In March 2018, the Human Rights Campaign (HRC), an advocacy organization dedicated to improving the lives of LGBTQ people, released its 11th Annual Healthcare Equality Index. The HEI is an indicator of how inclusive and equitable health care facilities are in providing care for their LGBTQ patients. My own institution, Children’s Hospital of Pittsburgh, scored very high on this index and received the “Leader in LGBTQ Healthcare Equality” designation. The process of receiving this designation is very rigorous, and I am proud of my institution for making great strides in expanding health care access for LGBTQ patients, especially transgender patients. However, this is no time to rest on one’s laurels, as many transgender people still experience challenges and barriers in navigating the health care system.

AlexRaths/Thinkstock

Dr. Montano is an assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].

Resources

• HRC HEI: If you’re interested in learning what policies are inclusive and equitable for LGBT patients, check out the HRC HEI scoring criteria. It’s a good place to start if you want to expand health care access for transgender individuals.
• To find out more about the health care legal protections transgender individuals are entitled to, check out the National Center for Transgender Equality.

References

1. Psychol Bull. 2003 Sep;129(5):674-97.

2. “Injustice at every turn: A report of the National Transgender Discrimination Survey.” (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011.)

3. J. Adolesc Health. 2018 Apr. doi: 10.1016/j.jadohealth.2018.02.003.

4. Int J Transgenderism. 2008. doi: 10.1300/J485v08n02_08.

5. Transgend Health. 2016 Nov 1;1(1):238-49.

In March 2018, the Human Rights Campaign (HRC), an advocacy organization dedicated to improving the lives of LGBTQ people, released its 11th Annual Healthcare Equality Index. The HEI is an indicator of how inclusive and equitable health care facilities are in providing care for their LGBTQ patients. My own institution, Children’s Hospital of Pittsburgh, scored very high on this index and received the “Leader in LGBTQ Healthcare Equality” designation. The process of receiving this designation is very rigorous, and I am proud of my institution for making great strides in expanding health care access for LGBTQ patients, especially transgender patients. However, this is no time to rest on one’s laurels, as many transgender people still experience challenges and barriers in navigating the health care system.

AlexRaths/Thinkstock

Dr. Montano is an assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].

Resources

• HRC HEI: If you’re interested in learning what policies are inclusive and equitable for LGBT patients, check out the HRC HEI scoring criteria. It’s a good place to start if you want to expand health care access for transgender individuals.
• To find out more about the health care legal protections transgender individuals are entitled to, check out the National Center for Transgender Equality.

References

1. Psychol Bull. 2003 Sep;129(5):674-97.

2. “Injustice at every turn: A report of the National Transgender Discrimination Survey.” (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011.)

3. J. Adolesc Health. 2018 Apr. doi: 10.1016/j.jadohealth.2018.02.003.

4. Int J Transgenderism. 2008. doi: 10.1300/J485v08n02_08.

5. Transgend Health. 2016 Nov 1;1(1):238-49.

In March 2018, the Human Rights Campaign (HRC), an advocacy organization dedicated to improving the lives of LGBTQ people, released its 11th Annual Healthcare Equality Index. The HEI is an indicator of how inclusive and equitable health care facilities are in providing care for their LGBTQ patients. My own institution, Children’s Hospital of Pittsburgh, scored very high on this index and received the “Leader in LGBTQ Healthcare Equality” designation. The process of receiving this designation is very rigorous, and I am proud of my institution for making great strides in expanding health care access for LGBTQ patients, especially transgender patients. However, this is no time to rest on one’s laurels, as many transgender people still experience challenges and barriers in navigating the health care system.

AlexRaths/Thinkstock

Dr. Montano is an assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].

Resources

• HRC HEI: If you’re interested in learning what policies are inclusive and equitable for LGBT patients, check out the HRC HEI scoring criteria. It’s a good place to start if you want to expand health care access for transgender individuals.
• To find out more about the health care legal protections transgender individuals are entitled to, check out the National Center for Transgender Equality.

References

1. Psychol Bull. 2003 Sep;129(5):674-97.

2. “Injustice at every turn: A report of the National Transgender Discrimination Survey.” (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011.)

3. J. Adolesc Health. 2018 Apr. doi: 10.1016/j.jadohealth.2018.02.003.

4. Int J Transgenderism. 2008. doi: 10.1300/J485v08n02_08.

5. Transgend Health. 2016 Nov 1;1(1):238-49.

The federal EHR Incentive Program – a program most doctors love to hate – is getting a new name to better reflect a focus on interoperability and improved patient access to their health care data, the Centers for Medicare & Medicaid Services announced.

For clinicians who participate in fee-for-service Medicare, eligible hospitals, and critical access hospitals, the new name of the program will be the Promoting Interoperability Program. For those participating in the Merit-Based Incentive Payment System (MIPS) track of the Quality Payment Program (QPP), the Advancing Care Information performance category will be rebranded the Promoting Interoperability performance category.

Skynesher/iStockphoto

pandpstock001/Thinktock

[email protected]

The federal EHR Incentive Program – a program most doctors love to hate – is getting a new name to better reflect a focus on interoperability and improved patient access to their health care data, the Centers for Medicare & Medicaid Services announced.

For clinicians who participate in fee-for-service Medicare, eligible hospitals, and critical access hospitals, the new name of the program will be the Promoting Interoperability Program. For those participating in the Merit-Based Incentive Payment System (MIPS) track of the Quality Payment Program (QPP), the Advancing Care Information performance category will be rebranded the Promoting Interoperability performance category.

Skynesher/iStockphoto

pandpstock001/Thinktock

[email protected]

The federal EHR Incentive Program – a program most doctors love to hate – is getting a new name to better reflect a focus on interoperability and improved patient access to their health care data, the Centers for Medicare & Medicaid Services announced.

For clinicians who participate in fee-for-service Medicare, eligible hospitals, and critical access hospitals, the new name of the program will be the Promoting Interoperability Program. For those participating in the Merit-Based Incentive Payment System (MIPS) track of the Quality Payment Program (QPP), the Advancing Care Information performance category will be rebranded the Promoting Interoperability performance category.

Skynesher/iStockphoto

pandpstock001/Thinktock

[email protected]

Intra-amniotic therapy with a novel recombinant protein enabled three patients with X-linked hypohidrotic ectodermal dysplasia (XLHED) to sweat normally, researchers reported.

For up to 22 months of postnatal follow-up, patients had no hyperthermia and were not hospitalized for respiratory reasons, reported Holm Schneider, MD, of the University of Erlangen-Nürnberg, Erlangen, Germany, and his associates. Treatment may have induced premature delivery at 33 weeks of a pair of twins, although most twins are born preterm, they noted. “Combined with the ability to identify affected fetuses through noninvasive sonographic prenatal screening, the approach we describe here represents a new means of protein-replacement therapy to correct XLHED,” they wrote online April 25 in the New England Journal of Medicine.

XLHED is caused by loss-of-function variants of the gene encoding ectodysplasin A (EDA). The investigational recombinant fusion protein Fc-EDA (EDI200) developed by Edimer Pharmaceuticals, which contains the receptor-binding domain of EDA and the Fc domain of human immunoglobulin G1, has shown no signs of toxicity in nonhuman primates. In prior studies, its intra-amniotic infusion prevented XLHED in EDA-deficient murine fetuses, while human postnatal Fc-EDA therapy was ineffective (NCT01775462).

Based on these data, University Hospital Erlangan approved a parental request for compassionate use of Fc-EDA in male twin fetuses with genetic deficiency of EDA. Treatment (100 mg/kg estimated fetal body weight) occurred at gestational weeks 26 and 31. Despite premature delivery at 33 weeks, 5-minute Apgar scores were 9 for one twin and 10 for the other. Cord blood testing detected Fc-EDA, suggesting its continuous uptake into fetal blood. The twins both had normal sweat-duct density, sweated as much as healthy controls, salivated normally, and had 8-10 tooth germs; their 5-year-old brother with XLHED had only three teeth and one tooth germ.

