Pulmonary Health Hub

National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.

MDedge News

Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.

Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.

ILI-related deaths among children, however, are not dropping. There were 20 pediatric deaths reported during the week, more than any other single week this season. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”

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National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.

MDedge News

Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.

Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.

ILI-related deaths among children, however, are not dropping. There were 20 pediatric deaths reported during the week, more than any other single week this season. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”

[email protected]

National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.

MDedge News

Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.

Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.

ILI-related deaths among children, however, are not dropping. There were 20 pediatric deaths reported during the week, more than any other single week this season. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”

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The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

[email protected]

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

[email protected]

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

[email protected]

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first generic version of Teva’s ProAir HFA (albuterol sulfate inhalation aerosol).

Generic albuterol sulfate inhalation, from Perrigo Pharmaceutical, is indicated for the treatment or prevention of bronchospasm in people aged 4 years or older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm.

“Approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our long-standing commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market,” FDA Commissioner Stephen Hahn, MD, said in a news release.

Metered-dose inhalers are hard to duplicate because of the complexities of their formulation or mode of delivery. “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval,” he explained.

“Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” Hahn added.

In the United States, more than 26 million people suffer from asthma; about 7 million of these people are children.

Perrigo said it will immediately launch a limited quantity of generic albuterol sulfate and, in collaboration with its development and manufacturing partner, Catalent Pharma Solutions, is ramping up production to meet future demand.

The company “anticipates that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020,” Perrigo Executive Vice President and Rx Pharmaceuticals President Sharon Kochan said in a statement.

This article originally appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first generic version of Teva’s ProAir HFA (albuterol sulfate inhalation aerosol).

Generic albuterol sulfate inhalation, from Perrigo Pharmaceutical, is indicated for the treatment or prevention of bronchospasm in people aged 4 years or older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm.

“Approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our long-standing commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market,” FDA Commissioner Stephen Hahn, MD, said in a news release.

Metered-dose inhalers are hard to duplicate because of the complexities of their formulation or mode of delivery. “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval,” he explained.

“Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” Hahn added.

In the United States, more than 26 million people suffer from asthma; about 7 million of these people are children.

Perrigo said it will immediately launch a limited quantity of generic albuterol sulfate and, in collaboration with its development and manufacturing partner, Catalent Pharma Solutions, is ramping up production to meet future demand.

The company “anticipates that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020,” Perrigo Executive Vice President and Rx Pharmaceuticals President Sharon Kochan said in a statement.

This article originally appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first generic version of Teva’s ProAir HFA (albuterol sulfate inhalation aerosol).

Generic albuterol sulfate inhalation, from Perrigo Pharmaceutical, is indicated for the treatment or prevention of bronchospasm in people aged 4 years or older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm.

“Approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our long-standing commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market,” FDA Commissioner Stephen Hahn, MD, said in a news release.

Metered-dose inhalers are hard to duplicate because of the complexities of their formulation or mode of delivery. “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval,” he explained.

“Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” Hahn added.

In the United States, more than 26 million people suffer from asthma; about 7 million of these people are children.

Perrigo said it will immediately launch a limited quantity of generic albuterol sulfate and, in collaboration with its development and manufacturing partner, Catalent Pharma Solutions, is ramping up production to meet future demand.

The company “anticipates that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020,” Perrigo Executive Vice President and Rx Pharmaceuticals President Sharon Kochan said in a statement.

This article originally appeared on Medscape.com.

Outbreaks of coronavirus in a wide range of countries have officials at the Centers for Disease Control and Prevention believing it is now a matter of when, not if, there will be community spread in the United States.

Courtesy NIAID-RML

“We have for many weeks been saying that, while we hope this is not going to be severe, we are planning as if it is,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the CDC, said during a Feb. 25, 2020, telebriefing with reporters. “The data over the last week and the spread in other countries has certainly raised our level of concern and raised our level expectation that we are going to have community spread here.”

Dr. Messonnier noted that the coronavirus is now showing signs of community spread without a known source of exposure in a number of countries, including in Hong Kong, Iran, Italy, Japan, Singapore, South Korea, Taiwan, and Thailand. This has now raised the belief that there will be more widespread outbreaks in the United States.

“What we still don’t know is what that will look like,” she said. “As many of you know, we can have community spread in the United States and have it be reasonably mild. We can have community spread in the U.S. and have it be very severe. That is what we don’t completely know yet and we certainly also don’t exactly know when it is going to happen.”

She reiterated the number of actions being taken to slow the potential spread in the United States, including detecting, tracking, and isolating all cases, as well as restricting travel into the United States and issuing travel advisories for countries where coronavirus outbreaks are known.

“We are doing this with the goal of slowing the introduction of this new virus into the U.S. and buying us more time to prepare,” Dr. Messonnier said, noting the containment strategies have been largely successful, though it will be more difficult as more countries experience community spread of the virus.

