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In reply: Human papillomavirus

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In reply: Human papillomavirus

In Reply: We would like to thank Dr. Lichtenberg for giving us the opportunity to clarify and expand on questions regarding HPV vaccine efficacy.

Our statement “HPV immunization can prevent up to 70% of cases of cervical cancer due to HPV as well as 90% of genital warts” was based on a statement by Thaxton and Waxman, ie, that immunization against HPV types 16 and 18 has the potential to prevent 70% of cancers of the cervix plus a large percentage of other lower anogenital tract cancers.1 This was meant to describe the prevention potential of the quadrivalent vaccine. The currently available Gardasil 9 targets the HPV types that account for 90% of cervical cancers,2 with projected effectiveness likely to vary based on geographic variation in HPV subtypes, ranging from 86.5% in Australia to 92% in North America.3 It is difficult to precisely calculate the effectiveness of HPV vaccination alone, given that cervical cancer prevention is twofold, with primary vaccination and secondary screening (with several notable updates to US national screening guidelines during the same time frame as vaccine development).4

It is true that the 29% decrease in US cervical cancer incidence rates during the years 2011–2014 compared with 2003–2006 is less than the predicted 70%.5 However, not all eligible US females are vaccinated; according to reports from the US Centers for Disease Control and Prevention, 49% of adolescents were appropriately immunized against HPV in 2017, an increase over the rate of only 35% in 2014.6 Low vaccination rates undoubtedly negatively impact any benefits from herd immunity, though the exact benefits of this population immunity are difficult to quantify.7

In Australia, a national school-based HPV vaccination program was initiated in 2007, making the vaccine available for free. Over 70% of girls ages 12 and 13 were vaccinated, and follow-up within the same decade showed a greater than 90% reduction in genital warts, as well as a reduction in high-grade cervical lesions.8 In addition, the incidence of genital warts in unvaccinated heterosexual males during the prevaccination vs the vaccination period decreased by up to 81% (a marker of herd immunity).9

In the US, the HPV subtypes found in the quadrivalent vaccine decreased by 71% in those ages 14 to 19, within 8 years of vaccine introduction.10 An analysis of US state cancer registries between 2009 and 2012 showed that in Michigan, the rates of high-grade, precancerous lesions declined by 37% each year for women ages 15 to 19, thought to be due to changes in screening and vaccination guidelines.11 Similarly, an analysis of 9 million privately insured US females showed that the presence of high-grade precancerous lesions significantly decreased between the years 2007 and 2014 in those ages 15 to 24 (vaccinated individuals), but not in those ages 25 to 39 (unvaccinated individuals).12 Most recently, a study of 10,206 women showed a 21.9% decrease in cervical intraepithelial neoplasia grade 2 or worse lesions due to HPV subtypes 16 or 18 in those who have received at least 1 dose of the vaccine; reduced rates in unvaccinated women were also seen, representing first evidence of herd immunity in the United States.13 In contrast, the rates of high-grade lesions due to nonvaccine HPV subtypes remained constant. Given that progression to cervical cancer can take 10 to 15 years or longer after HPV infection, true vaccine benefits will emerge once increased vaccination rates are achieved and after at least a decade of follow-up.

We applaud Dr. Lichtenberg’s efforts to clarify vaccine efficacy for appropriate counseling, as this is key to ensuring patient trust. Immunization fears have fueled the re-emergence of vaccine-preventable illnesses across the world. Given the wave of vaccine misinformation on the Internet, we all face patients and family members skeptical of vaccine efficacy and safety. Those requesting more information deserve an honest, informed discussion with their provider. Interestingly, however, among 955 unvaccinated women, the belief of not being at risk for HPV was the most common reason for not receiving the vaccine.14 Effective education can be achieved by focusing on the personal risks of HPV to the patient, as well as the overall favorable risk vs benefits of vaccination. Quoting an exact rate of cancer reduction is likely a less effective counseling strategy, and these efficacy estimates will change as vaccination rates and HPV prevalence within the population change over time.

References
  1. Thaxton L, Waxman AG. Cervical cancer prevention: Immunization and screening 2015. Med Clin North Am 2015; 99(3):469–477. doi:10.1016/j.mcna.2015.01.003
  2. McNamara M, Batur P, Walsh JM, Johnson KM. HPV update: vaccination, screening, and associated disease. J Gen Intern Med 2016; 31(11):1360–1366. doi:10.1007/s11606-016-3725-z
  3. Zhai L, Tumban E. Gardasil-9: A global survey of projected efficacy. Antiviral Res 2016 Jun;130:101–109. doi:10.1016/j.antiviral.2016.03.016
  4. Zhang S, Batur P. Human papillomavirus in 2019: An update on cervical cancer prevention and screening guidelines. Cleve Clin J Med 2019; 86(3):173–178. doi:10.3949/ccjm.86a.18018
  5. Guo F, Cofie LE, Berenson AB. Cervical cancer incidence in young U.S. females after human papillomavirus vaccine Introduction. Am J Prev Med 2018; 55(2):197–204. doi:10.1016/j.amepre.2018.03.013
  6. US Centers for Disease Control and Prevention. Human papillomavirus (HPV) coverage data. https://www.cdc.gov/hpv/hcp/vacc-coverage/index.html. Accessed April 8, 2019.
  7. Nymark LS, Sharma T, Miller A, Enemark U, Griffiths UK. Inclusion of the value of herd immunity in economic evaluations of vaccines. A systematic review of methods used. Vaccine 2017; 35(49 Pt B):6828–6841. doi:10.1016/j.vaccine.2017.10.024
  8. Garland SM. The Australian experience with the human papillomavirus vaccine. Clin Ther 2014; 36(1):17–23. doi:10.1016/j.clinthera.2013.12.005
  9. Ali H, Donovan B, Wand H, et al. Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ 2013; 346:f2032. doi:10.1136/bmj.f2032
  10. Oliver SE, Unger ER, Lewis R, et al. Prevalence of human papillomavirus among females after vaccine introduction—National Health and Nutrition Examination Survey, United States, 2003–2014. J Infect Dis 2017; 216(5):594–603. doi:10.1093/infdis/jix244
  11. Watson M, Soman A, Flagg EW, et al. Surveillance of high-grade cervical cancer precursors (CIN III/AIS) in four population-based cancer registries. Prev Med 2017; 103:60–65. doi:10.1016/j.ypmed.2017.07.027
  12. Flagg EW, Torrone EA, Weinstock H. Ecological association of human papillomavirus vaccination with cervical dysplasia prevalence in the United States, 2007–2014. Am J Public Health 2016; 106(12):2211–2218.
  13. McClung NM, Gargano JW, Bennett NM, et al; HPV-IMPACT Working Group. Trends in human papillomavirus vaccine types 16 and 18 in cervical precancers, 2008–2014. Cancer Epidemiol Biomarkers Prev 2019; 28(3):602–609. doi:10.1158/1055-9965.EPI-18-0885
  14. Liddon NC, Hood JE, Leichliter JS. Intent to receive HPV vaccine and reasons for not vaccinating among unvaccinated adolescent and young women: findings from the 2006–2008 National Survey of Family Growth. Vaccine 2012; 30(16):2676–2682. doi:10.1016/j.vaccine.2012.02.007
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Cleveland Clinic

Pelin Batur, MD
Cleveland Clinic

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In Reply: We would like to thank Dr. Lichtenberg for giving us the opportunity to clarify and expand on questions regarding HPV vaccine efficacy.

Our statement “HPV immunization can prevent up to 70% of cases of cervical cancer due to HPV as well as 90% of genital warts” was based on a statement by Thaxton and Waxman, ie, that immunization against HPV types 16 and 18 has the potential to prevent 70% of cancers of the cervix plus a large percentage of other lower anogenital tract cancers.1 This was meant to describe the prevention potential of the quadrivalent vaccine. The currently available Gardasil 9 targets the HPV types that account for 90% of cervical cancers,2 with projected effectiveness likely to vary based on geographic variation in HPV subtypes, ranging from 86.5% in Australia to 92% in North America.3 It is difficult to precisely calculate the effectiveness of HPV vaccination alone, given that cervical cancer prevention is twofold, with primary vaccination and secondary screening (with several notable updates to US national screening guidelines during the same time frame as vaccine development).4

It is true that the 29% decrease in US cervical cancer incidence rates during the years 2011–2014 compared with 2003–2006 is less than the predicted 70%.5 However, not all eligible US females are vaccinated; according to reports from the US Centers for Disease Control and Prevention, 49% of adolescents were appropriately immunized against HPV in 2017, an increase over the rate of only 35% in 2014.6 Low vaccination rates undoubtedly negatively impact any benefits from herd immunity, though the exact benefits of this population immunity are difficult to quantify.7

In Australia, a national school-based HPV vaccination program was initiated in 2007, making the vaccine available for free. Over 70% of girls ages 12 and 13 were vaccinated, and follow-up within the same decade showed a greater than 90% reduction in genital warts, as well as a reduction in high-grade cervical lesions.8 In addition, the incidence of genital warts in unvaccinated heterosexual males during the prevaccination vs the vaccination period decreased by up to 81% (a marker of herd immunity).9

In the US, the HPV subtypes found in the quadrivalent vaccine decreased by 71% in those ages 14 to 19, within 8 years of vaccine introduction.10 An analysis of US state cancer registries between 2009 and 2012 showed that in Michigan, the rates of high-grade, precancerous lesions declined by 37% each year for women ages 15 to 19, thought to be due to changes in screening and vaccination guidelines.11 Similarly, an analysis of 9 million privately insured US females showed that the presence of high-grade precancerous lesions significantly decreased between the years 2007 and 2014 in those ages 15 to 24 (vaccinated individuals), but not in those ages 25 to 39 (unvaccinated individuals).12 Most recently, a study of 10,206 women showed a 21.9% decrease in cervical intraepithelial neoplasia grade 2 or worse lesions due to HPV subtypes 16 or 18 in those who have received at least 1 dose of the vaccine; reduced rates in unvaccinated women were also seen, representing first evidence of herd immunity in the United States.13 In contrast, the rates of high-grade lesions due to nonvaccine HPV subtypes remained constant. Given that progression to cervical cancer can take 10 to 15 years or longer after HPV infection, true vaccine benefits will emerge once increased vaccination rates are achieved and after at least a decade of follow-up.

