MADRID – A combination of two immune checkpoint inhibitors was superior to the tyrosine kinase inhibitor (TKI) sunitinib (Sutent) in first-line treatment of patients with advanced or metastatic renal cell carcinoma (RCC), investigators reported

Median overall survival (OS) among 425 patients with intermediate- or poor-risk treatment-naive advanced/metastatic clear-cell RCC treated with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was not reached after 32 months of follow-up. In contrast, the median OS for 422 patients treated with sunitinib was 26 months, reported Bernard Escudier, MD from the Institut Gustave Roussy in Villejuif, France.

[email protected]

MADRID – A combination of two immune checkpoint inhibitors was superior to the tyrosine kinase inhibitor (TKI) sunitinib (Sutent) in first-line treatment of patients with advanced or metastatic renal cell carcinoma (RCC), investigators reported

Median overall survival (OS) among 425 patients with intermediate- or poor-risk treatment-naive advanced/metastatic clear-cell RCC treated with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was not reached after 32 months of follow-up. In contrast, the median OS for 422 patients treated with sunitinib was 26 months, reported Bernard Escudier, MD from the Institut Gustave Roussy in Villejuif, France.

[email protected]

MADRID – A combination of two immune checkpoint inhibitors was superior to the tyrosine kinase inhibitor (TKI) sunitinib (Sutent) in first-line treatment of patients with advanced or metastatic renal cell carcinoma (RCC), investigators reported

Median overall survival (OS) among 425 patients with intermediate- or poor-risk treatment-naive advanced/metastatic clear-cell RCC treated with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was not reached after 32 months of follow-up. In contrast, the median OS for 422 patients treated with sunitinib was 26 months, reported Bernard Escudier, MD from the Institut Gustave Roussy in Villejuif, France.

[email protected]

SAN FRANCISCO – In just 6 months, a commonsense quality improvement program increased the rate of blood pressure control from 66% to 75% among 21,035 hypertensive patients at 16 primary care clinics in northwestern South Carolina.

The American Medical Association collaborated with the Care Coordination Institute in Greenville, S.C., to develop the program, dubbed “MAP,” which stands for measuring blood pressure accurately; acting rapidly to manage uncontrolled blood pressure; and partnering with patients to promote blood pressure self-management.

[email protected]

SAN FRANCISCO – In just 6 months, a commonsense quality improvement program increased the rate of blood pressure control from 66% to 75% among 21,035 hypertensive patients at 16 primary care clinics in northwestern South Carolina.

The American Medical Association collaborated with the Care Coordination Institute in Greenville, S.C., to develop the program, dubbed “MAP,” which stands for measuring blood pressure accurately; acting rapidly to manage uncontrolled blood pressure; and partnering with patients to promote blood pressure self-management.

[email protected]

SAN FRANCISCO – In just 6 months, a commonsense quality improvement program increased the rate of blood pressure control from 66% to 75% among 21,035 hypertensive patients at 16 primary care clinics in northwestern South Carolina.

The American Medical Association collaborated with the Care Coordination Institute in Greenville, S.C., to develop the program, dubbed “MAP,” which stands for measuring blood pressure accurately; acting rapidly to manage uncontrolled blood pressure; and partnering with patients to promote blood pressure self-management.

[email protected]

The Food and Drug Administration has approved abemaciclib (Verzenio) to be given in combination with fulvestrant, to treat patients who have hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy.

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The Food and Drug Administration has approved abemaciclib (Verzenio) to be given in combination with fulvestrant, to treat patients who have hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy.

[email protected]

The Food and Drug Administration has approved abemaciclib (Verzenio) to be given in combination with fulvestrant, to treat patients who have hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy.

[email protected]

The way Edward J. Bujold, MD, sees it, the patient-centered medical home (PCMH) as a model of care has become unsustainable in the current health care landscape.

In an opinion piece published online in JAMA Internal Medicine, Dr. Bujold describes how he reinvested Medicare incentive payments to build a solo family medicine practice into a patient-centered medical home with a staff of 14 full-time and part-time employees, including an embedded psychologist, pharmacist, physical therapist, and dietitian.

“Although only about one-quarter of the patients cared for at our practice are Medicare beneficiaries, other insurers and those they insure have benefited immensely,” wrote Dr. Bujold, owner of Granite Falls (N.C.) Family Medical Care Center (JAMA Internal Med. 2017 Sept 25. doi: 10.1001/jamainternmed.2017.4651).

The bonuses from the Center for Medicare & Medicaid Services’ Meaningful Use and Physician Quality Reporting System “enabled us to develop and support the financial structure required to create the PCMH,” he noted. “For the most part, this financial support ended in December 2015. Our financial losses in 2016 are enough to jeopardize the foundation of our PCMH.”

When Congress voted to end the Medicare Sustainable Growth Rate formula, the Primary Care Incentive Payment Program authorized under the Affordable Care Act also ended.

“During 2017, a value-based payment system to replace and hopefully increase our reimbursement is to be phased in,” Dr. Bujold wrote. “The problem for practices like ours is the Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015/Merit-Based Incentive Payment System (MACRA/MIPS) does not take effect until 2019, and there is no guarantee we will receive any more money than we receive now. We may receive less.”

Citing studies from Oregon and from the Patient-Centered Primary Care Collaborative, Dr. Bujold said that for every dollar invested in primary care, the overarching health system saves about $13.

“The 80% reduction in hospital admissions for our practice is a testimony to these savings,” he stated. “The irony for me is that, 5 years ago, I generated a substantial amount of my income from the hospital portion of my practice, because I was seeing an average of five patients per day in the hospital.”

As a result of transitioning his practice to a PCMH, however, he now sees “one or two and sometimes no hospital patients per day.” At the same time, his office’s overhead cost is 65% and increasing – up from 50% when he opened his practice 31 years ago.

Dr. Bujold noted that about 60% of primary care physicians are employed by hospital organizations, which are able to charge a facility fee “above and beyond what the independent primary care physician charges in his or her office. This increases the cost of care in general by 20%-30% and the patient out-of-pocket costs by a factor of 2 or 3.”

In his view, “we have large hospital systems, the pharmaceutical industry, large insurance companies, and other moneyed players and their lobbyists with vested financial interests. The view from my practice is that these industries seem to hold all of the cards, and it is very difficult to move forward. I am more pessimistic than I was 5 years ago.”

Despite his current misgivings, Dr. Bujold ended his opinion piece by stating that the best way to “heal the health care system in the United States” is one directed by primary care and rooted in high-functioning PCMHs.

“The trajectory must be changed,” Dr. Bujold wrote. “In many areas, payers are not supporting PCMH transformation, and states are not engaging practices or working with Medicare to support transformation. Investing in high-functioning PCMH practices is the right thing to do.”

Dr. Bujold disclosed that he is employed by KPN Health as chief physician strategist and is an advisory board member of the Patient-Centered Primary Care Collaborative.

[email protected]

The way Edward J. Bujold, MD, sees it, the patient-centered medical home (PCMH) as a model of care has become unsustainable in the current health care landscape.

