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CHEST Health Policy and Advocacy Committee perspective on the FDA’s announcement of prohibiting menthol cigarettes and flavored cigars
The recently announced ruling by the FDA to ban menthol in tobacco products is a large step forward toward abolishing tobacco-related disease and death. It is also a big step forward to abolishing the institutional racism of the tobacco industry, which has targeted Black communities with menthol cigarettes for decades, and a step toward improving health equity. Although tobacco use across the United States has decreased from 45% of adults smoking in the 1950s to only 14% smoking today, tobacco continues to be the leading cause of preventable disease and death. Critically, some populations have not seen reductions in tobacco use that benefited others, namely communities of color, low-income populations and LGBTQ+ individuals. A key to this health disparity is the preference for menthol-flavored tobacco products by these groups. Menthol within cigarettes and cigars masks the unpleasant smell of tobacco and numbs the airways to irritation caused by tobacco smoke, while amplifying the effects of nicotine. Eighteen million people smoke menthol cigarettes, with 85% of Black smokers using menthol cigarettes – tobacco ends 45,000 Black lives every year, and menthol is the primary driver of over 38,000 of these Black deaths.
The data supporting a menthol ban has been strong for years. It is well known that flavors, like menthol, increase the appeal of tobacco and increase initiation of tobacco use by women, children, young adults, people of color, low-income, and LGBTQ+ communities. Menthol in particular increases the addictive potential of tobacco and makes it harder for menthol smokers to quit. The evidence behind banning menthol across tobacco products and flavored cigars to protect our children and young adults is also strong. Half of adolescents who try tobacco choose menthol-flavored products; 74% of teenagers aged 14-17 who smoke cigars say they do so because they enjoy the flavors.
There are many reasons why we as pulmonary and critical care medicine physicians are excited about this recent FDA ruling. The most important of which is that this rule is an important step toward advancing health equity in our country. Banning menthol-flavored tobacco products will save lives, including those of thousands of Black Americans. Banning menthol will reduce tobacco addiction, diminish youth experimentation and youth initiation of tobacco use, and increase the ability of tobacco smokers to successfully quit.
While celebrating this incredible win against the racist institution that is Big Tobacco, we must acknowledge the hard work of those who made it happen: the African American Tobacco Control Leadership Council, Center for Black Health & Equity, Campaign for Tobacco-Free Kids, American Medical Association, and many others. It is extremely exciting that menthol cigarettes, which are responsible for 10,000 deaths per year and >265,000 new smokers per year since 1980 (Le TT and Mendez D, Tob Control. 2021 Feb 25. doi: 10.1136/tobaccocontrol-2020-056256).
will soon be a thing of the past. Next on the CHEST Health Policy and Advocacy Committee (HPAC) to-do list? Ensuring that the menthol ban is extended to e-cigarettes, another tobacco product that targets Americans of all kinds. Finally, we must continue the fight to end tobacco-related disease and death across the country and across the world by helping our patients with smoking cessation efforts and by working to prevent initiation of tobacco use (including e-cigarettes and other vaping devices) by children, at-risk individuals, and communities of all kinds.
Laura E. Crotty Alexander, MD, is with UC San Diego and the VA San Diego Healthcare System.
The recently announced ruling by the FDA to ban menthol in tobacco products is a large step forward toward abolishing tobacco-related disease and death. It is also a big step forward to abolishing the institutional racism of the tobacco industry, which has targeted Black communities with menthol cigarettes for decades, and a step toward improving health equity. Although tobacco use across the United States has decreased from 45% of adults smoking in the 1950s to only 14% smoking today, tobacco continues to be the leading cause of preventable disease and death. Critically, some populations have not seen reductions in tobacco use that benefited others, namely communities of color, low-income populations and LGBTQ+ individuals. A key to this health disparity is the preference for menthol-flavored tobacco products by these groups. Menthol within cigarettes and cigars masks the unpleasant smell of tobacco and numbs the airways to irritation caused by tobacco smoke, while amplifying the effects of nicotine. Eighteen million people smoke menthol cigarettes, with 85% of Black smokers using menthol cigarettes – tobacco ends 45,000 Black lives every year, and menthol is the primary driver of over 38,000 of these Black deaths.
The data supporting a menthol ban has been strong for years. It is well known that flavors, like menthol, increase the appeal of tobacco and increase initiation of tobacco use by women, children, young adults, people of color, low-income, and LGBTQ+ communities. Menthol in particular increases the addictive potential of tobacco and makes it harder for menthol smokers to quit. The evidence behind banning menthol across tobacco products and flavored cigars to protect our children and young adults is also strong. Half of adolescents who try tobacco choose menthol-flavored products; 74% of teenagers aged 14-17 who smoke cigars say they do so because they enjoy the flavors.
There are many reasons why we as pulmonary and critical care medicine physicians are excited about this recent FDA ruling. The most important of which is that this rule is an important step toward advancing health equity in our country. Banning menthol-flavored tobacco products will save lives, including those of thousands of Black Americans. Banning menthol will reduce tobacco addiction, diminish youth experimentation and youth initiation of tobacco use, and increase the ability of tobacco smokers to successfully quit.
While celebrating this incredible win against the racist institution that is Big Tobacco, we must acknowledge the hard work of those who made it happen: the African American Tobacco Control Leadership Council, Center for Black Health & Equity, Campaign for Tobacco-Free Kids, American Medical Association, and many others. It is extremely exciting that menthol cigarettes, which are responsible for 10,000 deaths per year and >265,000 new smokers per year since 1980 (Le TT and Mendez D, Tob Control. 2021 Feb 25. doi: 10.1136/tobaccocontrol-2020-056256).
will soon be a thing of the past. Next on the CHEST Health Policy and Advocacy Committee (HPAC) to-do list? Ensuring that the menthol ban is extended to e-cigarettes, another tobacco product that targets Americans of all kinds. Finally, we must continue the fight to end tobacco-related disease and death across the country and across the world by helping our patients with smoking cessation efforts and by working to prevent initiation of tobacco use (including e-cigarettes and other vaping devices) by children, at-risk individuals, and communities of all kinds.