Dr. Messonnier also reiterated that at this time there are no vaccines and no medicines to treat the coronavirus. She stressed the need to adhere to nonpharmaceutical interventions (NPIs), as they will be “the most important tools in our response to this virus.”

She said the NPIs will vary based on the severity of the outbreak in any given local community and include personal protective measures that individuals can take every day (many of which mirror the recommendations for preventing the spread of the seasonal flu virus), community NPIs that involve social distancing measures designed to keep people away from others, and environmental NPIs such as surface cleaning measures.

CDC’s latest warning comes as parent agency the Department of Health & Human Services is seeking $2.5 billion in funds from Congress to address the coronavirus outbreak.

During a separate press conference on the same day, HHS Secretary Alex Azar noted that there are five major priorities related to those funds, which would be used in the current year, including expansion of surveillance work within the influenza surveillance network; supporting public health preparedness and response for state and local governments; support the development of therapeutics and the development of vaccines; and the purchase of personal protective equipment for national stockpiles.

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health, added during the press conference that vaccine work is in progress and could be ready for phase 1 testing within a month and a half. If all goes well, it would still be at least 12 - 18 months following the completion of a phase 2 trial before it could be produced for mass consumption.

“It is certainly conceivable that this issue with this coronavirus will go well beyond this season into next season,” Dr. Fauci said. “So a vaccine may not solve the problems of the next couple of months, but it certainly would be an important tool that we would have and we will keep you posted on that.”

He also mentioned that NIAID is looking at a number of candidates for therapeutic treatment of coronavirus. He highlighted Gilead’s remdesivir, a nucleotide analog, as one which undergoing two trials – a randomized controlled trial in China and a copy of that trial in Nebraska among patients with the coronavirus who were taken from the Diamond Princess cruise line in Japan.

“I am optimistic that we will at least get an answer if we do have do have a therapy that really is a gamechanger because then we could do something from the standpoint of intervention for those who are sick,” Dr. Fauci said.  

[email protected]

UPDATE: This story was updated 2/25 at 4:51 p.m. ET

Outbreaks of coronavirus in a wide range of countries have officials at the Centers for Disease Control and Prevention believing it is now a matter of when, not if, there will be community spread in the United States.

Courtesy NIAID-RML

“We have for many weeks been saying that, while we hope this is not going to be severe, we are planning as if it is,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the CDC, said during a Feb. 25, 2020, telebriefing with reporters. “The data over the last week and the spread in other countries has certainly raised our level of concern and raised our level expectation that we are going to have community spread here.”

Dr. Messonnier noted that the coronavirus is now showing signs of community spread without a known source of exposure in a number of countries, including in Hong Kong, Iran, Italy, Japan, Singapore, South Korea, Taiwan, and Thailand. This has now raised the belief that there will be more widespread outbreaks in the United States.

“What we still don’t know is what that will look like,” she said. “As many of you know, we can have community spread in the United States and have it be reasonably mild. We can have community spread in the U.S. and have it be very severe. That is what we don’t completely know yet and we certainly also don’t exactly know when it is going to happen.”

She reiterated the number of actions being taken to slow the potential spread in the United States, including detecting, tracking, and isolating all cases, as well as restricting travel into the United States and issuing travel advisories for countries where coronavirus outbreaks are known.

“We are doing this with the goal of slowing the introduction of this new virus into the U.S. and buying us more time to prepare,” Dr. Messonnier said, noting the containment strategies have been largely successful, though it will be more difficult as more countries experience community spread of the virus.

Dr. Messonnier also reiterated that at this time there are no vaccines and no medicines to treat the coronavirus. She stressed the need to adhere to nonpharmaceutical interventions (NPIs), as they will be “the most important tools in our response to this virus.”

She said the NPIs will vary based on the severity of the outbreak in any given local community and include personal protective measures that individuals can take every day (many of which mirror the recommendations for preventing the spread of the seasonal flu virus), community NPIs that involve social distancing measures designed to keep people away from others, and environmental NPIs such as surface cleaning measures.

CDC’s latest warning comes as parent agency the Department of Health & Human Services is seeking $2.5 billion in funds from Congress to address the coronavirus outbreak.

During a separate press conference on the same day, HHS Secretary Alex Azar noted that there are five major priorities related to those funds, which would be used in the current year, including expansion of surveillance work within the influenza surveillance network; supporting public health preparedness and response for state and local governments; support the development of therapeutics and the development of vaccines; and the purchase of personal protective equipment for national stockpiles.

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health, added during the press conference that vaccine work is in progress and could be ready for phase 1 testing within a month and a half. If all goes well, it would still be at least 12 - 18 months following the completion of a phase 2 trial before it could be produced for mass consumption.

“It is certainly conceivable that this issue with this coronavirus will go well beyond this season into next season,” Dr. Fauci said. “So a vaccine may not solve the problems of the next couple of months, but it certainly would be an important tool that we would have and we will keep you posted on that.”