In an opinion piece published online in JAMA Internal Medicine, Dr. Bujold describes how he reinvested Medicare incentive payments to build a solo family medicine practice into a patient-centered medical home with a staff of 14 full-time and part-time employees, including an embedded psychologist, pharmacist, physical therapist, and dietitian.

“Although only about one-quarter of the patients cared for at our practice are Medicare beneficiaries, other insurers and those they insure have benefited immensely,” wrote Dr. Bujold, owner of Granite Falls (N.C.) Family Medical Care Center (JAMA Internal Med. 2017 Sept 25. doi: 10.1001/jamainternmed.2017.4651).

The bonuses from the Center for Medicare & Medicaid Services’ Meaningful Use and Physician Quality Reporting System “enabled us to develop and support the financial structure required to create the PCMH,” he noted. “For the most part, this financial support ended in December 2015. Our financial losses in 2016 are enough to jeopardize the foundation of our PCMH.”

When Congress voted to end the Medicare Sustainable Growth Rate formula, the Primary Care Incentive Payment Program authorized under the Affordable Care Act also ended.

“During 2017, a value-based payment system to replace and hopefully increase our reimbursement is to be phased in,” Dr. Bujold wrote. “The problem for practices like ours is the Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015/Merit-Based Incentive Payment System (MACRA/MIPS) does not take effect until 2019, and there is no guarantee we will receive any more money than we receive now. We may receive less.”

Citing studies from Oregon and from the Patient-Centered Primary Care Collaborative, Dr. Bujold said that for every dollar invested in primary care, the overarching health system saves about $13.

“The 80% reduction in hospital admissions for our practice is a testimony to these savings,” he stated. “The irony for me is that, 5 years ago, I generated a substantial amount of my income from the hospital portion of my practice, because I was seeing an average of five patients per day in the hospital.”

As a result of transitioning his practice to a PCMH, however, he now sees “one or two and sometimes no hospital patients per day.” At the same time, his office’s overhead cost is 65% and increasing – up from 50% when he opened his practice 31 years ago.

Dr. Bujold noted that about 60% of primary care physicians are employed by hospital organizations, which are able to charge a facility fee “above and beyond what the independent primary care physician charges in his or her office. This increases the cost of care in general by 20%-30% and the patient out-of-pocket costs by a factor of 2 or 3.”

In his view, “we have large hospital systems, the pharmaceutical industry, large insurance companies, and other moneyed players and their lobbyists with vested financial interests. The view from my practice is that these industries seem to hold all of the cards, and it is very difficult to move forward. I am more pessimistic than I was 5 years ago.”

Despite his current misgivings, Dr. Bujold ended his opinion piece by stating that the best way to “heal the health care system in the United States” is one directed by primary care and rooted in high-functioning PCMHs.

“The trajectory must be changed,” Dr. Bujold wrote. “In many areas, payers are not supporting PCMH transformation, and states are not engaging practices or working with Medicare to support transformation. Investing in high-functioning PCMH practices is the right thing to do.”

Dr. Bujold disclosed that he is employed by KPN Health as chief physician strategist and is an advisory board member of the Patient-Centered Primary Care Collaborative.

[email protected]

The way Edward J. Bujold, MD, sees it, the patient-centered medical home (PCMH) as a model of care has become unsustainable in the current health care landscape.

In an opinion piece published online in JAMA Internal Medicine, Dr. Bujold describes how he reinvested Medicare incentive payments to build a solo family medicine practice into a patient-centered medical home with a staff of 14 full-time and part-time employees, including an embedded psychologist, pharmacist, physical therapist, and dietitian.

“Although only about one-quarter of the patients cared for at our practice are Medicare beneficiaries, other insurers and those they insure have benefited immensely,” wrote Dr. Bujold, owner of Granite Falls (N.C.) Family Medical Care Center (JAMA Internal Med. 2017 Sept 25. doi: 10.1001/jamainternmed.2017.4651).

The bonuses from the Center for Medicare & Medicaid Services’ Meaningful Use and Physician Quality Reporting System “enabled us to develop and support the financial structure required to create the PCMH,” he noted. “For the most part, this financial support ended in December 2015. Our financial losses in 2016 are enough to jeopardize the foundation of our PCMH.”

When Congress voted to end the Medicare Sustainable Growth Rate formula, the Primary Care Incentive Payment Program authorized under the Affordable Care Act also ended.

“During 2017, a value-based payment system to replace and hopefully increase our reimbursement is to be phased in,” Dr. Bujold wrote. “The problem for practices like ours is the Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015/Merit-Based Incentive Payment System (MACRA/MIPS) does not take effect until 2019, and there is no guarantee we will receive any more money than we receive now. We may receive less.”

Citing studies from Oregon and from the Patient-Centered Primary Care Collaborative, Dr. Bujold said that for every dollar invested in primary care, the overarching health system saves about $13.

“The 80% reduction in hospital admissions for our practice is a testimony to these savings,” he stated. “The irony for me is that, 5 years ago, I generated a substantial amount of my income from the hospital portion of my practice, because I was seeing an average of five patients per day in the hospital.”

As a result of transitioning his practice to a PCMH, however, he now sees “one or two and sometimes no hospital patients per day.” At the same time, his office’s overhead cost is 65% and increasing – up from 50% when he opened his practice 31 years ago.

Dr. Bujold noted that about 60% of primary care physicians are employed by hospital organizations, which are able to charge a facility fee “above and beyond what the independent primary care physician charges in his or her office. This increases the cost of care in general by 20%-30% and the patient out-of-pocket costs by a factor of 2 or 3.”

In his view, “we have large hospital systems, the pharmaceutical industry, large insurance companies, and other moneyed players and their lobbyists with vested financial interests. The view from my practice is that these industries seem to hold all of the cards, and it is very difficult to move forward. I am more pessimistic than I was 5 years ago.”

Despite his current misgivings, Dr. Bujold ended his opinion piece by stating that the best way to “heal the health care system in the United States” is one directed by primary care and rooted in high-functioning PCMHs.

“The trajectory must be changed,” Dr. Bujold wrote. “In many areas, payers are not supporting PCMH transformation, and states are not engaging practices or working with Medicare to support transformation. Investing in high-functioning PCMH practices is the right thing to do.”

Dr. Bujold disclosed that he is employed by KPN Health as chief physician strategist and is an advisory board member of the Patient-Centered Primary Care Collaborative.

[email protected]

Discordance in HER2 status between the primary breast tumor and circulating tumor cells (CTCs) in women with HER2-negative metastatic disease was 18.8% in a prospective cohort of patients.

The probability of discordance decreased with increasing age but increased with primary tumors that were hormone-receptor positive, higher grade, and of lobular histology, Amelie De Gregorio, MD, and associates reported in JCO Precision Oncology.

The investigators evaluated the HER2 status of CTCs obtained from women with HER2-negative breast cancer screened in the ongoing German DETECT III trial, which is aimed at determining the efficacy of lapatinib in patients with initially HER2-negative metastatic breast cancer but HER2-positive CTCs. HER2 discordance was defined as the presence of a single CTC or more within 7.5 mL of peripheral blood that showed a strong immunohistochemical (IHC) staining intensity (IHC score 3+).