Laura E. Crotty Alexander, MD, is with UC San Diego and the VA San Diego Healthcare System.
The recently announced ruling by the FDA to ban menthol in tobacco products is a large step forward toward abolishing tobacco-related disease and death. It is also a big step forward to abolishing the institutional racism of the tobacco industry, which has targeted Black communities with menthol cigarettes for decades, and a step toward improving health equity. Although tobacco use across the United States has decreased from 45% of adults smoking in the 1950s to only 14% smoking today, tobacco continues to be the leading cause of preventable disease and death. Critically, some populations have not seen reductions in tobacco use that benefited others, namely communities of color, low-income populations and LGBTQ+ individuals. A key to this health disparity is the preference for menthol-flavored tobacco products by these groups. Menthol within cigarettes and cigars masks the unpleasant smell of tobacco and numbs the airways to irritation caused by tobacco smoke, while amplifying the effects of nicotine. Eighteen million people smoke menthol cigarettes, with 85% of Black smokers using menthol cigarettes – tobacco ends 45,000 Black lives every year, and menthol is the primary driver of over 38,000 of these Black deaths.
The data supporting a menthol ban has been strong for years. It is well known that flavors, like menthol, increase the appeal of tobacco and increase initiation of tobacco use by women, children, young adults, people of color, low-income, and LGBTQ+ communities. Menthol in particular increases the addictive potential of tobacco and makes it harder for menthol smokers to quit. The evidence behind banning menthol across tobacco products and flavored cigars to protect our children and young adults is also strong. Half of adolescents who try tobacco choose menthol-flavored products; 74% of teenagers aged 14-17 who smoke cigars say they do so because they enjoy the flavors.
There are many reasons why we as pulmonary and critical care medicine physicians are excited about this recent FDA ruling. The most important of which is that this rule is an important step toward advancing health equity in our country. Banning menthol-flavored tobacco products will save lives, including those of thousands of Black Americans. Banning menthol will reduce tobacco addiction, diminish youth experimentation and youth initiation of tobacco use, and increase the ability of tobacco smokers to successfully quit.
While celebrating this incredible win against the racist institution that is Big Tobacco, we must acknowledge the hard work of those who made it happen: the African American Tobacco Control Leadership Council, Center for Black Health & Equity, Campaign for Tobacco-Free Kids, American Medical Association, and many others. It is extremely exciting that menthol cigarettes, which are responsible for 10,000 deaths per year and >265,000 new smokers per year since 1980 (Le TT and Mendez D, Tob Control. 2021 Feb 25. doi: 10.1136/tobaccocontrol-2020-056256).
will soon be a thing of the past. Next on the CHEST Health Policy and Advocacy Committee (HPAC) to-do list? Ensuring that the menthol ban is extended to e-cigarettes, another tobacco product that targets Americans of all kinds. Finally, we must continue the fight to end tobacco-related disease and death across the country and across the world by helping our patients with smoking cessation efforts and by working to prevent initiation of tobacco use (including e-cigarettes and other vaping devices) by children, at-risk individuals, and communities of all kinds.
Laura E. Crotty Alexander, MD, is with UC San Diego and the VA San Diego Healthcare System.
This month in the journal CHEST®
Editor’s picks
1. POINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments During Crisis Standards of Care? YesBy Dr. J. Bishop and Dr. J. Eberl
2. COUNTERPOINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments for Reallocation During Crisis Standards of Care? NoBy Dr. D. Sulmasy and Dr. F. Maldonado
3. National Trends and Disparities in Health-Care Access and Coverage Among Adults With Asthma and COPD: 1997-2018By Dr. A. Gaffney, et al.
4. Geographic Variation in Racial Disparities in Mortality From Influenza and Pneumonia in the United States in the Pre-Coronavirus Disease 2019 EraBy Dr. S. Donaldson, et al.
5. Palliative Care Needs and Integration of Palliative Care Support in COPD: A Qualitative StudyBy Dr. F. Yu, et al.
6. How I Do It: Building Teams in Health CareBy. Dr. J. Stoller
Editor’s picks
Editor’s picks
1. POINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments During Crisis Standards of Care? YesBy Dr. J. Bishop and Dr. J. Eberl
2. COUNTERPOINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments for Reallocation During Crisis Standards of Care? NoBy Dr. D. Sulmasy and Dr. F. Maldonado
3. National Trends and Disparities in Health-Care Access and Coverage Among Adults With Asthma and COPD: 1997-2018By Dr. A. Gaffney, et al.
4. Geographic Variation in Racial Disparities in Mortality From Influenza and Pneumonia in the United States in the Pre-Coronavirus Disease 2019 EraBy Dr. S. Donaldson, et al.
5. Palliative Care Needs and Integration of Palliative Care Support in COPD: A Qualitative StudyBy Dr. F. Yu, et al.
6. How I Do It: Building Teams in Health CareBy. Dr. J. Stoller
1. POINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments During Crisis Standards of Care? YesBy Dr. J. Bishop and Dr. J. Eberl
2. COUNTERPOINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments for Reallocation During Crisis Standards of Care? NoBy Dr. D. Sulmasy and Dr. F. Maldonado
3. National Trends and Disparities in Health-Care Access and Coverage Among Adults With Asthma and COPD: 1997-2018By Dr. A. Gaffney, et al.
4. Geographic Variation in Racial Disparities in Mortality From Influenza and Pneumonia in the United States in the Pre-Coronavirus Disease 2019 EraBy Dr. S. Donaldson, et al.
5. Palliative Care Needs and Integration of Palliative Care Support in COPD: A Qualitative StudyBy Dr. F. Yu, et al.
6. How I Do It: Building Teams in Health CareBy. Dr. J. Stoller
Under new administration, best time to lobby for health care may be now
The ambitious infrastructure bill now being debated in the US Congress might be one of the best immediate opportunities to lobby for legislative or policy changes in delivery of health care during the current Biden administration, according to an analysis delivered at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.