He also mentioned that NIAID is looking at a number of candidates for therapeutic treatment of coronavirus. He highlighted Gilead’s remdesivir, a nucleotide analog, as one which undergoing two trials – a randomized controlled trial in China and a copy of that trial in Nebraska among patients with the coronavirus who were taken from the Diamond Princess cruise line in Japan.

“I am optimistic that we will at least get an answer if we do have do have a therapy that really is a gamechanger because then we could do something from the standpoint of intervention for those who are sick,” Dr. Fauci said.  

[email protected]

UPDATE: This story was updated 2/25 at 4:51 p.m. ET

Outbreaks of coronavirus in a wide range of countries have officials at the Centers for Disease Control and Prevention believing it is now a matter of when, not if, there will be community spread in the United States.

Courtesy NIAID-RML

“We have for many weeks been saying that, while we hope this is not going to be severe, we are planning as if it is,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the CDC, said during a Feb. 25, 2020, telebriefing with reporters. “The data over the last week and the spread in other countries has certainly raised our level of concern and raised our level expectation that we are going to have community spread here.”

Dr. Messonnier noted that the coronavirus is now showing signs of community spread without a known source of exposure in a number of countries, including in Hong Kong, Iran, Italy, Japan, Singapore, South Korea, Taiwan, and Thailand. This has now raised the belief that there will be more widespread outbreaks in the United States.

“What we still don’t know is what that will look like,” she said. “As many of you know, we can have community spread in the United States and have it be reasonably mild. We can have community spread in the U.S. and have it be very severe. That is what we don’t completely know yet and we certainly also don’t exactly know when it is going to happen.”

She reiterated the number of actions being taken to slow the potential spread in the United States, including detecting, tracking, and isolating all cases, as well as restricting travel into the United States and issuing travel advisories for countries where coronavirus outbreaks are known.

“We are doing this with the goal of slowing the introduction of this new virus into the U.S. and buying us more time to prepare,” Dr. Messonnier said, noting the containment strategies have been largely successful, though it will be more difficult as more countries experience community spread of the virus.

Dr. Messonnier also reiterated that at this time there are no vaccines and no medicines to treat the coronavirus. She stressed the need to adhere to nonpharmaceutical interventions (NPIs), as they will be “the most important tools in our response to this virus.”

She said the NPIs will vary based on the severity of the outbreak in any given local community and include personal protective measures that individuals can take every day (many of which mirror the recommendations for preventing the spread of the seasonal flu virus), community NPIs that involve social distancing measures designed to keep people away from others, and environmental NPIs such as surface cleaning measures.

CDC’s latest warning comes as parent agency the Department of Health & Human Services is seeking $2.5 billion in funds from Congress to address the coronavirus outbreak.

During a separate press conference on the same day, HHS Secretary Alex Azar noted that there are five major priorities related to those funds, which would be used in the current year, including expansion of surveillance work within the influenza surveillance network; supporting public health preparedness and response for state and local governments; support the development of therapeutics and the development of vaccines; and the purchase of personal protective equipment for national stockpiles.

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health, added during the press conference that vaccine work is in progress and could be ready for phase 1 testing within a month and a half. If all goes well, it would still be at least 12 - 18 months following the completion of a phase 2 trial before it could be produced for mass consumption.

“It is certainly conceivable that this issue with this coronavirus will go well beyond this season into next season,” Dr. Fauci said. “So a vaccine may not solve the problems of the next couple of months, but it certainly would be an important tool that we would have and we will keep you posted on that.”

He also mentioned that NIAID is looking at a number of candidates for therapeutic treatment of coronavirus. He highlighted Gilead’s remdesivir, a nucleotide analog, as one which undergoing two trials – a randomized controlled trial in China and a copy of that trial in Nebraska among patients with the coronavirus who were taken from the Diamond Princess cruise line in Japan.

“I am optimistic that we will at least get an answer if we do have do have a therapy that really is a gamechanger because then we could do something from the standpoint of intervention for those who are sick,” Dr. Fauci said.  

[email protected]

UPDATE: This story was updated 2/25 at 4:51 p.m. ET

The Chinese Center for Disease Control and Prevention has released the largest case series to date for novel coronavirus 2019 (COVID-19), and a summary of key findings appears in JAMA.

• The virus, which spread from a single city to a whole country in only 30 days, has so far has caused over 72,314 cases as of Feb. 11, 2020, and 1,023 fatalities (2.3%) overall.
• The age distribution shows that most of the cases (87%) occurred in patients aged 30-79 years, while 10% were in patients 29 years and younger and 3% at 80 years and older.
• Following the SARS outbreak in 2002-2003, the Chinese government adjusted its epidemic response protocol. For example, according to the summary, while there were 300 cases and 5 deaths with SARS before the Chinese government reported it to the World Health Organization, there were only 27 cases and no deaths with COVID-19 before it was reported to that agency.
• A major goal, the authors wrote, is to buy enough time for scientific research, hopefully before the disease has become too widespread.

