Inhaled nitric oxide explored for COVID-19 oxygenation

Article Type
Changed
Thu, 08/26/2021 - 16:08

The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

 

 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

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The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

 

 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

 

 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

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Medscape Article

Week-old COVID-19 urology guidelines already outdated

Article Type
Changed
Thu, 08/26/2021 - 16:18

Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.com.

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Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.com.

Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.com.

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Marijuana allergies on the rise

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Mon, 03/22/2021 - 14:08

Cannabis sativa is a weed and it causes reactions just like any other pollen allergy,” said William Silvers, MD, from the University of Colorado School of Medicine in Aurora.

Marijuana leaves

Silvers’ clinic began to see people with allergic reactions to the plant after the increase in direct exposure that accompanied the legalization of recreational marijuana in Colorado. For people with allergic tendencies, first- and second-hand exposure to C. sativa will increase “classic responses,” such as allergic rhinitis, sneezing, wheezing, itching, and asthma, he told Medscape Medical News.

Smoking the weed, direct exposure to the plant, contact with others who have touched plants, and breathing air in a grow operation “can all cause reactions,” he said. “And the more exposure they had, the greater the reaction, especially those who have allergic tendency,” he said.

The type of exposure to C. sativa is also a factor. Smoking the plant can induce typical allergic responses, the ingestion of hemp seed has been known to induce anaphylaxis, and “working with the plant can lead to dermatitis or contact urticaria,” he explained.

Edibles made with C. sativa have led to overdoses because dosing is difficult to determine. “It takes an hour or so to have an effect, so you don›t have as much control as inhaling it,” Silvers explained.
 

Stoned Fruit, Stoned Patient

A 2018 case report describes a 24-year-old daily marijuana smoker who experienced anaphylaxis after ingesting hemp seed. He had a history of allergies to stoned fruits, nuts, crustaceans, and aeroallergens. It was his first known exposure to hemp seed.

The patient developed urticaria on his arms after contact with C. sativa leaves and flowers, but had no reaction when smoking marijuana. This case indicates how important mode of exposure is.

“There are only a few cases of anaphylaxis known from ingestion of hemp seed,” Silvers said, “but the ‘stoned fruit, stoned patients’ cross-reactivity looks to be a real thing.”

People allergic to ragweed and sage are more likely than others to have a reaction to cantaloupe and other fruits in the melon family, he explained. There is a common antigen in the C. sativa pollen and in certain foods with cross-reacting proteins, such as tomato, peach, and hazelnut. “We see a pollen and food cross-reactivity via nonspecific lipid transfer proteins.”

A 2017 review of C. sativa allergy points out that few reports of IgE-dependent allergic reactions have been published because of the illegal status of cannabis. However, it is becoming more prevalent as a potential allergen. For example, in Nebraska, C. sativa pollen accounts for 36% of the total pollen count.

People with IgE-mediated cannabis allergy can have a sensitization to the nonspecific lipid transfer protein of C. sativa, Can s 3, which might explain the secondary plant-derived food allergies seen in European patients with a cannabis allergy, according to the review. Can s 3 cross-reacts with various plant homologues.

“This is the sort of information that allergists need to have,” Silvers said.

Stigma Limits Discussion

The fact that federal law prohibits cannabis use in the United States has made research difficult.

A strain distributed by the University of Mississippi can be used for research, “but its potency is very low, at 5% or 7%,” Silvers explained. At medical marijuana dispensaries, the potency of the flower can be as high as 25%, and in other forms, the THC content can be above 80%.

The legal status makes cannabis allergy difficult to diagnose and impossible to treat. Immunotherapy is out of the question. “With federal illegality, we need to stay out of trouble in that regard,” said Silvers, adding that, currently, avoidance is advised.

But research is emerging from Canada, where medicinal and recreational marijuana use is legal.

Stigma around cannabis is still high. “Nobody wants to be seen as a ‘pot doctor’,” said Silvers. But after it became legal in Colorado in 2015, he was asked to give a talk and decided to speak up.

“I have never written a medical prescription for marijuana,” he said, explaining that he is involved with the Center for Bioethics and Humanities at the University of Colorado. “I try to take a societal as well as a medical perspective, looking at the value and concerns for abuse and misuse.”