The infrastructure bill is likely to be pushed forward in the filibuster-proof reconciliation process, which means “that some things might get passed that otherwise would not,” explained Keith S. Studdard, Vice President, Jeffrey J. Kimbell & Associates, Washington, DC.
With few exceptions, the key players in the health care team of President Joe Biden’s new administration are in place, according to Mr. Studdard, who is a lobbyist and health care expert. By moving quickly to fill key positions, the new administration “got off to a good start” for a health care agenda that Mr. Studdard believes will be a focus of the Biden presidency. There is some degree of urgency.
“The amount of time [the Biden administration has] to get their agenda through is fairly limited,” Mr. Studdard reported. The problems include a slim majority of fellow Democrats in the House of Representatives (222 vs 213), no majority of Democrats over Republicans in the Senate (50 vs 50), and mid-term elections that are already looming.
“Midterms historically favor the opposition party,” Mr. Studdard said. He expects party lines to harden as the midterms approach, dissipating the already limited appetite for bipartisan cooperation.
The midterms provide the basis for trying to affect change in advance of legislative gridlock, but the recently announced $2 trillion infrastructure bill is an even more compelling impetus. Infrastructure in this case is not limited to the construction of bridges and roads. Rather, this bill “is a massive package that will almost certainly touch on health care policy,” according to Mr. Studdard.
As the infrastructure bill winds its way through the legislative process, Mr. Studdard expects there will be efforts to include language that favors expansion of services and funding for health care. This includes those related to the Affordable Care Act (ACA) and the temporary modifications permitted under the CARES Act, which was passed during the early months of the COVID-19 pandemic.
For those who think that waivers and exceptions introduced in the CARES Act, such as the expansion of telehealth, should be made permanent, “this will be your main shot on goal,” Mr. Studdard said.
The debates around the ambitious infrastructure bill are “all that we will be hearing about from the legislative standpoint for the next few months,” Mr. Studdard said. He expects major lobbying efforts in regard to this legislation from a vast array of interest groups, not just those with a stake in health care.
If the bill passes, it will likely to be greatly helped by a vote under the reconciliation process. Created in 1974 to allow expedited consideration of spending legislation, the reconciliation process allows bills to be enacted with a simple majority, which is 51 votes in the Senate and 218 votes in the House. Filibustering is not permitted.
This means that the infrastructure bill, like the CARES Act, which was also passed through the reconciliation process, can be made into law even if all 50 Republican senators vote against it. As she has already done three times since taking office—most recently for COVID19 relief bill in early March—Vice President Kamala Harris can break a 50-50 tie with her vote for the administration’s agenda.
Legislation is one of two paths for altering funding and rules regarding health care in the United States. Policy is the other. For reaching decision makers with influence on policy, Mr. Studdard provided a long list of agencies, political appointees, and elected representatives that could be targeted. Many, such as the director of the Centers for Medicare & Medicaid Services (CMS), are well known, but others might be overlooked without a detailed list of the players.
As one example, he pointed to the Center for Medicare and Medicaid Innovation (CMMI), which is a relatively new organization within CMS. Led by Liz Fowler, a former Senate aide involved in writing the ACA, the CMMI has broad authority over several aspects of health policy, such as value-based care.
“The CCMI is something you should put on your radar. It moves with more flexibility than the HHS [Department of Health and Human Services],” Mr. Studdard said.
Mr. Studdard’s detailed overview of the intricacies of how to affect change in health policy and the likely trajectory under the Biden Administration included frequent comments about the traits, background, and goals of the specific decision makers he identified. The implication is that personal relations matter. Mr. Studdard indicated that knowing who to contact is just the first step.
For the Health Policy and Advocacy Committee, this information is critical. In his outline of the numerous paths for influencing health care policy, Mr. Studdard’s comments lead directly to strategies to lobbying goals for CHEST.
“CHEST and its Health Policy and Advocacy Committee are keeping a focus on health care policy to improve access and to improve care for our patients and reduce the burden on our providers,” according to the Chair of the Committee, Neil Freedman, MD, FCCP. Dr, Freedman is the Division Head Pulmonary, Critical Care, Allergy, and Immunology, Northshore University HeatlhSystem, Evanston, Illinois.
“We would hope that, in addition to the proposed infrastructure bill subsidizing some additional costs for the ACA and COBRA [Consolidated Omnibus Budget Reconciliation Act] and enhancing Medicaid eligibility, the bill would also provide some additional funding for the provider relief fund,” he said.
Mr. Studdard or his lobbying firm represent 62 clients with interests in health care policy.
The ambitious infrastructure bill now being debated in the US Congress might be one of the best immediate opportunities to lobby for legislative or policy changes in delivery of health care during the current Biden administration, according to an analysis delivered at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.
The infrastructure bill is likely to be pushed forward in the filibuster-proof reconciliation process, which means “that some things might get passed that otherwise would not,” explained Keith S. Studdard, Vice President, Jeffrey J. Kimbell & Associates, Washington, DC.
With few exceptions, the key players in the health care team of President Joe Biden’s new administration are in place, according to Mr. Studdard, who is a lobbyist and health care expert. By moving quickly to fill key positions, the new administration “got off to a good start” for a health care agenda that Mr. Studdard believes will be a focus of the Biden presidency. There is some degree of urgency.
“The amount of time [the Biden administration has] to get their agenda through is fairly limited,” Mr. Studdard reported. The problems include a slim majority of fellow Democrats in the House of Representatives (222 vs 213), no majority of Democrats over Republicans in the Senate (50 vs 50), and mid-term elections that are already looming.
“Midterms historically favor the opposition party,” Mr. Studdard said. He expects party lines to harden as the midterms approach, dissipating the already limited appetite for bipartisan cooperation.
The midterms provide the basis for trying to affect change in advance of legislative gridlock, but the recently announced $2 trillion infrastructure bill is an even more compelling impetus. Infrastructure in this case is not limited to the construction of bridges and roads. Rather, this bill “is a massive package that will almost certainly touch on health care policy,” according to Mr. Studdard.
