work tremendously hard. They are implementing new areas to the website in an effort to improve the user experience by making information easier to find and more timely. In the publishing space, Dr. Peter Mazzone and the journal team have been receiving hundreds of COVID-related publications, which they have been reviewing and expediting for publication where appropriate. There will also be additional podcasts coming from our journal. The guidelines group has been working on shorter expert panel statements in the setting of rapidly changing evidence. And, to keep us all well, there are opportunities to share our personal feelings and experiences with treating those with COVID in video format on the website and across CHEST social media channels. The CHEST and the CHEST Foundation have initiated a new microgrants program and have reached out to over 150 ILD and COPD support groups across the country to offer them the opportunity to apply for a max $2,500 grant. So far, 7seven groups have requested support. These grants go directly to patients and caregivers and provide needed relief through provision of:

1. Groceries

2. Gift cards

3. Medical supplies (including PPE for patients)

4. Technology needed to communicate with their community and HCPs

5. Household supplies, cleaning supplies

In an attempt to assist our colleagues in New York City, a call went out for volunteers at the end of March and has resulted in over 200 volunteers and more than 400 inquiries from our members. Bravo!!! We want to thank our sister societies for joining our efforts during this time to help all of our respective members and, ultimately, those patients stricken with this terrible illness. As I don and doff my COVID gear, I hope you are all safe and well in this time of unprecedented change in our lives. I look forward to my next report in a few months, hopefully on a happier note.

Stay safe!

Stephanie

As I write, I must admit this message is different than the one I’d envisioned sharing with you weeks ago. I anticipated updating you on meetings and collaborations with sister societies, new educational offerings, and how the Bologna World Congress and Annual Meeting plans were progressing, but activities at CHEST – and our sense of priority – have evolved along with those of our global community.

Pulmonary and critical care providers are now at the forefront of health care. Our patients, and now the greater public, are relying on our efforts and those of our teams. Amid this crisis, there is a renewed appreciation for the work all of you do; and with it, an opportunity for CHEST to lead and help ensure that the profession and our systems emerge stronger.

Back in February, we held the program committee meeting for the Annual Meeting with over 1000 submissions. It is astounding how the program came together over just a few days thanks to the preemptive work done by Chair, Dr. Victor Test, and, Co-Chair, Dr. Christopher Carroll, and all of the curricular groups, program committee members, and staff putting in so much work prior to the face-to-face meeting. Also during February, CHEST leadership held the Forum of International Respiratory Societies’ (FIRS) strategic planning meeting. The main outcome is a plan to engage a lobbyist to represent the worldwide respiratory societies in the WHO in Geneva on universal topics such as air pollution and now, unfortunately, COVID-19. CHEST was represented at the Society of Critical Care Medicine (SCCM) Congress where we heard late-breaking information as the pandemic was beginning to unfold. We met with the Critical Care Societies Collaborative (CCSC), which is composed of representatives from CHEST, SCCM, the American Thoracic Society (ATS), and the American Association of Critical-Care Nurses (AACN). We had an opportunity to meet with the European Society of Intensive Care Medicine (ESICM) and initiate discussions toward future collaboration.

In early March, as COVID-19 began to interfere with in-person meetings, we participated virtually in the NAMDRC meeting, and finalized our commitment to formally joining forces under the umbrella of CHEST to better serve our members in the area of advocacy. To this end, a new standing CHEST committee was founded, consisting of members from the former NAMRDC Board and members from the CHEST Board of Regents and Board of Trustees and chaired by Dr. Neil Freedman and Dr. Jim Lamberti. We look forward to hosting advocacy sessions during our October meeting, and going forward, our Spring Leadership Meeting will be combined with the former NAMDRC meeting to allow our leaders to participate in advocacy efforts. We will continue to publish the Washington Watchline, bringing important news on efforts to enhance access to care and our ability to deliver it effectively. Our spring leadership meetings, board meetings, and committee meetings in early April were held virtually in light of the pandemic.

Since March, CHEST has been heavily immersed in COVID-19 preparation with new plans for alternate methods of educational delivery, new business models, and curtailment of travel on both our home fronts and on the CHEST front. Zoom and like platforms are now my best friend! Our daily vocabulary now includes an abundance of caution, surge, sheltering in place, quarantine, social distancing, flattening the curve, tele-medicine, and don and doff, and we close e-mails, texts, and phone calls with Stay Safe! I established a COVID task force led by Dr. Steve Simpson (CHEST President-Elect) and with representation from the Critical Care, Chest Infections, and Disaster Response and Global Health NetWorks. They have been meeting weekly with the goals of disseminating and distilling COVID-related materials for the busy practitioner with links to the specific article or statement along with the BLUF (Bottom Line Up Front). I’m sure you were able to see and hear some of the reports by Dr. Mangala Narasimhan and others on the front lines in New York, on the CHEST website, 60 Minutes, and CNN. CHEST held a two-part webinar with our Chinese colleagues who shared their COVID experiences with us. These relationships were in part built from the PCCM Fellowship Training program we conducted with Chinese physicians, led by Dr. Darcy Marciniuk and Dr. Chen Wang under the guidance of Dr. Renli Qiao, and with the help of the late Dr. Mark Rosen, Dr. Jack Buckley, and myself. CHEST has posted a webinar on point of care ultrasound testing in the setting of COVID since many units are now using more POCUS instead of standard imaging for the critically ill. We have also posted some of our board review lectures on demand for those who want to brush up on their critical care skills and knowledge.

CHEST, unfortunately, had to reschedule the Bologna meeting due to the tragic situation in Italy and plans to reconvene the meeting June 24-26 of 2021. As of now, CHEST 2020 in Chicago is a go, but, of course, we will monitor that situation carefully. We have extended the deadline for abstracts and case reports to June 1, 2020, given the ongoing crisis. The team is busy planning for standalone and complementary online offerings to ensure seamless delivery of critical education in formats that cater easily to our newly formed habits.