The summary argues that, while some measures the Chinese government has taken could be seen as extreme, the overall benefits and lives saved outweigh the potential infringement on civil liberties. It also suggests that countries need to work together in situations like this because disease pathogens do not respect geopolitical borders.

[email protected]

SOURCE: Wu Z, McGoogan JM. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

The Chinese Center for Disease Control and Prevention has released the largest case series to date for novel coronavirus 2019 (COVID-19), and a summary of key findings appears in JAMA.

• The virus, which spread from a single city to a whole country in only 30 days, has so far has caused over 72,314 cases as of Feb. 11, 2020, and 1,023 fatalities (2.3%) overall.
• The age distribution shows that most of the cases (87%) occurred in patients aged 30-79 years, while 10% were in patients 29 years and younger and 3% at 80 years and older.
• Following the SARS outbreak in 2002-2003, the Chinese government adjusted its epidemic response protocol. For example, according to the summary, while there were 300 cases and 5 deaths with SARS before the Chinese government reported it to the World Health Organization, there were only 27 cases and no deaths with COVID-19 before it was reported to that agency.
• A major goal, the authors wrote, is to buy enough time for scientific research, hopefully before the disease has become too widespread.

The summary argues that, while some measures the Chinese government has taken could be seen as extreme, the overall benefits and lives saved outweigh the potential infringement on civil liberties. It also suggests that countries need to work together in situations like this because disease pathogens do not respect geopolitical borders.

[email protected]

SOURCE: Wu Z, McGoogan JM. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

The Chinese Center for Disease Control and Prevention has released the largest case series to date for novel coronavirus 2019 (COVID-19), and a summary of key findings appears in JAMA.

• The virus, which spread from a single city to a whole country in only 30 days, has so far has caused over 72,314 cases as of Feb. 11, 2020, and 1,023 fatalities (2.3%) overall.
• The age distribution shows that most of the cases (87%) occurred in patients aged 30-79 years, while 10% were in patients 29 years and younger and 3% at 80 years and older.
• Following the SARS outbreak in 2002-2003, the Chinese government adjusted its epidemic response protocol. For example, according to the summary, while there were 300 cases and 5 deaths with SARS before the Chinese government reported it to the World Health Organization, there were only 27 cases and no deaths with COVID-19 before it was reported to that agency.
• A major goal, the authors wrote, is to buy enough time for scientific research, hopefully before the disease has become too widespread.

The summary argues that, while some measures the Chinese government has taken could be seen as extreme, the overall benefits and lives saved outweigh the potential infringement on civil liberties. It also suggests that countries need to work together in situations like this because disease pathogens do not respect geopolitical borders.

[email protected]

SOURCE: Wu Z, McGoogan JM. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

A unique collection of bacteria in the gut may have a strong association with pulmonary arterial hypertension and could be highly predictive of the disease in undiagnosed patients, according to a study published in the journal Hypertension.

This is the first study to show that people with PAH have a common specific gut microbiota profile, wrote lead study author Mohan Raizada, PhD, distinguished professor in the department of physiology and functional genomics at the University of Florida, Gainesville.

The findings have the potential to change how cardiologists diagnose and treat PAH, he added. “While current PAH treatments focus on the lungs, looking at the lung/gut axis could open the door to new therapies centered in the digestive system,” Dr. Raizada said.

The researchers developed a model that found the specific microbiota profile was 83% accurate in predicting the presence or absence of PAH. If a larger study can validate the findings, the researchers wrote, this could lead to a new test for diagnosing PAH that’s less invasive than cardiac catheterization. It could also lead to new treatments that target the gut microbiome.

Study investigators collected stool samples from 18 PAH patients and 12 people without a history of cardiopulmonary disease. The microbiota DNA from the stool samples were isolated and sequenced. The analysis revealed that PAH patients had reduced richness and evenness of the gut bacteria, known as alpha diversity. They had increased levels of bacteria associated with atherosclerosis, and healthy patients had increased levels of bacteria that produced short-chain fatty acids.

Although recent studies have begun to show potential associations between the gut microbiome and cardiovascular diseases, this research is in its infancy, Mariell Jessup, MD, commented. “Even though the study by Dr. Raizada and colleagues predicted pulmonary arterial hypertension based on an individual’s microbiome with some accuracy, it is an observational study, so it does not prove cause and effect. Many other factors, especially diet, affect the gut microbiome,” added Dr. Jessup, Chief Science and Medical Officer for the American Heart Association.

SOURCE: Raizada MK et al. Hypertension. 2020. doi: 10.1161/HYPERTENSIONAHA.119.14294.

A unique collection of bacteria in the gut may have a strong association with pulmonary arterial hypertension and could be highly predictive of the disease in undiagnosed patients, according to a study published in the journal Hypertension.

This is the first study to show that people with PAH have a common specific gut microbiota profile, wrote lead study author Mohan Raizada, PhD, distinguished professor in the department of physiology and functional genomics at the University of Florida, Gainesville.