We applaud Dr. Lichtenberg’s efforts to clarify vaccine efficacy for appropriate counseling, as this is key to ensuring patient trust. Immunization fears have fueled the re-emergence of vaccine-preventable illnesses across the world. Given the wave of vaccine misinformation on the Internet, we all face patients and family members skeptical of vaccine efficacy and safety. Those requesting more information deserve an honest, informed discussion with their provider. Interestingly, however, among 955 unvaccinated women, the belief of not being at risk for HPV was the most common reason for not receiving the vaccine.14 Effective education can be achieved by focusing on the personal risks of HPV to the patient, as well as the overall favorable risk vs benefits of vaccination. Quoting an exact rate of cancer reduction is likely a less effective counseling strategy, and these efficacy estimates will change as vaccination rates and HPV prevalence within the population change over time.

In Reply: We would like to thank Dr. Lichtenberg for giving us the opportunity to clarify and expand on questions regarding HPV vaccine efficacy.

Our statement “HPV immunization can prevent up to 70% of cases of cervical cancer due to HPV as well as 90% of genital warts” was based on a statement by Thaxton and Waxman, ie, that immunization against HPV types 16 and 18 has the potential to prevent 70% of cancers of the cervix plus a large percentage of other lower anogenital tract cancers.1 This was meant to describe the prevention potential of the quadrivalent vaccine. The currently available Gardasil 9 targets the HPV types that account for 90% of cervical cancers,2 with projected effectiveness likely to vary based on geographic variation in HPV subtypes, ranging from 86.5% in Australia to 92% in North America.3 It is difficult to precisely calculate the effectiveness of HPV vaccination alone, given that cervical cancer prevention is twofold, with primary vaccination and secondary screening (with several notable updates to US national screening guidelines during the same time frame as vaccine development).4

It is true that the 29% decrease in US cervical cancer incidence rates during the years 2011–2014 compared with 2003–2006 is less than the predicted 70%.5 However, not all eligible US females are vaccinated; according to reports from the US Centers for Disease Control and Prevention, 49% of adolescents were appropriately immunized against HPV in 2017, an increase over the rate of only 35% in 2014.6 Low vaccination rates undoubtedly negatively impact any benefits from herd immunity, though the exact benefits of this population immunity are difficult to quantify.7

In Australia, a national school-based HPV vaccination program was initiated in 2007, making the vaccine available for free. Over 70% of girls ages 12 and 13 were vaccinated, and follow-up within the same decade showed a greater than 90% reduction in genital warts, as well as a reduction in high-grade cervical lesions.8 In addition, the incidence of genital warts in unvaccinated heterosexual males during the prevaccination vs the vaccination period decreased by up to 81% (a marker of herd immunity).9

In the US, the HPV subtypes found in the quadrivalent vaccine decreased by 71% in those ages 14 to 19, within 8 years of vaccine introduction.10 An analysis of US state cancer registries between 2009 and 2012 showed that in Michigan, the rates of high-grade, precancerous lesions declined by 37% each year for women ages 15 to 19, thought to be due to changes in screening and vaccination guidelines.11 Similarly, an analysis of 9 million privately insured US females showed that the presence of high-grade precancerous lesions significantly decreased between the years 2007 and 2014 in those ages 15 to 24 (vaccinated individuals), but not in those ages 25 to 39 (unvaccinated individuals).12 Most recently, a study of 10,206 women showed a 21.9% decrease in cervical intraepithelial neoplasia grade 2 or worse lesions due to HPV subtypes 16 or 18 in those who have received at least 1 dose of the vaccine; reduced rates in unvaccinated women were also seen, representing first evidence of herd immunity in the United States.13 In contrast, the rates of high-grade lesions due to nonvaccine HPV subtypes remained constant. Given that progression to cervical cancer can take 10 to 15 years or longer after HPV infection, true vaccine benefits will emerge once increased vaccination rates are achieved and after at least a decade of follow-up.

We applaud Dr. Lichtenberg’s efforts to clarify vaccine efficacy for appropriate counseling, as this is key to ensuring patient trust. Immunization fears have fueled the re-emergence of vaccine-preventable illnesses across the world. Given the wave of vaccine misinformation on the Internet, we all face patients and family members skeptical of vaccine efficacy and safety. Those requesting more information deserve an honest, informed discussion with their provider. Interestingly, however, among 955 unvaccinated women, the belief of not being at risk for HPV was the most common reason for not receiving the vaccine.14 Effective education can be achieved by focusing on the personal risks of HPV to the patient, as well as the overall favorable risk vs benefits of vaccination. Quoting an exact rate of cancer reduction is likely a less effective counseling strategy, and these efficacy estimates will change as vaccination rates and HPV prevalence within the population change over time.

References
  1. Thaxton L, Waxman AG. Cervical cancer prevention: Immunization and screening 2015. Med Clin North Am 2015; 99(3):469–477. doi:10.1016/j.mcna.2015.01.003
  2. McNamara M, Batur P, Walsh JM, Johnson KM. HPV update: vaccination, screening, and associated disease. J Gen Intern Med 2016; 31(11):1360–1366. doi:10.1007/s11606-016-3725-z
  3. Zhai L, Tumban E. Gardasil-9: A global survey of projected efficacy. Antiviral Res 2016 Jun;130:101–109. doi:10.1016/j.antiviral.2016.03.016
  4. Zhang S, Batur P. Human papillomavirus in 2019: An update on cervical cancer prevention and screening guidelines. Cleve Clin J Med 2019; 86(3):173–178. doi:10.3949/ccjm.86a.18018
  5. Guo F, Cofie LE, Berenson AB. Cervical cancer incidence in young U.S. females after human papillomavirus vaccine Introduction. Am J Prev Med 2018; 55(2):197–204. doi:10.1016/j.amepre.2018.03.013
  6. US Centers for Disease Control and Prevention. Human papillomavirus (HPV) coverage data. https://www.cdc.gov/hpv/hcp/vacc-coverage/index.html. Accessed April 8, 2019.
  7. Nymark LS, Sharma T, Miller A, Enemark U, Griffiths UK. Inclusion of the value of herd immunity in economic evaluations of vaccines. A systematic review of methods used. Vaccine 2017; 35(49 Pt B):6828–6841. doi:10.1016/j.vaccine.2017.10.024
  8. Garland SM. The Australian experience with the human papillomavirus vaccine. Clin Ther 2014; 36(1):17–23. doi:10.1016/j.clinthera.2013.12.005
  9. Ali H, Donovan B, Wand H, et al. Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ 2013; 346:f2032. doi:10.1136/bmj.f2032
  10. Oliver SE, Unger ER, Lewis R, et al. Prevalence of human papillomavirus among females after vaccine introduction—National Health and Nutrition Examination Survey, United States, 2003–2014. J Infect Dis 2017; 216(5):594–603. doi:10.1093/infdis/jix244
  11. Watson M, Soman A, Flagg EW, et al. Surveillance of high-grade cervical cancer precursors (CIN III/AIS) in four population-based cancer registries. Prev Med 2017; 103:60–65. doi:10.1016/j.ypmed.2017.07.027
  12. Flagg EW, Torrone EA, Weinstock H. Ecological association of human papillomavirus vaccination with cervical dysplasia prevalence in the United States, 2007–2014. Am J Public Health 2016; 106(12):2211–2218.
  13. McClung NM, Gargano JW, Bennett NM, et al; HPV-IMPACT Working Group. Trends in human papillomavirus vaccine types 16 and 18 in cervical precancers, 2008–2014. Cancer Epidemiol Biomarkers Prev 2019; 28(3):602–609. doi:10.1158/1055-9965.EPI-18-0885
  14. Liddon NC, Hood JE, Leichliter JS. Intent to receive HPV vaccine and reasons for not vaccinating among unvaccinated adolescent and young women: findings from the 2006–2008 National Survey of Family Growth. Vaccine 2012; 30(16):2676–2682. doi:10.1016/j.vaccine.2012.02.007
References
  1. Thaxton L, Waxman AG. Cervical cancer prevention: Immunization and screening 2015. Med Clin North Am 2015; 99(3):469–477. doi:10.1016/j.mcna.2015.01.003
  2. McNamara M, Batur P, Walsh JM, Johnson KM. HPV update: vaccination, screening, and associated disease. J Gen Intern Med 2016; 31(11):1360–1366. doi:10.1007/s11606-016-3725-z
  3. Zhai L, Tumban E. Gardasil-9: A global survey of projected efficacy. Antiviral Res 2016 Jun;130:101–109. doi:10.1016/j.antiviral.2016.03.016
  4. Zhang S, Batur P. Human papillomavirus in 2019: An update on cervical cancer prevention and screening guidelines. Cleve Clin J Med 2019; 86(3):173–178. doi:10.3949/ccjm.86a.18018
  5. Guo F, Cofie LE, Berenson AB. Cervical cancer incidence in young U.S. females after human papillomavirus vaccine Introduction. Am J Prev Med 2018; 55(2):197–204. doi:10.1016/j.amepre.2018.03.013
  6. US Centers for Disease Control and Prevention. Human papillomavirus (HPV) coverage data. https://www.cdc.gov/hpv/hcp/vacc-coverage/index.html. Accessed April 8, 2019.
  7. Nymark LS, Sharma T, Miller A, Enemark U, Griffiths UK. Inclusion of the value of herd immunity in economic evaluations of vaccines. A systematic review of methods used. Vaccine 2017; 35(49 Pt B):6828–6841. doi:10.1016/j.vaccine.2017.10.024
  8. Garland SM. The Australian experience with the human papillomavirus vaccine. Clin Ther 2014; 36(1):17–23. doi:10.1016/j.clinthera.2013.12.005
  9. Ali H, Donovan B, Wand H, et al. Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ 2013; 346:f2032. doi:10.1136/bmj.f2032
  10. Oliver SE, Unger ER, Lewis R, et al. Prevalence of human papillomavirus among females after vaccine introduction—National Health and Nutrition Examination Survey, United States, 2003–2014. J Infect Dis 2017; 216(5):594–603. doi:10.1093/infdis/jix244
  11. Watson M, Soman A, Flagg EW, et al. Surveillance of high-grade cervical cancer precursors (CIN III/AIS) in four population-based cancer registries. Prev Med 2017; 103:60–65. doi:10.1016/j.ypmed.2017.07.027
  12. Flagg EW, Torrone EA, Weinstock H. Ecological association of human papillomavirus vaccination with cervical dysplasia prevalence in the United States, 2007–2014. Am J Public Health 2016; 106(12):2211–2218.
  13. McClung NM, Gargano JW, Bennett NM, et al; HPV-IMPACT Working Group. Trends in human papillomavirus vaccine types 16 and 18 in cervical precancers, 2008–2014. Cancer Epidemiol Biomarkers Prev 2019; 28(3):602–609. doi:10.1158/1055-9965.EPI-18-0885
  14. Liddon NC, Hood JE, Leichliter JS. Intent to receive HPV vaccine and reasons for not vaccinating among unvaccinated adolescent and young women: findings from the 2006–2008 National Survey of Family Growth. Vaccine 2012; 30(16):2676–2682. doi:10.1016/j.vaccine.2012.02.007
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Courts temporarily block Title X changes