As the infrastructure bill winds its way through the legislative process, Mr. Studdard expects there will be efforts to include language that favors expansion of services and funding for health care. This includes those related to the Affordable Care Act (ACA) and the temporary modifications permitted under the CARES Act, which was passed during the early months of the COVID-19 pandemic.
For those who think that waivers and exceptions introduced in the CARES Act, such as the expansion of telehealth, should be made permanent, “this will be your main shot on goal,” Mr. Studdard said.
The debates around the ambitious infrastructure bill are “all that we will be hearing about from the legislative standpoint for the next few months,” Mr. Studdard said. He expects major lobbying efforts in regard to this legislation from a vast array of interest groups, not just those with a stake in health care.
If the bill passes, it will likely to be greatly helped by a vote under the reconciliation process. Created in 1974 to allow expedited consideration of spending legislation, the reconciliation process allows bills to be enacted with a simple majority, which is 51 votes in the Senate and 218 votes in the House. Filibustering is not permitted.
This means that the infrastructure bill, like the CARES Act, which was also passed through the reconciliation process, can be made into law even if all 50 Republican senators vote against it. As she has already done three times since taking office—most recently for COVID19 relief bill in early March—Vice President Kamala Harris can break a 50-50 tie with her vote for the administration’s agenda.
Legislation is one of two paths for altering funding and rules regarding health care in the United States. Policy is the other. For reaching decision makers with influence on policy, Mr. Studdard provided a long list of agencies, political appointees, and elected representatives that could be targeted. Many, such as the director of the Centers for Medicare & Medicaid Services (CMS), are well known, but others might be overlooked without a detailed list of the players.
As one example, he pointed to the Center for Medicare and Medicaid Innovation (CMMI), which is a relatively new organization within CMS. Led by Liz Fowler, a former Senate aide involved in writing the ACA, the CMMI has broad authority over several aspects of health policy, such as value-based care.
“The CCMI is something you should put on your radar. It moves with more flexibility than the HHS [Department of Health and Human Services],” Mr. Studdard said.
Mr. Studdard’s detailed overview of the intricacies of how to affect change in health policy and the likely trajectory under the Biden Administration included frequent comments about the traits, background, and goals of the specific decision makers he identified. The implication is that personal relations matter. Mr. Studdard indicated that knowing who to contact is just the first step.
For the Health Policy and Advocacy Committee, this information is critical. In his outline of the numerous paths for influencing health care policy, Mr. Studdard’s comments lead directly to strategies to lobbying goals for CHEST.
“CHEST and its Health Policy and Advocacy Committee are keeping a focus on health care policy to improve access and to improve care for our patients and reduce the burden on our providers,” according to the Chair of the Committee, Neil Freedman, MD, FCCP. Dr, Freedman is the Division Head Pulmonary, Critical Care, Allergy, and Immunology, Northshore University HeatlhSystem, Evanston, Illinois.
“We would hope that, in addition to the proposed infrastructure bill subsidizing some additional costs for the ACA and COBRA [Consolidated Omnibus Budget Reconciliation Act] and enhancing Medicaid eligibility, the bill would also provide some additional funding for the provider relief fund,” he said.
Mr. Studdard or his lobbying firm represent 62 clients with interests in health care policy.
The ambitious infrastructure bill now being debated in the US Congress might be one of the best immediate opportunities to lobby for legislative or policy changes in delivery of health care during the current Biden administration, according to an analysis delivered at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.
The infrastructure bill is likely to be pushed forward in the filibuster-proof reconciliation process, which means “that some things might get passed that otherwise would not,” explained Keith S. Studdard, Vice President, Jeffrey J. Kimbell & Associates, Washington, DC.
With few exceptions, the key players in the health care team of President Joe Biden’s new administration are in place, according to Mr. Studdard, who is a lobbyist and health care expert. By moving quickly to fill key positions, the new administration “got off to a good start” for a health care agenda that Mr. Studdard believes will be a focus of the Biden presidency. There is some degree of urgency.
“The amount of time [the Biden administration has] to get their agenda through is fairly limited,” Mr. Studdard reported. The problems include a slim majority of fellow Democrats in the House of Representatives (222 vs 213), no majority of Democrats over Republicans in the Senate (50 vs 50), and mid-term elections that are already looming.
“Midterms historically favor the opposition party,” Mr. Studdard said. He expects party lines to harden as the midterms approach, dissipating the already limited appetite for bipartisan cooperation.
The midterms provide the basis for trying to affect change in advance of legislative gridlock, but the recently announced $2 trillion infrastructure bill is an even more compelling impetus. Infrastructure in this case is not limited to the construction of bridges and roads. Rather, this bill “is a massive package that will almost certainly touch on health care policy,” according to Mr. Studdard.
As the infrastructure bill winds its way through the legislative process, Mr. Studdard expects there will be efforts to include language that favors expansion of services and funding for health care. This includes those related to the Affordable Care Act (ACA) and the temporary modifications permitted under the CARES Act, which was passed during the early months of the COVID-19 pandemic.
For those who think that waivers and exceptions introduced in the CARES Act, such as the expansion of telehealth, should be made permanent, “this will be your main shot on goal,” Mr. Studdard said.
The debates around the ambitious infrastructure bill are “all that we will be hearing about from the legislative standpoint for the next few months,” Mr. Studdard said. He expects major lobbying efforts in regard to this legislation from a vast array of interest groups, not just those with a stake in health care.
If the bill passes, it will likely to be greatly helped by a vote under the reconciliation process. Created in 1974 to allow expedited consideration of spending legislation, the reconciliation process allows bills to be enacted with a simple majority, which is 51 votes in the Senate and 218 votes in the House. Filibustering is not permitted.
This means that the infrastructure bill, like the CARES Act, which was also passed through the reconciliation process, can be made into law even if all 50 Republican senators vote against it. As she has already done three times since taking office—most recently for COVID19 relief bill in early March—Vice President Kamala Harris can break a 50-50 tie with her vote for the administration’s agenda.