Parents of another EDA-deficient fetus also requested compassionate use of Fc-EDA, which was administrated as a single dose (because of limited supply) at gestational week 26. Birth occurred at week 39 and Apgar scores all were 10s. Sweat pore density was slightly low, compared with healthy controls, and by age 4 months, the patient had developed moderate urticaria pigmentosa.

In all cases, maternal circulation showed no trace of Fc-EDA within 24 hours of treatment.

Funders included Edimer Pharmaceuticals, Deutsche Forschungsgemeinschaft, Swiss National Science Foundation, the German-Swiss-Austrian ectodermal dysplasia patient organization, and the National Foundation for Ectodermal Dysplasias. Three of the investigators have either patents issued or patents pending related to the treatment, one is an employee of Edimer Pharmaceuticals, and two have grants from some of the abovementioned companies or organizations.
 

SOURCE: Schneider H et al. N Engl J Med. 2018 Apr 25. doi: 10.1056/NEJMoa1714322.

Intra-amniotic therapy with a novel recombinant protein enabled three patients with X-linked hypohidrotic ectodermal dysplasia (XLHED) to sweat normally, researchers reported.

For up to 22 months of postnatal follow-up, patients had no hyperthermia and were not hospitalized for respiratory reasons, reported Holm Schneider, MD, of the University of Erlangen-Nürnberg, Erlangen, Germany, and his associates. Treatment may have induced premature delivery at 33 weeks of a pair of twins, although most twins are born preterm, they noted. “Combined with the ability to identify affected fetuses through noninvasive sonographic prenatal screening, the approach we describe here represents a new means of protein-replacement therapy to correct XLHED,” they wrote online April 25 in the New England Journal of Medicine.

XLHED is caused by loss-of-function variants of the gene encoding ectodysplasin A (EDA). The investigational recombinant fusion protein Fc-EDA (EDI200) developed by Edimer Pharmaceuticals, which contains the receptor-binding domain of EDA and the Fc domain of human immunoglobulin G1, has shown no signs of toxicity in nonhuman primates. In prior studies, its intra-amniotic infusion prevented XLHED in EDA-deficient murine fetuses, while human postnatal Fc-EDA therapy was ineffective (NCT01775462).

Based on these data, University Hospital Erlangan approved a parental request for compassionate use of Fc-EDA in male twin fetuses with genetic deficiency of EDA. Treatment (100 mg/kg estimated fetal body weight) occurred at gestational weeks 26 and 31. Despite premature delivery at 33 weeks, 5-minute Apgar scores were 9 for one twin and 10 for the other. Cord blood testing detected Fc-EDA, suggesting its continuous uptake into fetal blood. The twins both had normal sweat-duct density, sweated as much as healthy controls, salivated normally, and had 8-10 tooth germs; their 5-year-old brother with XLHED had only three teeth and one tooth germ.

Parents of another EDA-deficient fetus also requested compassionate use of Fc-EDA, which was administrated as a single dose (because of limited supply) at gestational week 26. Birth occurred at week 39 and Apgar scores all were 10s. Sweat pore density was slightly low, compared with healthy controls, and by age 4 months, the patient had developed moderate urticaria pigmentosa.

In all cases, maternal circulation showed no trace of Fc-EDA within 24 hours of treatment.

Funders included Edimer Pharmaceuticals, Deutsche Forschungsgemeinschaft, Swiss National Science Foundation, the German-Swiss-Austrian ectodermal dysplasia patient organization, and the National Foundation for Ectodermal Dysplasias. Three of the investigators have either patents issued or patents pending related to the treatment, one is an employee of Edimer Pharmaceuticals, and two have grants from some of the abovementioned companies or organizations.
 

SOURCE: Schneider H et al. N Engl J Med. 2018 Apr 25. doi: 10.1056/NEJMoa1714322.

Intra-amniotic therapy with a novel recombinant protein enabled three patients with X-linked hypohidrotic ectodermal dysplasia (XLHED) to sweat normally, researchers reported.

For up to 22 months of postnatal follow-up, patients had no hyperthermia and were not hospitalized for respiratory reasons, reported Holm Schneider, MD, of the University of Erlangen-Nürnberg, Erlangen, Germany, and his associates. Treatment may have induced premature delivery at 33 weeks of a pair of twins, although most twins are born preterm, they noted. “Combined with the ability to identify affected fetuses through noninvasive sonographic prenatal screening, the approach we describe here represents a new means of protein-replacement therapy to correct XLHED,” they wrote online April 25 in the New England Journal of Medicine.

XLHED is caused by loss-of-function variants of the gene encoding ectodysplasin A (EDA). The investigational recombinant fusion protein Fc-EDA (EDI200) developed by Edimer Pharmaceuticals, which contains the receptor-binding domain of EDA and the Fc domain of human immunoglobulin G1, has shown no signs of toxicity in nonhuman primates. In prior studies, its intra-amniotic infusion prevented XLHED in EDA-deficient murine fetuses, while human postnatal Fc-EDA therapy was ineffective (NCT01775462).

Based on these data, University Hospital Erlangan approved a parental request for compassionate use of Fc-EDA in male twin fetuses with genetic deficiency of EDA. Treatment (100 mg/kg estimated fetal body weight) occurred at gestational weeks 26 and 31. Despite premature delivery at 33 weeks, 5-minute Apgar scores were 9 for one twin and 10 for the other. Cord blood testing detected Fc-EDA, suggesting its continuous uptake into fetal blood. The twins both had normal sweat-duct density, sweated as much as healthy controls, salivated normally, and had 8-10 tooth germs; their 5-year-old brother with XLHED had only three teeth and one tooth germ.

Parents of another EDA-deficient fetus also requested compassionate use of Fc-EDA, which was administrated as a single dose (because of limited supply) at gestational week 26. Birth occurred at week 39 and Apgar scores all were 10s. Sweat pore density was slightly low, compared with healthy controls, and by age 4 months, the patient had developed moderate urticaria pigmentosa.

In all cases, maternal circulation showed no trace of Fc-EDA within 24 hours of treatment.

Funders included Edimer Pharmaceuticals, Deutsche Forschungsgemeinschaft, Swiss National Science Foundation, the German-Swiss-Austrian ectodermal dysplasia patient organization, and the National Foundation for Ectodermal Dysplasias. Three of the investigators have either patents issued or patents pending related to the treatment, one is an employee of Edimer Pharmaceuticals, and two have grants from some of the abovementioned companies or organizations.
 

SOURCE: Schneider H et al. N Engl J Med. 2018 Apr 25. doi: 10.1056/NEJMoa1714322.

Three different regimens of antiretroviral therapy did not produce significantly different adverse birth outcomes in women with HIV despite previous research showing an increased risk in premature birth or death in infants after a regimen of tenofovir, emtricitabine, and ritonavir-boosted lopinavir therapy, according to a recent analysis of two multicenter cohort studies published in the New England Journal of Medicine.

Kathryn Rough, ScD, of the Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues analyzed 4,646 birth outcomes in the SMARTT (NCT01310023) and P1025 (NCT00028145) trials from 3,847 unique women who received tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r), zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r), or TDF–FTC with ritonavir-boosted atazanavir (ATV/r) during gestation. There were 954 infants or fetuses exposed to ZDV–3TC–LPV/r (20.5%), 539 infants or fetuses exposed to TDF–FTC–ATV/r (11.6%), and 128 infants or fetuses exposed to TDF–FTC–LPV/r (2.8%), with 4,480 singleton, 80 twin, and 2 triplet pregnancies.

©PhotoDisk

One author reported stock from Abbott, AbbVie, Novartis, and Roche outside the submitted work; one author reported personal fees from Boehringer-Ingelheim; and five authors reported grants from pharmaceutical companies and Google outside the submitted work.

SOURCE: Rough K et al. N Engl J Med 2018;378:1593-603.