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Two federal judges have temporarily barred the Trump administration from making changes to the Title X program that would restrict funding from clinics that provide abortion counseling or that refer patients for abortion services.

jsmith/iStockphoto

U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.

Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.

“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.

Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.

 

 


Washington state and the National Family Planning & Reproductive Health Association sued the U.S. Department of Health & Human Services in early March to block the agency from enforcing the modifications. A separate lawsuit was filed by the American Medical Association and the Planned Parenthood Federation of America to stop the funding changes, and 22 states issued a third legal challenge. The Title X changes impose a “government gag rule” on what information physicians can provide to their patients, according to the plaintiffs.

The American College of Physicians (ACP) and other groups, including the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics have voiced their opposition to the Title X restrictions. In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.

Washington Attorney General Bob Ferguson said the nationwide ban ensures that clinics across the nation can remain open and continue to provide quality, unbiased health care to women

“Trump’s ‘gag rule’ would have jeopardized health care access to women across the country,” he said in a statement. “Title X clinics, such as Planned Parenthood, provide essential services – now they can keep serving women while we continue to fight to keep the federal government out of the exam room.”

AMA President Barbara L. McAneny, MD, praised Judge McShane’s order. “The new rule would have placed obstacles to health care for low-income patients,” Dr. McAneny said in a statement. “We are pleased the judge shared the AMA’s concern about the physician-patient relationship that the rule would have jeopardized.”

The Trump administration had not said at press time whether it would appeal the order.

Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support of the Title X funding restrictions.

“The rule advances President Trump’s promise to stop taxpayer funding of abortion businesses like Planned Parenthood,” SBA List President Marjorie Dannenfelser said in a statement. “The Protect Life Rule does not cut family planning funding by a single dime, and instead directs tax dollars to entities that provide health care to women but do not perform abortions.”

agallegos@mdedge.com
Publications
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Sections

 

Two federal judges have temporarily barred the Trump administration from making changes to the Title X program that would restrict funding from clinics that provide abortion counseling or that refer patients for abortion services.

jsmith/iStockphoto

U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.

Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.

“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.

Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.

 

 


Washington state and the National Family Planning & Reproductive Health Association sued the U.S. Department of Health & Human Services in early March to block the agency from enforcing the modifications. A separate lawsuit was filed by the American Medical Association and the Planned Parenthood Federation of America to stop the funding changes, and 22 states issued a third legal challenge. The Title X changes impose a “government gag rule” on what information physicians can provide to their patients, according to the plaintiffs.

The American College of Physicians (ACP) and other groups, including the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics have voiced their opposition to the Title X restrictions. In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.

Washington Attorney General Bob Ferguson said the nationwide ban ensures that clinics across the nation can remain open and continue to provide quality, unbiased health care to women

“Trump’s ‘gag rule’ would have jeopardized health care access to women across the country,” he said in a statement. “Title X clinics, such as Planned Parenthood, provide essential services – now they can keep serving women while we continue to fight to keep the federal government out of the exam room.”

AMA President Barbara L. McAneny, MD, praised Judge McShane’s order. “The new rule would have placed obstacles to health care for low-income patients,” Dr. McAneny said in a statement. “We are pleased the judge shared the AMA’s concern about the physician-patient relationship that the rule would have jeopardized.”

The Trump administration had not said at press time whether it would appeal the order.

Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support of the Title X funding restrictions.

“The rule advances President Trump’s promise to stop taxpayer funding of abortion businesses like Planned Parenthood,” SBA List President Marjorie Dannenfelser said in a statement. “The Protect Life Rule does not cut family planning funding by a single dime, and instead directs tax dollars to entities that provide health care to women but do not perform abortions.”

agallegos@mdedge.com

 

Two federal judges have temporarily barred the Trump administration from making changes to the Title X program that would restrict funding from clinics that provide abortion counseling or that refer patients for abortion services.

jsmith/iStockphoto

U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.

Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.

“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.

Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.

 

 


Washington state and the National Family Planning & Reproductive Health Association sued the U.S. Department of Health & Human Services in early March to block the agency from enforcing the modifications. A separate lawsuit was filed by the American Medical Association and the Planned Parenthood Federation of America to stop the funding changes, and 22 states issued a third legal challenge. The Title X changes impose a “government gag rule” on what information physicians can provide to their patients, according to the plaintiffs.

The American College of Physicians (ACP) and other groups, including the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics have voiced their opposition to the Title X restrictions. In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.

Washington Attorney General Bob Ferguson said the nationwide ban ensures that clinics across the nation can remain open and continue to provide quality, unbiased health care to women

“Trump’s ‘gag rule’ would have jeopardized health care access to women across the country,” he said in a statement. “Title X clinics, such as Planned Parenthood, provide essential services – now they can keep serving women while we continue to fight to keep the federal government out of the exam room.”

AMA President Barbara L. McAneny, MD, praised Judge McShane’s order. “The new rule would have placed obstacles to health care for low-income patients,” Dr. McAneny said in a statement. “We are pleased the judge shared the AMA’s concern about the physician-patient relationship that the rule would have jeopardized.”

The Trump administration had not said at press time whether it would appeal the order.

Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support of the Title X funding restrictions.

“The rule advances President Trump’s promise to stop taxpayer funding of abortion businesses like Planned Parenthood,” SBA List President Marjorie Dannenfelser said in a statement. “The Protect Life Rule does not cut family planning funding by a single dime, and instead directs tax dollars to entities that provide health care to women but do not perform abortions.”

agallegos@mdedge.com
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Teen e-cigarette use: A public health crisis

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After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2

licsiren/iStock/Getty Images

E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6

One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.

E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.

Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10

Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.

Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” After screening, a brief intervention includes a clear recommendation against e-cigarette use and education about the risks. Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.

Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.

Dr. Peter R. Jackson

The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
 

 

 

Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at pdnews@mdedge.com.

References

1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.

2. e-cigarettes.surgeongeneral.gov

3. N Engl J Med 2019;380:629-37.

4. Pediatrics. 2018 Dec; 142(6):e20180486.

5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.

6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.

7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).

8. N Engl J Med 2014;371:932-43.

9. N Engl J Med 2019;380:689-90.

10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.

11. Pediatrics. 2019 Feb;143(2). pii: e20183652.

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After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2

licsiren/iStock/Getty Images

E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6

One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.

E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.

Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10

Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.

Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” After screening, a brief intervention includes a clear recommendation against e-cigarette use and education about the risks. Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.

Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.

Dr. Peter R. Jackson

The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
 

 

 

Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at pdnews@mdedge.com.

References

1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.

2. e-cigarettes.surgeongeneral.gov

3. N Engl J Med 2019;380:629-37.

4. Pediatrics. 2018 Dec; 142(6):e20180486.

5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.

6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.

7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).

8. N Engl J Med 2014;371:932-43.

9. N Engl J Med 2019;380:689-90.

10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.

11. Pediatrics. 2019 Feb;143(2). pii: e20183652.

 

After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2

licsiren/iStock/Getty Images

E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6

One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.

E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.

Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10

Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.

Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” After screening, a brief intervention includes a clear recommendation against e-cigarette use and education about the risks. Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.

Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.

Dr. Peter R. Jackson

The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
 

 

 

Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at pdnews@mdedge.com.

References

1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.

2. e-cigarettes.surgeongeneral.gov

3. N Engl J Med 2019;380:629-37.

4. Pediatrics. 2018 Dec; 142(6):e20180486.

5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.

6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.

7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).

8. N Engl J Med 2014;371:932-43.

9. N Engl J Med 2019;380:689-90.

10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.

11. Pediatrics. 2019 Feb;143(2). pii: e20183652.

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Young lupus patients need more than medications

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Adolescents and young adults diagnosed with SLE during childhood constitute a special subgroup with “very, very low” quality of life and poor treatment adherence – and therein lies the importance of introducing interventions beyond simply prescribing appropriate medications, Hermine I. Brunner, MD, asserted at an international congress on systemic lupus erythematosus.

Bruce Jancin/MDedge News
Dr. Hermine I. Brunner

Pilot studies conducted by her research group as well as others suggest that brief cognitive-behavioral interventions, web-based patient and caregiver education, and social media interactions significantly improve the fatigue and depression, poor quality of life, and lack of adherence to medication that are pervasive in young patients with SLE, according to Dr. Brunner, director of the division of rheumatology and professor of pediatrics at the University of Cincinnati and scientific director of the Pediatric Rheumatology Collaborative Study Group.

“Don’t misunderstand: I don’t think we can treat lupus simply with a psychological intervention at the bedside. However, I think doctors would be well advised to offer both psychological interventions and medication when they see young lupus patients, because without the psychological intervention the patients may not feel sufficiently at ease to take their medication. They will not get the benefit of the medications you’ve prescribed,” she said.

Patients with SLE take an average of eight medications daily. Their medication adherence rate is comparable to that of patients with diabetes or many other chronic diseases: that is to say, lousy. When investigators at the University of Texas MD Anderson Cancer Center, Houston, utilized an electronic monitoring system to chart adherence to prescribed oral medications in adults with SLE, they found that over the course of 2 years of follow-up only one-fourth of them had an adherence rate of 80% or better, which is the standard definition of adherence (Lupus. 2012 Oct;21[11]:1158-65).

Treatment adherence is particularly problematic in adolescents and young adults with SLE. They often have great difficulty in mastering the self-management skills required to stay on top of their disease when they have so much else going on during what is a vulnerable and challenging period of development, even for healthy youths.
 

The texting intervention

Dr. Brunner and her colleagues at Cincinnati Children’s Hospital Medical Center recognized the scope of the nonadherence problem early on. Years ago they started sending text messaging reminders of pending clinic visits to their patients who had a poor track record of showing up for appointments.

“We texted patients 2 weeks before their scheduled visit, 1 week before, and then again the day before the visit,” she explained.

This simple intervention resulted in a 47% reduction in missed appointments, compared with a control group. Also, text recipients were more likely to cancel appointments instead of simply not showing up, an important benefit from a practice management and scheduling standpoint (J Rheumatol. 2012 Jan;39[1]:174-9). Disappointingly, however, the text messaging intervention had no impact on adherence to prescribed use of hydroxychloroquine. This led the investigators to conduct a deeper dive into the roots of the nonadherence problem in childhood-onset lupus.
 

 

 

Disease control, quality of life

Dr. Brunner and her coworkers conducted an in-depth assessment of health-related quality of life in 50 patients with childhood-onset SLE over the course of 6 months. The results were surprising.

“When we looked at the correlation between disease control and quality of life, actually there was none,” according to the pediatric rheumatologist.

Instead, the investigators found that young patients with persistently low quality of life despite objectively measured good disease control scored high for fatigue and depressive symptoms (Lupus. 2018 Jan;27[1]:124-33). This led Dr. Brunner and her coinvestigators to consider developing a practical behavioral intervention to address these potentially modifiable predictors of impaired health-related quality of life in their patient population.

The need for novel approaches was highlighted in focus groups conducted by the investigators, in which patients and their primary caregivers emphasized that current therapeutic strategies don’t adequately address key problems of living with lupus, especially the prominent fatigue, pain, and depressed mood that hamper daily function and personal relationships. Patients said they don’t feel an immediate benefit from taking their medications, so why bother? And parents expressed frustration about how difficult it is to get their teenagers to understand the consequences of nonadherence when they’re at an age when they don’t yet even grasp the concept of their own mortality (Lupus. 2019 Mar. doi: 10.1177/0961203319839478. These observations spurred the Cincinnati investigators to develop a modified cognitive-behavioral therapy (CBT) protocol, known as TEACH, which they believe is the first CBT intervention to specifically target psychological problems in young people with childhood-onset SLE.
 

The TEACH program

TEACH (Treatment and Education Approach for Childhood-Onset Lupus) is a six-session program that teaches patients and caregivers self-advocacy, relaxation techniques, how to improve sleep hygiene, the importance of engaging in planned pleasant activities, and why taking medications matters. The program content differs depending upon whether the patient is an adolescent or young adult.

Results of a recently published small feasibility study were highly encouraging, showing that 83% of people who enrolled in the program completed it. Posttreatment assessment showed that patients had a marked decrease in depressive symptoms as measured by both the Children’s Depression Inventory and the Beck Depression Inventory. They also showed a significant reduction in fatigue. However, while favorable trends in terms of reduced pain and anxiety symptoms were noted, they didn’t achieve statistical significance (Pediatr Rheumatol Online J. 2019 Feb 18. doi: 10.1186/s12969-019-0307-8). The next step in this project is a planned controlled randomized trial.
 

A web-based medication adherence program

Researchers at Pennsylvania State University took a different approach. They created a publicly available educational website, www.facinglupustogether.com, aimed at improving self-management skills – and especially medication adherence – in teens and young adults with SLE.

The website contains eight modules: Making the transition and taking charge of my medications, Learning about lupus, Learning about lupus medications, Managing symptoms of lupus, How do I handle lupus and my family, How do I handle lupus and my friends, Lupus and stress, and My personal goals and how I will achieve them. Each takes about 10 minutes to complete.

In a pilot study, 37 patients tackled one module per week and were randomized to respond to questions about the weekly topic either in a journal or by discussing the key points in an online social media forum with other young people with SLE. The idea was to create an intervention that capitalizes on the excellent social media skills possessed by today’s youth. And indeed, incorporation of social media proved to be a winning strategy. Medication adherence for hydroxychloroquine in the group randomized to social media participation jumped from 50% in the 3 months prior to starting the program to 92% in the first 3 months post completion, whereas medication adherence didn’t change significantly in the other study arm. The social media group also experienced significant improvements in self-efficacy, sense of community, acceptance of illness, optimism and control over the future, and other measures of empowerment. The control group did not show significant change in any of these domains (Pediatr Rheumatol Online J. 2018 Mar 14. doi: 10.1186/s12969-018-0232-2).

The TEACH study was sponsored by the National Institutes of Health. The web-based medication adherence program pilot study was supported by the Lupus Foundation of America. What the two approaches share in common is a conviction that, when it comes to addressing pain, fatigue, diminished quality of life, and poor medication adherence in young patients with SLE: “Our medication prescription alone doesn’t do it,” Dr. Brunner said.

She reported having no financial conflicts regarding her presentation.

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Adolescents and young adults diagnosed with SLE during childhood constitute a special subgroup with “very, very low” quality of life and poor treatment adherence – and therein lies the importance of introducing interventions beyond simply prescribing appropriate medications, Hermine I. Brunner, MD, asserted at an international congress on systemic lupus erythematosus.

Bruce Jancin/MDedge News
Dr. Hermine I. Brunner

Pilot studies conducted by her research group as well as others suggest that brief cognitive-behavioral interventions, web-based patient and caregiver education, and social media interactions significantly improve the fatigue and depression, poor quality of life, and lack of adherence to medication that are pervasive in young patients with SLE, according to Dr. Brunner, director of the division of rheumatology and professor of pediatrics at the University of Cincinnati and scientific director of the Pediatric Rheumatology Collaborative Study Group.

“Don’t misunderstand: I don’t think we can treat lupus simply with a psychological intervention at the bedside. However, I think doctors would be well advised to offer both psychological interventions and medication when they see young lupus patients, because without the psychological intervention the patients may not feel sufficiently at ease to take their medication. They will not get the benefit of the medications you’ve prescribed,” she said.