The findings have the potential to change how cardiologists diagnose and treat PAH, he added. “While current PAH treatments focus on the lungs, looking at the lung/gut axis could open the door to new therapies centered in the digestive system,” Dr. Raizada said.

The researchers developed a model that found the specific microbiota profile was 83% accurate in predicting the presence or absence of PAH. If a larger study can validate the findings, the researchers wrote, this could lead to a new test for diagnosing PAH that’s less invasive than cardiac catheterization. It could also lead to new treatments that target the gut microbiome.

Study investigators collected stool samples from 18 PAH patients and 12 people without a history of cardiopulmonary disease. The microbiota DNA from the stool samples were isolated and sequenced. The analysis revealed that PAH patients had reduced richness and evenness of the gut bacteria, known as alpha diversity. They had increased levels of bacteria associated with atherosclerosis, and healthy patients had increased levels of bacteria that produced short-chain fatty acids.

Although recent studies have begun to show potential associations between the gut microbiome and cardiovascular diseases, this research is in its infancy, Mariell Jessup, MD, commented. “Even though the study by Dr. Raizada and colleagues predicted pulmonary arterial hypertension based on an individual’s microbiome with some accuracy, it is an observational study, so it does not prove cause and effect. Many other factors, especially diet, affect the gut microbiome,” added Dr. Jessup, Chief Science and Medical Officer for the American Heart Association.

SOURCE: Raizada MK et al. Hypertension. 2020. doi: 10.1161/HYPERTENSIONAHA.119.14294.

A unique collection of bacteria in the gut may have a strong association with pulmonary arterial hypertension and could be highly predictive of the disease in undiagnosed patients, according to a study published in the journal Hypertension.

This is the first study to show that people with PAH have a common specific gut microbiota profile, wrote lead study author Mohan Raizada, PhD, distinguished professor in the department of physiology and functional genomics at the University of Florida, Gainesville.

The findings have the potential to change how cardiologists diagnose and treat PAH, he added. “While current PAH treatments focus on the lungs, looking at the lung/gut axis could open the door to new therapies centered in the digestive system,” Dr. Raizada said.

The researchers developed a model that found the specific microbiota profile was 83% accurate in predicting the presence or absence of PAH. If a larger study can validate the findings, the researchers wrote, this could lead to a new test for diagnosing PAH that’s less invasive than cardiac catheterization. It could also lead to new treatments that target the gut microbiome.

Study investigators collected stool samples from 18 PAH patients and 12 people without a history of cardiopulmonary disease. The microbiota DNA from the stool samples were isolated and sequenced. The analysis revealed that PAH patients had reduced richness and evenness of the gut bacteria, known as alpha diversity. They had increased levels of bacteria associated with atherosclerosis, and healthy patients had increased levels of bacteria that produced short-chain fatty acids.

Although recent studies have begun to show potential associations between the gut microbiome and cardiovascular diseases, this research is in its infancy, Mariell Jessup, MD, commented. “Even though the study by Dr. Raizada and colleagues predicted pulmonary arterial hypertension based on an individual’s microbiome with some accuracy, it is an observational study, so it does not prove cause and effect. Many other factors, especially diet, affect the gut microbiome,” added Dr. Jessup, Chief Science and Medical Officer for the American Heart Association.

SOURCE: Raizada MK et al. Hypertension. 2020. doi: 10.1161/HYPERTENSIONAHA.119.14294.

ORLANDO – Knowledge of vaping devices, familiarity with terminology, and the ability to quickly pinpoint individuals at risk of lung injury are just a few skills that can help critical care professionals confronted with patients who may have vaping-associated lung disease, according to a new guidance document.

Andrew D. Bowser/MDedge News

The guidance offers a risk-stratification system that classifies patients into groups based on exposure, symptoms, and imaging results, and provides specific evaluation needs and management strategies for each. The guidance is designed to help critical care professionals efficiently identify those at high risk of respiratory failure.

Physicians also need to communicate with patients to identify what substances are being vaped and develop effective methods to encourage abstinence, according to the authors, led by Craig M. Lilly, MD, FCCP, professor of medicine, anesthesiology, and surgery at the University of Massachusetts, Worcester.

“I would encourage every intensivist, when they leave their intensive care unit at night, [to ask], ‘have I advised against vaping today?’ ” Dr. Lilly said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The guidelines, concurrently published as a review article in Critical Care Explorations, propose the term vaping-associated respiratory distress syndrome (VARDS), which the authors say constitutes an acute and progressive respiratory syndrome marked by pathologic changes of lung injury and potentially life-threatening hypoxemic respiratory failure.

They also introduce the three-group Worcester classification system, which is intended to triage vaping-exposed individuals for risk of VARDS based on the presence or absence of vaping-related symptoms and infiltrates, and normal or abnormal oxygen saturation.

“It’s very simple,” said Dr. Lilly, who added that the risk stratification model was developed at the request of Massachusetts public health officials.

Patients with vaping exposure but no symptoms attributable to vaping, such as cough, chest pain, or weight loss, are classified as Worcester Low Risk and testing is not recommended, he said.