CHEST staff have been working from home due to the Illinois shelter in place order but continue to work tremendously hard. They are implementing new areas to the website in an effort to improve the user experience by making information easier to find and more timely. In the publishing space, Dr. Peter Mazzone and the journal team have been receiving hundreds of COVID-related publications, which they have been reviewing and expediting for publication where appropriate. There will also be additional podcasts coming from our journal. The guidelines group has been working on shorter expert panel statements in the setting of rapidly changing evidence. And, to keep us all well, there are opportunities to share our personal feelings and experiences with treating those with COVID in video format on the website and across CHEST social media channels. The CHEST and the CHEST Foundation have initiated a new microgrants program and have reached out to over 150 ILD and COPD support groups across the country to offer them the opportunity to apply for a max $2,500 grant. So far, 7seven groups have requested support. These grants go directly to patients and caregivers and provide needed relief through provision of:

1. Groceries

2. Gift cards

3. Medical supplies (including PPE for patients)

4. Technology needed to communicate with their community and HCPs

5. Household supplies, cleaning supplies

In an attempt to assist our colleagues in New York City, a call went out for volunteers at the end of March and has resulted in over 200 volunteers and more than 400 inquiries from our members. Bravo!!! We want to thank our sister societies for joining our efforts during this time to help all of our respective members and, ultimately, those patients stricken with this terrible illness. As I don and doff my COVID gear, I hope you are all safe and well in this time of unprecedented change in our lives. I look forward to my next report in a few months, hopefully on a happier note.

Stay safe!

Stephanie

AGA has advocated for provisions to protect our providers and businesses and we’re happy to report that the following provisions are in the third installation of the COVID-19 economic relief legislation.

We’ll continue to push for direct funding for physicians recognizing that many practices and ASCs are struggling.
 

Small business relief

• Small Business Administration (SBA) loans:

Businesses with 500 employees or less are eligible unless the covered industry’s SBA size standard allows more than 500 employees.

Allows 501(c)(3) non-profits to gain access to the program.

Increases the maximum loan amount to $10 million.

Expands allowable uses of loans to include payroll support, such as:

1. Paid sick or medical leave.

2. Employee salaries.

3. Mortgage payments.

Provides a process for loan forgiveness for certain payroll costs as well as mortgage, rent and utility obligations.

• Public Health and Social Services Emergency Fund:

$100 billion for health care services related to the COVID-19.

Reimbursement to eligible health care providers for health care related expenses or lost revenues that are attributable to the pandemic.

• Coronavirus Economic Stabilization Act:

$454 billion for loans, loan guarantees and other investments for companies with losses tied to the pandemic that threaten continued operation.
 

Medicare provisions

• Suspension of sequestration – Physicians avoid a 2% cut in their Medicare reimbursement.
• Extension of geographic index floor – Increases Medicare payments for providers in nonurban areas.
• Increased Medicare telehealth flexibilities during the emergency period.
• AGA will continue to advocate for audio-only coverage as this issue is still not resolved.

Other key health care provisions

• Liability protections for health care professionals during the emergency response.
• Coverage of preventive services and vaccines.
• $16 billion to replenish the Strategic National Stockpile.
• $1 billion for the Defense Production Act to ensure production of personal protective equipment (PPE).

Correspondence to congressional leadership

• March 25, 2020 – With the American Medical Association, a letter is sent requesting the inclusion of support for physician practices in any economic stimulus package.
• March 24, 2020 – With the Alliance of Specialty Medicine, a letter is sent asking for relief for independent physicians’ offices.
• March 20, 2020 – A joint society letter is sent asking for increased funding for and access to PPE; softened prior authorization, telehealth reimbursement and Medicare reporting requirements; and financial safeguards for health care professionals and practices.

ginews@gastro.org

AGA has advocated for provisions to protect our providers and businesses and we’re happy to report that the following provisions are in the third installation of the COVID-19 economic relief legislation.

We’ll continue to push for direct funding for physicians recognizing that many practices and ASCs are struggling.
 

Small business relief

• Small Business Administration (SBA) loans:

Businesses with 500 employees or less are eligible unless the covered industry’s SBA size standard allows more than 500 employees.

Allows 501(c)(3) non-profits to gain access to the program.

Increases the maximum loan amount to $10 million.

Expands allowable uses of loans to include payroll support, such as:

1. Paid sick or medical leave.

2. Employee salaries.

3. Mortgage payments.

Provides a process for loan forgiveness for certain payroll costs as well as mortgage, rent and utility obligations.

• Public Health and Social Services Emergency Fund:

$100 billion for health care services related to the COVID-19.

Reimbursement to eligible health care providers for health care related expenses or lost revenues that are attributable to the pandemic.

• Coronavirus Economic Stabilization Act:

$454 billion for loans, loan guarantees and other investments for companies with losses tied to the pandemic that threaten continued operation.
 

Medicare provisions

• Suspension of sequestration – Physicians avoid a 2% cut in their Medicare reimbursement.
• Extension of geographic index floor – Increases Medicare payments for providers in nonurban areas.
• Increased Medicare telehealth flexibilities during the emergency period.
• AGA will continue to advocate for audio-only coverage as this issue is still not resolved.

Other key health care provisions

• Liability protections for health care professionals during the emergency response.
• Coverage of preventive services and vaccines.
• $16 billion to replenish the Strategic National Stockpile.
• $1 billion for the Defense Production Act to ensure production of personal protective equipment (PPE).