Patients with SLE take an average of eight medications daily. Their medication adherence rate is comparable to that of patients with diabetes or many other chronic diseases: that is to say, lousy. When investigators at the University of Texas MD Anderson Cancer Center, Houston, utilized an electronic monitoring system to chart adherence to prescribed oral medications in adults with SLE, they found that over the course of 2 years of follow-up only one-fourth of them had an adherence rate of 80% or better, which is the standard definition of adherence (Lupus. 2012 Oct;21[11]:1158-65).

Treatment adherence is particularly problematic in adolescents and young adults with SLE. They often have great difficulty in mastering the self-management skills required to stay on top of their disease when they have so much else going on during what is a vulnerable and challenging period of development, even for healthy youths.
 

The texting intervention

Dr. Brunner and her colleagues at Cincinnati Children’s Hospital Medical Center recognized the scope of the nonadherence problem early on. Years ago they started sending text messaging reminders of pending clinic visits to their patients who had a poor track record of showing up for appointments.

“We texted patients 2 weeks before their scheduled visit, 1 week before, and then again the day before the visit,” she explained.

This simple intervention resulted in a 47% reduction in missed appointments, compared with a control group. Also, text recipients were more likely to cancel appointments instead of simply not showing up, an important benefit from a practice management and scheduling standpoint (J Rheumatol. 2012 Jan;39[1]:174-9). Disappointingly, however, the text messaging intervention had no impact on adherence to prescribed use of hydroxychloroquine. This led the investigators to conduct a deeper dive into the roots of the nonadherence problem in childhood-onset lupus.
 

 

 

Disease control, quality of life

Dr. Brunner and her coworkers conducted an in-depth assessment of health-related quality of life in 50 patients with childhood-onset SLE over the course of 6 months. The results were surprising.

“When we looked at the correlation between disease control and quality of life, actually there was none,” according to the pediatric rheumatologist.

Instead, the investigators found that young patients with persistently low quality of life despite objectively measured good disease control scored high for fatigue and depressive symptoms (Lupus. 2018 Jan;27[1]:124-33). This led Dr. Brunner and her coinvestigators to consider developing a practical behavioral intervention to address these potentially modifiable predictors of impaired health-related quality of life in their patient population.

The need for novel approaches was highlighted in focus groups conducted by the investigators, in which patients and their primary caregivers emphasized that current therapeutic strategies don’t adequately address key problems of living with lupus, especially the prominent fatigue, pain, and depressed mood that hamper daily function and personal relationships. Patients said they don’t feel an immediate benefit from taking their medications, so why bother? And parents expressed frustration about how difficult it is to get their teenagers to understand the consequences of nonadherence when they’re at an age when they don’t yet even grasp the concept of their own mortality (Lupus. 2019 Mar. doi: 10.1177/0961203319839478. These observations spurred the Cincinnati investigators to develop a modified cognitive-behavioral therapy (CBT) protocol, known as TEACH, which they believe is the first CBT intervention to specifically target psychological problems in young people with childhood-onset SLE.
 

The TEACH program

TEACH (Treatment and Education Approach for Childhood-Onset Lupus) is a six-session program that teaches patients and caregivers self-advocacy, relaxation techniques, how to improve sleep hygiene, the importance of engaging in planned pleasant activities, and why taking medications matters. The program content differs depending upon whether the patient is an adolescent or young adult.

Results of a recently published small feasibility study were highly encouraging, showing that 83% of people who enrolled in the program completed it. Posttreatment assessment showed that patients had a marked decrease in depressive symptoms as measured by both the Children’s Depression Inventory and the Beck Depression Inventory. They also showed a significant reduction in fatigue. However, while favorable trends in terms of reduced pain and anxiety symptoms were noted, they didn’t achieve statistical significance (Pediatr Rheumatol Online J. 2019 Feb 18. doi: 10.1186/s12969-019-0307-8). The next step in this project is a planned controlled randomized trial.
 

A web-based medication adherence program

Researchers at Pennsylvania State University took a different approach. They created a publicly available educational website, www.facinglupustogether.com, aimed at improving self-management skills – and especially medication adherence – in teens and young adults with SLE.

The website contains eight modules: Making the transition and taking charge of my medications, Learning about lupus, Learning about lupus medications, Managing symptoms of lupus, How do I handle lupus and my family, How do I handle lupus and my friends, Lupus and stress, and My personal goals and how I will achieve them. Each takes about 10 minutes to complete.

In a pilot study, 37 patients tackled one module per week and were randomized to respond to questions about the weekly topic either in a journal or by discussing the key points in an online social media forum with other young people with SLE. The idea was to create an intervention that capitalizes on the excellent social media skills possessed by today’s youth. And indeed, incorporation of social media proved to be a winning strategy. Medication adherence for hydroxychloroquine in the group randomized to social media participation jumped from 50% in the 3 months prior to starting the program to 92% in the first 3 months post completion, whereas medication adherence didn’t change significantly in the other study arm. The social media group also experienced significant improvements in self-efficacy, sense of community, acceptance of illness, optimism and control over the future, and other measures of empowerment. The control group did not show significant change in any of these domains (Pediatr Rheumatol Online J. 2018 Mar 14. doi: 10.1186/s12969-018-0232-2).

The TEACH study was sponsored by the National Institutes of Health. The web-based medication adherence program pilot study was supported by the Lupus Foundation of America. What the two approaches share in common is a conviction that, when it comes to addressing pain, fatigue, diminished quality of life, and poor medication adherence in young patients with SLE: “Our medication prescription alone doesn’t do it,” Dr. Brunner said.

She reported having no financial conflicts regarding her presentation.

 

Adolescents and young adults diagnosed with SLE during childhood constitute a special subgroup with “very, very low” quality of life and poor treatment adherence – and therein lies the importance of introducing interventions beyond simply prescribing appropriate medications, Hermine I. Brunner, MD, asserted at an international congress on systemic lupus erythematosus.

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Dr. Hermine I. Brunner

Pilot studies conducted by her research group as well as others suggest that brief cognitive-behavioral interventions, web-based patient and caregiver education, and social media interactions significantly improve the fatigue and depression, poor quality of life, and lack of adherence to medication that are pervasive in young patients with SLE, according to Dr. Brunner, director of the division of rheumatology and professor of pediatrics at the University of Cincinnati and scientific director of the Pediatric Rheumatology Collaborative Study Group.

“Don’t misunderstand: I don’t think we can treat lupus simply with a psychological intervention at the bedside. However, I think doctors would be well advised to offer both psychological interventions and medication when they see young lupus patients, because without the psychological intervention the patients may not feel sufficiently at ease to take their medication. They will not get the benefit of the medications you’ve prescribed,” she said.

Patients with SLE take an average of eight medications daily. Their medication adherence rate is comparable to that of patients with diabetes or many other chronic diseases: that is to say, lousy. When investigators at the University of Texas MD Anderson Cancer Center, Houston, utilized an electronic monitoring system to chart adherence to prescribed oral medications in adults with SLE, they found that over the course of 2 years of follow-up only one-fourth of them had an adherence rate of 80% or better, which is the standard definition of adherence (Lupus. 2012 Oct;21[11]:1158-65).

Treatment adherence is particularly problematic in adolescents and young adults with SLE. They often have great difficulty in mastering the self-management skills required to stay on top of their disease when they have so much else going on during what is a vulnerable and challenging period of development, even for healthy youths.
 

The texting intervention

Dr. Brunner and her colleagues at Cincinnati Children’s Hospital Medical Center recognized the scope of the nonadherence problem early on. Years ago they started sending text messaging reminders of pending clinic visits to their patients who had a poor track record of showing up for appointments.

“We texted patients 2 weeks before their scheduled visit, 1 week before, and then again the day before the visit,” she explained.

This simple intervention resulted in a 47% reduction in missed appointments, compared with a control group. Also, text recipients were more likely to cancel appointments instead of simply not showing up, an important benefit from a practice management and scheduling standpoint (J Rheumatol. 2012 Jan;39[1]:174-9). Disappointingly, however, the text messaging intervention had no impact on adherence to prescribed use of hydroxychloroquine. This led the investigators to conduct a deeper dive into the roots of the nonadherence problem in childhood-onset lupus.
 

 

 

Disease control, quality of life

Dr. Brunner and her coworkers conducted an in-depth assessment of health-related quality of life in 50 patients with childhood-onset SLE over the course of 6 months. The results were surprising.

“When we looked at the correlation between disease control and quality of life, actually there was none,” according to the pediatric rheumatologist.

Instead, the investigators found that young patients with persistently low quality of life despite objectively measured good disease control scored high for fatigue and depressive symptoms (Lupus. 2018 Jan;27[1]:124-33). This led Dr. Brunner and her coinvestigators to consider developing a practical behavioral intervention to address these potentially modifiable predictors of impaired health-related quality of life in their patient population.

The need for novel approaches was highlighted in focus groups conducted by the investigators, in which patients and their primary caregivers emphasized that current therapeutic strategies don’t adequately address key problems of living with lupus, especially the prominent fatigue, pain, and depressed mood that hamper daily function and personal relationships. Patients said they don’t feel an immediate benefit from taking their medications, so why bother? And parents expressed frustration about how difficult it is to get their teenagers to understand the consequences of nonadherence when they’re at an age when they don’t yet even grasp the concept of their own mortality (Lupus. 2019 Mar. doi: 10.1177/0961203319839478. These observations spurred the Cincinnati investigators to develop a modified cognitive-behavioral therapy (CBT) protocol, known as TEACH, which they believe is the first CBT intervention to specifically target psychological problems in young people with childhood-onset SLE.
 