“As it becomes more available, more legalized, patients are having more reactions,” he said. “Allergists need to get in the game.”

Attitudes need to change. Physicians and allergists need to understand what’s happening in the population “and be open-minded about it so they know what to do,” he added.
 

 

 

Patients Don’t Want to Be Told to Stop

Users of medical marijuana can become dependent, said Ellen Burnham, MD, also from the University of Colorado.

“Patients want a blessing from care providers that it’s okay to use,” she told Medscape Medical News. “We’re in a state where people are really interested in holistic approaches to health, and cannabis is a natural product, but it may exacerbate allergies.”

Some components of cannabis might have bronchodilator properties but there are so many unknowns at this time. “I don’t think allergists should be recommending or condoning cannabis as part of a patient’s therapy,” she said. “It’s not okay for everybody.”

As business flourishes for operators in the cannabis industry and for the legal profession, Burnham said she worries that there isn’t enough protection for workers. “Do workers exposed to plant material on a daily basis have adequate workplace protection,” such as masks and gowns? “There’s a downstream effect that impacts people that nobody has really thought about,” she pointed out.

If the cannabis industry becomes driven by money, with a lobby like the tobacco industry, there will be no way to keep people who are vulnerable from using cannabis.

Is an occasional joint, much like an occasional glass of wine, okay? “We don’t know,” said Burnham. “We just don’t have enough information about it.”

Research is needed to develop medicinal strains of cannabidiol, cannabigerol, and cannabinol, which offer “medicinal and anti-inflammatory relief without the psychologic affects,” Silvers added.

This article first appeared on Medscape.com.

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Cannabis sativa is a weed and it causes reactions just like any other pollen allergy,” said William Silvers, MD, from the University of Colorado School of Medicine in Aurora.

Marijuana leaves

Silvers’ clinic began to see people with allergic reactions to the plant after the increase in direct exposure that accompanied the legalization of recreational marijuana in Colorado. For people with allergic tendencies, first- and second-hand exposure to C. sativa will increase “classic responses,” such as allergic rhinitis, sneezing, wheezing, itching, and asthma, he told Medscape Medical News.

Smoking the weed, direct exposure to the plant, contact with others who have touched plants, and breathing air in a grow operation “can all cause reactions,” he said. “And the more exposure they had, the greater the reaction, especially those who have allergic tendency,” he said.

The type of exposure to C. sativa is also a factor. Smoking the plant can induce typical allergic responses, the ingestion of hemp seed has been known to induce anaphylaxis, and “working with the plant can lead to dermatitis or contact urticaria,” he explained.

Edibles made with C. sativa have led to overdoses because dosing is difficult to determine. “It takes an hour or so to have an effect, so you don›t have as much control as inhaling it,” Silvers explained.
 

Stoned Fruit, Stoned Patient

A 2018 case report describes a 24-year-old daily marijuana smoker who experienced anaphylaxis after ingesting hemp seed. He had a history of allergies to stoned fruits, nuts, crustaceans, and aeroallergens. It was his first known exposure to hemp seed.

The patient developed urticaria on his arms after contact with C. sativa leaves and flowers, but had no reaction when smoking marijuana. This case indicates how important mode of exposure is.

“There are only a few cases of anaphylaxis known from ingestion of hemp seed,” Silvers said, “but the ‘stoned fruit, stoned patients’ cross-reactivity looks to be a real thing.”

People allergic to ragweed and sage are more likely than others to have a reaction to cantaloupe and other fruits in the melon family, he explained. There is a common antigen in the C. sativa pollen and in certain foods with cross-reacting proteins, such as tomato, peach, and hazelnut. “We see a pollen and food cross-reactivity via nonspecific lipid transfer proteins.”

A 2017 review of C. sativa allergy points out that few reports of IgE-dependent allergic reactions have been published because of the illegal status of cannabis. However, it is becoming more prevalent as a potential allergen. For example, in Nebraska, C. sativa pollen accounts for 36% of the total pollen count.