By contrast, individuals are considered Worcester Medium Risk if they have vaping exposure, symptoms, and a vaping-associated abnormal pattern on imaging, but no hypoxemia; the presence of hypoxemia would tip the scale toward Worcester High Risk.

“Most patients that have died from vaping have been sent out of emergency rooms when they were noted to be hypoxic,” Dr. Lilly told meeting attendees.

ORLANDO – Knowledge of vaping devices, familiarity with terminology, and the ability to quickly pinpoint individuals at risk of lung injury are just a few skills that can help critical care professionals confronted with patients who may have vaping-associated lung disease, according to a new guidance document.

Andrew D. Bowser/MDedge News

The guidance offers a risk-stratification system that classifies patients into groups based on exposure, symptoms, and imaging results, and provides specific evaluation needs and management strategies for each. The guidance is designed to help critical care professionals efficiently identify those at high risk of respiratory failure.

Physicians also need to communicate with patients to identify what substances are being vaped and develop effective methods to encourage abstinence, according to the authors, led by Craig M. Lilly, MD, FCCP, professor of medicine, anesthesiology, and surgery at the University of Massachusetts, Worcester.

“I would encourage every intensivist, when they leave their intensive care unit at night, [to ask], ‘have I advised against vaping today?’ ” Dr. Lilly said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The guidelines, concurrently published as a review article in Critical Care Explorations, propose the term vaping-associated respiratory distress syndrome (VARDS), which the authors say constitutes an acute and progressive respiratory syndrome marked by pathologic changes of lung injury and potentially life-threatening hypoxemic respiratory failure.

They also introduce the three-group Worcester classification system, which is intended to triage vaping-exposed individuals for risk of VARDS based on the presence or absence of vaping-related symptoms and infiltrates, and normal or abnormal oxygen saturation.

“It’s very simple,” said Dr. Lilly, who added that the risk stratification model was developed at the request of Massachusetts public health officials.

Patients with vaping exposure but no symptoms attributable to vaping, such as cough, chest pain, or weight loss, are classified as Worcester Low Risk and testing is not recommended, he said.

By contrast, individuals are considered Worcester Medium Risk if they have vaping exposure, symptoms, and a vaping-associated abnormal pattern on imaging, but no hypoxemia; the presence of hypoxemia would tip the scale toward Worcester High Risk.

“Most patients that have died from vaping have been sent out of emergency rooms when they were noted to be hypoxic,” Dr. Lilly told meeting attendees.

ORLANDO – Knowledge of vaping devices, familiarity with terminology, and the ability to quickly pinpoint individuals at risk of lung injury are just a few skills that can help critical care professionals confronted with patients who may have vaping-associated lung disease, according to a new guidance document.

Andrew D. Bowser/MDedge News

The guidance offers a risk-stratification system that classifies patients into groups based on exposure, symptoms, and imaging results, and provides specific evaluation needs and management strategies for each. The guidance is designed to help critical care professionals efficiently identify those at high risk of respiratory failure.

Physicians also need to communicate with patients to identify what substances are being vaped and develop effective methods to encourage abstinence, according to the authors, led by Craig M. Lilly, MD, FCCP, professor of medicine, anesthesiology, and surgery at the University of Massachusetts, Worcester.

“I would encourage every intensivist, when they leave their intensive care unit at night, [to ask], ‘have I advised against vaping today?’ ” Dr. Lilly said at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The guidelines, concurrently published as a review article in Critical Care Explorations, propose the term vaping-associated respiratory distress syndrome (VARDS), which the authors say constitutes an acute and progressive respiratory syndrome marked by pathologic changes of lung injury and potentially life-threatening hypoxemic respiratory failure.

They also introduce the three-group Worcester classification system, which is intended to triage vaping-exposed individuals for risk of VARDS based on the presence or absence of vaping-related symptoms and infiltrates, and normal or abnormal oxygen saturation.

“It’s very simple,” said Dr. Lilly, who added that the risk stratification model was developed at the request of Massachusetts public health officials.

Patients with vaping exposure but no symptoms attributable to vaping, such as cough, chest pain, or weight loss, are classified as Worcester Low Risk and testing is not recommended, he said.

By contrast, individuals are considered Worcester Medium Risk if they have vaping exposure, symptoms, and a vaping-associated abnormal pattern on imaging, but no hypoxemia; the presence of hypoxemia would tip the scale toward Worcester High Risk.

“Most patients that have died from vaping have been sent out of emergency rooms when they were noted to be hypoxic,” Dr. Lilly told meeting attendees.

Analysis of additional lung fluid samples confirms the presence of vitamin E acetate in patients with electronic-cigarette, or vaping, product use–associated lung injury, according to a report on 51 patients in 16 states.

The average age of the patients was 23 years; 69% were male.