Correspondence to congressional leadership

• March 25, 2020 – With the American Medical Association, a letter is sent requesting the inclusion of support for physician practices in any economic stimulus package.
• March 24, 2020 – With the Alliance of Specialty Medicine, a letter is sent asking for relief for independent physicians’ offices.
• March 20, 2020 – A joint society letter is sent asking for increased funding for and access to PPE; softened prior authorization, telehealth reimbursement and Medicare reporting requirements; and financial safeguards for health care professionals and practices.

ginews@gastro.org

AGA has advocated for provisions to protect our providers and businesses and we’re happy to report that the following provisions are in the third installation of the COVID-19 economic relief legislation.

We’ll continue to push for direct funding for physicians recognizing that many practices and ASCs are struggling.
 

Small business relief

• Small Business Administration (SBA) loans:

Businesses with 500 employees or less are eligible unless the covered industry’s SBA size standard allows more than 500 employees.

Allows 501(c)(3) non-profits to gain access to the program.

Increases the maximum loan amount to $10 million.

Expands allowable uses of loans to include payroll support, such as:

1. Paid sick or medical leave.

2. Employee salaries.

3. Mortgage payments.

Provides a process for loan forgiveness for certain payroll costs as well as mortgage, rent and utility obligations.

• Public Health and Social Services Emergency Fund:

$100 billion for health care services related to the COVID-19.

Reimbursement to eligible health care providers for health care related expenses or lost revenues that are attributable to the pandemic.

• Coronavirus Economic Stabilization Act:

$454 billion for loans, loan guarantees and other investments for companies with losses tied to the pandemic that threaten continued operation.
 

Medicare provisions

• Suspension of sequestration – Physicians avoid a 2% cut in their Medicare reimbursement.
• Extension of geographic index floor – Increases Medicare payments for providers in nonurban areas.
• Increased Medicare telehealth flexibilities during the emergency period.
• AGA will continue to advocate for audio-only coverage as this issue is still not resolved.

Other key health care provisions

• Liability protections for health care professionals during the emergency response.
• Coverage of preventive services and vaccines.
• $16 billion to replenish the Strategic National Stockpile.
• $1 billion for the Defense Production Act to ensure production of personal protective equipment (PPE).

Correspondence to congressional leadership

• March 25, 2020 – With the American Medical Association, a letter is sent requesting the inclusion of support for physician practices in any economic stimulus package.
• March 24, 2020 – With the Alliance of Specialty Medicine, a letter is sent asking for relief for independent physicians’ offices.
• March 20, 2020 – A joint society letter is sent asking for increased funding for and access to PPE; softened prior authorization, telehealth reimbursement and Medicare reporting requirements; and financial safeguards for health care professionals and practices.

ginews@gastro.org

As you know, the COVID-19 pandemic has caused immense strain on global health systems. With our membership at the epicenter, many of you have experienced firsthand the shortages that result from a surging patient population – lack of personal protective equipment (PPE), access to ventilators, and increasing demand for more qualified health-care workers needed on the front lines to treat and care for patients. As the staff leader of your organization, I feel an immense responsibility to support our community through this crisis.

In recent weeks, CHEST petitioned the federal and local governments on several issues, advocating for tax relief for COVID responders, expansion of liability protections, and the development of a provider relief fund. We will continue to collaborate with other societies and push such efforts. However, we also recognize an obligation to make a more tangible, real-time difference in the circumstances of our membership and the lives of the patients you are working to save.

An opportunity arose when we received a call from Dr. Doreen Addrizzo-Harris, Immediate Past President of the CHEST Foundation and Professor of Medicine at NYU Langone Health. In late March, New York City was seeing an uptick in patients with confirmed COVID infection in critical condition that was escalating by the day. The situation was beginning to resemble the trajectory of hotspots in Wuhan, China and Italy, and it was already taking a toll on health-care teams. Dr. Adrizzo-Harris asked whether there was any way to leverage the strength of the CHEST community to provide help. Already, our headquarters team had received unsolicited offers to travel to areas in need from our members. The question was how could we more proactively identify such willing and able clinicians.

We quickly drew upon our existing CHEST Analytics platform to target physicians outside New York City who might be well-positioned to travel. We harnessed our communication channels to get the word out. The response was immediate, with more than 100 people completing applications to join forces with their colleagues in New York. In the first 10 days of recruitment efforts, we added an additional 250 interested volunteers to the system. The positive response from members showed both the willingness of qualified medical staff to assist on the front lines but also highlighted deficiencies in other registration systems overwhelmed with requests in the face of this pandemic. Finding certified pulmonary and critical care physicians who are willing to step in where they are needed is time- and labor-intensive and detracts from health systems’ ability to focus on care. Watching the projections in other regions, we recognized other areas may soon need this same help.

With this in mind, CHEST approached ATS and our long-time partner PA Consulting to help us address the problem on a national scale. We felt we had the resources to leverage our databases and our analytic tools to create a more efficient process that would put physicians in hospitals where they could do the most good more efficiently. We knew that if we could apply our knowledge and deploy our heroic members, we could develop a solution that could save lives and relieve frontline clinicians. By leveraging the existing CHEST Analytics platform, the team created a solution that can be used by provider institutions, government agencies, and willing clinicians to quickly and effectively provide care where it is needed most. The team has engineered the solution to be scalable nationally and expandable to other critical care specialties (eg, anesthesia, emergency, nursing, respiratory therapy).

The Clinician Matching Network formally launched on April 14, 2020. It provides a two-way input that accepts sign up from individual clinicians and gathers needs and requirements from hospital systems, connecting health-care providers with the systems most in need of the specific support they are equipped to provide. We believe this has the potential to enable us to move ahead of the curve of the crisis.

I am very proud of the teams that lead this effort and have gained a greater appreciation of how CHEST, in partnership with other medical societies, can fully utilize data and analytics toward implementing public health solutions. The design and development of the Clinician Matching Network was accomplished in less than a week, leveraging a methodology that will enable the team to continuously improve and iterate through weekly releases, adding functionality quickly as the pandemic evolves.