Out of 1,123 women screened, at least one CTC was detected in blood samples from 711 women (63.3%; 95% confidence interval, 60.4%-66.1%). The median number of CTCs detected was seven (interquartile range, 2-30; range, 1-35,078 CTCs), and discordance in HER2 phenotype between primary tumor and CTCs was found in 134 patients (18.8%), Dr. De Gregorio of University Hospital Ulm (Germany) and associates reported (JCO Precis Oncol. 2017 Sep 28. doi: 10.1200/PO.17.00023).

In a multivariable analysis, histologic type (lobular vs. ductal; odds ratio, 2.67; P less than .001), hormone receptor status (positive vs. negative; OR, 2.84; P = .024), and CTC number (greater than 5 vs. 1-4 CTCs; OR, 7.64; P less than .001) significantly and independently predicted discordance in HER2 phenotype between primary tumor and CTCs. There was also a significant effect of age, with the probability of discordance decreasing with increasing age, the investigators noted.

“The knowledge of factors associated with discordance in HER2 status may be incorporated into today’s clinical practice by guiding the decision process for performing biopsy to characterize metastatic relapse,” the investigators wrote.

“Moreover, the concept of liquid biopsy using CTCs as a real-time noninvasive monitoring tool to evaluate tumor biology, progression, and heterogeneity as a basis for more personalized treatment decisions should be tested in prospective randomized clinical trials,” they added.

The DETECT study program is supported by the Investigator-Initiated Study Program of Janssen Diagnostics, with clinical trials also supported by Pierre Fabre Pharma, TEVA Pharmaceuticals Industries, Amgen, Novartis Pharma, and Eisai. Dr. De Gregorio disclosed an advisory role with Roche Pharma AG; several coauthors disclosed consultancy and funding from various pharmaceutical companies.

[email protected]

On Twitter @nikolaideslaura

Discordance in HER2 status between the primary breast tumor and circulating tumor cells (CTCs) in women with HER2-negative metastatic disease was 18.8% in a prospective cohort of patients.

The probability of discordance decreased with increasing age but increased with primary tumors that were hormone-receptor positive, higher grade, and of lobular histology, Amelie De Gregorio, MD, and associates reported in JCO Precision Oncology.

The investigators evaluated the HER2 status of CTCs obtained from women with HER2-negative breast cancer screened in the ongoing German DETECT III trial, which is aimed at determining the efficacy of lapatinib in patients with initially HER2-negative metastatic breast cancer but HER2-positive CTCs. HER2 discordance was defined as the presence of a single CTC or more within 7.5 mL of peripheral blood that showed a strong immunohistochemical (IHC) staining intensity (IHC score 3+).

Out of 1,123 women screened, at least one CTC was detected in blood samples from 711 women (63.3%; 95% confidence interval, 60.4%-66.1%). The median number of CTCs detected was seven (interquartile range, 2-30; range, 1-35,078 CTCs), and discordance in HER2 phenotype between primary tumor and CTCs was found in 134 patients (18.8%), Dr. De Gregorio of University Hospital Ulm (Germany) and associates reported (JCO Precis Oncol. 2017 Sep 28. doi: 10.1200/PO.17.00023).

In a multivariable analysis, histologic type (lobular vs. ductal; odds ratio, 2.67; P less than .001), hormone receptor status (positive vs. negative; OR, 2.84; P = .024), and CTC number (greater than 5 vs. 1-4 CTCs; OR, 7.64; P less than .001) significantly and independently predicted discordance in HER2 phenotype between primary tumor and CTCs. There was also a significant effect of age, with the probability of discordance decreasing with increasing age, the investigators noted.

“The knowledge of factors associated with discordance in HER2 status may be incorporated into today’s clinical practice by guiding the decision process for performing biopsy to characterize metastatic relapse,” the investigators wrote.

“Moreover, the concept of liquid biopsy using CTCs as a real-time noninvasive monitoring tool to evaluate tumor biology, progression, and heterogeneity as a basis for more personalized treatment decisions should be tested in prospective randomized clinical trials,” they added.

The DETECT study program is supported by the Investigator-Initiated Study Program of Janssen Diagnostics, with clinical trials also supported by Pierre Fabre Pharma, TEVA Pharmaceuticals Industries, Amgen, Novartis Pharma, and Eisai. Dr. De Gregorio disclosed an advisory role with Roche Pharma AG; several coauthors disclosed consultancy and funding from various pharmaceutical companies.

[email protected]

On Twitter @nikolaideslaura

Discordance in HER2 status between the primary breast tumor and circulating tumor cells (CTCs) in women with HER2-negative metastatic disease was 18.8% in a prospective cohort of patients.

The probability of discordance decreased with increasing age but increased with primary tumors that were hormone-receptor positive, higher grade, and of lobular histology, Amelie De Gregorio, MD, and associates reported in JCO Precision Oncology.

The investigators evaluated the HER2 status of CTCs obtained from women with HER2-negative breast cancer screened in the ongoing German DETECT III trial, which is aimed at determining the efficacy of lapatinib in patients with initially HER2-negative metastatic breast cancer but HER2-positive CTCs. HER2 discordance was defined as the presence of a single CTC or more within 7.5 mL of peripheral blood that showed a strong immunohistochemical (IHC) staining intensity (IHC score 3+).

Out of 1,123 women screened, at least one CTC was detected in blood samples from 711 women (63.3%; 95% confidence interval, 60.4%-66.1%). The median number of CTCs detected was seven (interquartile range, 2-30; range, 1-35,078 CTCs), and discordance in HER2 phenotype between primary tumor and CTCs was found in 134 patients (18.8%), Dr. De Gregorio of University Hospital Ulm (Germany) and associates reported (JCO Precis Oncol. 2017 Sep 28. doi: 10.1200/PO.17.00023).

In a multivariable analysis, histologic type (lobular vs. ductal; odds ratio, 2.67; P less than .001), hormone receptor status (positive vs. negative; OR, 2.84; P = .024), and CTC number (greater than 5 vs. 1-4 CTCs; OR, 7.64; P less than .001) significantly and independently predicted discordance in HER2 phenotype between primary tumor and CTCs. There was also a significant effect of age, with the probability of discordance decreasing with increasing age, the investigators noted.

“The knowledge of factors associated with discordance in HER2 status may be incorporated into today’s clinical practice by guiding the decision process for performing biopsy to characterize metastatic relapse,” the investigators wrote.

“Moreover, the concept of liquid biopsy using CTCs as a real-time noninvasive monitoring tool to evaluate tumor biology, progression, and heterogeneity as a basis for more personalized treatment decisions should be tested in prospective randomized clinical trials,” they added.

The DETECT study program is supported by the Investigator-Initiated Study Program of Janssen Diagnostics, with clinical trials also supported by Pierre Fabre Pharma, TEVA Pharmaceuticals Industries, Amgen, Novartis Pharma, and Eisai. Dr. De Gregorio disclosed an advisory role with Roche Pharma AG; several coauthors disclosed consultancy and funding from various pharmaceutical companies.

[email protected]

On Twitter @nikolaideslaura

Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.

Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.

The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.

The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).

Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.

However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).

Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.

The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.

Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.

Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.

Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.

The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.

The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).

Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.

However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).

Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.

The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.

Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.

Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.

Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.

The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.

The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).

Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.

However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).

Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.

The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.

Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.