The report extends previous work by the Centers for Disease Control and Prevention to test for harmful substances in bronchoalveolar-lavage (BAL) fluid obtained from patients with electronic-cigarette, or vaping, product use–associated lung injury (EVALI) as part of a strategy to understand and manage the recent outbreak of EVALI cases in the United States, wrote Benjamin C. Blount, PhD, of the Division of Laboratory Sciences at the CDC’s National Center for Environmental Health, and colleagues.

“CDC was addressing a serious outbreak of lung injury that was sometimes lethal; but after the first 10 weeks of the outbreak investigation, the cause was still unknown,” Dr. Blount said in an interview. “Possible theories could not be evaluated unless the laboratory could develop tests that could confidently connect exposure to lung injury. Detection of toxicants in bronchoalveolar-lavage fluid from patients with EVALI can provide direct information on exposure within the lung.”

In a study published in the New England Journal of Medicine, the researchers examined the BAL of 51 cases of EVALI from 16 states. They analyzed the samples for multiple toxicants, including vitamin E acetate, plant oils, medium-chain triglyceride oil, coconut oil, petroleum distillates, and diluent terpenes.

Overall, 77% of the patients reported using products containing THC, 67% reported using products containing nicotine, and 51% reported using both types.

Researchers found vitamin E acetate in 48 of the 51 patients (94%); no vitamin E acetate was found in the BAL of healthy controls. Coconut oil and limonene were found in one patient each, but none of the other toxicants was found in the samples from the patients or controls.

In addition, 47 of the 50 patients for whom data were available either had detectable tetrahydrocannabinol (THC) or its metabolites in their BAL fluid samples, or they reported vaping THC products within 90 days before they became ill. Nicotine or its metabolites were found in 30 of 47 patients (64%).

The study findings were limited by several factors, including the potential role of vitamin E acetate as a marker for exposure to other toxicants, the uncertainty of the role of aerosolized constituents formed when vitamin E acetate is heated, and the lack of data on the timing and burden of toxicant exposure, the investigators noted.

As for the next steps in research, “additional studies are needed to examine the respiratory effects of inhaling aerosolized vitamin E acetate and provide information on whether vitamin E acetate in isolation causes lung injury,” Dr. Blount explained. Analysis of the aerosol and gases generated by case-associated product fluids is ongoing.

“When CDC developed the BAL study for this response, we considered several possible toxicants in this investigation to find a possible cause of the outbreak,” Dr. Blount noted. “To accomplish the study, CDC’s Environmental Health Laboratory developed 12 analytical methods and validated them in less than 3 weeks because of the urgent nature of the emergency.”

Dr. Blount said he would advise clinicians to “continue to reference CDC guidance on treating suspected or EVALI patients.” In December, the CDC published updated guidance for clinicians on hospitalized EVALI patients. “Following this guidance and other recommendations could reduce EVALI-associated morbidity and mortality,” Dr. Blount said.

The study was supported in part by the National Cancer Institute, the FDA Center for Tobacco Products, and Ohio State University Pelotonia Intramural Research. The researchers had no financial conflicts to disclose.

SOURCE: Blount BC et al. N Engl J Med. 2020 Feb 20. doi: 10.1056/NEJMoa1916433.

Analysis of additional lung fluid samples confirms the presence of vitamin E acetate in patients with electronic-cigarette, or vaping, product use–associated lung injury, according to a report on 51 patients in 16 states.

The average age of the patients was 23 years; 69% were male.

The report extends previous work by the Centers for Disease Control and Prevention to test for harmful substances in bronchoalveolar-lavage (BAL) fluid obtained from patients with electronic-cigarette, or vaping, product use–associated lung injury (EVALI) as part of a strategy to understand and manage the recent outbreak of EVALI cases in the United States, wrote Benjamin C. Blount, PhD, of the Division of Laboratory Sciences at the CDC’s National Center for Environmental Health, and colleagues.

“CDC was addressing a serious outbreak of lung injury that was sometimes lethal; but after the first 10 weeks of the outbreak investigation, the cause was still unknown,” Dr. Blount said in an interview. “Possible theories could not be evaluated unless the laboratory could develop tests that could confidently connect exposure to lung injury. Detection of toxicants in bronchoalveolar-lavage fluid from patients with EVALI can provide direct information on exposure within the lung.”

In a study published in the New England Journal of Medicine, the researchers examined the BAL of 51 cases of EVALI from 16 states. They analyzed the samples for multiple toxicants, including vitamin E acetate, plant oils, medium-chain triglyceride oil, coconut oil, petroleum distillates, and diluent terpenes.

Overall, 77% of the patients reported using products containing THC, 67% reported using products containing nicotine, and 51% reported using both types.

Researchers found vitamin E acetate in 48 of the 51 patients (94%); no vitamin E acetate was found in the BAL of healthy controls. Coconut oil and limonene were found in one patient each, but none of the other toxicants was found in the samples from the patients or controls.

In addition, 47 of the 50 patients for whom data were available either had detectable tetrahydrocannabinol (THC) or its metabolites in their BAL fluid samples, or they reported vaping THC products within 90 days before they became ill. Nicotine or its metabolites were found in 30 of 47 patients (64%).