In the weeks ahead, communications will be distributed to hospitals and hospital systems to help identify their staffing needs, encourage them to input their needs into the Clinician Matching Network, and expand the clinician-to-hospital matching effort. We aim to increase the number of collaborationg associations to grow the pool of clinicians who can be deployed to areas in need.

Please visit www.chestnet.org/clinician-matching to learn more, sign up to serve, tell us about the needs of your institution, or collaborate toward this cause.

As you know, the COVID-19 pandemic has caused immense strain on global health systems. With our membership at the epicenter, many of you have experienced firsthand the shortages that result from a surging patient population – lack of personal protective equipment (PPE), access to ventilators, and increasing demand for more qualified health-care workers needed on the front lines to treat and care for patients. As the staff leader of your organization, I feel an immense responsibility to support our community through this crisis.

In recent weeks, CHEST petitioned the federal and local governments on several issues, advocating for tax relief for COVID responders, expansion of liability protections, and the development of a provider relief fund. We will continue to collaborate with other societies and push such efforts. However, we also recognize an obligation to make a more tangible, real-time difference in the circumstances of our membership and the lives of the patients you are working to save.

An opportunity arose when we received a call from Dr. Doreen Addrizzo-Harris, Immediate Past President of the CHEST Foundation and Professor of Medicine at NYU Langone Health. In late March, New York City was seeing an uptick in patients with confirmed COVID infection in critical condition that was escalating by the day. The situation was beginning to resemble the trajectory of hotspots in Wuhan, China and Italy, and it was already taking a toll on health-care teams. Dr. Adrizzo-Harris asked whether there was any way to leverage the strength of the CHEST community to provide help. Already, our headquarters team had received unsolicited offers to travel to areas in need from our members. The question was how could we more proactively identify such willing and able clinicians.

We quickly drew upon our existing CHEST Analytics platform to target physicians outside New York City who might be well-positioned to travel. We harnessed our communication channels to get the word out. The response was immediate, with more than 100 people completing applications to join forces with their colleagues in New York. In the first 10 days of recruitment efforts, we added an additional 250 interested volunteers to the system. The positive response from members showed both the willingness of qualified medical staff to assist on the front lines but also highlighted deficiencies in other registration systems overwhelmed with requests in the face of this pandemic. Finding certified pulmonary and critical care physicians who are willing to step in where they are needed is time- and labor-intensive and detracts from health systems’ ability to focus on care. Watching the projections in other regions, we recognized other areas may soon need this same help.

With this in mind, CHEST approached ATS and our long-time partner PA Consulting to help us address the problem on a national scale. We felt we had the resources to leverage our databases and our analytic tools to create a more efficient process that would put physicians in hospitals where they could do the most good more efficiently. We knew that if we could apply our knowledge and deploy our heroic members, we could develop a solution that could save lives and relieve frontline clinicians. By leveraging the existing CHEST Analytics platform, the team created a solution that can be used by provider institutions, government agencies, and willing clinicians to quickly and effectively provide care where it is needed most. The team has engineered the solution to be scalable nationally and expandable to other critical care specialties (eg, anesthesia, emergency, nursing, respiratory therapy).

The Clinician Matching Network formally launched on April 14, 2020. It provides a two-way input that accepts sign up from individual clinicians and gathers needs and requirements from hospital systems, connecting health-care providers with the systems most in need of the specific support they are equipped to provide. We believe this has the potential to enable us to move ahead of the curve of the crisis.

I am very proud of the teams that lead this effort and have gained a greater appreciation of how CHEST, in partnership with other medical societies, can fully utilize data and analytics toward implementing public health solutions. The design and development of the Clinician Matching Network was accomplished in less than a week, leveraging a methodology that will enable the team to continuously improve and iterate through weekly releases, adding functionality quickly as the pandemic evolves.

In the weeks ahead, communications will be distributed to hospitals and hospital systems to help identify their staffing needs, encourage them to input their needs into the Clinician Matching Network, and expand the clinician-to-hospital matching effort. We aim to increase the number of collaborationg associations to grow the pool of clinicians who can be deployed to areas in need.

Please visit www.chestnet.org/clinician-matching to learn more, sign up to serve, tell us about the needs of your institution, or collaborate toward this cause.

As you know, the COVID-19 pandemic has caused immense strain on global health systems. With our membership at the epicenter, many of you have experienced firsthand the shortages that result from a surging patient population – lack of personal protective equipment (PPE), access to ventilators, and increasing demand for more qualified health-care workers needed on the front lines to treat and care for patients. As the staff leader of your organization, I feel an immense responsibility to support our community through this crisis.

In recent weeks, CHEST petitioned the federal and local governments on several issues, advocating for tax relief for COVID responders, expansion of liability protections, and the development of a provider relief fund. We will continue to collaborate with other societies and push such efforts. However, we also recognize an obligation to make a more tangible, real-time difference in the circumstances of our membership and the lives of the patients you are working to save.

An opportunity arose when we received a call from Dr. Doreen Addrizzo-Harris, Immediate Past President of the CHEST Foundation and Professor of Medicine at NYU Langone Health. In late March, New York City was seeing an uptick in patients with confirmed COVID infection in critical condition that was escalating by the day. The situation was beginning to resemble the trajectory of hotspots in Wuhan, China and Italy, and it was already taking a toll on health-care teams. Dr. Adrizzo-Harris asked whether there was any way to leverage the strength of the CHEST community to provide help. Already, our headquarters team had received unsolicited offers to travel to areas in need from our members. The question was how could we more proactively identify such willing and able clinicians.