The TEACH program

TEACH (Treatment and Education Approach for Childhood-Onset Lupus) is a six-session program that teaches patients and caregivers self-advocacy, relaxation techniques, how to improve sleep hygiene, the importance of engaging in planned pleasant activities, and why taking medications matters. The program content differs depending upon whether the patient is an adolescent or young adult.

Results of a recently published small feasibility study were highly encouraging, showing that 83% of people who enrolled in the program completed it. Posttreatment assessment showed that patients had a marked decrease in depressive symptoms as measured by both the Children’s Depression Inventory and the Beck Depression Inventory. They also showed a significant reduction in fatigue. However, while favorable trends in terms of reduced pain and anxiety symptoms were noted, they didn’t achieve statistical significance (Pediatr Rheumatol Online J. 2019 Feb 18. doi: 10.1186/s12969-019-0307-8). The next step in this project is a planned controlled randomized trial.
 

A web-based medication adherence program

Researchers at Pennsylvania State University took a different approach. They created a publicly available educational website, www.facinglupustogether.com, aimed at improving self-management skills – and especially medication adherence – in teens and young adults with SLE.

The website contains eight modules: Making the transition and taking charge of my medications, Learning about lupus, Learning about lupus medications, Managing symptoms of lupus, How do I handle lupus and my family, How do I handle lupus and my friends, Lupus and stress, and My personal goals and how I will achieve them. Each takes about 10 minutes to complete.

In a pilot study, 37 patients tackled one module per week and were randomized to respond to questions about the weekly topic either in a journal or by discussing the key points in an online social media forum with other young people with SLE. The idea was to create an intervention that capitalizes on the excellent social media skills possessed by today’s youth. And indeed, incorporation of social media proved to be a winning strategy. Medication adherence for hydroxychloroquine in the group randomized to social media participation jumped from 50% in the 3 months prior to starting the program to 92% in the first 3 months post completion, whereas medication adherence didn’t change significantly in the other study arm. The social media group also experienced significant improvements in self-efficacy, sense of community, acceptance of illness, optimism and control over the future, and other measures of empowerment. The control group did not show significant change in any of these domains (Pediatr Rheumatol Online J. 2018 Mar 14. doi: 10.1186/s12969-018-0232-2).

The TEACH study was sponsored by the National Institutes of Health. The web-based medication adherence program pilot study was supported by the Lupus Foundation of America. What the two approaches share in common is a conviction that, when it comes to addressing pain, fatigue, diminished quality of life, and poor medication adherence in young patients with SLE: “Our medication prescription alone doesn’t do it,” Dr. Brunner said.

She reported having no financial conflicts regarding her presentation.

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FDA concerned about e-cigs/seizures in youth

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The Food and Drug Administration has received reports about people who use e-cigarettes experiencing seizures, and a “recent uptick in voluntary reports” may signal the potential for an emerging safety concern, the agency announced April 3.

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Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.

“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”

In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.

Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.

“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.

Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.

The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
 

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The Food and Drug Administration has received reports about people who use e-cigarettes experiencing seizures, and a “recent uptick in voluntary reports” may signal the potential for an emerging safety concern, the agency announced April 3.

mauro grigollo/Thinkstock

Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.

“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”

In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.

Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.

“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.

Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.

The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
 

 

The Food and Drug Administration has received reports about people who use e-cigarettes experiencing seizures, and a “recent uptick in voluntary reports” may signal the potential for an emerging safety concern, the agency announced April 3.

mauro grigollo/Thinkstock

Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.

“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”

In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.

Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.

“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.

Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.

The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
 

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Valproate, topiramate prescribed in young women despite known teratogenicity risks

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Despite their known teratogenic risks, both valproate and topiramate are being prescribed relatively often in women of childbearing age, results of a retrospective analysis suggest.

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Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.

Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.

Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.

Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.

“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.

The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.

 

 


Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).

Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).

The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.

However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.

UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.

SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.

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Despite their known teratogenic risks, both valproate and topiramate are being prescribed relatively often in women of childbearing age, results of a retrospective analysis suggest.

Antonio_Diaz/Thinkstock

Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.

Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.

Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.

Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.

“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.

The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.

 

 


Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).

Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).

The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.

However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.

UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.

SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.

Despite their known teratogenic risks, both valproate and topiramate are being prescribed relatively often in women of childbearing age, results of a retrospective analysis suggest.

Antonio_Diaz/Thinkstock

Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.

Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.

Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.

Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.

“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.

The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.

 

 


Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).

Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).

The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.

However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.

UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.

SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.

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Key clinical point: Both valproate and topiramate are prescribed relatively often in women of childbearing age despite known teratogenic risks.

Major finding: Topiramate was the second- or third-most prescribed AED in the analyses. Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy.

Study details: Retrospective cohort study including nearly 47,000 women of childbearing age enrolled in claims databases between 2009 and 2013.

Disclosures: UCB Pharma sponsored the study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.

Source: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.

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Adolescent psychiatric ED visits more than doubled in 4 years

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Adolescent psychiatric visits to U.S. emergency departments increased 54% between 2011 and 2015, and suicide-related visits from teens more than doubled, a study found.

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Visits by African American youth and Latino youth both increased by a significant amount, yet only a minority of all youth (16%) were seen by mental health professionals during their psychiatric ED visits.

“This study unmistakably reveals that adolescents are a population with urgent mental health needs,” Luther G. Kalb, PhD, of the Johns Hopkins Bloomberg School of Public Health and the Kennedy Krieger Institute in Baltimore, and his colleagues reported in Pediatrics. “Not only were their visits the most acute, but their probability of suicidal attempt and/or self-harm increased as well,” a finding that matches recent national increases in suicidal ideation.

The researchers used the 2011-2015 National Hospital Ambulatory Medical Care Survey to analyze data on psychiatric ED visits among U.S. youth aged 6-24 years. A psychiatric visit was identified based on the patient’s reason for visit and the International Classification of Diseases, ninth revision, codes for mood, behavioral, or substance use disorders; psychosis; or other psychiatric reasons. Suicide attempt or intentional self-harm were identified with reason for visit codes.

Psychiatric ED visits among all youth increased 28%, from 31 to 40 visits per 1,000 U.S. youth, in the period from 2011 to 2015, a finding “heavily driven by 2015, in which the largest increase in visits was observed,” the authors noted.

The biggest jump occurred among adolescents, whose visits increased 54%, and among black and Latino patients, whose visits rose 53% and 91%, respectively. Adolescent suicide-related and self-injury ED visits more than doubled from 2011 to 2015, from 5 to 12 visits per 1,000 U.S. youth. They were the only age group to see an increase in odds of a suicide-related visit over time (odds ratio, 1.27, P less than .01)

“Ultimately, it is unclear if the findings represent a change in identification (by providers) or reporting (by patients or family members) of mental health in the ED, a shift in the epidemiology of psychiatric disorders in the United States, or fluctuations in referral patterns or service-seeking behavior,” Dr. Kalb and his associates reported.

Study limitations included “an inability to confirm diagnostic validity” and some missing data for visit acuity and race/ethnicity, they said.

The research was funded by the National Institute of Health, and in part by the National Institute of Mental Health Intramural Research program. The authors reported no relevant financial disclosures.

SOURCE: Kalb LG et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2018-2192.

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Even though the “fast-paced, stimulating environment” of an emergency department is not the ideal setting for children and families to receive care for mental health concerns, it remains a crucial safety net – particularly for lower-income individuals – because so many children lack access to mental health services, Dr. Chun and his associates wrote in an accompanying editorial.

“Some of the factors contributing to deficiencies in ED preparedness include a lack of staff trained in the identification and management of acute mental health problems; safe and quiet spaces within the ED; appropriate milieu for respectful, safe care; policies and procedures for ensuring best practices and consistent care; professional expertise to evaluate children’s mental health problems; and access to appropriate and timely follow-up care.”

Yet rates of youth’s psychiatric visits to the ED continue to climb because of a combination of increasing awareness, decreasing stigma for care seeking, limited mental health services, a shortage of pediatric mental health providers, insufficient specialty services, and true increases in mental health needs.

Solving this problem will require multiple coordinated approaches, but innovative options already are being explored, such as integrating child psychiatry services into EDs and “instituting next-day or other timely mental health evaluations,” they wrote. Other approaches include telepsychiatry; bringing mental health resources into schools and clinics; mental health resource sharing among communities; and mobile crisis units that visit schools, homes, primary care clinics, and low-resourced EDs.

Finally, medical training programs must change to adapt to the increasing need for pediatric mental health needs. “Embracing mental health problems as a routine component of pediatric medicine may be part of the solution to addressing the crisis,” they wrote.

Thomas H. Chun, MD, MPH, and Susan J. Duffy, MD, MPH, are at the Hasbro Children’s Hospital in Providence, R.I., and Jacqueline Grupp-Phelan, MD, MPH, is at the University of California, San Francisco, Benioff Children’s Hospital. These comments are a summary of a commentary accompanying Kalb et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2019-0251. The physicians used no external funding and had no financial disclosures relevant to their commentary.