People with IgE-mediated cannabis allergy can have a sensitization to the nonspecific lipid transfer protein of C. sativa, Can s 3, which might explain the secondary plant-derived food allergies seen in European patients with a cannabis allergy, according to the review. Can s 3 cross-reacts with various plant homologues.

“This is the sort of information that allergists need to have,” Silvers said.

Stigma Limits Discussion

The fact that federal law prohibits cannabis use in the United States has made research difficult.

A strain distributed by the University of Mississippi can be used for research, “but its potency is very low, at 5% or 7%,” Silvers explained. At medical marijuana dispensaries, the potency of the flower can be as high as 25%, and in other forms, the THC content can be above 80%.

The legal status makes cannabis allergy difficult to diagnose and impossible to treat. Immunotherapy is out of the question. “With federal illegality, we need to stay out of trouble in that regard,” said Silvers, adding that, currently, avoidance is advised.

But research is emerging from Canada, where medicinal and recreational marijuana use is legal.

Stigma around cannabis is still high. “Nobody wants to be seen as a ‘pot doctor’,” said Silvers. But after it became legal in Colorado in 2015, he was asked to give a talk and decided to speak up.

“I have never written a medical prescription for marijuana,” he said, explaining that he is involved with the Center for Bioethics and Humanities at the University of Colorado. “I try to take a societal as well as a medical perspective, looking at the value and concerns for abuse and misuse.”

“As it becomes more available, more legalized, patients are having more reactions,” he said. “Allergists need to get in the game.”

Attitudes need to change. Physicians and allergists need to understand what’s happening in the population “and be open-minded about it so they know what to do,” he added.
 

 

 

Patients Don’t Want to Be Told to Stop

Users of medical marijuana can become dependent, said Ellen Burnham, MD, also from the University of Colorado.

“Patients want a blessing from care providers that it’s okay to use,” she told Medscape Medical News. “We’re in a state where people are really interested in holistic approaches to health, and cannabis is a natural product, but it may exacerbate allergies.”

Some components of cannabis might have bronchodilator properties but there are so many unknowns at this time. “I don’t think allergists should be recommending or condoning cannabis as part of a patient’s therapy,” she said. “It’s not okay for everybody.”

As business flourishes for operators in the cannabis industry and for the legal profession, Burnham said she worries that there isn’t enough protection for workers. “Do workers exposed to plant material on a daily basis have adequate workplace protection,” such as masks and gowns? “There’s a downstream effect that impacts people that nobody has really thought about,” she pointed out.

If the cannabis industry becomes driven by money, with a lobby like the tobacco industry, there will be no way to keep people who are vulnerable from using cannabis.

Is an occasional joint, much like an occasional glass of wine, okay? “We don’t know,” said Burnham. “We just don’t have enough information about it.”

Research is needed to develop medicinal strains of cannabidiol, cannabigerol, and cannabinol, which offer “medicinal and anti-inflammatory relief without the psychologic affects,” Silvers added.

This article first appeared on Medscape.com.

Cannabis sativa is a weed and it causes reactions just like any other pollen allergy,” said William Silvers, MD, from the University of Colorado School of Medicine in Aurora.

Marijuana leaves

Silvers’ clinic began to see people with allergic reactions to the plant after the increase in direct exposure that accompanied the legalization of recreational marijuana in Colorado. For people with allergic tendencies, first- and second-hand exposure to C. sativa will increase “classic responses,” such as allergic rhinitis, sneezing, wheezing, itching, and asthma, he told Medscape Medical News.

Smoking the weed, direct exposure to the plant, contact with others who have touched plants, and breathing air in a grow operation “can all cause reactions,” he said. “And the more exposure they had, the greater the reaction, especially those who have allergic tendency,” he said.

The type of exposure to C. sativa is also a factor. Smoking the plant can induce typical allergic responses, the ingestion of hemp seed has been known to induce anaphylaxis, and “working with the plant can lead to dermatitis or contact urticaria,” he explained.

Edibles made with C. sativa have led to overdoses because dosing is difficult to determine. “It takes an hour or so to have an effect, so you don›t have as much control as inhaling it,” Silvers explained.
 