The Food and Drug Administration is concerned about incidents of overheating, fires, and explosions of e-cigarettes, or “vapes,” which in some cases have resulted in serious injuries. The agency is reviewing these types of incidents and has taken steps to protect the public.

The FDA recently developed resources for consumers, including tips to help avoid e-cigarette overheating and explosions, as well as social media tools to help spread the word about protective steps. The agency also has a reporting system to collect information about adverse experiences associated with e-cigarettes and other tobacco products. Comprehensive and accurate reports could provide evidence to help inform future actions to protect the public.

For e-cigarette users: Tips to help prevent fires and explosions

Learn about your device.

The best protection against battery explosions may be knowing about your device and how to handle and charge its batteries appropriately. Read and follow the manufacturer’s use and care recommendations. If the e-cigarette did not come with instructions or you have additional questions, contact the manufacturer.

Consider using e-cigarettes with protective features.

Some e-cigarettes have features such as firing button locks, vent holes, and protection against overcharging. These features are designed to prevent battery overheating and explosions, so do not remove or disable them.

Choose batteries carefully and replace them if necessary:

• Use only the batteries recommended for your device. Do not mix different brands, different charge levels, or old and new batteries in the same device.

• Replace the batteries if they get damaged or wet. If your e-cigarette is damaged and the batteries are not replaceable, contact the manufacturer.

• Stop using the device under certain circumstances. Although battery explosions can occur with no warning, you should immediately stop using your e-cigarette and get a safe distance from it if you notice any of these during use or while charging: strange noises; unusual smells; a leaking battery; the e-cigarette becoming unusually hot; or the device beginning to smoke, spark, emit flashes, or catch fire.

Be aware when charging your e-cigarette:

• Use only the charger that came with your device, and never charge it with a phone or tablet charger.

• Charge the device on a clean, flat surface, in a place you can clearly see it, and away from anything that can easily catch fire. Do not leave the e-cigarette charging on a surface such as a couch or pillow, where it may be more likely to overheat or turn on unintentionally.

• Do not charge the device overnight or leave it charging unattended.

Know this about carrying and storing your e-cigarette:

• Keep your e-cigarette covered. If you are carrying it in your pocket, avoid having it come in contact with coins or loose batteries.

• Protect the e-cigarette from extreme temperatures. Do not leave it in direct sunlight or in your car in extremely cold or hot temperatures.

Report any problems.

If something goes wrong with an e-cigarette, please submit a report to https://www.safetyreporting.hhs.gov

To make it easy to share the FDA’s top tips, the agency has developed a 5 Tips to Help Avoid “Vape” Battery Explosion infographic.

This infographic and other public-health resources can be found on a dedicated CTP webpage, which offers shareable and downloadable content to help spread the word about e-cigarette battery issues, as well as a video on how to report adverse experiences related to tobacco products to the FDA.
 

When a fire or explosion does occur: The Safety Reporting Portal

The CTP identified 143 reported incidents of e-cigarette overheating, fires, and explosions during 2009-2015, and 20 additional reports during 2016. Based on the FDA’s experience with underreporting of adverse events for other regulated products, the number of actual events is probably higher.

The FDA is working to collect more information to identify the true number of events and why these incidents are occurring. The agency has a Safety Reporting Portal (SRP) dedicated to receiving reports of issues associated with FDA-regulated products, including e-cigarettes and other tobacco products.

The FDA strongly encourages any physicians, other health care professionals, or those with firsthand knowledge about an unexpected e-cigarette incident to report it through the SRP. Family physicians can play a valuable reporting role by informing patients about the reporting system, helping people submit complete information about incidents related to e-cigarettes, or providing information about an incident on a patient’s behalf.

To report an e-cigarette failure or other tobacco-related adverse event, please go to the SRP and follow the instructions in each section. Those unable to use the SRP to submit a report can call 877-CTP-1373 or email [email protected].

The more complete and accurate a report is, the more helpful it can be to the FDA and, in turn, to public health. When submitting a report about an e-cigarette, please include:

• E-cigarette manufacturer’s name.

• E-cigarette’s brand name, model, and serial number.

• Battery’s brand name and model.

• Place the e-cigarette was purchased.

• Whether, and how, the product was being used at the time of the incident.

• Whether the product was used differently than intended by the manufacturer.

• Whether the product was modified in any way.

To collect as much detail as possible, the FDA encourages those submitting reports to upload photos or other files, such as police or hospital reports. They also appreciate submission of contact information, such as a phone number or email address, which will help the agency follow up with any questions related to the report. Personal information will not be shared or used for any additional matter and is protected by security practices. The HHS Privacy Policy contains more information.
 

Ongoing public health protection efforts

The FDA continues to evaluate possible ways to protect the public from device-related fires and explosions. During a public workshop in April, the FDA heard from experts including scientists, engineers, and e-cigarette manufacturers and retailers, as well as from the general public, about hazards and possible solutions related to batteries in e-cigarettes and other electronic nicotine delivery systems. Also, the agency’s premarket review process for electronic nicotine delivery systems includes an assessment of device operation and any features that may reduce the risks associated with product use, including testing related to overheating and exploding batteries.

Through these and other measures, the FDA is committed to identifying and addressing factors leading to e-cigarette overheating and any subsequent injuries. Health care professionals can help by spreading the word about the agency’s user tips and reporting portal.

To learn more broadly about the FDA’s ongoing efforts to protect the public health by regulating the manufacture, marketing, and distribution of tobacco products, please visit the Center for Tobacco Products website.

Dr. Holman is director of the office of science at the FDA’s Center for Tobacco Products.

The Food and Drug Administration is concerned about incidents of overheating, fires, and explosions of e-cigarettes, or “vapes,” which in some cases have resulted in serious injuries. The agency is reviewing these types of incidents and has taken steps to protect the public.

The FDA recently developed resources for consumers, including tips to help avoid e-cigarette overheating and explosions, as well as social media tools to help spread the word about protective steps. The agency also has a reporting system to collect information about adverse experiences associated with e-cigarettes and other tobacco products. Comprehensive and accurate reports could provide evidence to help inform future actions to protect the public.

For e-cigarette users: Tips to help prevent fires and explosions

Learn about your device.

The best protection against battery explosions may be knowing about your device and how to handle and charge its batteries appropriately. Read and follow the manufacturer’s use and care recommendations. If the e-cigarette did not come with instructions or you have additional questions, contact the manufacturer.

Consider using e-cigarettes with protective features.

Some e-cigarettes have features such as firing button locks, vent holes, and protection against overcharging. These features are designed to prevent battery overheating and explosions, so do not remove or disable them.

Choose batteries carefully and replace them if necessary:

• Use only the batteries recommended for your device. Do not mix different brands, different charge levels, or old and new batteries in the same device.

• Replace the batteries if they get damaged or wet. If your e-cigarette is damaged and the batteries are not replaceable, contact the manufacturer.

• Stop using the device under certain circumstances. Although battery explosions can occur with no warning, you should immediately stop using your e-cigarette and get a safe distance from it if you notice any of these during use or while charging: strange noises; unusual smells; a leaking battery; the e-cigarette becoming unusually hot; or the device beginning to smoke, spark, emit flashes, or catch fire.