Three different regimens of antiretroviral therapy did not produce significantly different adverse birth outcomes in women with HIV despite previous research showing an increased risk in premature birth or death in infants after a regimen of tenofovir, emtricitabine, and ritonavir-boosted lopinavir therapy, according to a recent analysis of two multicenter cohort studies published in the New England Journal of Medicine.

Kathryn Rough, ScD, of the Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues analyzed 4,646 birth outcomes in the SMARTT (NCT01310023) and P1025 (NCT00028145) trials from 3,847 unique women who received tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r), zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r), or TDF–FTC with ritonavir-boosted atazanavir (ATV/r) during gestation. There were 954 infants or fetuses exposed to ZDV–3TC–LPV/r (20.5%), 539 infants or fetuses exposed to TDF–FTC–ATV/r (11.6%), and 128 infants or fetuses exposed to TDF–FTC–LPV/r (2.8%), with 4,480 singleton, 80 twin, and 2 triplet pregnancies.

©PhotoDisk

One author reported stock from Abbott, AbbVie, Novartis, and Roche outside the submitted work; one author reported personal fees from Boehringer-Ingelheim; and five authors reported grants from pharmaceutical companies and Google outside the submitted work.

SOURCE: Rough K et al. N Engl J Med 2018;378:1593-603.

Three different regimens of antiretroviral therapy did not produce significantly different adverse birth outcomes in women with HIV despite previous research showing an increased risk in premature birth or death in infants after a regimen of tenofovir, emtricitabine, and ritonavir-boosted lopinavir therapy, according to a recent analysis of two multicenter cohort studies published in the New England Journal of Medicine.

Kathryn Rough, ScD, of the Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues analyzed 4,646 birth outcomes in the SMARTT (NCT01310023) and P1025 (NCT00028145) trials from 3,847 unique women who received tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r), zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r), or TDF–FTC with ritonavir-boosted atazanavir (ATV/r) during gestation. There were 954 infants or fetuses exposed to ZDV–3TC–LPV/r (20.5%), 539 infants or fetuses exposed to TDF–FTC–ATV/r (11.6%), and 128 infants or fetuses exposed to TDF–FTC–LPV/r (2.8%), with 4,480 singleton, 80 twin, and 2 triplet pregnancies.

©PhotoDisk

One author reported stock from Abbott, AbbVie, Novartis, and Roche outside the submitted work; one author reported personal fees from Boehringer-Ingelheim; and five authors reported grants from pharmaceutical companies and Google outside the submitted work.

SOURCE: Rough K et al. N Engl J Med 2018;378:1593-603.

I recently received a letter from a former fellow who completed his training almost 25 years ago, thanking me for guiding him through his education and to his successful medical career. It’s one of those letters that we all have received and that makes us feel that it is all worth it. When he went through his requisite 2 years of training, it seemed to me that my responsibility was to provide a model of how to provide excellent care at the bedside and clinic with expertise and compassion.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
 

I recently received a letter from a former fellow who completed his training almost 25 years ago, thanking me for guiding him through his education and to his successful medical career. It’s one of those letters that we all have received and that makes us feel that it is all worth it. When he went through his requisite 2 years of training, it seemed to me that my responsibility was to provide a model of how to provide excellent care at the bedside and clinic with expertise and compassion.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
 

I recently received a letter from a former fellow who completed his training almost 25 years ago, thanking me for guiding him through his education and to his successful medical career. It’s one of those letters that we all have received and that makes us feel that it is all worth it. When he went through his requisite 2 years of training, it seemed to me that my responsibility was to provide a model of how to provide excellent care at the bedside and clinic with expertise and compassion.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
 

DALLAS – A low-cost compact oral probe combined with a cloud-based diagnostic algorithm was able to differentiate between healthy, dysplastic, and malignant oral cancer, in a clinical study of 92 people.

“Oral cancer is the sixth most common cancer in the world, but it’s the only major cancer whose outcome has not improved in the last 50 years,” study author Petra Wilder-Smith DDS, PhD, said in an interview following the annual conference of the American Society for Laser Medicine and Surgery Inc. “The main challenge is that over two-thirds of oral cancers are detected after they’ve metastasized. When you get spread like that, your survival is about 20% at 5 years, whereas if you detect it before spread, your survival is about 80% at 5 years.”

At the meeting, Vania Firmalino, an undergraduate student at the University of California, Irvine, discussed efforts by Dr. Wilder-Smith, Rongguang Liang, PhD, of the College of Optical Sciences at the University of Arizona, Tucson, and their colleagues to develop and evaluate the screening performance of a novel, low-cost smartphone-based mini probe for oral cancer screening and oral potentially premalignant lesions (OPMLs). The device provides high-resolution polarized white light images in combination with autofluorescence (AF) imaging capability.

Courtesy Petra Wilder-Smith, DDS, PhD

[email protected]

DALLAS – A low-cost compact oral probe combined with a cloud-based diagnostic algorithm was able to differentiate between healthy, dysplastic, and malignant oral cancer, in a clinical study of 92 people.

“Oral cancer is the sixth most common cancer in the world, but it’s the only major cancer whose outcome has not improved in the last 50 years,” study author Petra Wilder-Smith DDS, PhD, said in an interview following the annual conference of the American Society for Laser Medicine and Surgery Inc. “The main challenge is that over two-thirds of oral cancers are detected after they’ve metastasized. When you get spread like that, your survival is about 20% at 5 years, whereas if you detect it before spread, your survival is about 80% at 5 years.”

At the meeting, Vania Firmalino, an undergraduate student at the University of California, Irvine, discussed efforts by Dr. Wilder-Smith, Rongguang Liang, PhD, of the College of Optical Sciences at the University of Arizona, Tucson, and their colleagues to develop and evaluate the screening performance of a novel, low-cost smartphone-based mini probe for oral cancer screening and oral potentially premalignant lesions (OPMLs). The device provides high-resolution polarized white light images in combination with autofluorescence (AF) imaging capability.

Courtesy Petra Wilder-Smith, DDS, PhD

[email protected]

DALLAS – A low-cost compact oral probe combined with a cloud-based diagnostic algorithm was able to differentiate between healthy, dysplastic, and malignant oral cancer, in a clinical study of 92 people.

“Oral cancer is the sixth most common cancer in the world, but it’s the only major cancer whose outcome has not improved in the last 50 years,” study author Petra Wilder-Smith DDS, PhD, said in an interview following the annual conference of the American Society for Laser Medicine and Surgery Inc. “The main challenge is that over two-thirds of oral cancers are detected after they’ve metastasized. When you get spread like that, your survival is about 20% at 5 years, whereas if you detect it before spread, your survival is about 80% at 5 years.”

At the meeting, Vania Firmalino, an undergraduate student at the University of California, Irvine, discussed efforts by Dr. Wilder-Smith, Rongguang Liang, PhD, of the College of Optical Sciences at the University of Arizona, Tucson, and their colleagues to develop and evaluate the screening performance of a novel, low-cost smartphone-based mini probe for oral cancer screening and oral potentially premalignant lesions (OPMLs). The device provides high-resolution polarized white light images in combination with autofluorescence (AF) imaging capability.

Courtesy Petra Wilder-Smith, DDS, PhD

[email protected]

In women with breast cancer undergoing breast-conserving surgery, accelerated partial breast irradiation (APBI) using multicatheter brachytherapy does not negatively affect quality of life, compared with standard whole breast irradiation, investigators have reported.

Patients reported similar quality of life scores for multicatheter brachytherapy–based APBI and whole breast irradiation in the study by the Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).

Moreover, breast symptom scores were significantly worse for whole-breast radiation, Rebekka Schäfer, MD, of the department of radiation oncology at the University Hospital Würzburg (Germany) and colleagues reported in Lancet Oncology.

“This trial provides further clinical evidence that APBI with interstitial brachytherapy can be considered as an alternative treatment option after breast-conserving surgery for patients with low-risk breast cancer,” Dr. Schäfer and coauthors wrote.