Legislation is one of two paths for altering funding and rules regarding health care in the United States. Policy is the other. For reaching decision makers with influence on policy, Mr. Studdard provided a long list of agencies, political appointees, and elected representatives that could be targeted. Many, such as the director of the Centers for Medicare & Medicaid Services (CMS), are well known, but others might be overlooked without a detailed list of the players.
As one example, he pointed to the Center for Medicare and Medicaid Innovation (CMMI), which is a relatively new organization within CMS. Led by Liz Fowler, a former Senate aide involved in writing the ACA, the CMMI has broad authority over several aspects of health policy, such as value-based care.
“The CCMI is something you should put on your radar. It moves with more flexibility than the HHS [Department of Health and Human Services],” Mr. Studdard said.
Mr. Studdard’s detailed overview of the intricacies of how to affect change in health policy and the likely trajectory under the Biden Administration included frequent comments about the traits, background, and goals of the specific decision makers he identified. The implication is that personal relations matter. Mr. Studdard indicated that knowing who to contact is just the first step.
For the Health Policy and Advocacy Committee, this information is critical. In his outline of the numerous paths for influencing health care policy, Mr. Studdard’s comments lead directly to strategies to lobbying goals for CHEST.
“CHEST and its Health Policy and Advocacy Committee are keeping a focus on health care policy to improve access and to improve care for our patients and reduce the burden on our providers,” according to the Chair of the Committee, Neil Freedman, MD, FCCP. Dr, Freedman is the Division Head Pulmonary, Critical Care, Allergy, and Immunology, Northshore University HeatlhSystem, Evanston, Illinois.
“We would hope that, in addition to the proposed infrastructure bill subsidizing some additional costs for the ACA and COBRA [Consolidated Omnibus Budget Reconciliation Act] and enhancing Medicaid eligibility, the bill would also provide some additional funding for the provider relief fund,” he said.
Mr. Studdard or his lobbying firm represent 62 clients with interests in health care policy.
REPORTING FROM THE CHEST HEALTH POLICY AND ADVOCACY CONFERENCE
Pediatric Dermatology 2021 Supplement
Pediatric Dermatology: A Supplement to Pediatric News & Dermatology News
- Dupilumab curbed itch intensity, frequency in children with severe eczema
- Vitiligo treatment options abound but consider patient goals
- Beware a pair of dermatologic emergencies in children
- Database offers snapshot of common causes of pediatric allergic contact dermatitis
- Who’s at risk for depression on isotretinoin?
- Expert shares his approach to treating warts in children
Pediatric Dermatology: A Supplement to Pediatric News & Dermatology News
- Dupilumab curbed itch intensity, frequency in children with severe eczema
- Vitiligo treatment options abound but consider patient goals
- Beware a pair of dermatologic emergencies in children
- Database offers snapshot of common causes of pediatric allergic contact dermatitis
- Who’s at risk for depression on isotretinoin?
- Expert shares his approach to treating warts in children
Pediatric Dermatology: A Supplement to Pediatric News & Dermatology News
- Dupilumab curbed itch intensity, frequency in children with severe eczema
- Vitiligo treatment options abound but consider patient goals
- Beware a pair of dermatologic emergencies in children
- Database offers snapshot of common causes of pediatric allergic contact dermatitis
- Who’s at risk for depression on isotretinoin?
- Expert shares his approach to treating warts in children
Venetoclax-based regimens show promise in relapsed/refractory AML
Key clinical point: Venetoclax-based therapies offered good efficacy with an acceptable toxicity profile in a real-life setting of patients with relapsed/refractory acute myeloid leukemia (AML).
Major finding: During median follow-up of 10.7 months, composite complete remission was achieved in 55% of patients, of which 61% achieved minimal residual disease negativity. Overall survival and event-free survival were 10.7 and 4.5 months, respectively. Grade 4 neutropenia, thrombocytopenia, and febrile neutropenia occurred in 100%, 95%, and 45% of patients, respectively.
Study details: Data come from retrospective assessment of 47 patients with relapsed/refractory AML treated with venetoclax in combination with azacytidine, decitabine, or low-dose cytarabine.
Disclosures: This study was supported by a grant from AIRC to the MYNERVA project. The authors declared no conflicts of interest.
Source: Piccini M et al. J Clin Med. 2021 Apr 14. doi: 10.3390/jcm10081684.
Key clinical point: Venetoclax-based therapies offered good efficacy with an acceptable toxicity profile in a real-life setting of patients with relapsed/refractory acute myeloid leukemia (AML).
Major finding: During median follow-up of 10.7 months, composite complete remission was achieved in 55% of patients, of which 61% achieved minimal residual disease negativity. Overall survival and event-free survival were 10.7 and 4.5 months, respectively. Grade 4 neutropenia, thrombocytopenia, and febrile neutropenia occurred in 100%, 95%, and 45% of patients, respectively.
Study details: Data come from retrospective assessment of 47 patients with relapsed/refractory AML treated with venetoclax in combination with azacytidine, decitabine, or low-dose cytarabine.
Disclosures: This study was supported by a grant from AIRC to the MYNERVA project. The authors declared no conflicts of interest.
Source: Piccini M et al. J Clin Med. 2021 Apr 14. doi: 10.3390/jcm10081684.
Key clinical point: Venetoclax-based therapies offered good efficacy with an acceptable toxicity profile in a real-life setting of patients with relapsed/refractory acute myeloid leukemia (AML).
Major finding: During median follow-up of 10.7 months, composite complete remission was achieved in 55% of patients, of which 61% achieved minimal residual disease negativity. Overall survival and event-free survival were 10.7 and 4.5 months, respectively. Grade 4 neutropenia, thrombocytopenia, and febrile neutropenia occurred in 100%, 95%, and 45% of patients, respectively.
Study details: Data come from retrospective assessment of 47 patients with relapsed/refractory AML treated with venetoclax in combination with azacytidine, decitabine, or low-dose cytarabine.