The study findings were limited by several factors, including the potential role of vitamin E acetate as a marker for exposure to other toxicants, the uncertainty of the role of aerosolized constituents formed when vitamin E acetate is heated, and the lack of data on the timing and burden of toxicant exposure, the investigators noted.

As for the next steps in research, “additional studies are needed to examine the respiratory effects of inhaling aerosolized vitamin E acetate and provide information on whether vitamin E acetate in isolation causes lung injury,” Dr. Blount explained. Analysis of the aerosol and gases generated by case-associated product fluids is ongoing.

“When CDC developed the BAL study for this response, we considered several possible toxicants in this investigation to find a possible cause of the outbreak,” Dr. Blount noted. “To accomplish the study, CDC’s Environmental Health Laboratory developed 12 analytical methods and validated them in less than 3 weeks because of the urgent nature of the emergency.”

Dr. Blount said he would advise clinicians to “continue to reference CDC guidance on treating suspected or EVALI patients.” In December, the CDC published updated guidance for clinicians on hospitalized EVALI patients. “Following this guidance and other recommendations could reduce EVALI-associated morbidity and mortality,” Dr. Blount said.

The study was supported in part by the National Cancer Institute, the FDA Center for Tobacco Products, and Ohio State University Pelotonia Intramural Research. The researchers had no financial conflicts to disclose.

SOURCE: Blount BC et al. N Engl J Med. 2020 Feb 20. doi: 10.1056/NEJMoa1916433.

Analysis of additional lung fluid samples confirms the presence of vitamin E acetate in patients with electronic-cigarette, or vaping, product use–associated lung injury, according to a report on 51 patients in 16 states.

The average age of the patients was 23 years; 69% were male.

The report extends previous work by the Centers for Disease Control and Prevention to test for harmful substances in bronchoalveolar-lavage (BAL) fluid obtained from patients with electronic-cigarette, or vaping, product use–associated lung injury (EVALI) as part of a strategy to understand and manage the recent outbreak of EVALI cases in the United States, wrote Benjamin C. Blount, PhD, of the Division of Laboratory Sciences at the CDC’s National Center for Environmental Health, and colleagues.

“CDC was addressing a serious outbreak of lung injury that was sometimes lethal; but after the first 10 weeks of the outbreak investigation, the cause was still unknown,” Dr. Blount said in an interview. “Possible theories could not be evaluated unless the laboratory could develop tests that could confidently connect exposure to lung injury. Detection of toxicants in bronchoalveolar-lavage fluid from patients with EVALI can provide direct information on exposure within the lung.”

In a study published in the New England Journal of Medicine, the researchers examined the BAL of 51 cases of EVALI from 16 states. They analyzed the samples for multiple toxicants, including vitamin E acetate, plant oils, medium-chain triglyceride oil, coconut oil, petroleum distillates, and diluent terpenes.

Overall, 77% of the patients reported using products containing THC, 67% reported using products containing nicotine, and 51% reported using both types.

Researchers found vitamin E acetate in 48 of the 51 patients (94%); no vitamin E acetate was found in the BAL of healthy controls. Coconut oil and limonene were found in one patient each, but none of the other toxicants was found in the samples from the patients or controls.

In addition, 47 of the 50 patients for whom data were available either had detectable tetrahydrocannabinol (THC) or its metabolites in their BAL fluid samples, or they reported vaping THC products within 90 days before they became ill. Nicotine or its metabolites were found in 30 of 47 patients (64%).

The study findings were limited by several factors, including the potential role of vitamin E acetate as a marker for exposure to other toxicants, the uncertainty of the role of aerosolized constituents formed when vitamin E acetate is heated, and the lack of data on the timing and burden of toxicant exposure, the investigators noted.

As for the next steps in research, “additional studies are needed to examine the respiratory effects of inhaling aerosolized vitamin E acetate and provide information on whether vitamin E acetate in isolation causes lung injury,” Dr. Blount explained. Analysis of the aerosol and gases generated by case-associated product fluids is ongoing.

“When CDC developed the BAL study for this response, we considered several possible toxicants in this investigation to find a possible cause of the outbreak,” Dr. Blount noted. “To accomplish the study, CDC’s Environmental Health Laboratory developed 12 analytical methods and validated them in less than 3 weeks because of the urgent nature of the emergency.”

Dr. Blount said he would advise clinicians to “continue to reference CDC guidance on treating suspected or EVALI patients.” In December, the CDC published updated guidance for clinicians on hospitalized EVALI patients. “Following this guidance and other recommendations could reduce EVALI-associated morbidity and mortality,” Dr. Blount said.

The study was supported in part by the National Cancer Institute, the FDA Center for Tobacco Products, and Ohio State University Pelotonia Intramural Research. The researchers had no financial conflicts to disclose.

SOURCE: Blount BC et al. N Engl J Med. 2020 Feb 20. doi: 10.1056/NEJMoa1916433.