In several previous studies, APBI has been shown to have clinical outcomes equivalent to those of whole breast irradiation in terms of disease recurrence, survival, and treatment side effects, they added.

The quality of life findings in the present report come from long-term follow-up of a randomized, controlled, phase 3 trial conducted at 16 European centers. This study included 1,184 women with early breast cancer randomly who, after receiving breast-conserving surgery, were assigned either to APBI that used multicatheter brachytherapy or to whole breast irradiation.

Women in the study completed validated quality of life questionnaires right before and right after radiotherapy, as well as during follow-up.

A little more than half of the women in each group completed the quality of life questionnaires after the treatment and again at follow-up, investigators said.

Global health status was stable over time in both groups, investigators reported. In the APBI group, global health status score on a scale of 0-100 was 65.6 right after the procedure and 66.2 at 5 years; similarly, scores in the whole breast irradiation group were 64.6 after radiotherapy and 66.0 at 5 years.

The only quality of life difference between arms that investigators characterized as moderately clinically relevant was in breast symptom scores, which were significantly worse in the whole breast radiation group right after radiotherapy (difference of means, 13.6; 95% CI, 9.7-17.5; P less than .0001) and at 3-month follow-up (difference of means, 12.7; 95% CI, 9.8-15.6; P less than .0001).

Emotional functioning, fatigue, and financial difficulty scores in the APBI group were “slightly better” than in the whole breast radiation group right after radiotherapy and at a 3-month follow-up, investigators reported; however, at 5 year follow-up, there were no significant differences between arms in those measures.

“Our findings show that APBI using multicatheter interstitial brachytherapy does not result in clinically significant deterioration of overall quality of life and that the different domains of quality of life after APBI were not worse in comparison with whole breast irradiation in terms of clinically relevant differences,” Dr. Schäfer and colleagues concluded in their report.

Dr. Schäfer reported no conflicts of interest. Coauthors reported disclosures outside of the submitted work including Nucletron Operations BV, Elekta Company, Merck Serono, Novocure, AstraZeneca, and Bristol-Myers Squibb, among others.

SOURCE: Schäfer R et al. Lancet Oncol. 2018 Apr 22. doi: 10.1016/S1470-2045(18)30195-5.

In women with breast cancer undergoing breast-conserving surgery, accelerated partial breast irradiation (APBI) using multicatheter brachytherapy does not negatively affect quality of life, compared with standard whole breast irradiation, investigators have reported.

Patients reported similar quality of life scores for multicatheter brachytherapy–based APBI and whole breast irradiation in the study by the Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).

Moreover, breast symptom scores were significantly worse for whole-breast radiation, Rebekka Schäfer, MD, of the department of radiation oncology at the University Hospital Würzburg (Germany) and colleagues reported in Lancet Oncology.

“This trial provides further clinical evidence that APBI with interstitial brachytherapy can be considered as an alternative treatment option after breast-conserving surgery for patients with low-risk breast cancer,” Dr. Schäfer and coauthors wrote.

In several previous studies, APBI has been shown to have clinical outcomes equivalent to those of whole breast irradiation in terms of disease recurrence, survival, and treatment side effects, they added.

The quality of life findings in the present report come from long-term follow-up of a randomized, controlled, phase 3 trial conducted at 16 European centers. This study included 1,184 women with early breast cancer randomly who, after receiving breast-conserving surgery, were assigned either to APBI that used multicatheter brachytherapy or to whole breast irradiation.

Women in the study completed validated quality of life questionnaires right before and right after radiotherapy, as well as during follow-up.

A little more than half of the women in each group completed the quality of life questionnaires after the treatment and again at follow-up, investigators said.

Global health status was stable over time in both groups, investigators reported. In the APBI group, global health status score on a scale of 0-100 was 65.6 right after the procedure and 66.2 at 5 years; similarly, scores in the whole breast irradiation group were 64.6 after radiotherapy and 66.0 at 5 years.

The only quality of life difference between arms that investigators characterized as moderately clinically relevant was in breast symptom scores, which were significantly worse in the whole breast radiation group right after radiotherapy (difference of means, 13.6; 95% CI, 9.7-17.5; P less than .0001) and at 3-month follow-up (difference of means, 12.7; 95% CI, 9.8-15.6; P less than .0001).

Emotional functioning, fatigue, and financial difficulty scores in the APBI group were “slightly better” than in the whole breast radiation group right after radiotherapy and at a 3-month follow-up, investigators reported; however, at 5 year follow-up, there were no significant differences between arms in those measures.

“Our findings show that APBI using multicatheter interstitial brachytherapy does not result in clinically significant deterioration of overall quality of life and that the different domains of quality of life after APBI were not worse in comparison with whole breast irradiation in terms of clinically relevant differences,” Dr. Schäfer and colleagues concluded in their report.

Dr. Schäfer reported no conflicts of interest. Coauthors reported disclosures outside of the submitted work including Nucletron Operations BV, Elekta Company, Merck Serono, Novocure, AstraZeneca, and Bristol-Myers Squibb, among others.

SOURCE: Schäfer R et al. Lancet Oncol. 2018 Apr 22. doi: 10.1016/S1470-2045(18)30195-5.

In women with breast cancer undergoing breast-conserving surgery, accelerated partial breast irradiation (APBI) using multicatheter brachytherapy does not negatively affect quality of life, compared with standard whole breast irradiation, investigators have reported.

Patients reported similar quality of life scores for multicatheter brachytherapy–based APBI and whole breast irradiation in the study by the Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).

Moreover, breast symptom scores were significantly worse for whole-breast radiation, Rebekka Schäfer, MD, of the department of radiation oncology at the University Hospital Würzburg (Germany) and colleagues reported in Lancet Oncology.

“This trial provides further clinical evidence that APBI with interstitial brachytherapy can be considered as an alternative treatment option after breast-conserving surgery for patients with low-risk breast cancer,” Dr. Schäfer and coauthors wrote.

In several previous studies, APBI has been shown to have clinical outcomes equivalent to those of whole breast irradiation in terms of disease recurrence, survival, and treatment side effects, they added.

The quality of life findings in the present report come from long-term follow-up of a randomized, controlled, phase 3 trial conducted at 16 European centers. This study included 1,184 women with early breast cancer randomly who, after receiving breast-conserving surgery, were assigned either to APBI that used multicatheter brachytherapy or to whole breast irradiation.

Women in the study completed validated quality of life questionnaires right before and right after radiotherapy, as well as during follow-up.

A little more than half of the women in each group completed the quality of life questionnaires after the treatment and again at follow-up, investigators said.

Global health status was stable over time in both groups, investigators reported. In the APBI group, global health status score on a scale of 0-100 was 65.6 right after the procedure and 66.2 at 5 years; similarly, scores in the whole breast irradiation group were 64.6 after radiotherapy and 66.0 at 5 years.

The only quality of life difference between arms that investigators characterized as moderately clinically relevant was in breast symptom scores, which were significantly worse in the whole breast radiation group right after radiotherapy (difference of means, 13.6; 95% CI, 9.7-17.5; P less than .0001) and at 3-month follow-up (difference of means, 12.7; 95% CI, 9.8-15.6; P less than .0001).

Emotional functioning, fatigue, and financial difficulty scores in the APBI group were “slightly better” than in the whole breast radiation group right after radiotherapy and at a 3-month follow-up, investigators reported; however, at 5 year follow-up, there were no significant differences between arms in those measures.

“Our findings show that APBI using multicatheter interstitial brachytherapy does not result in clinically significant deterioration of overall quality of life and that the different domains of quality of life after APBI were not worse in comparison with whole breast irradiation in terms of clinically relevant differences,” Dr. Schäfer and colleagues concluded in their report.

Dr. Schäfer reported no conflicts of interest. Coauthors reported disclosures outside of the submitted work including Nucletron Operations BV, Elekta Company, Merck Serono, Novocure, AstraZeneca, and Bristol-Myers Squibb, among others.