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Even though the “fast-paced, stimulating environment” of an emergency department is not the ideal setting for children and families to receive care for mental health concerns, it remains a crucial safety net – particularly for lower-income individuals – because so many children lack access to mental health services, Dr. Chun and his associates wrote in an accompanying editorial.

“Some of the factors contributing to deficiencies in ED preparedness include a lack of staff trained in the identification and management of acute mental health problems; safe and quiet spaces within the ED; appropriate milieu for respectful, safe care; policies and procedures for ensuring best practices and consistent care; professional expertise to evaluate children’s mental health problems; and access to appropriate and timely follow-up care.”

Yet rates of youth’s psychiatric visits to the ED continue to climb because of a combination of increasing awareness, decreasing stigma for care seeking, limited mental health services, a shortage of pediatric mental health providers, insufficient specialty services, and true increases in mental health needs.

Solving this problem will require multiple coordinated approaches, but innovative options already are being explored, such as integrating child psychiatry services into EDs and “instituting next-day or other timely mental health evaluations,” they wrote. Other approaches include telepsychiatry; bringing mental health resources into schools and clinics; mental health resource sharing among communities; and mobile crisis units that visit schools, homes, primary care clinics, and low-resourced EDs.

Finally, medical training programs must change to adapt to the increasing need for pediatric mental health needs. “Embracing mental health problems as a routine component of pediatric medicine may be part of the solution to addressing the crisis,” they wrote.

Thomas H. Chun, MD, MPH, and Susan J. Duffy, MD, MPH, are at the Hasbro Children’s Hospital in Providence, R.I., and Jacqueline Grupp-Phelan, MD, MPH, is at the University of California, San Francisco, Benioff Children’s Hospital. These comments are a summary of a commentary accompanying Kalb et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2019-0251. The physicians used no external funding and had no financial disclosures relevant to their commentary.

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Even though the “fast-paced, stimulating environment” of an emergency department is not the ideal setting for children and families to receive care for mental health concerns, it remains a crucial safety net – particularly for lower-income individuals – because so many children lack access to mental health services, Dr. Chun and his associates wrote in an accompanying editorial.

“Some of the factors contributing to deficiencies in ED preparedness include a lack of staff trained in the identification and management of acute mental health problems; safe and quiet spaces within the ED; appropriate milieu for respectful, safe care; policies and procedures for ensuring best practices and consistent care; professional expertise to evaluate children’s mental health problems; and access to appropriate and timely follow-up care.”

Yet rates of youth’s psychiatric visits to the ED continue to climb because of a combination of increasing awareness, decreasing stigma for care seeking, limited mental health services, a shortage of pediatric mental health providers, insufficient specialty services, and true increases in mental health needs.

Solving this problem will require multiple coordinated approaches, but innovative options already are being explored, such as integrating child psychiatry services into EDs and “instituting next-day or other timely mental health evaluations,” they wrote. Other approaches include telepsychiatry; bringing mental health resources into schools and clinics; mental health resource sharing among communities; and mobile crisis units that visit schools, homes, primary care clinics, and low-resourced EDs.

Finally, medical training programs must change to adapt to the increasing need for pediatric mental health needs. “Embracing mental health problems as a routine component of pediatric medicine may be part of the solution to addressing the crisis,” they wrote.

Thomas H. Chun, MD, MPH, and Susan J. Duffy, MD, MPH, are at the Hasbro Children’s Hospital in Providence, R.I., and Jacqueline Grupp-Phelan, MD, MPH, is at the University of California, San Francisco, Benioff Children’s Hospital. These comments are a summary of a commentary accompanying Kalb et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2019-0251. The physicians used no external funding and had no financial disclosures relevant to their commentary.

Title
Multiple approaches needed to relieve psychiatric ED care
Multiple approaches needed to relieve psychiatric ED care

 

Adolescent psychiatric visits to U.S. emergency departments increased 54% between 2011 and 2015, and suicide-related visits from teens more than doubled, a study found.

Fuse/thinkstockphotos.com

Visits by African American youth and Latino youth both increased by a significant amount, yet only a minority of all youth (16%) were seen by mental health professionals during their psychiatric ED visits.

“This study unmistakably reveals that adolescents are a population with urgent mental health needs,” Luther G. Kalb, PhD, of the Johns Hopkins Bloomberg School of Public Health and the Kennedy Krieger Institute in Baltimore, and his colleagues reported in Pediatrics. “Not only were their visits the most acute, but their probability of suicidal attempt and/or self-harm increased as well,” a finding that matches recent national increases in suicidal ideation.

The researchers used the 2011-2015 National Hospital Ambulatory Medical Care Survey to analyze data on psychiatric ED visits among U.S. youth aged 6-24 years. A psychiatric visit was identified based on the patient’s reason for visit and the International Classification of Diseases, ninth revision, codes for mood, behavioral, or substance use disorders; psychosis; or other psychiatric reasons. Suicide attempt or intentional self-harm were identified with reason for visit codes.

Psychiatric ED visits among all youth increased 28%, from 31 to 40 visits per 1,000 U.S. youth, in the period from 2011 to 2015, a finding “heavily driven by 2015, in which the largest increase in visits was observed,” the authors noted.

The biggest jump occurred among adolescents, whose visits increased 54%, and among black and Latino patients, whose visits rose 53% and 91%, respectively. Adolescent suicide-related and self-injury ED visits more than doubled from 2011 to 2015, from 5 to 12 visits per 1,000 U.S. youth. They were the only age group to see an increase in odds of a suicide-related visit over time (odds ratio, 1.27, P less than .01)

“Ultimately, it is unclear if the findings represent a change in identification (by providers) or reporting (by patients or family members) of mental health in the ED, a shift in the epidemiology of psychiatric disorders in the United States, or fluctuations in referral patterns or service-seeking behavior,” Dr. Kalb and his associates reported.

Study limitations included “an inability to confirm diagnostic validity” and some missing data for visit acuity and race/ethnicity, they said.

The research was funded by the National Institute of Health, and in part by the National Institute of Mental Health Intramural Research program. The authors reported no relevant financial disclosures.

SOURCE: Kalb LG et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2018-2192.

 

Adolescent psychiatric visits to U.S. emergency departments increased 54% between 2011 and 2015, and suicide-related visits from teens more than doubled, a study found.

Fuse/thinkstockphotos.com

Visits by African American youth and Latino youth both increased by a significant amount, yet only a minority of all youth (16%) were seen by mental health professionals during their psychiatric ED visits.

“This study unmistakably reveals that adolescents are a population with urgent mental health needs,” Luther G. Kalb, PhD, of the Johns Hopkins Bloomberg School of Public Health and the Kennedy Krieger Institute in Baltimore, and his colleagues reported in Pediatrics. “Not only were their visits the most acute, but their probability of suicidal attempt and/or self-harm increased as well,” a finding that matches recent national increases in suicidal ideation.

The researchers used the 2011-2015 National Hospital Ambulatory Medical Care Survey to analyze data on psychiatric ED visits among U.S. youth aged 6-24 years. A psychiatric visit was identified based on the patient’s reason for visit and the International Classification of Diseases, ninth revision, codes for mood, behavioral, or substance use disorders; psychosis; or other psychiatric reasons. Suicide attempt or intentional self-harm were identified with reason for visit codes.

Psychiatric ED visits among all youth increased 28%, from 31 to 40 visits per 1,000 U.S. youth, in the period from 2011 to 2015, a finding “heavily driven by 2015, in which the largest increase in visits was observed,” the authors noted.

The biggest jump occurred among adolescents, whose visits increased 54%, and among black and Latino patients, whose visits rose 53% and 91%, respectively. Adolescent suicide-related and self-injury ED visits more than doubled from 2011 to 2015, from 5 to 12 visits per 1,000 U.S. youth. They were the only age group to see an increase in odds of a suicide-related visit over time (odds ratio, 1.27, P less than .01)

“Ultimately, it is unclear if the findings represent a change in identification (by providers) or reporting (by patients or family members) of mental health in the ED, a shift in the epidemiology of psychiatric disorders in the United States, or fluctuations in referral patterns or service-seeking behavior,” Dr. Kalb and his associates reported.

Study limitations included “an inability to confirm diagnostic validity” and some missing data for visit acuity and race/ethnicity, they said.

The research was funded by the National Institute of Health, and in part by the National Institute of Mental Health Intramural Research program. The authors reported no relevant financial disclosures.

SOURCE: Kalb LG et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2018-2192.

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Hope for hyperhidrosis

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Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise. 

Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:

1. It occurs in eccrine dense areas (axilla, soles, palms or head).

2. It is bilateral and symmetrical.

3. It is absent nocturnally.

4. Its onset should be before age 25 years.

5. It occurs at least weekly.

6. There is a positive family history.

7. It impairs daily activities.

If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1

The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2

Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1

Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3

Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1

Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2

The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2

Dr. Francine Pearce

Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.

It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.

More studies are on the horizon, but finally there is hope for hyperhidrosis.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. Skin Appendage Disord. 2015 Mar;1(1):6-13.

2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.

3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.

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Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise. 

Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:

1. It occurs in eccrine dense areas (axilla, soles, palms or head).

2. It is bilateral and symmetrical.

3. It is absent nocturnally.

4. Its onset should be before age 25 years.

5. It occurs at least weekly.

6. There is a positive family history.

7. It impairs daily activities.

If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1

The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2

Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1

Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3

Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1

Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2

The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2

Dr. Francine Pearce

Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.