We quickly drew upon our existing CHEST Analytics platform to target physicians outside New York City who might be well-positioned to travel. We harnessed our communication channels to get the word out. The response was immediate, with more than 100 people completing applications to join forces with their colleagues in New York. In the first 10 days of recruitment efforts, we added an additional 250 interested volunteers to the system. The positive response from members showed both the willingness of qualified medical staff to assist on the front lines but also highlighted deficiencies in other registration systems overwhelmed with requests in the face of this pandemic. Finding certified pulmonary and critical care physicians who are willing to step in where they are needed is time- and labor-intensive and detracts from health systems’ ability to focus on care. Watching the projections in other regions, we recognized other areas may soon need this same help.

With this in mind, CHEST approached ATS and our long-time partner PA Consulting to help us address the problem on a national scale. We felt we had the resources to leverage our databases and our analytic tools to create a more efficient process that would put physicians in hospitals where they could do the most good more efficiently. We knew that if we could apply our knowledge and deploy our heroic members, we could develop a solution that could save lives and relieve frontline clinicians. By leveraging the existing CHEST Analytics platform, the team created a solution that can be used by provider institutions, government agencies, and willing clinicians to quickly and effectively provide care where it is needed most. The team has engineered the solution to be scalable nationally and expandable to other critical care specialties (eg, anesthesia, emergency, nursing, respiratory therapy).

The Clinician Matching Network formally launched on April 14, 2020. It provides a two-way input that accepts sign up from individual clinicians and gathers needs and requirements from hospital systems, connecting health-care providers with the systems most in need of the specific support they are equipped to provide. We believe this has the potential to enable us to move ahead of the curve of the crisis.

I am very proud of the teams that lead this effort and have gained a greater appreciation of how CHEST, in partnership with other medical societies, can fully utilize data and analytics toward implementing public health solutions. The design and development of the Clinician Matching Network was accomplished in less than a week, leveraging a methodology that will enable the team to continuously improve and iterate through weekly releases, adding functionality quickly as the pandemic evolves.

In the weeks ahead, communications will be distributed to hospitals and hospital systems to help identify their staffing needs, encourage them to input their needs into the Clinician Matching Network, and expand the clinician-to-hospital matching effort. We aim to increase the number of collaborationg associations to grow the pool of clinicians who can be deployed to areas in need.

Please visit www.chestnet.org/clinician-matching to learn more, sign up to serve, tell us about the needs of your institution, or collaborate toward this cause.

Pemphigoid gestationis
 

Pemphigoid gestationis, which is also known as herpes gestationis or gestational pemphigoid, is a rare, autoimmune vesiculobullous eruption that occurs during the third trimester of pregnancy or in the postpartum period.

Holly Hanson MD, Associated Skin Care Specialists, Eden Prairie, Minn.

It typically presents with the abrupt onset of very pruritic urticarial plaques and papules, which start around the umbilicus and then spread to involve the trunk and extremities. The papules and plaques evolve to generalized tense blisters, which typically spare the face, palms, soles, and mucous membranes. Half of affected patients may present in an atypical distribution involving the extremities, palms, or soles. Patients may be at an increased risk for the development of Graves disease.

The cause of pemphigoid gestationis is a factor known as “herpes gestationis factor” that induces C3 deposition along the dermal-epidermal junction. As in bullous pemphigoid, patients with pemphigoid gestationis have antibodies to a transmembrane hemidesmosomal protein called BPAG2/BP180/collagen XVII.

Holly Hanson MD, Associated Skin Care Specialists, Eden Prairie, Minn.

Three-quarters of patients worsen at the time of delivery and up to 10% of newborns will have bullous lesions secondary to placental transfer of antibodies. In most cases, lesions will spontaneously resolve over a few weeks following delivery. Recurrence with future pregnancies is common, with severity increasing with each pregnancy. Recurrence with menstruation and with the use of oral contraceptives can also occur. Although there is no increase in maternal mortality, onset in the first or second trimester and presence of blisters is associated with decreased gestational age of baby at delivery and lower-birth-weight infants. There is no increase in fetal mortality.

Histopathology reveals a subepidermal vesicle and perivascular infiltrate consisting of lymphocytes and eosinophils. Diagnosis can be confirmed with direct immunofluorescence showing C3 in a linear band along the basement membrane zone. IgG may be present as well. Complement added indirect immunofluorescence reveals circulating anti–basement zone IgG, which allows differentiation from pruritic urticarial papules and plaques of pregnancy.

Treatment for localized disease includes class I topical steroids and oral antihistamines. More severe cases require systemic corticosteroid treatment. Systemic steroids may cause lower-birth-weight infants.

This case and the photos were submitted by Dr. Hanson of Associated Skin Care Specialists in Eden Prairie, Minn. The case was edited by Donna Bilu Martin, MD.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Pemphigoid gestationis
 

Pemphigoid gestationis, which is also known as herpes gestationis or gestational pemphigoid, is a rare, autoimmune vesiculobullous eruption that occurs during the third trimester of pregnancy or in the postpartum period.

Holly Hanson MD, Associated Skin Care Specialists, Eden Prairie, Minn.

It typically presents with the abrupt onset of very pruritic urticarial plaques and papules, which start around the umbilicus and then spread to involve the trunk and extremities. The papules and plaques evolve to generalized tense blisters, which typically spare the face, palms, soles, and mucous membranes. Half of affected patients may present in an atypical distribution involving the extremities, palms, or soles. Patients may be at an increased risk for the development of Graves disease.

The cause of pemphigoid gestationis is a factor known as “herpes gestationis factor” that induces C3 deposition along the dermal-epidermal junction. As in bullous pemphigoid, patients with pemphigoid gestationis have antibodies to a transmembrane hemidesmosomal protein called BPAG2/BP180/collagen XVII.

Holly Hanson MD, Associated Skin Care Specialists, Eden Prairie, Minn.