Be aware when charging your e-cigarette:

• Use only the charger that came with your device, and never charge it with a phone or tablet charger.

• Charge the device on a clean, flat surface, in a place you can clearly see it, and away from anything that can easily catch fire. Do not leave the e-cigarette charging on a surface such as a couch or pillow, where it may be more likely to overheat or turn on unintentionally.

• Do not charge the device overnight or leave it charging unattended.

Know this about carrying and storing your e-cigarette:

• Keep your e-cigarette covered. If you are carrying it in your pocket, avoid having it come in contact with coins or loose batteries.

• Protect the e-cigarette from extreme temperatures. Do not leave it in direct sunlight or in your car in extremely cold or hot temperatures.

Report any problems.

If something goes wrong with an e-cigarette, please submit a report to https://www.safetyreporting.hhs.gov

To make it easy to share the FDA’s top tips, the agency has developed a 5 Tips to Help Avoid “Vape” Battery Explosion infographic.

This infographic and other public-health resources can be found on a dedicated CTP webpage, which offers shareable and downloadable content to help spread the word about e-cigarette battery issues, as well as a video on how to report adverse experiences related to tobacco products to the FDA.
 

When a fire or explosion does occur: The Safety Reporting Portal

The CTP identified 143 reported incidents of e-cigarette overheating, fires, and explosions during 2009-2015, and 20 additional reports during 2016. Based on the FDA’s experience with underreporting of adverse events for other regulated products, the number of actual events is probably higher.

The FDA is working to collect more information to identify the true number of events and why these incidents are occurring. The agency has a Safety Reporting Portal (SRP) dedicated to receiving reports of issues associated with FDA-regulated products, including e-cigarettes and other tobacco products.

The FDA strongly encourages any physicians, other health care professionals, or those with firsthand knowledge about an unexpected e-cigarette incident to report it through the SRP. Family physicians can play a valuable reporting role by informing patients about the reporting system, helping people submit complete information about incidents related to e-cigarettes, or providing information about an incident on a patient’s behalf.

To report an e-cigarette failure or other tobacco-related adverse event, please go to the SRP and follow the instructions in each section. Those unable to use the SRP to submit a report can call 877-CTP-1373 or email [email protected].

The more complete and accurate a report is, the more helpful it can be to the FDA and, in turn, to public health. When submitting a report about an e-cigarette, please include:

• E-cigarette manufacturer’s name.

• E-cigarette’s brand name, model, and serial number.

• Battery’s brand name and model.

• Place the e-cigarette was purchased.

• Whether, and how, the product was being used at the time of the incident.

• Whether the product was used differently than intended by the manufacturer.

• Whether the product was modified in any way.

To collect as much detail as possible, the FDA encourages those submitting reports to upload photos or other files, such as police or hospital reports. They also appreciate submission of contact information, such as a phone number or email address, which will help the agency follow up with any questions related to the report. Personal information will not be shared or used for any additional matter and is protected by security practices. The HHS Privacy Policy contains more information.
 

Ongoing public health protection efforts

The FDA continues to evaluate possible ways to protect the public from device-related fires and explosions. During a public workshop in April, the FDA heard from experts including scientists, engineers, and e-cigarette manufacturers and retailers, as well as from the general public, about hazards and possible solutions related to batteries in e-cigarettes and other electronic nicotine delivery systems. Also, the agency’s premarket review process for electronic nicotine delivery systems includes an assessment of device operation and any features that may reduce the risks associated with product use, including testing related to overheating and exploding batteries.

Through these and other measures, the FDA is committed to identifying and addressing factors leading to e-cigarette overheating and any subsequent injuries. Health care professionals can help by spreading the word about the agency’s user tips and reporting portal.

To learn more broadly about the FDA’s ongoing efforts to protect the public health by regulating the manufacture, marketing, and distribution of tobacco products, please visit the Center for Tobacco Products website.

Dr. Holman is director of the office of science at the FDA’s Center for Tobacco Products.

The Food and Drug Administration is concerned about incidents of overheating, fires, and explosions of e-cigarettes, or “vapes,” which in some cases have resulted in serious injuries. The agency is reviewing these types of incidents and has taken steps to protect the public.

The FDA recently developed resources for consumers, including tips to help avoid e-cigarette overheating and explosions, as well as social media tools to help spread the word about protective steps. The agency also has a reporting system to collect information about adverse experiences associated with e-cigarettes and other tobacco products. Comprehensive and accurate reports could provide evidence to help inform future actions to protect the public.

For e-cigarette users: Tips to help prevent fires and explosions

Learn about your device.

The best protection against battery explosions may be knowing about your device and how to handle and charge its batteries appropriately. Read and follow the manufacturer’s use and care recommendations. If the e-cigarette did not come with instructions or you have additional questions, contact the manufacturer.

Consider using e-cigarettes with protective features.

Some e-cigarettes have features such as firing button locks, vent holes, and protection against overcharging. These features are designed to prevent battery overheating and explosions, so do not remove or disable them.

Choose batteries carefully and replace them if necessary:

• Use only the batteries recommended for your device. Do not mix different brands, different charge levels, or old and new batteries in the same device.

• Replace the batteries if they get damaged or wet. If your e-cigarette is damaged and the batteries are not replaceable, contact the manufacturer.

• Stop using the device under certain circumstances. Although battery explosions can occur with no warning, you should immediately stop using your e-cigarette and get a safe distance from it if you notice any of these during use or while charging: strange noises; unusual smells; a leaking battery; the e-cigarette becoming unusually hot; or the device beginning to smoke, spark, emit flashes, or catch fire.

Be aware when charging your e-cigarette:

• Use only the charger that came with your device, and never charge it with a phone or tablet charger.

• Charge the device on a clean, flat surface, in a place you can clearly see it, and away from anything that can easily catch fire. Do not leave the e-cigarette charging on a surface such as a couch or pillow, where it may be more likely to overheat or turn on unintentionally.

• Do not charge the device overnight or leave it charging unattended.

Know this about carrying and storing your e-cigarette:

• Keep your e-cigarette covered. If you are carrying it in your pocket, avoid having it come in contact with coins or loose batteries.

• Protect the e-cigarette from extreme temperatures. Do not leave it in direct sunlight or in your car in extremely cold or hot temperatures.

Report any problems.

If something goes wrong with an e-cigarette, please submit a report to https://www.safetyreporting.hhs.gov

To make it easy to share the FDA’s top tips, the agency has developed a 5 Tips to Help Avoid “Vape” Battery Explosion infographic.

This infographic and other public-health resources can be found on a dedicated CTP webpage, which offers shareable and downloadable content to help spread the word about e-cigarette battery issues, as well as a video on how to report adverse experiences related to tobacco products to the FDA.
 

When a fire or explosion does occur: The Safety Reporting Portal

The CTP identified 143 reported incidents of e-cigarette overheating, fires, and explosions during 2009-2015, and 20 additional reports during 2016. Based on the FDA’s experience with underreporting of adverse events for other regulated products, the number of actual events is probably higher.

The FDA is working to collect more information to identify the true number of events and why these incidents are occurring. The agency has a Safety Reporting Portal (SRP) dedicated to receiving reports of issues associated with FDA-regulated products, including e-cigarettes and other tobacco products.