SOURCE: Schäfer R et al. Lancet Oncol. 2018 Apr 22. doi: 10.1016/S1470-2045(18)30195-5.

When Surgeon General Jerome Adams issued an advisory calling for more people to carry naloxone — not just people at overdose risk, but also friends and family — experts and advocates were almost giddy.

This is an “unequivocally positive” step forward, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University.

And not necessarily a surprise. Adams, who previously was Indiana’s health commissioner, was recruited to be the nation’s top doctor in part because of his work with then-Gov. Mike Pence, now the vice president. In Indiana, Adams pushed for harm-reduction approaches, which included expanded access to naloxone and the implementation of a needle exchange to combat the state’s much-publicized HIV outbreak, which began in 2015 and was linked to injection drug use.

Others cautioned, though, that his have-naloxone-will-carry recommendation is at best limited in what it can achieve, in part because the drug is relatively expensive.

Kaiser Health News breaks down what the advisory means, experts’ concerns and what policy approaches may be in the pipeline.

Many public health advocates applaud the surgeon general’s position.

Naloxone, which is a drug that can keep drug users alive by reversing opioid overdoses, is viewed by many as the cornerstone of the harm-reduction approach to the epidemic. Experts say people with addiction problems should carry it, and so should their family, friends and acquaintances.

“We want to put it more in reach,” said Traci Green, an associate professor of emergency medicine and community health sciences at Boston University, who has extensively researched the opioid abuse crisis. “It could not have been a better endorsement.”

Others, including Diane Goodman, who penned a recent Medscape commentary reflecting on the advisory, wonder whether this is a “rational” response to the scourge, since opioid addiction is one of many health problems people might encounter in everyday life and for which treatment options are still limited.

“I’m not sure it makes much more sense than any of us carrying a bottle of nitroglycerin to treat patients with end-stage angina,” wrote Goodman, an acute-care nurse practitioner, referring to chest pain.

“What, exactly, are we offering to addicts once their condition has been reversed?” she asked, noting that without treatment and therapy programs that help wean people from addiction “the odds of survival for any length of time remain low, no matter how much reversal medication is kept nearby.”

Results would likely be limited by naloxone’s price tag.

Take Baltimore, which has been hit particularly hard by the opioid epidemic. Its health department already has pushed for more people to carry naloxone.

But the drug’s price is an issue, said Dr. Leana Wen, the city’s health commissioner, and an emergency physician. She suggested that the federal government negotiate directly for a lower price, or give more money to organizations and agencies like hers so they can afford to maintain an adequate supply.

“Every day, people are calling us at the Baltimore City Health Department and requesting naloxone, and I have to tell them I can’t afford for them to have it,” Wen said.

The drug is available in generic form, which can be stored in a vial and injected via a needle, as well as in patented products, such as the nasal spray Narcan, sold by ADAPT Pharmaceuticals, and Kaleo’s Evzio, a talking auto-injector.

Generic naloxone costs $20 to $40 per dose. Narcan, the nasal spray, costs $125 for a two-dose carton, according to ADAPT’s website. A two-pack of Evzio costs close to $4,000, according to GoodRx.

Health departments and first responders qualify for a discounted rate of $75 per carton of Narcan. Kaleo has made Evzio coupons available to consumers, so that some will not have a copay, and it advertises a discount for federal and state agencies.

Skeptics point out that similar methods have been used to build brand loyalty and potentially make a particular product a household name. That’s how Epi-Pen became synonymous with epinephrine for the treatment of anaphylactic shock.

“There’s clearly some overlap” here between the pricing strategies used by naloxone manufacturers and Epi-Pen distributor Mylan, said Richard Evans, co-founder of SSR Health, which tracks the pharmaceutical industry.

But it’s not a perfect comparison. The presence of low-cost generics changes the calculus, he said, as does the different level of demand.

Nonprofit organizations and health care providers keenly feel the pressures of increasing demand and cost.

Experts say price breaks on naloxone are not sufficient to cover the costs on the ground.

“Sixty-four thousand people lost their lives [nationally in 2016] — that’s someone every 12 minutes,” said Justin Phillips, executive director of Overdose Lifeline, an Indianapolis-based nonprofit. “Ten free kits is not going to be enough.”

Phillips said her organization relies on generic naloxone, which is the least expensive formulation. It’s the only feasible option, using dedicated grant money the group received from the state attorney general’s office as part of a program funded by a settlement with pharmaceutical companies.

But that money is almost dried up. “We need to be able to access naloxone — which I’m told is pennies to make — for the pennies it cost to make it,” Phillips said.

Phillips, who worked with Adams when he ran Indiana’s health department, said she has discussed the need for naloxone funding with the surgeon general, but never its price.

Pharmacies assess the hurdles of distribution.

Local pharmacies are key in this chain, but the overdose antidote is new territory for many pharmacists, said Randy Hitchens, the executive vice president of the Indiana Pharmacists Alliance. He said in 2015, when Adams began his push to get naloxone into the hands of drug users and their families, only one or two retail pharmacies carried it.

“This has always been an emergency room drug. Retail pharmacists typically were not used to dealing with [it],” Hitchens said. “A lot were probably saying, ‘What in the devil is naloxone?’”

Today, he estimates 60 to 70 percent of Indiana’s more than 1,100 retail pharmacies carry the drug. Walgreens, the pharmacy chain, has committed to stocking Narcan.

Access, though, is always subject to retail pressures.

“If pharmacies are not seeing a steady stream coming in asking for it, they won’t be incentivized to carry it on their shelves,” said Daniel Raymond, the deputy director of policy and planning for the Harm Reduction Coalition.

A patchwork of other decentralized sources for naloxone exist: syringe-exchange vans, county and state health departments, churches and community centers, all trying to find ways to get overdose medication into the hands of people who need it.

That supply stream “meets people where they are,” Raymond said, but those little programs don’t have the muscle to negotiate discounted prices.

“Individual health programs are trying to navigate the crisis on their own, but when you see … growing demand and limited supply, it’s a role for federal intervention,” Raymond said.

He’d like to see the federal government step in to negotiate prices where smaller programs can’t.

The surgeon general’s message is one part of Washington’s broader response to the epidemic. But even as Congress crafts an opioid epidemic response package, it’s not clear it will tackle these concerns.

In the House of Representatives’ Energy and Commerce Committee, one bill being discussed would require all state Medicaid programs to cover at least one form of naloxone. Currently, not all state Medicaid programs do so.

A Senate bill would authorize $300 million annually to equip first responders with naloxone.

But critics say those approaches still don’t address the underlying problems: cost and funding.

“You can either make naloxone available, at a much discounted price, or we need to have a lot more resources in order to purchase it,” Wen said. “I don’t care which one. My only concern is the health and well-being of our residents.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

When Surgeon General Jerome Adams issued an advisory calling for more people to carry naloxone — not just people at overdose risk, but also friends and family — experts and advocates were almost giddy.

This is an “unequivocally positive” step forward, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University.

And not necessarily a surprise. Adams, who previously was Indiana’s health commissioner, was recruited to be the nation’s top doctor in part because of his work with then-Gov. Mike Pence, now the vice president. In Indiana, Adams pushed for harm-reduction approaches, which included expanded access to naloxone and the implementation of a needle exchange to combat the state’s much-publicized HIV outbreak, which began in 2015 and was linked to injection drug use.

Others cautioned, though, that his have-naloxone-will-carry recommendation is at best limited in what it can achieve, in part because the drug is relatively expensive.

Kaiser Health News breaks down what the advisory means, experts’ concerns and what policy approaches may be in the pipeline.

Many public health advocates applaud the surgeon general’s position.

Naloxone, which is a drug that can keep drug users alive by reversing opioid overdoses, is viewed by many as the cornerstone of the harm-reduction approach to the epidemic. Experts say people with addiction problems should carry it, and so should their family, friends and acquaintances.