Disclosures: This study was supported by a grant from AIRC to the MYNERVA project. The authors declared no conflicts of interest.
Source: Piccini M et al. J Clin Med. 2021 Apr 14. doi: 10.3390/jcm10081684.
Impact of age on biology and outcomes of AML
Key clinical point: Age has a significant impact on the biology and outcomes of patients with acute myeloid leukemia (AML). The proportion of patients in the favorable-risk group receiving induction remission chemotherapy and rates of complete response (CR) among patients who received induction therapy decreased with age.
Major finding: Only 6% of patients older than 70 years were in the favorable-risk group, and less than 50% of patients older than 70 years received induction therapy. After induction therapy, 81.5% of patients with acute promyelocytic leukemia (APL) and 62.4% of non-APL patients achieved CR, which decreased with increasing age.
Study details: Findings are from a retrospective analysis of 3,011 adult patients with AML, of which 329 patients had APL and 2,682 were non-APL patients.
Disclosures: This study was supported by the Korean Society of Hematology AML/MDS Working Party and funding from Gachon University to H Kim. The authors declared no conflicts of interest.
Source: Yoo KH et al. PLoS One. 2021 May 7. doi: 10.1371/journal.pone.0251011.
Key clinical point: Age has a significant impact on the biology and outcomes of patients with acute myeloid leukemia (AML). The proportion of patients in the favorable-risk group receiving induction remission chemotherapy and rates of complete response (CR) among patients who received induction therapy decreased with age.
Major finding: Only 6% of patients older than 70 years were in the favorable-risk group, and less than 50% of patients older than 70 years received induction therapy. After induction therapy, 81.5% of patients with acute promyelocytic leukemia (APL) and 62.4% of non-APL patients achieved CR, which decreased with increasing age.
Study details: Findings are from a retrospective analysis of 3,011 adult patients with AML, of which 329 patients had APL and 2,682 were non-APL patients.
Disclosures: This study was supported by the Korean Society of Hematology AML/MDS Working Party and funding from Gachon University to H Kim. The authors declared no conflicts of interest.
Source: Yoo KH et al. PLoS One. 2021 May 7. doi: 10.1371/journal.pone.0251011.
Key clinical point: Age has a significant impact on the biology and outcomes of patients with acute myeloid leukemia (AML). The proportion of patients in the favorable-risk group receiving induction remission chemotherapy and rates of complete response (CR) among patients who received induction therapy decreased with age.
Major finding: Only 6% of patients older than 70 years were in the favorable-risk group, and less than 50% of patients older than 70 years received induction therapy. After induction therapy, 81.5% of patients with acute promyelocytic leukemia (APL) and 62.4% of non-APL patients achieved CR, which decreased with increasing age.
Study details: Findings are from a retrospective analysis of 3,011 adult patients with AML, of which 329 patients had APL and 2,682 were non-APL patients.
Disclosures: This study was supported by the Korean Society of Hematology AML/MDS Working Party and funding from Gachon University to H Kim. The authors declared no conflicts of interest.
Source: Yoo KH et al. PLoS One. 2021 May 7. doi: 10.1371/journal.pone.0251011.
FLT3-mutated AML: FLT3i-based induction and allo-SCT in first remission improves survival
Key clinical point: Treatment with FMS-like tyrosine kinase inhibitor (FLT3i)-based induction and allogeneic stem cell transplantation (allo-SCT) in the first complete remission (CR1) improved survival in patients with newly diagnosed acute myeloid leukemia (AML) with very low FLT3 allelic burden (0.1 or lower).
Major finding: The 5-year overall survival (OS) rates among patients who received FLT3i induction and allo-SCT in CR1 vs. those who neither received FLT3i nor allo-SCT in CR1 were 100% vs. 27% (P = .02). The 5-year OS rate among patients who did not receive FLT3i-based induction but underwent allo-SCT in CR1 was 71%. Moreover, patients who received FLT3i-based induction and underwent allo-SCT achieved the highest OS.
Study details: Findings are from the retrospective analysis of 50 patients with newly diagnosed FLT3-mutated AML. Patients received frontline chemotherapy without FLT3i (n=30) or induction therapy with FLT3i (n=20).
Disclosures: This study was partly supported by the MD Anderson Cancer Centre Support Grant. Some investigators including the lead author reported research funding, personal fees, grants, honoraria, consultancy, and advisory roles for various pharmaceutical companies.
Source: Yilmaz M et al. Am J Hematol. 2021 Apr 23. doi: 10.1002/ajh.26202.
Key clinical point: Treatment with FMS-like tyrosine kinase inhibitor (FLT3i)-based induction and allogeneic stem cell transplantation (allo-SCT) in the first complete remission (CR1) improved survival in patients with newly diagnosed acute myeloid leukemia (AML) with very low FLT3 allelic burden (0.1 or lower).
Major finding: The 5-year overall survival (OS) rates among patients who received FLT3i induction and allo-SCT in CR1 vs. those who neither received FLT3i nor allo-SCT in CR1 were 100% vs. 27% (P = .02). The 5-year OS rate among patients who did not receive FLT3i-based induction but underwent allo-SCT in CR1 was 71%. Moreover, patients who received FLT3i-based induction and underwent allo-SCT achieved the highest OS.
Study details: Findings are from the retrospective analysis of 50 patients with newly diagnosed FLT3-mutated AML. Patients received frontline chemotherapy without FLT3i (n=30) or induction therapy with FLT3i (n=20).
Disclosures: This study was partly supported by the MD Anderson Cancer Centre Support Grant. Some investigators including the lead author reported research funding, personal fees, grants, honoraria, consultancy, and advisory roles for various pharmaceutical companies.
Source: Yilmaz M et al. Am J Hematol. 2021 Apr 23. doi: 10.1002/ajh.26202.