The FDA strongly encourages any physicians, other health care professionals, or those with firsthand knowledge about an unexpected e-cigarette incident to report it through the SRP. Family physicians can play a valuable reporting role by informing patients about the reporting system, helping people submit complete information about incidents related to e-cigarettes, or providing information about an incident on a patient’s behalf.

To report an e-cigarette failure or other tobacco-related adverse event, please go to the SRP and follow the instructions in each section. Those unable to use the SRP to submit a report can call 877-CTP-1373 or email [email protected].

The more complete and accurate a report is, the more helpful it can be to the FDA and, in turn, to public health. When submitting a report about an e-cigarette, please include:

• E-cigarette manufacturer’s name.

• E-cigarette’s brand name, model, and serial number.

• Battery’s brand name and model.

• Place the e-cigarette was purchased.

• Whether, and how, the product was being used at the time of the incident.

• Whether the product was used differently than intended by the manufacturer.

• Whether the product was modified in any way.

To collect as much detail as possible, the FDA encourages those submitting reports to upload photos or other files, such as police or hospital reports. They also appreciate submission of contact information, such as a phone number or email address, which will help the agency follow up with any questions related to the report. Personal information will not be shared or used for any additional matter and is protected by security practices. The HHS Privacy Policy contains more information.
 

Ongoing public health protection efforts

The FDA continues to evaluate possible ways to protect the public from device-related fires and explosions. During a public workshop in April, the FDA heard from experts including scientists, engineers, and e-cigarette manufacturers and retailers, as well as from the general public, about hazards and possible solutions related to batteries in e-cigarettes and other electronic nicotine delivery systems. Also, the agency’s premarket review process for electronic nicotine delivery systems includes an assessment of device operation and any features that may reduce the risks associated with product use, including testing related to overheating and exploding batteries.

Through these and other measures, the FDA is committed to identifying and addressing factors leading to e-cigarette overheating and any subsequent injuries. Health care professionals can help by spreading the word about the agency’s user tips and reporting portal.

To learn more broadly about the FDA’s ongoing efforts to protect the public health by regulating the manufacture, marketing, and distribution of tobacco products, please visit the Center for Tobacco Products website.

Dr. Holman is director of the office of science at the FDA’s Center for Tobacco Products.

PARIS – Results of the randomized phase 2 portion of the landmark PRIDE study of electroconvulsive therapy for severe unipolar depression in geriatric patients hold a key message for clinicians, according to Charles H. Kellner, MD.

“The clinical take-home message is that practitioners should be liberal in prescribing additional ECT past the acute course. So our recommendation is that tapering ECT courses and being liberal with continuation and maintenance ECT should be adopted in clinical practice more widely with the aim of preventing full syndromic relapse and its catastrophic consequences,” Dr. Kellner said at the annual congress of the European College of Neuropsychopharmacology.

Bruce Jancin/Frontline Medical News

A swipe at ECT’s critics

Dr. Kellner called ECT “a fabulous therapy,” albeit one with a serious image problem.

“I think the problem with ECT is not that we don’t know all the details of how it works or what it does clinically, it’s really a sociopolitical issue about ECT not being adequately accepted. I break down this lack of acceptance into two forms: The first is passive lack of acceptance based on our profession not having embraced ECT and continuing to fail to embrace it. The other is the active propaganda against ECT that is promulgated by the Church of Scientology, which has taken on a life of its own now because of the Internet. ECT is still fought by the Church of Scientology. They fund lots of people to say incorrect nasty things about ECT to inappropriately frighten our patients,” Dr. Kellner charged.

He cautioned that proposed new Food and Drug Administration regulations governing ECT devices would greatly limit the use of ECT, restricting it to adults with treatment-resistant major depressive disorder or bipolar disorder or who require a rapid response. Other currently cleared indications would become off-label uses.

“With off-label ECT, the potential problem is practitioners may not be covered by their malpractice insurance. And the bigger issue is health insurers may not pay for it unless the ECT is for an on-label indication,” Dr. Kellner said.

He shared that he has found extremely helpful a colleague’s advice to demystify ECT by inviting a family member to witness a patient’s treatment session. That witness can then testify to others that what goes on bears no resemblance to what happens to Jack Nicholson in the classic film “One Flew Over the Cuckoo’s Nest.”

The PRIDE study was funded by the National Institute of Mental Health. Dr. Kellner reported having no financial conflicts of interest.
 

[email protected]

PARIS – Results of the randomized phase 2 portion of the landmark PRIDE study of electroconvulsive therapy for severe unipolar depression in geriatric patients hold a key message for clinicians, according to Charles H. Kellner, MD.

“The clinical take-home message is that practitioners should be liberal in prescribing additional ECT past the acute course. So our recommendation is that tapering ECT courses and being liberal with continuation and maintenance ECT should be adopted in clinical practice more widely with the aim of preventing full syndromic relapse and its catastrophic consequences,” Dr. Kellner said at the annual congress of the European College of Neuropsychopharmacology.

Bruce Jancin/Frontline Medical News

A swipe at ECT’s critics

Dr. Kellner called ECT “a fabulous therapy,” albeit one with a serious image problem.

“I think the problem with ECT is not that we don’t know all the details of how it works or what it does clinically, it’s really a sociopolitical issue about ECT not being adequately accepted. I break down this lack of acceptance into two forms: The first is passive lack of acceptance based on our profession not having embraced ECT and continuing to fail to embrace it. The other is the active propaganda against ECT that is promulgated by the Church of Scientology, which has taken on a life of its own now because of the Internet. ECT is still fought by the Church of Scientology. They fund lots of people to say incorrect nasty things about ECT to inappropriately frighten our patients,” Dr. Kellner charged.

He cautioned that proposed new Food and Drug Administration regulations governing ECT devices would greatly limit the use of ECT, restricting it to adults with treatment-resistant major depressive disorder or bipolar disorder or who require a rapid response. Other currently cleared indications would become off-label uses.

“With off-label ECT, the potential problem is practitioners may not be covered by their malpractice insurance. And the bigger issue is health insurers may not pay for it unless the ECT is for an on-label indication,” Dr. Kellner said.

He shared that he has found extremely helpful a colleague’s advice to demystify ECT by inviting a family member to witness a patient’s treatment session. That witness can then testify to others that what goes on bears no resemblance to what happens to Jack Nicholson in the classic film “One Flew Over the Cuckoo’s Nest.”

The PRIDE study was funded by the National Institute of Mental Health. Dr. Kellner reported having no financial conflicts of interest.
 

[email protected]

PARIS – Results of the randomized phase 2 portion of the landmark PRIDE study of electroconvulsive therapy for severe unipolar depression in geriatric patients hold a key message for clinicians, according to Charles H. Kellner, MD.

“The clinical take-home message is that practitioners should be liberal in prescribing additional ECT past the acute course. So our recommendation is that tapering ECT courses and being liberal with continuation and maintenance ECT should be adopted in clinical practice more widely with the aim of preventing full syndromic relapse and its catastrophic consequences,” Dr. Kellner said at the annual congress of the European College of Neuropsychopharmacology.