Stoned Fruit, Stoned Patient

A 2018 case report describes a 24-year-old daily marijuana smoker who experienced anaphylaxis after ingesting hemp seed. He had a history of allergies to stoned fruits, nuts, crustaceans, and aeroallergens. It was his first known exposure to hemp seed.

The patient developed urticaria on his arms after contact with C. sativa leaves and flowers, but had no reaction when smoking marijuana. This case indicates how important mode of exposure is.

“There are only a few cases of anaphylaxis known from ingestion of hemp seed,” Silvers said, “but the ‘stoned fruit, stoned patients’ cross-reactivity looks to be a real thing.”

People allergic to ragweed and sage are more likely than others to have a reaction to cantaloupe and other fruits in the melon family, he explained. There is a common antigen in the C. sativa pollen and in certain foods with cross-reacting proteins, such as tomato, peach, and hazelnut. “We see a pollen and food cross-reactivity via nonspecific lipid transfer proteins.”

A 2017 review of C. sativa allergy points out that few reports of IgE-dependent allergic reactions have been published because of the illegal status of cannabis. However, it is becoming more prevalent as a potential allergen. For example, in Nebraska, C. sativa pollen accounts for 36% of the total pollen count.

People with IgE-mediated cannabis allergy can have a sensitization to the nonspecific lipid transfer protein of C. sativa, Can s 3, which might explain the secondary plant-derived food allergies seen in European patients with a cannabis allergy, according to the review. Can s 3 cross-reacts with various plant homologues.

“This is the sort of information that allergists need to have,” Silvers said.

Stigma Limits Discussion

The fact that federal law prohibits cannabis use in the United States has made research difficult.

A strain distributed by the University of Mississippi can be used for research, “but its potency is very low, at 5% or 7%,” Silvers explained. At medical marijuana dispensaries, the potency of the flower can be as high as 25%, and in other forms, the THC content can be above 80%.

The legal status makes cannabis allergy difficult to diagnose and impossible to treat. Immunotherapy is out of the question. “With federal illegality, we need to stay out of trouble in that regard,” said Silvers, adding that, currently, avoidance is advised.

But research is emerging from Canada, where medicinal and recreational marijuana use is legal.

Stigma around cannabis is still high. “Nobody wants to be seen as a ‘pot doctor’,” said Silvers. But after it became legal in Colorado in 2015, he was asked to give a talk and decided to speak up.

“I have never written a medical prescription for marijuana,” he said, explaining that he is involved with the Center for Bioethics and Humanities at the University of Colorado. “I try to take a societal as well as a medical perspective, looking at the value and concerns for abuse and misuse.”

“As it becomes more available, more legalized, patients are having more reactions,” he said. “Allergists need to get in the game.”

Attitudes need to change. Physicians and allergists need to understand what’s happening in the population “and be open-minded about it so they know what to do,” he added.
 

 

 

Patients Don’t Want to Be Told to Stop

Users of medical marijuana can become dependent, said Ellen Burnham, MD, also from the University of Colorado.

“Patients want a blessing from care providers that it’s okay to use,” she told Medscape Medical News. “We’re in a state where people are really interested in holistic approaches to health, and cannabis is a natural product, but it may exacerbate allergies.”

Some components of cannabis might have bronchodilator properties but there are so many unknowns at this time. “I don’t think allergists should be recommending or condoning cannabis as part of a patient’s therapy,” she said. “It’s not okay for everybody.”

As business flourishes for operators in the cannabis industry and for the legal profession, Burnham said she worries that there isn’t enough protection for workers. “Do workers exposed to plant material on a daily basis have adequate workplace protection,” such as masks and gowns? “There’s a downstream effect that impacts people that nobody has really thought about,” she pointed out.

If the cannabis industry becomes driven by money, with a lobby like the tobacco industry, there will be no way to keep people who are vulnerable from using cannabis.

Is an occasional joint, much like an occasional glass of wine, okay? “We don’t know,” said Burnham. “We just don’t have enough information about it.”

Research is needed to develop medicinal strains of cannabidiol, cannabigerol, and cannabinol, which offer “medicinal and anti-inflammatory relief without the psychologic affects,” Silvers added.

This article first appeared on Medscape.com.

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