Key clinical point: Treatment with FMS-like tyrosine kinase inhibitor (FLT3i)-based induction and allogeneic stem cell transplantation (allo-SCT) in the first complete remission (CR1) improved survival in patients with newly diagnosed acute myeloid leukemia (AML) with very low FLT3 allelic burden (0.1 or lower).
Major finding: The 5-year overall survival (OS) rates among patients who received FLT3i induction and allo-SCT in CR1 vs. those who neither received FLT3i nor allo-SCT in CR1 were 100% vs. 27% (P = .02). The 5-year OS rate among patients who did not receive FLT3i-based induction but underwent allo-SCT in CR1 was 71%. Moreover, patients who received FLT3i-based induction and underwent allo-SCT achieved the highest OS.
Study details: Findings are from the retrospective analysis of 50 patients with newly diagnosed FLT3-mutated AML. Patients received frontline chemotherapy without FLT3i (n=30) or induction therapy with FLT3i (n=20).
Disclosures: This study was partly supported by the MD Anderson Cancer Centre Support Grant. Some investigators including the lead author reported research funding, personal fees, grants, honoraria, consultancy, and advisory roles for various pharmaceutical companies.
Source: Yilmaz M et al. Am J Hematol. 2021 Apr 23. doi: 10.1002/ajh.26202.
NK-AML: DAC regimen significantly improves outcomes in patients with IDH2 mutation
Key clinical point: Mutation in isocitrate dehydrogenase 2 (IDH2) gene predicted a favorable response to daunorubicin, cytarabine, and cladribine (DAC) regimen in patients with normal karyotype acute myeloid leukemia (NK-AML).
Major finding: IDH2 mutation had a positive impact on overall survival in patients treated with DAC regimen (54% vs. 33%; P = .0087) but not in those treated with daunorubicin+cytarabine (DA; 21% vs. 23%; P = .22) regimen. Moreover, DAC induction was independently associated with a reduced risk for death when the observations were censored at allogeneic hematopoietic stem cell transplant (hazard ratio, 0.21; P = .02).
Study details: Findings are from a retrospective analysis of 398 patients with NK-AML (IDH2+, n=50) treated with DA (48%), DAC (44%), or DA+fludarabine (8%) regimens.
Disclosures: This study was supported by grants from the Polish Ministry of Science and Education, Polish National Center for Research and Development, and Nicolaus Copernicus University in Bydgoszcz. The authors declared no conflicts of interest.
Source: Libura M et al. Sci Rep. 2021 May 11. doi: 10.1038/s41598-021-88120-y.
Key clinical point: Mutation in isocitrate dehydrogenase 2 (IDH2) gene predicted a favorable response to daunorubicin, cytarabine, and cladribine (DAC) regimen in patients with normal karyotype acute myeloid leukemia (NK-AML).
Major finding: IDH2 mutation had a positive impact on overall survival in patients treated with DAC regimen (54% vs. 33%; P = .0087) but not in those treated with daunorubicin+cytarabine (DA; 21% vs. 23%; P = .22) regimen. Moreover, DAC induction was independently associated with a reduced risk for death when the observations were censored at allogeneic hematopoietic stem cell transplant (hazard ratio, 0.21; P = .02).
Study details: Findings are from a retrospective analysis of 398 patients with NK-AML (IDH2+, n=50) treated with DA (48%), DAC (44%), or DA+fludarabine (8%) regimens.
Disclosures: This study was supported by grants from the Polish Ministry of Science and Education, Polish National Center for Research and Development, and Nicolaus Copernicus University in Bydgoszcz. The authors declared no conflicts of interest.
Source: Libura M et al. Sci Rep. 2021 May 11. doi: 10.1038/s41598-021-88120-y.
Key clinical point: Mutation in isocitrate dehydrogenase 2 (IDH2) gene predicted a favorable response to daunorubicin, cytarabine, and cladribine (DAC) regimen in patients with normal karyotype acute myeloid leukemia (NK-AML).
Major finding: IDH2 mutation had a positive impact on overall survival in patients treated with DAC regimen (54% vs. 33%; P = .0087) but not in those treated with daunorubicin+cytarabine (DA; 21% vs. 23%; P = .22) regimen. Moreover, DAC induction was independently associated with a reduced risk for death when the observations were censored at allogeneic hematopoietic stem cell transplant (hazard ratio, 0.21; P = .02).
Study details: Findings are from a retrospective analysis of 398 patients with NK-AML (IDH2+, n=50) treated with DA (48%), DAC (44%), or DA+fludarabine (8%) regimens.
Disclosures: This study was supported by grants from the Polish Ministry of Science and Education, Polish National Center for Research and Development, and Nicolaus Copernicus University in Bydgoszcz. The authors declared no conflicts of interest.
Source: Libura M et al. Sci Rep. 2021 May 11. doi: 10.1038/s41598-021-88120-y.
Venetoclax combinations offer modest clinical response with high toxicities in post-MPN-AML
Key clinical point: In patients with newly diagnosed and relapsed/refractory (R/R) acute myeloid leukemia (AML) evolving from myeloproliferative neoplasms (MPNs), treatment with venetoclax-based (VEN-b) regimens led to modest clinical responses with no substantial improvement in survival, but high treatment-associated hematologic toxicity and mortality.
Major finding: Median overall survival from initiation of VEN-b regimen was 4 (95% confidence interval, 2-8) months with 8-week mortality being 32%. Only 7 patients with newly diagnosed AML achieved a response, with 3 achieving complete remission, 3 achieving complete remission with incomplete count recovery, and 1 achieving partial remission. Grade 3 or higher infections were observed in 84% of patients during the initial treatment cycle, with severe hemorrhagic complications in 45% of patients.
Study details: Findings are from a retrospective analysis of 31 patients with newly diagnosed (n=14) or R/R (n=17) post-MPN-AML who were treated with VEN-b therapies.
Disclosures: This study was supported partly by a Cancer Center Support Grant from the National Cancer Institute, National Institutes of Health to MD Anderson Cancer Center. Some investigators reported financial and nonfinancial ties with various pharmaceutical companies.