“We want to put it more in reach,” said Traci Green, an associate professor of emergency medicine and community health sciences at Boston University, who has extensively researched the opioid abuse crisis. “It could not have been a better endorsement.”

Others, including Diane Goodman, who penned a recent Medscape commentary reflecting on the advisory, wonder whether this is a “rational” response to the scourge, since opioid addiction is one of many health problems people might encounter in everyday life and for which treatment options are still limited.

“I’m not sure it makes much more sense than any of us carrying a bottle of nitroglycerin to treat patients with end-stage angina,” wrote Goodman, an acute-care nurse practitioner, referring to chest pain.

“What, exactly, are we offering to addicts once their condition has been reversed?” she asked, noting that without treatment and therapy programs that help wean people from addiction “the odds of survival for any length of time remain low, no matter how much reversal medication is kept nearby.”

Results would likely be limited by naloxone’s price tag.

Take Baltimore, which has been hit particularly hard by the opioid epidemic. Its health department already has pushed for more people to carry naloxone.

But the drug’s price is an issue, said Dr. Leana Wen, the city’s health commissioner, and an emergency physician. She suggested that the federal government negotiate directly for a lower price, or give more money to organizations and agencies like hers so they can afford to maintain an adequate supply.

“Every day, people are calling us at the Baltimore City Health Department and requesting naloxone, and I have to tell them I can’t afford for them to have it,” Wen said.

The drug is available in generic form, which can be stored in a vial and injected via a needle, as well as in patented products, such as the nasal spray Narcan, sold by ADAPT Pharmaceuticals, and Kaleo’s Evzio, a talking auto-injector.

Generic naloxone costs $20 to $40 per dose. Narcan, the nasal spray, costs $125 for a two-dose carton, according to ADAPT’s website. A two-pack of Evzio costs close to $4,000, according to GoodRx.

Health departments and first responders qualify for a discounted rate of $75 per carton of Narcan. Kaleo has made Evzio coupons available to consumers, so that some will not have a copay, and it advertises a discount for federal and state agencies.

Skeptics point out that similar methods have been used to build brand loyalty and potentially make a particular product a household name. That’s how Epi-Pen became synonymous with epinephrine for the treatment of anaphylactic shock.

“There’s clearly some overlap” here between the pricing strategies used by naloxone manufacturers and Epi-Pen distributor Mylan, said Richard Evans, co-founder of SSR Health, which tracks the pharmaceutical industry.

But it’s not a perfect comparison. The presence of low-cost generics changes the calculus, he said, as does the different level of demand.

Nonprofit organizations and health care providers keenly feel the pressures of increasing demand and cost.

Experts say price breaks on naloxone are not sufficient to cover the costs on the ground.

“Sixty-four thousand people lost their lives [nationally in 2016] — that’s someone every 12 minutes,” said Justin Phillips, executive director of Overdose Lifeline, an Indianapolis-based nonprofit. “Ten free kits is not going to be enough.”

Phillips said her organization relies on generic naloxone, which is the least expensive formulation. It’s the only feasible option, using dedicated grant money the group received from the state attorney general’s office as part of a program funded by a settlement with pharmaceutical companies.

But that money is almost dried up. “We need to be able to access naloxone — which I’m told is pennies to make — for the pennies it cost to make it,” Phillips said.

Phillips, who worked with Adams when he ran Indiana’s health department, said she has discussed the need for naloxone funding with the surgeon general, but never its price.

Pharmacies assess the hurdles of distribution.

Local pharmacies are key in this chain, but the overdose antidote is new territory for many pharmacists, said Randy Hitchens, the executive vice president of the Indiana Pharmacists Alliance. He said in 2015, when Adams began his push to get naloxone into the hands of drug users and their families, only one or two retail pharmacies carried it.

“This has always been an emergency room drug. Retail pharmacists typically were not used to dealing with [it],” Hitchens said. “A lot were probably saying, ‘What in the devil is naloxone?’”

Today, he estimates 60 to 70 percent of Indiana’s more than 1,100 retail pharmacies carry the drug. Walgreens, the pharmacy chain, has committed to stocking Narcan.

Access, though, is always subject to retail pressures.

“If pharmacies are not seeing a steady stream coming in asking for it, they won’t be incentivized to carry it on their shelves,” said Daniel Raymond, the deputy director of policy and planning for the Harm Reduction Coalition.

A patchwork of other decentralized sources for naloxone exist: syringe-exchange vans, county and state health departments, churches and community centers, all trying to find ways to get overdose medication into the hands of people who need it.

That supply stream “meets people where they are,” Raymond said, but those little programs don’t have the muscle to negotiate discounted prices.

“Individual health programs are trying to navigate the crisis on their own, but when you see … growing demand and limited supply, it’s a role for federal intervention,” Raymond said.

He’d like to see the federal government step in to negotiate prices where smaller programs can’t.

The surgeon general’s message is one part of Washington’s broader response to the epidemic. But even as Congress crafts an opioid epidemic response package, it’s not clear it will tackle these concerns.

In the House of Representatives’ Energy and Commerce Committee, one bill being discussed would require all state Medicaid programs to cover at least one form of naloxone. Currently, not all state Medicaid programs do so.

A Senate bill would authorize $300 million annually to equip first responders with naloxone.

But critics say those approaches still don’t address the underlying problems: cost and funding.

“You can either make naloxone available, at a much discounted price, or we need to have a lot more resources in order to purchase it,” Wen said. “I don’t care which one. My only concern is the health and well-being of our residents.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

When Surgeon General Jerome Adams issued an advisory calling for more people to carry naloxone — not just people at overdose risk, but also friends and family — experts and advocates were almost giddy.

This is an “unequivocally positive” step forward, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University.

And not necessarily a surprise. Adams, who previously was Indiana’s health commissioner, was recruited to be the nation’s top doctor in part because of his work with then-Gov. Mike Pence, now the vice president. In Indiana, Adams pushed for harm-reduction approaches, which included expanded access to naloxone and the implementation of a needle exchange to combat the state’s much-publicized HIV outbreak, which began in 2015 and was linked to injection drug use.

Others cautioned, though, that his have-naloxone-will-carry recommendation is at best limited in what it can achieve, in part because the drug is relatively expensive.

Kaiser Health News breaks down what the advisory means, experts’ concerns and what policy approaches may be in the pipeline.

Many public health advocates applaud the surgeon general’s position.

Naloxone, which is a drug that can keep drug users alive by reversing opioid overdoses, is viewed by many as the cornerstone of the harm-reduction approach to the epidemic. Experts say people with addiction problems should carry it, and so should their family, friends and acquaintances.

“We want to put it more in reach,” said Traci Green, an associate professor of emergency medicine and community health sciences at Boston University, who has extensively researched the opioid abuse crisis. “It could not have been a better endorsement.”

Others, including Diane Goodman, who penned a recent Medscape commentary reflecting on the advisory, wonder whether this is a “rational” response to the scourge, since opioid addiction is one of many health problems people might encounter in everyday life and for which treatment options are still limited.

“I’m not sure it makes much more sense than any of us carrying a bottle of nitroglycerin to treat patients with end-stage angina,” wrote Goodman, an acute-care nurse practitioner, referring to chest pain.

“What, exactly, are we offering to addicts once their condition has been reversed?” she asked, noting that without treatment and therapy programs that help wean people from addiction “the odds of survival for any length of time remain low, no matter how much reversal medication is kept nearby.”

Results would likely be limited by naloxone’s price tag.

Take Baltimore, which has been hit particularly hard by the opioid epidemic. Its health department already has pushed for more people to carry naloxone.

But the drug’s price is an issue, said Dr. Leana Wen, the city’s health commissioner, and an emergency physician. She suggested that the federal government negotiate directly for a lower price, or give more money to organizations and agencies like hers so they can afford to maintain an adequate supply.