Three-quarters of patients worsen at the time of delivery and up to 10% of newborns will have bullous lesions secondary to placental transfer of antibodies. In most cases, lesions will spontaneously resolve over a few weeks following delivery. Recurrence with future pregnancies is common, with severity increasing with each pregnancy. Recurrence with menstruation and with the use of oral contraceptives can also occur. Although there is no increase in maternal mortality, onset in the first or second trimester and presence of blisters is associated with decreased gestational age of baby at delivery and lower-birth-weight infants. There is no increase in fetal mortality.

Histopathology reveals a subepidermal vesicle and perivascular infiltrate consisting of lymphocytes and eosinophils. Diagnosis can be confirmed with direct immunofluorescence showing C3 in a linear band along the basement membrane zone. IgG may be present as well. Complement added indirect immunofluorescence reveals circulating anti–basement zone IgG, which allows differentiation from pruritic urticarial papules and plaques of pregnancy.

Treatment for localized disease includes class I topical steroids and oral antihistamines. More severe cases require systemic corticosteroid treatment. Systemic steroids may cause lower-birth-weight infants.

This case and the photos were submitted by Dr. Hanson of Associated Skin Care Specialists in Eden Prairie, Minn. The case was edited by Donna Bilu Martin, MD.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Pemphigoid gestationis
 

Pemphigoid gestationis, which is also known as herpes gestationis or gestational pemphigoid, is a rare, autoimmune vesiculobullous eruption that occurs during the third trimester of pregnancy or in the postpartum period.

Holly Hanson MD, Associated Skin Care Specialists, Eden Prairie, Minn.

It typically presents with the abrupt onset of very pruritic urticarial plaques and papules, which start around the umbilicus and then spread to involve the trunk and extremities. The papules and plaques evolve to generalized tense blisters, which typically spare the face, palms, soles, and mucous membranes. Half of affected patients may present in an atypical distribution involving the extremities, palms, or soles. Patients may be at an increased risk for the development of Graves disease.

The cause of pemphigoid gestationis is a factor known as “herpes gestationis factor” that induces C3 deposition along the dermal-epidermal junction. As in bullous pemphigoid, patients with pemphigoid gestationis have antibodies to a transmembrane hemidesmosomal protein called BPAG2/BP180/collagen XVII.

Holly Hanson MD, Associated Skin Care Specialists, Eden Prairie, Minn.

Three-quarters of patients worsen at the time of delivery and up to 10% of newborns will have bullous lesions secondary to placental transfer of antibodies. In most cases, lesions will spontaneously resolve over a few weeks following delivery. Recurrence with future pregnancies is common, with severity increasing with each pregnancy. Recurrence with menstruation and with the use of oral contraceptives can also occur. Although there is no increase in maternal mortality, onset in the first or second trimester and presence of blisters is associated with decreased gestational age of baby at delivery and lower-birth-weight infants. There is no increase in fetal mortality.

Histopathology reveals a subepidermal vesicle and perivascular infiltrate consisting of lymphocytes and eosinophils. Diagnosis can be confirmed with direct immunofluorescence showing C3 in a linear band along the basement membrane zone. IgG may be present as well. Complement added indirect immunofluorescence reveals circulating anti–basement zone IgG, which allows differentiation from pruritic urticarial papules and plaques of pregnancy.

Treatment for localized disease includes class I topical steroids and oral antihistamines. More severe cases require systemic corticosteroid treatment. Systemic steroids may cause lower-birth-weight infants.

This case and the photos were submitted by Dr. Hanson of Associated Skin Care Specialists in Eden Prairie, Minn. The case was edited by Donna Bilu Martin, MD.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.

The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.

A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.

Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.

The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.

The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.

“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”

Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
 

Elective procedures down

In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.

Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.

“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”

Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.

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

Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.

The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.

A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.

Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.

The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.

The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.

“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”

Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
 

Elective procedures down

In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.

Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.

“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”

Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.

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

Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.

The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.

A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.

Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.

The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.

The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.

“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”

Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
 

Elective procedures down

In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.

Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.

“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”

Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.

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

The U.S. Food and Drug Administration (FDA) has granted accelerated approval of a new targeted therapy for use in some patients with cholangiocarcinoma, a rare cancer of the bile ducts.

The product is pemigatinib (Pemazyre, Incyte), an oral kinase inhibitor.

It was approved specifically for use in patients with advanced cholangiocarcinoma who have received prior treatment and who have tumors that have a fusion or other rearrangement of the fibroblast growth factor receptor 2 (FGFR2) gene.

These FGFR2 genetic abnormalities are found in about 9% to 14% of patients with cholangiocarcinoma, notes the FDA.

At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery, the agency also notes. Until now, a combination of chemotherapy drugs has been the standard initial treatment.

Now the subgroup of patients with FGFR2 tumors have the option of a targeted therapy.

“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,” commented Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center, New York City, in a press release. “It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”

The accelerated approval was based on the overall response rate (ORR) and duration of response in an open-label clinical trial that involved 107 patients (the FIGHT-202 study).

As a condition of the accelerated approval, the manufacturer will complete and submit the results of a randomized trial demonstrating an improvement in progression-free survival or overall survival, the FDA noted.
 

Results from open-label clinical trial

The FIGHT-202 study enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma who had received prior treatment and who had tumors with an FGFR2 fusion or rearrangement.

All patients received pemigatinib once a day for 14 days, followed by 7 days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects. Patients underwent scanning every 8 weeks to assess ORR.

The ORR was 36% (38 of 107 patients), which included 2.8% of patients with a complete response and 33% with partial response.

Among the 38 patients who had a response, 24 patients (63%) had a response that lasted 6 months or longer, and 7 patients (18%) had a response that lasted 12 months or longer.