Source: Masarova L et al. Blood Adv. 2021 Apr 22. doi: 10.1182/bloodadvances.2020003934.
Key clinical point: In patients with newly diagnosed and relapsed/refractory (R/R) acute myeloid leukemia (AML) evolving from myeloproliferative neoplasms (MPNs), treatment with venetoclax-based (VEN-b) regimens led to modest clinical responses with no substantial improvement in survival, but high treatment-associated hematologic toxicity and mortality.
Major finding: Median overall survival from initiation of VEN-b regimen was 4 (95% confidence interval, 2-8) months with 8-week mortality being 32%. Only 7 patients with newly diagnosed AML achieved a response, with 3 achieving complete remission, 3 achieving complete remission with incomplete count recovery, and 1 achieving partial remission. Grade 3 or higher infections were observed in 84% of patients during the initial treatment cycle, with severe hemorrhagic complications in 45% of patients.
Study details: Findings are from a retrospective analysis of 31 patients with newly diagnosed (n=14) or R/R (n=17) post-MPN-AML who were treated with VEN-b therapies.
Disclosures: This study was supported partly by a Cancer Center Support Grant from the National Cancer Institute, National Institutes of Health to MD Anderson Cancer Center. Some investigators reported financial and nonfinancial ties with various pharmaceutical companies.
Source: Masarova L et al. Blood Adv. 2021 Apr 22. doi: 10.1182/bloodadvances.2020003934.
Key clinical point: In patients with newly diagnosed and relapsed/refractory (R/R) acute myeloid leukemia (AML) evolving from myeloproliferative neoplasms (MPNs), treatment with venetoclax-based (VEN-b) regimens led to modest clinical responses with no substantial improvement in survival, but high treatment-associated hematologic toxicity and mortality.
Major finding: Median overall survival from initiation of VEN-b regimen was 4 (95% confidence interval, 2-8) months with 8-week mortality being 32%. Only 7 patients with newly diagnosed AML achieved a response, with 3 achieving complete remission, 3 achieving complete remission with incomplete count recovery, and 1 achieving partial remission. Grade 3 or higher infections were observed in 84% of patients during the initial treatment cycle, with severe hemorrhagic complications in 45% of patients.
Study details: Findings are from a retrospective analysis of 31 patients with newly diagnosed (n=14) or R/R (n=17) post-MPN-AML who were treated with VEN-b therapies.
Disclosures: This study was supported partly by a Cancer Center Support Grant from the National Cancer Institute, National Institutes of Health to MD Anderson Cancer Center. Some investigators reported financial and nonfinancial ties with various pharmaceutical companies.
Source: Masarova L et al. Blood Adv. 2021 Apr 22. doi: 10.1182/bloodadvances.2020003934.
AML: Favorable outcomes with HMA+VEN therapy in patients with spliceosome mutations
Key clinical point: Treatment with a combination of hypomethylating agents (HMA) and venetoclax (VEN) was similarly effective in patients with acute myeloid leukemia (AML) with or without spliceosome mutations with specific mutational pairs demonstrating favorable outcomes.
Major finding: Overall response rate (89% vs. 79%; P = .32), composite complete response (79% vs. 75%; P = .65), and median overall survival (OS; 35 vs. 14 months; P = .58) were not significantly different in patients with vs. without spliceosome mutations. Co-occurrence of IDH2 and SRSF2 mutations was associated with favorable outcomes (1- and 2-year OS, 100% and 88%, respectively).
Study details: Findings are from a retrospective study of 119 adult patients with AML treated with frontline HMA+VEN-based therapy. Mutation in the spliceosome gene was observed in 39 patients.
Disclosures: No specific funding source was identified. Some investigators reported research funding, support, honoraria, consultancy, and advisory roles for various pharmaceutical companies.
Source: Lachowiez CA et al. Blood Adv. 2021 Apr 22. doi: 10.1182/bloodadvances.2020004173.
Key clinical point: Treatment with a combination of hypomethylating agents (HMA) and venetoclax (VEN) was similarly effective in patients with acute myeloid leukemia (AML) with or without spliceosome mutations with specific mutational pairs demonstrating favorable outcomes.
Major finding: Overall response rate (89% vs. 79%; P = .32), composite complete response (79% vs. 75%; P = .65), and median overall survival (OS; 35 vs. 14 months; P = .58) were not significantly different in patients with vs. without spliceosome mutations. Co-occurrence of IDH2 and SRSF2 mutations was associated with favorable outcomes (1- and 2-year OS, 100% and 88%, respectively).
Study details: Findings are from a retrospective study of 119 adult patients with AML treated with frontline HMA+VEN-based therapy. Mutation in the spliceosome gene was observed in 39 patients.
Disclosures: No specific funding source was identified. Some investigators reported research funding, support, honoraria, consultancy, and advisory roles for various pharmaceutical companies.
Source: Lachowiez CA et al. Blood Adv. 2021 Apr 22. doi: 10.1182/bloodadvances.2020004173.
Key clinical point: Treatment with a combination of hypomethylating agents (HMA) and venetoclax (VEN) was similarly effective in patients with acute myeloid leukemia (AML) with or without spliceosome mutations with specific mutational pairs demonstrating favorable outcomes.
Major finding: Overall response rate (89% vs. 79%; P = .32), composite complete response (79% vs. 75%; P = .65), and median overall survival (OS; 35 vs. 14 months; P = .58) were not significantly different in patients with vs. without spliceosome mutations. Co-occurrence of IDH2 and SRSF2 mutations was associated with favorable outcomes (1- and 2-year OS, 100% and 88%, respectively).
Study details: Findings are from a retrospective study of 119 adult patients with AML treated with frontline HMA+VEN-based therapy. Mutation in the spliceosome gene was observed in 39 patients.
Disclosures: No specific funding source was identified. Some investigators reported research funding, support, honoraria, consultancy, and advisory roles for various pharmaceutical companies.
Source: Lachowiez CA et al. Blood Adv. 2021 Apr 22. doi: 10.1182/bloodadvances.2020004173.