Bruce Jancin/Frontline Medical News

A swipe at ECT’s critics

Dr. Kellner called ECT “a fabulous therapy,” albeit one with a serious image problem.

“I think the problem with ECT is not that we don’t know all the details of how it works or what it does clinically, it’s really a sociopolitical issue about ECT not being adequately accepted. I break down this lack of acceptance into two forms: The first is passive lack of acceptance based on our profession not having embraced ECT and continuing to fail to embrace it. The other is the active propaganda against ECT that is promulgated by the Church of Scientology, which has taken on a life of its own now because of the Internet. ECT is still fought by the Church of Scientology. They fund lots of people to say incorrect nasty things about ECT to inappropriately frighten our patients,” Dr. Kellner charged.

He cautioned that proposed new Food and Drug Administration regulations governing ECT devices would greatly limit the use of ECT, restricting it to adults with treatment-resistant major depressive disorder or bipolar disorder or who require a rapid response. Other currently cleared indications would become off-label uses.

“With off-label ECT, the potential problem is practitioners may not be covered by their malpractice insurance. And the bigger issue is health insurers may not pay for it unless the ECT is for an on-label indication,” Dr. Kellner said.

He shared that he has found extremely helpful a colleague’s advice to demystify ECT by inviting a family member to witness a patient’s treatment session. That witness can then testify to others that what goes on bears no resemblance to what happens to Jack Nicholson in the classic film “One Flew Over the Cuckoo’s Nest.”

The PRIDE study was funded by the National Institute of Mental Health. Dr. Kellner reported having no financial conflicts of interest.
 

[email protected]

The Food and Drug Administration has approved the FreeStyle Libre Flash Glucose Monitoring System for the continuous monitoring of glucose in adults with diabetes, the first system of its type that does not require blood samples for calibration, according to a press release.

Instead of using a more standard finger stick with which patients must draw blood samples multiple times a day to measure glucose levels, the FreeStyle Libre Flash Glucose Monitoring System uses a thin wire less than 0.4-mm thick inserted underneath the skin in the back of the upper arm to continually monitor glucose. Blood glucose levels are read by swiping a mobile reader over the wire. After a 12-hour start-up period, the wire can be worn for 10 days.

FDA approval was based on results from a study of diabetes patients older than 18 years, as well as a performance review comparing readings obtained by the device with readings obtained in a traditional laboratory method utilizing blood samples.

“This system allows people with diabetes to avoid the additional step of finger-stick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes – with a wave of the mobile reader,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has approved the FreeStyle Libre Flash Glucose Monitoring System for the continuous monitoring of glucose in adults with diabetes, the first system of its type that does not require blood samples for calibration, according to a press release.

Instead of using a more standard finger stick with which patients must draw blood samples multiple times a day to measure glucose levels, the FreeStyle Libre Flash Glucose Monitoring System uses a thin wire less than 0.4-mm thick inserted underneath the skin in the back of the upper arm to continually monitor glucose. Blood glucose levels are read by swiping a mobile reader over the wire. After a 12-hour start-up period, the wire can be worn for 10 days.

FDA approval was based on results from a study of diabetes patients older than 18 years, as well as a performance review comparing readings obtained by the device with readings obtained in a traditional laboratory method utilizing blood samples.

“This system allows people with diabetes to avoid the additional step of finger-stick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes – with a wave of the mobile reader,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has approved the FreeStyle Libre Flash Glucose Monitoring System for the continuous monitoring of glucose in adults with diabetes, the first system of its type that does not require blood samples for calibration, according to a press release.

Instead of using a more standard finger stick with which patients must draw blood samples multiple times a day to measure glucose levels, the FreeStyle Libre Flash Glucose Monitoring System uses a thin wire less than 0.4-mm thick inserted underneath the skin in the back of the upper arm to continually monitor glucose. Blood glucose levels are read by swiping a mobile reader over the wire. After a 12-hour start-up period, the wire can be worn for 10 days.

FDA approval was based on results from a study of diabetes patients older than 18 years, as well as a performance review comparing readings obtained by the device with readings obtained in a traditional laboratory method utilizing blood samples.

“This system allows people with diabetes to avoid the additional step of finger-stick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes – with a wave of the mobile reader,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

Fifteen years ago, reported cases of syphilis in the United States were so infrequent that public health officials thought it might join the ranks of malaria, polio, and smallpox as an eradicated disease. That turned out to be wishful thinking.

According to data from the Centers for Disease Control and Prevention, between 2012 and 2015, the overall rates of syphilis in the United States increased by 48%, while the rates of primary and secondary infection among women spiked by 56%. That was a compelling enough rise, but fresh data from the agency indicate that the overall rates of syphilis increased by 17.6% between 2015 and 2016, and by 74% between 2012 and 2016.

Lack of prenatal care

CDC guidelines recommend that all pregnant women undergo routine serologic screening for syphilis during their first prenatal visit. Additional testing at 28 weeks’ gestation and again at delivery is warranted for women who are at increased risk or live in communities with increased prevalence of syphilis infection. That approach may seem sensible, but such prevention measures are ineffective when mothers don’t receive any prenatal care or receive it late, which happens in about half of all CS cases, Dr. Kidd said.

Inconsistent, inadequate, or a total absence of prenatal care is “probably the biggest risk factor for vertical transmission, especially among high-risk populations, where there is an increased background prevalence of syphilis in childbearing women,” said Robert Maupin, MD, professor of clinical obstetrics and gynecology in the section of maternal-fetal medicine at Louisiana State University Health Sciences Center, New Orleans.

Repeat screening

In 2015, a large analysis of women who were commercially-insured or Medicaid-insured found that more than 95% who received prenatal care were screened for syphilis at least once during pregnancy (Obstet Gynecol. 2015;125[5]:1211-6). However, CDC data of CS cases shows that about 15% of their mothers are infected during pregnancy, which would occur after that first screening test.

“That’s where the repeat screening early in the third trimester and at delivery becomes the real issue,” Dr. Kidd said. “For high-risk women, including those who live in the high morbidity areas, they should be screened again later in pregnancy. Many ob.gyns. may not be aware of that recommendation, or may not be aware they’re in an area that does have a high syphilis morbidity, and that the pregnant women who are seeing them may be at increased risk of syphilis.”

Dr. Maupin, who is associate dean of diversity and community engagement at LSU Health Sciences Center, advised clinicians to view CS with the same sense of urgency that existed in previous years with perinatal HIV transmission.

“In the last decade and a half we’ve seen a substantial decline in perinatal HIV transmission because of intensive efforts on the public health side in terms of both screening and use of treatment,” he said. “If we look at this with a similar level of contemporary urgency, it will bear similar fruit over time. Additionally, from a maternal-fetal medicine standpoint, the more effectively we treat and/or control diseases and comorbidities prior to pregnancy, the less likely those things will have an adverse impact on the health and well-being of the newborn.”
 

Steps you can take to curb CS

In its “call to action” on syphilis, the Centers for Disease Control and Prevention cited several practical ways that clinicians can combat the spread of congenital syphilis (CS).

1. Complete a sexual history for your patients. The CDC recommends following this with STD counseling for those at risk and contraception counseling for women at risk of unintended pregnancy.