“With pemigatinib, we considered the observed efficacy results to be clinically meaningful and the overall risk to benefit assessment for patients with tumors harboring FGFR2 gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first-line treatment with chemotherapy,” commented Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

The most common adverse reactions, which occurred in 20% or more of patients who received pemigatinib, were electrolyte disorders (hyperphosphatemia and hypophosphatemia), alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain, and dry skin. Ocular toxicity was seen rarely, the agency notes.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration (FDA) has granted accelerated approval of a new targeted therapy for use in some patients with cholangiocarcinoma, a rare cancer of the bile ducts.

The product is pemigatinib (Pemazyre, Incyte), an oral kinase inhibitor.

It was approved specifically for use in patients with advanced cholangiocarcinoma who have received prior treatment and who have tumors that have a fusion or other rearrangement of the fibroblast growth factor receptor 2 (FGFR2) gene.

These FGFR2 genetic abnormalities are found in about 9% to 14% of patients with cholangiocarcinoma, notes the FDA.

At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery, the agency also notes. Until now, a combination of chemotherapy drugs has been the standard initial treatment.

Now the subgroup of patients with FGFR2 tumors have the option of a targeted therapy.

“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,” commented Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center, New York City, in a press release. “It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”

The accelerated approval was based on the overall response rate (ORR) and duration of response in an open-label clinical trial that involved 107 patients (the FIGHT-202 study).

As a condition of the accelerated approval, the manufacturer will complete and submit the results of a randomized trial demonstrating an improvement in progression-free survival or overall survival, the FDA noted.
 

Results from open-label clinical trial

The FIGHT-202 study enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma who had received prior treatment and who had tumors with an FGFR2 fusion or rearrangement.

All patients received pemigatinib once a day for 14 days, followed by 7 days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects. Patients underwent scanning every 8 weeks to assess ORR.

The ORR was 36% (38 of 107 patients), which included 2.8% of patients with a complete response and 33% with partial response.

Among the 38 patients who had a response, 24 patients (63%) had a response that lasted 6 months or longer, and 7 patients (18%) had a response that lasted 12 months or longer.

“With pemigatinib, we considered the observed efficacy results to be clinically meaningful and the overall risk to benefit assessment for patients with tumors harboring FGFR2 gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first-line treatment with chemotherapy,” commented Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

The most common adverse reactions, which occurred in 20% or more of patients who received pemigatinib, were electrolyte disorders (hyperphosphatemia and hypophosphatemia), alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain, and dry skin. Ocular toxicity was seen rarely, the agency notes.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration (FDA) has granted accelerated approval of a new targeted therapy for use in some patients with cholangiocarcinoma, a rare cancer of the bile ducts.

The product is pemigatinib (Pemazyre, Incyte), an oral kinase inhibitor.

It was approved specifically for use in patients with advanced cholangiocarcinoma who have received prior treatment and who have tumors that have a fusion or other rearrangement of the fibroblast growth factor receptor 2 (FGFR2) gene.

These FGFR2 genetic abnormalities are found in about 9% to 14% of patients with cholangiocarcinoma, notes the FDA.

At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery, the agency also notes. Until now, a combination of chemotherapy drugs has been the standard initial treatment.

Now the subgroup of patients with FGFR2 tumors have the option of a targeted therapy.

“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,” commented Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center, New York City, in a press release. “It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”

The accelerated approval was based on the overall response rate (ORR) and duration of response in an open-label clinical trial that involved 107 patients (the FIGHT-202 study).

As a condition of the accelerated approval, the manufacturer will complete and submit the results of a randomized trial demonstrating an improvement in progression-free survival or overall survival, the FDA noted.
 

Results from open-label clinical trial

The FIGHT-202 study enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma who had received prior treatment and who had tumors with an FGFR2 fusion or rearrangement.

All patients received pemigatinib once a day for 14 days, followed by 7 days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects. Patients underwent scanning every 8 weeks to assess ORR.

The ORR was 36% (38 of 107 patients), which included 2.8% of patients with a complete response and 33% with partial response.

Among the 38 patients who had a response, 24 patients (63%) had a response that lasted 6 months or longer, and 7 patients (18%) had a response that lasted 12 months or longer.

“With pemigatinib, we considered the observed efficacy results to be clinically meaningful and the overall risk to benefit assessment for patients with tumors harboring FGFR2 gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first-line treatment with chemotherapy,” commented Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

The most common adverse reactions, which occurred in 20% or more of patients who received pemigatinib, were electrolyte disorders (hyperphosphatemia and hypophosphatemia), alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain, and dry skin. Ocular toxicity was seen rarely, the agency notes.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the oral therapy tucatinib (Tukysa, Seattle Genetics) for the treatment of advanced HER2-positive breast cancer. This is the first new drug approved under Project Orbis, an international collaboration.

Tucatinib, which is a small-molecule tyrosine kinase inhibitor, is approved in combination with trastuzumab and capecitabine to treat patients who have received one or more prior treatments for advanced disease.

The FDA collaborated with the regulatory authorities of Australia, Canada, Singapore, and Switzerland on this review. However, only the FDA has approved tucatinib; the application is still under review at the other agencies.

While working with Project Orbis in 2019, the FDA granted an accelerated, conditional approval to a drug combination that included previously approved agents.

“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators,” said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement.

Collaboration among regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, according to the FDA.

The new drug is a “valuable addition” to the roster of treatments for advanced HER2-positive breast cancer, said study investigator Eric Winer, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, in a company press statement.

“With highly significant and clinically important results for overall and progression-free survival, the addition of [tucatinib] to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,” he said.

The new approval is based on safety and efficacy results from the phase 2 HER2CLIMB trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine.

Nearly half (48%) of patients in the study had brain metastases at the start of the trial. The primary outcome measure was progression-free survival (PFS). All patients received trastuzumab and capecitabine and were randomly assigned to either tucatinib or placebo.

Median PFS in the tucatinib patient group was 7.8 months, compared with 5.6 months in the placebo group. The PFS results in the subgroup of patients with brain metastases were nearly the same.