“Every day, people are calling us at the Baltimore City Health Department and requesting naloxone, and I have to tell them I can’t afford for them to have it,” Wen said.

The drug is available in generic form, which can be stored in a vial and injected via a needle, as well as in patented products, such as the nasal spray Narcan, sold by ADAPT Pharmaceuticals, and Kaleo’s Evzio, a talking auto-injector.

Generic naloxone costs $20 to $40 per dose. Narcan, the nasal spray, costs $125 for a two-dose carton, according to ADAPT’s website. A two-pack of Evzio costs close to $4,000, according to GoodRx.

Health departments and first responders qualify for a discounted rate of $75 per carton of Narcan. Kaleo has made Evzio coupons available to consumers, so that some will not have a copay, and it advertises a discount for federal and state agencies.

Skeptics point out that similar methods have been used to build brand loyalty and potentially make a particular product a household name. That’s how Epi-Pen became synonymous with epinephrine for the treatment of anaphylactic shock.

“There’s clearly some overlap” here between the pricing strategies used by naloxone manufacturers and Epi-Pen distributor Mylan, said Richard Evans, co-founder of SSR Health, which tracks the pharmaceutical industry.

But it’s not a perfect comparison. The presence of low-cost generics changes the calculus, he said, as does the different level of demand.

Nonprofit organizations and health care providers keenly feel the pressures of increasing demand and cost.

Experts say price breaks on naloxone are not sufficient to cover the costs on the ground.

“Sixty-four thousand people lost their lives [nationally in 2016] — that’s someone every 12 minutes,” said Justin Phillips, executive director of Overdose Lifeline, an Indianapolis-based nonprofit. “Ten free kits is not going to be enough.”

Phillips said her organization relies on generic naloxone, which is the least expensive formulation. It’s the only feasible option, using dedicated grant money the group received from the state attorney general’s office as part of a program funded by a settlement with pharmaceutical companies.

But that money is almost dried up. “We need to be able to access naloxone — which I’m told is pennies to make — for the pennies it cost to make it,” Phillips said.

Phillips, who worked with Adams when he ran Indiana’s health department, said she has discussed the need for naloxone funding with the surgeon general, but never its price.

Pharmacies assess the hurdles of distribution.

Local pharmacies are key in this chain, but the overdose antidote is new territory for many pharmacists, said Randy Hitchens, the executive vice president of the Indiana Pharmacists Alliance. He said in 2015, when Adams began his push to get naloxone into the hands of drug users and their families, only one or two retail pharmacies carried it.

“This has always been an emergency room drug. Retail pharmacists typically were not used to dealing with [it],” Hitchens said. “A lot were probably saying, ‘What in the devil is naloxone?’”

Today, he estimates 60 to 70 percent of Indiana’s more than 1,100 retail pharmacies carry the drug. Walgreens, the pharmacy chain, has committed to stocking Narcan.

Access, though, is always subject to retail pressures.

“If pharmacies are not seeing a steady stream coming in asking for it, they won’t be incentivized to carry it on their shelves,” said Daniel Raymond, the deputy director of policy and planning for the Harm Reduction Coalition.

A patchwork of other decentralized sources for naloxone exist: syringe-exchange vans, county and state health departments, churches and community centers, all trying to find ways to get overdose medication into the hands of people who need it.

That supply stream “meets people where they are,” Raymond said, but those little programs don’t have the muscle to negotiate discounted prices.

“Individual health programs are trying to navigate the crisis on their own, but when you see … growing demand and limited supply, it’s a role for federal intervention,” Raymond said.

He’d like to see the federal government step in to negotiate prices where smaller programs can’t.

The surgeon general’s message is one part of Washington’s broader response to the epidemic. But even as Congress crafts an opioid epidemic response package, it’s not clear it will tackle these concerns.

In the House of Representatives’ Energy and Commerce Committee, one bill being discussed would require all state Medicaid programs to cover at least one form of naloxone. Currently, not all state Medicaid programs do so.

A Senate bill would authorize $300 million annually to equip first responders with naloxone.

But critics say those approaches still don’t address the underlying problems: cost and funding.

“You can either make naloxone available, at a much discounted price, or we need to have a lot more resources in order to purchase it,” Wen said. “I don’t care which one. My only concern is the health and well-being of our residents.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

A validated screening tool may help to identify older adults with early-stage non–small cell lung cancer who could benefit from stereotactic body radiotherapy with curative intent, investigators contend,

Among 43 patients aged 65-89 years (median age 78) with stage T1 or T2 non–small cell lung cancer tumors who underwent stereotactic body radiotherapy (SBRT), scores of 13 or higher on the Geriatric 8 (G8) screening tool were associated with high 2- and 5-year survival rates, reported Toshiya Maebayashi, MD, PhD, from Nihon University in Tokyo, and colleagues.

“Regardless of age, the G8 screening tool may enable us to identify relatively healthy seniors who would be likely to have longer survival times after SBRT for early lung cancer,” they wrote in a study published in the Journal of Geriatric Oncology.

The G8 Screening tool assesses the health status of older patients according to their food intake, recent weight loss, mobility, neuropsychological problems, body mass index, prescription drug use, and age. Higher scores on the scale, which can range from 0 to 17, are indicative of better health status.

To see whether the G8 tool could predict the benefits of SBRT, the investigators performed a retrospective study of long-term outcomes in older patients with early-stage non–small cell lung cancer.

They included 34 patients with T1 tumors and 9 patients with T2 tumors who underwent SBRT from 2004 to 2011 at their center. The median follow-up was 46 months (range, 3-112 months).

Patients with T1 tumors had G8 scores ranging from 9 to 16 (median 13). Patients with T2 tumors had scores ranging from 8 to 15 (median 12).

SOURCE: Maebayashi T et al. J Geriatr Oncol. 2018 Mar 22. doi: 10.1016/j.jgo.2018.03.005.

A validated screening tool may help to identify older adults with early-stage non–small cell lung cancer who could benefit from stereotactic body radiotherapy with curative intent, investigators contend,

Among 43 patients aged 65-89 years (median age 78) with stage T1 or T2 non–small cell lung cancer tumors who underwent stereotactic body radiotherapy (SBRT), scores of 13 or higher on the Geriatric 8 (G8) screening tool were associated with high 2- and 5-year survival rates, reported Toshiya Maebayashi, MD, PhD, from Nihon University in Tokyo, and colleagues.

“Regardless of age, the G8 screening tool may enable us to identify relatively healthy seniors who would be likely to have longer survival times after SBRT for early lung cancer,” they wrote in a study published in the Journal of Geriatric Oncology.

The G8 Screening tool assesses the health status of older patients according to their food intake, recent weight loss, mobility, neuropsychological problems, body mass index, prescription drug use, and age. Higher scores on the scale, which can range from 0 to 17, are indicative of better health status.

To see whether the G8 tool could predict the benefits of SBRT, the investigators performed a retrospective study of long-term outcomes in older patients with early-stage non–small cell lung cancer.

They included 34 patients with T1 tumors and 9 patients with T2 tumors who underwent SBRT from 2004 to 2011 at their center. The median follow-up was 46 months (range, 3-112 months).

Patients with T1 tumors had G8 scores ranging from 9 to 16 (median 13). Patients with T2 tumors had scores ranging from 8 to 15 (median 12).

SOURCE: Maebayashi T et al. J Geriatr Oncol. 2018 Mar 22. doi: 10.1016/j.jgo.2018.03.005.

A validated screening tool may help to identify older adults with early-stage non–small cell lung cancer who could benefit from stereotactic body radiotherapy with curative intent, investigators contend,

Among 43 patients aged 65-89 years (median age 78) with stage T1 or T2 non–small cell lung cancer tumors who underwent stereotactic body radiotherapy (SBRT), scores of 13 or higher on the Geriatric 8 (G8) screening tool were associated with high 2- and 5-year survival rates, reported Toshiya Maebayashi, MD, PhD, from Nihon University in Tokyo, and colleagues.