It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.

More studies are on the horizon, but finally there is hope for hyperhidrosis.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. Skin Appendage Disord. 2015 Mar;1(1):6-13.

2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.

3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.

 

Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise. 

Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:

1. It occurs in eccrine dense areas (axilla, soles, palms or head).

2. It is bilateral and symmetrical.

3. It is absent nocturnally.

4. Its onset should be before age 25 years.

5. It occurs at least weekly.

6. There is a positive family history.

7. It impairs daily activities.

If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1

The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2

Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1

Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3

Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1

Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2

The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2

Dr. Francine Pearce

Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.

It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.

More studies are on the horizon, but finally there is hope for hyperhidrosis.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. Skin Appendage Disord. 2015 Mar;1(1):6-13.

2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.

3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.

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FDA extends Dupixent indication for 12- to 17-year-olds

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The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.” 

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.

While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.

FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”

With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”

Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.

Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”

These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.

“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”

The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications

The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.

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The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.” 

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.

While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.

FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”

With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”

Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.

Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”

These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.

“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”

The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications

The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.

 

The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.” 

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.

While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.

FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”

With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”

Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.

Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”

These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.

“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”

The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications

The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.

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Heart-harming toxins may hurt hookah smokers

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Smoking a water pipe, or hookah, can result in significant inhalation of toxins and an increased risk for short- and long-term cardiovascular health problems, according to a scientific statement issued by the American Heart Association on March 8.

Gina Smith/Thinkstock

In the statement, published in the journal Circulation, Aruni Bhatnagar, PhD, of the University of Louisville (Ky.) and his colleagues reviewed the potential dangers of water pipe use and offered strategies for prevention.

Data from the 2016 National Youth Tobacco Survey showed that current use (defined as use within the past 30 days) of water pipes by high school students increased in a nonlinear trend from 4.1% in 2011 to 4.8% in 2016, with a peak of 9.4% in 2014. Water pipe tobacco is sold in flavors such as cherry, chocolate, and coffee that appeal to younger consumers, and epidemiology data suggest that youth view water pipes as safer than conventional cigarettes because the water “filters out toxins” according to the statement.

Findings from the National Adult Tobacco Survey showed an increase as well, from 1.5% during 2009-2010 to 3.2% during 2013-2014. Adults cite cultural and social influences, as well as psychological benefits of reduced stress and anger and improved concentration, which may be attributable to nicotine, the researchers noted.

Water pipe smoking involves placing charcoal briquettes on top of a tobacco-filled bowl with a stem immersed in water such that the smoke is pulled through and bubbles up through the water into a mouthpiece. The harmful or potentially harmful constituents (HPHCs) involved in water pipe are similar to those in standard cigarettes and include tar, phenanthrene, carbon monoxide, heavy metals, and arsenic, as well as nicotine.

The patterns of exposure to toxins during water pipe smoking are unclear, the authors noted.

However, the risks for both short-term and long-term health effects are similar to those associated with cigarettes. “Overall, the short-term cardiovascular effects are consistent with the sympathomimetic effects of nicotine,” according to the statement.

Data on the long-term effects of water pipe smoking on cardiovascular health are limited, but “lifetime exposures exceeding 40 water pipe–years (2 water pipes per day for a total of 20 years or 1 water pipe for 40 years) are associated with a threefold increase in the odds of angiographically diagnosed coronary artery stenosis,” according to the statement. Additional research on long-term health effects may help guide regulation of water pipe products, the authors suggested.

The AHA statement encourages health care providers to take a proactive approach in addressing hookah use by asking patients about it, by advising those who use water pipes to quit, by assisting those who want to quit by providing counseling and social support, and by referring water pipe smokers to legitimate resources for information on the potential for addiction and health risks.

Dr. Bhatnagar received funding from the National Institutes of Health, but he had no other financial conflicts to disclose.

SOURCE: Bhatnagar A et al. Circulation. 2019 Mar 8. doi: 10.1161/CIR.0000000000000671.

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Smoking a water pipe, or hookah, can result in significant inhalation of toxins and an increased risk for short- and long-term cardiovascular health problems, according to a scientific statement issued by the American Heart Association on March 8.

Gina Smith/Thinkstock

In the statement, published in the journal Circulation, Aruni Bhatnagar, PhD, of the University of Louisville (Ky.) and his colleagues reviewed the potential dangers of water pipe use and offered strategies for prevention.

Data from the 2016 National Youth Tobacco Survey showed that current use (defined as use within the past 30 days) of water pipes by high school students increased in a nonlinear trend from 4.1% in 2011 to 4.8% in 2016, with a peak of 9.4% in 2014. Water pipe tobacco is sold in flavors such as cherry, chocolate, and coffee that appeal to younger consumers, and epidemiology data suggest that youth view water pipes as safer than conventional cigarettes because the water “filters out toxins” according to the statement.

Findings from the National Adult Tobacco Survey showed an increase as well, from 1.5% during 2009-2010 to 3.2% during 2013-2014. Adults cite cultural and social influences, as well as psychological benefits of reduced stress and anger and improved concentration, which may be attributable to nicotine, the researchers noted.

Water pipe smoking involves placing charcoal briquettes on top of a tobacco-filled bowl with a stem immersed in water such that the smoke is pulled through and bubbles up through the water into a mouthpiece. The harmful or potentially harmful constituents (HPHCs) involved in water pipe are similar to those in standard cigarettes and include tar, phenanthrene, carbon monoxide, heavy metals, and arsenic, as well as nicotine.

The patterns of exposure to toxins during water pipe smoking are unclear, the authors noted.

However, the risks for both short-term and long-term health effects are similar to those associated with cigarettes. “Overall, the short-term cardiovascular effects are consistent with the sympathomimetic effects of nicotine,” according to the statement.

Data on the long-term effects of water pipe smoking on cardiovascular health are limited, but “lifetime exposures exceeding 40 water pipe–years (2 water pipes per day for a total of 20 years or 1 water pipe for 40 years) are associated with a threefold increase in the odds of angiographically diagnosed coronary artery stenosis,” according to the statement. Additional research on long-term health effects may help guide regulation of water pipe products, the authors suggested.

The AHA statement encourages health care providers to take a proactive approach in addressing hookah use by asking patients about it, by advising those who use water pipes to quit, by assisting those who want to quit by providing counseling and social support, and by referring water pipe smokers to legitimate resources for information on the potential for addiction and health risks.

Dr. Bhatnagar received funding from the National Institutes of Health, but he had no other financial conflicts to disclose.

SOURCE: Bhatnagar A et al. Circulation. 2019 Mar 8. doi: 10.1161/CIR.0000000000000671.

 

Smoking a water pipe, or hookah, can result in significant inhalation of toxins and an increased risk for short- and long-term cardiovascular health problems, according to a scientific statement issued by the American Heart Association on March 8.

Gina Smith/Thinkstock

In the statement, published in the journal Circulation, Aruni Bhatnagar, PhD, of the University of Louisville (Ky.) and his colleagues reviewed the potential dangers of water pipe use and offered strategies for prevention.

Data from the 2016 National Youth Tobacco Survey showed that current use (defined as use within the past 30 days) of water pipes by high school students increased in a nonlinear trend from 4.1% in 2011 to 4.8% in 2016, with a peak of 9.4% in 2014. Water pipe tobacco is sold in flavors such as cherry, chocolate, and coffee that appeal to younger consumers, and epidemiology data suggest that youth view water pipes as safer than conventional cigarettes because the water “filters out toxins” according to the statement.

Findings from the National Adult Tobacco Survey showed an increase as well, from 1.5% during 2009-2010 to 3.2% during 2013-2014. Adults cite cultural and social influences, as well as psychological benefits of reduced stress and anger and improved concentration, which may be attributable to nicotine, the researchers noted.

Water pipe smoking involves placing charcoal briquettes on top of a tobacco-filled bowl with a stem immersed in water such that the smoke is pulled through and bubbles up through the water into a mouthpiece. The harmful or potentially harmful constituents (HPHCs) involved in water pipe are similar to those in standard cigarettes and include tar, phenanthrene, carbon monoxide, heavy metals, and arsenic, as well as nicotine.

The patterns of exposure to toxins during water pipe smoking are unclear, the authors noted.

However, the risks for both short-term and long-term health effects are similar to those associated with cigarettes. “Overall, the short-term cardiovascular effects are consistent with the sympathomimetic effects of nicotine,” according to the statement.

Data on the long-term effects of water pipe smoking on cardiovascular health are limited, but “lifetime exposures exceeding 40 water pipe–years (2 water pipes per day for a total of 20 years or 1 water pipe for 40 years) are associated with a threefold increase in the odds of angiographically diagnosed coronary artery stenosis,” according to the statement. Additional research on long-term health effects may help guide regulation of water pipe products, the authors suggested.

The AHA statement encourages health care providers to take a proactive approach in addressing hookah use by asking patients about it, by advising those who use water pipes to quit, by assisting those who want to quit by providing counseling and social support, and by referring water pipe smokers to legitimate resources for information on the potential for addiction and health risks.

Dr. Bhatnagar received funding from the National Institutes of Health, but he had no other financial conflicts to disclose.

SOURCE: Bhatnagar A et al. Circulation. 2019 Mar 8. doi: 10.1161/CIR.0000000000000671.

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