Median overall survival in the tucatinib patient group was 21.9 months versus 17.4 months in the placebo group.

The new drug is a rare success in the treatment of breast cancer brain metastases, said Jawad Fares, MD, of Northwestern University, Chicago, Illinois, who spoke to Medscape Medical News when the phase 3 trial data were first presented at the 2019 San Antonio Breast Cancer Symposium.

“Outcomes in the field have been pretty dismal,” summarized Fares, who was not involved in the study.

The results of the HER2CLIMB study, which was funded by Seattle Genetics, were published in the New England Journal of Medicine last year.

According to the FDA, common side effects with tucatinib were diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Tucatinib can cause serious side effects, including diarrhea associated with dehydration, acute kidney injury, and death. Health care professionals should start antidiarrheals as clinically indicated if diarrhea occurs and should interrupt treatment or reduce the dosage. Tucatinib can also cause severe hepatotoxicity; patients should be monitored with liver tests.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the oral therapy tucatinib (Tukysa, Seattle Genetics) for the treatment of advanced HER2-positive breast cancer. This is the first new drug approved under Project Orbis, an international collaboration.

Tucatinib, which is a small-molecule tyrosine kinase inhibitor, is approved in combination with trastuzumab and capecitabine to treat patients who have received one or more prior treatments for advanced disease.

The FDA collaborated with the regulatory authorities of Australia, Canada, Singapore, and Switzerland on this review. However, only the FDA has approved tucatinib; the application is still under review at the other agencies.

While working with Project Orbis in 2019, the FDA granted an accelerated, conditional approval to a drug combination that included previously approved agents.

“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators,” said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement.

Collaboration among regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, according to the FDA.

The new drug is a “valuable addition” to the roster of treatments for advanced HER2-positive breast cancer, said study investigator Eric Winer, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, in a company press statement.

“With highly significant and clinically important results for overall and progression-free survival, the addition of [tucatinib] to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,” he said.

The new approval is based on safety and efficacy results from the phase 2 HER2CLIMB trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine.

Nearly half (48%) of patients in the study had brain metastases at the start of the trial. The primary outcome measure was progression-free survival (PFS). All patients received trastuzumab and capecitabine and were randomly assigned to either tucatinib or placebo.

Median PFS in the tucatinib patient group was 7.8 months, compared with 5.6 months in the placebo group. The PFS results in the subgroup of patients with brain metastases were nearly the same.

Median overall survival in the tucatinib patient group was 21.9 months versus 17.4 months in the placebo group.

The new drug is a rare success in the treatment of breast cancer brain metastases, said Jawad Fares, MD, of Northwestern University, Chicago, Illinois, who spoke to Medscape Medical News when the phase 3 trial data were first presented at the 2019 San Antonio Breast Cancer Symposium.

“Outcomes in the field have been pretty dismal,” summarized Fares, who was not involved in the study.

The results of the HER2CLIMB study, which was funded by Seattle Genetics, were published in the New England Journal of Medicine last year.

According to the FDA, common side effects with tucatinib were diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Tucatinib can cause serious side effects, including diarrhea associated with dehydration, acute kidney injury, and death. Health care professionals should start antidiarrheals as clinically indicated if diarrhea occurs and should interrupt treatment or reduce the dosage. Tucatinib can also cause severe hepatotoxicity; patients should be monitored with liver tests.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the oral therapy tucatinib (Tukysa, Seattle Genetics) for the treatment of advanced HER2-positive breast cancer. This is the first new drug approved under Project Orbis, an international collaboration.

Tucatinib, which is a small-molecule tyrosine kinase inhibitor, is approved in combination with trastuzumab and capecitabine to treat patients who have received one or more prior treatments for advanced disease.

The FDA collaborated with the regulatory authorities of Australia, Canada, Singapore, and Switzerland on this review. However, only the FDA has approved tucatinib; the application is still under review at the other agencies.

While working with Project Orbis in 2019, the FDA granted an accelerated, conditional approval to a drug combination that included previously approved agents.

“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators,” said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement.

Collaboration among regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, according to the FDA.

The new drug is a “valuable addition” to the roster of treatments for advanced HER2-positive breast cancer, said study investigator Eric Winer, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, in a company press statement.

“With highly significant and clinically important results for overall and progression-free survival, the addition of [tucatinib] to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,” he said.

The new approval is based on safety and efficacy results from the phase 2 HER2CLIMB trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine.

Nearly half (48%) of patients in the study had brain metastases at the start of the trial. The primary outcome measure was progression-free survival (PFS). All patients received trastuzumab and capecitabine and were randomly assigned to either tucatinib or placebo.

Median PFS in the tucatinib patient group was 7.8 months, compared with 5.6 months in the placebo group. The PFS results in the subgroup of patients with brain metastases were nearly the same.

Median overall survival in the tucatinib patient group was 21.9 months versus 17.4 months in the placebo group.

The new drug is a rare success in the treatment of breast cancer brain metastases, said Jawad Fares, MD, of Northwestern University, Chicago, Illinois, who spoke to Medscape Medical News when the phase 3 trial data were first presented at the 2019 San Antonio Breast Cancer Symposium.

“Outcomes in the field have been pretty dismal,” summarized Fares, who was not involved in the study.

The results of the HER2CLIMB study, which was funded by Seattle Genetics, were published in the New England Journal of Medicine last year.

According to the FDA, common side effects with tucatinib were diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Tucatinib can cause serious side effects, including diarrhea associated with dehydration, acute kidney injury, and death. Health care professionals should start antidiarrheals as clinically indicated if diarrhea occurs and should interrupt treatment or reduce the dosage. Tucatinib can also cause severe hepatotoxicity; patients should be monitored with liver tests.

This article first appeared on Medscape.com.