“Regardless of age, the G8 screening tool may enable us to identify relatively healthy seniors who would be likely to have longer survival times after SBRT for early lung cancer,” they wrote in a study published in the Journal of Geriatric Oncology.

The G8 Screening tool assesses the health status of older patients according to their food intake, recent weight loss, mobility, neuropsychological problems, body mass index, prescription drug use, and age. Higher scores on the scale, which can range from 0 to 17, are indicative of better health status.

To see whether the G8 tool could predict the benefits of SBRT, the investigators performed a retrospective study of long-term outcomes in older patients with early-stage non–small cell lung cancer.

They included 34 patients with T1 tumors and 9 patients with T2 tumors who underwent SBRT from 2004 to 2011 at their center. The median follow-up was 46 months (range, 3-112 months).

Patients with T1 tumors had G8 scores ranging from 9 to 16 (median 13). Patients with T2 tumors had scores ranging from 8 to 15 (median 12).

SOURCE: Maebayashi T et al. J Geriatr Oncol. 2018 Mar 22. doi: 10.1016/j.jgo.2018.03.005.

Colchicine may be an effective alternative treatment for the rare inflammatory skin disorder prurigo pigmentosa, said Isa An, MD of Dicle University, Diyarbakır, Turkey, and associates.

They described a 16-year-old Turkish girl who presented with an itchy rash on her back of 4 weeks’ duration. Treatment with oral antihistamines, and topical and systemic steroids were ineffective. On physical examination, there were erythematous macules, sporadic excoriated papules, and reticulate hyperpigmentation on her back. Complete blood count and liver function tests were normal.

Histopathologic examination showed “infrequent necrotic keratinocytes with marked acanthosis and spongiosis on the epidermis, increased basal layer pigmentation, and perivascular lymphocytic infiltrate on the upper dermis.” Because of these findings, a diagnosis of prurigo pigmentosa was made, they wrote in Pediatric Dermatology.

Treatment with colchicine 1.5 g/day was started, and while the lesions resolved in the second week of treatment, the reticulate hyperpigmentation remained, Dr. An and her associates reported. The reticulate hyperpigmentation did not regress during the first month of treatment. At 6-month follow-up, there were no more symptoms of itch or recurrence of the original lesions. The reticulate hyperpigmentation was not treated.

A rare inflammatory skin disease seen principally in young Japanese women, prurigo pigmentosa has been reported in both men and women of other ethnicities, they said. Generally, macrolide antibiotics, such as clarithromycin, dapsone, and isotretinoin have been used effectively to treat prurigo pigmentosa. Minocycline and doxycycline are considered to be effective in treating this skin disease because of their anti-inflammatory effects and because they have “been shown to inhibit the synthesis of cytokines and chemokines that regulate leukocyte differentiation and activation.” Leukocyte differentiation and activation “are key pathologic features of prurigo pigmentosa,” the authors added.

Colchicine, a neutral, liposoluble tricyclic alkaloid, “exerts an anti-inflammatory effect by inhibiting neutrophil chemotaxis,” said Dr. An and her associates, which is why it is thought to be a potentially effective drug for treating prurigo pigmentosa, as shown in this case study. “Further studies are required to verify whether colchicine is an effective treatment option,” for prurigo pigmentosa, they added.

SOURCE: An I et al. Pediatr Dermatol. 2018 Apr 11. doi: 10.1111/pde.13480.

Colchicine may be an effective alternative treatment for the rare inflammatory skin disorder prurigo pigmentosa, said Isa An, MD of Dicle University, Diyarbakır, Turkey, and associates.

They described a 16-year-old Turkish girl who presented with an itchy rash on her back of 4 weeks’ duration. Treatment with oral antihistamines, and topical and systemic steroids were ineffective. On physical examination, there were erythematous macules, sporadic excoriated papules, and reticulate hyperpigmentation on her back. Complete blood count and liver function tests were normal.

Histopathologic examination showed “infrequent necrotic keratinocytes with marked acanthosis and spongiosis on the epidermis, increased basal layer pigmentation, and perivascular lymphocytic infiltrate on the upper dermis.” Because of these findings, a diagnosis of prurigo pigmentosa was made, they wrote in Pediatric Dermatology.

Treatment with colchicine 1.5 g/day was started, and while the lesions resolved in the second week of treatment, the reticulate hyperpigmentation remained, Dr. An and her associates reported. The reticulate hyperpigmentation did not regress during the first month of treatment. At 6-month follow-up, there were no more symptoms of itch or recurrence of the original lesions. The reticulate hyperpigmentation was not treated.

A rare inflammatory skin disease seen principally in young Japanese women, prurigo pigmentosa has been reported in both men and women of other ethnicities, they said. Generally, macrolide antibiotics, such as clarithromycin, dapsone, and isotretinoin have been used effectively to treat prurigo pigmentosa. Minocycline and doxycycline are considered to be effective in treating this skin disease because of their anti-inflammatory effects and because they have “been shown to inhibit the synthesis of cytokines and chemokines that regulate leukocyte differentiation and activation.” Leukocyte differentiation and activation “are key pathologic features of prurigo pigmentosa,” the authors added.

Colchicine, a neutral, liposoluble tricyclic alkaloid, “exerts an anti-inflammatory effect by inhibiting neutrophil chemotaxis,” said Dr. An and her associates, which is why it is thought to be a potentially effective drug for treating prurigo pigmentosa, as shown in this case study. “Further studies are required to verify whether colchicine is an effective treatment option,” for prurigo pigmentosa, they added.

SOURCE: An I et al. Pediatr Dermatol. 2018 Apr 11. doi: 10.1111/pde.13480.

Colchicine may be an effective alternative treatment for the rare inflammatory skin disorder prurigo pigmentosa, said Isa An, MD of Dicle University, Diyarbakır, Turkey, and associates.

They described a 16-year-old Turkish girl who presented with an itchy rash on her back of 4 weeks’ duration. Treatment with oral antihistamines, and topical and systemic steroids were ineffective. On physical examination, there were erythematous macules, sporadic excoriated papules, and reticulate hyperpigmentation on her back. Complete blood count and liver function tests were normal.

Histopathologic examination showed “infrequent necrotic keratinocytes with marked acanthosis and spongiosis on the epidermis, increased basal layer pigmentation, and perivascular lymphocytic infiltrate on the upper dermis.” Because of these findings, a diagnosis of prurigo pigmentosa was made, they wrote in Pediatric Dermatology.

Treatment with colchicine 1.5 g/day was started, and while the lesions resolved in the second week of treatment, the reticulate hyperpigmentation remained, Dr. An and her associates reported. The reticulate hyperpigmentation did not regress during the first month of treatment. At 6-month follow-up, there were no more symptoms of itch or recurrence of the original lesions. The reticulate hyperpigmentation was not treated.

A rare inflammatory skin disease seen principally in young Japanese women, prurigo pigmentosa has been reported in both men and women of other ethnicities, they said. Generally, macrolide antibiotics, such as clarithromycin, dapsone, and isotretinoin have been used effectively to treat prurigo pigmentosa. Minocycline and doxycycline are considered to be effective in treating this skin disease because of their anti-inflammatory effects and because they have “been shown to inhibit the synthesis of cytokines and chemokines that regulate leukocyte differentiation and activation.” Leukocyte differentiation and activation “are key pathologic features of prurigo pigmentosa,” the authors added.

Colchicine, a neutral, liposoluble tricyclic alkaloid, “exerts an anti-inflammatory effect by inhibiting neutrophil chemotaxis,” said Dr. An and her associates, which is why it is thought to be a potentially effective drug for treating prurigo pigmentosa, as shown in this case study. “Further studies are required to verify whether colchicine is an effective treatment option,” for prurigo pigmentosa, they added.

SOURCE: An I et al. Pediatr Dermatol. 2018 Apr 11. doi: 10.1111/pde.13480.