2. Test all pregnant women for syphilis. This should be done at the first prenatal visit, with repeat screening for pregnant women at high risk and in areas of high prevalence at the beginning of the third trimester and again at delivery.

3. Treat women infected with syphilis immediately. If a woman has syphilis or suspected syphilis, she should be treated with long-acting penicillin G, especially if she is pregnant. CDC also calls for testing and treating the infected woman’s sex partner(s) to avoid reinfection.

4. Confirm syphilis testing at delivery. Before discharging the mother or infant from the hospital, check that the mother has been tested for syphilis at least once during pregnancy or at delivery. All women who deliver a stillborn infant should be tested for syphilis.

5. Report CS cases to the local or state health department within 24 hours.

[email protected]

Fifteen years ago, reported cases of syphilis in the United States were so infrequent that public health officials thought it might join the ranks of malaria, polio, and smallpox as an eradicated disease. That turned out to be wishful thinking.

According to data from the Centers for Disease Control and Prevention, between 2012 and 2015, the overall rates of syphilis in the United States increased by 48%, while the rates of primary and secondary infection among women spiked by 56%. That was a compelling enough rise, but fresh data from the agency indicate that the overall rates of syphilis increased by 17.6% between 2015 and 2016, and by 74% between 2012 and 2016.

Lack of prenatal care

CDC guidelines recommend that all pregnant women undergo routine serologic screening for syphilis during their first prenatal visit. Additional testing at 28 weeks’ gestation and again at delivery is warranted for women who are at increased risk or live in communities with increased prevalence of syphilis infection. That approach may seem sensible, but such prevention measures are ineffective when mothers don’t receive any prenatal care or receive it late, which happens in about half of all CS cases, Dr. Kidd said.

Inconsistent, inadequate, or a total absence of prenatal care is “probably the biggest risk factor for vertical transmission, especially among high-risk populations, where there is an increased background prevalence of syphilis in childbearing women,” said Robert Maupin, MD, professor of clinical obstetrics and gynecology in the section of maternal-fetal medicine at Louisiana State University Health Sciences Center, New Orleans.

Repeat screening

In 2015, a large analysis of women who were commercially-insured or Medicaid-insured found that more than 95% who received prenatal care were screened for syphilis at least once during pregnancy (Obstet Gynecol. 2015;125[5]:1211-6). However, CDC data of CS cases shows that about 15% of their mothers are infected during pregnancy, which would occur after that first screening test.

“That’s where the repeat screening early in the third trimester and at delivery becomes the real issue,” Dr. Kidd said. “For high-risk women, including those who live in the high morbidity areas, they should be screened again later in pregnancy. Many ob.gyns. may not be aware of that recommendation, or may not be aware they’re in an area that does have a high syphilis morbidity, and that the pregnant women who are seeing them may be at increased risk of syphilis.”

Dr. Maupin, who is associate dean of diversity and community engagement at LSU Health Sciences Center, advised clinicians to view CS with the same sense of urgency that existed in previous years with perinatal HIV transmission.

“In the last decade and a half we’ve seen a substantial decline in perinatal HIV transmission because of intensive efforts on the public health side in terms of both screening and use of treatment,” he said. “If we look at this with a similar level of contemporary urgency, it will bear similar fruit over time. Additionally, from a maternal-fetal medicine standpoint, the more effectively we treat and/or control diseases and comorbidities prior to pregnancy, the less likely those things will have an adverse impact on the health and well-being of the newborn.”
 

Steps you can take to curb CS

In its “call to action” on syphilis, the Centers for Disease Control and Prevention cited several practical ways that clinicians can combat the spread of congenital syphilis (CS).

1. Complete a sexual history for your patients. The CDC recommends following this with STD counseling for those at risk and contraception counseling for women at risk of unintended pregnancy.

2. Test all pregnant women for syphilis. This should be done at the first prenatal visit, with repeat screening for pregnant women at high risk and in areas of high prevalence at the beginning of the third trimester and again at delivery.

3. Treat women infected with syphilis immediately. If a woman has syphilis or suspected syphilis, she should be treated with long-acting penicillin G, especially if she is pregnant. CDC also calls for testing and treating the infected woman’s sex partner(s) to avoid reinfection.

4. Confirm syphilis testing at delivery. Before discharging the mother or infant from the hospital, check that the mother has been tested for syphilis at least once during pregnancy or at delivery. All women who deliver a stillborn infant should be tested for syphilis.

5. Report CS cases to the local or state health department within 24 hours.

[email protected]

Fifteen years ago, reported cases of syphilis in the United States were so infrequent that public health officials thought it might join the ranks of malaria, polio, and smallpox as an eradicated disease. That turned out to be wishful thinking.

According to data from the Centers for Disease Control and Prevention, between 2012 and 2015, the overall rates of syphilis in the United States increased by 48%, while the rates of primary and secondary infection among women spiked by 56%. That was a compelling enough rise, but fresh data from the agency indicate that the overall rates of syphilis increased by 17.6% between 2015 and 2016, and by 74% between 2012 and 2016.

Lack of prenatal care

CDC guidelines recommend that all pregnant women undergo routine serologic screening for syphilis during their first prenatal visit. Additional testing at 28 weeks’ gestation and again at delivery is warranted for women who are at increased risk or live in communities with increased prevalence of syphilis infection. That approach may seem sensible, but such prevention measures are ineffective when mothers don’t receive any prenatal care or receive it late, which happens in about half of all CS cases, Dr. Kidd said.

Inconsistent, inadequate, or a total absence of prenatal care is “probably the biggest risk factor for vertical transmission, especially among high-risk populations, where there is an increased background prevalence of syphilis in childbearing women,” said Robert Maupin, MD, professor of clinical obstetrics and gynecology in the section of maternal-fetal medicine at Louisiana State University Health Sciences Center, New Orleans.

Repeat screening

In 2015, a large analysis of women who were commercially-insured or Medicaid-insured found that more than 95% who received prenatal care were screened for syphilis at least once during pregnancy (Obstet Gynecol. 2015;125[5]:1211-6). However, CDC data of CS cases shows that about 15% of their mothers are infected during pregnancy, which would occur after that first screening test.

“That’s where the repeat screening early in the third trimester and at delivery becomes the real issue,” Dr. Kidd said. “For high-risk women, including those who live in the high morbidity areas, they should be screened again later in pregnancy. Many ob.gyns. may not be aware of that recommendation, or may not be aware they’re in an area that does have a high syphilis morbidity, and that the pregnant women who are seeing them may be at increased risk of syphilis.”

Dr. Maupin, who is associate dean of diversity and community engagement at LSU Health Sciences Center, advised clinicians to view CS with the same sense of urgency that existed in previous years with perinatal HIV transmission.

“In the last decade and a half we’ve seen a substantial decline in perinatal HIV transmission because of intensive efforts on the public health side in terms of both screening and use of treatment,” he said. “If we look at this with a similar level of contemporary urgency, it will bear similar fruit over time. Additionally, from a maternal-fetal medicine standpoint, the more effectively we treat and/or control diseases and comorbidities prior to pregnancy, the less likely those things will have an adverse impact on the health and well-being of the newborn.”
 

Steps you can take to curb CS

In its “call to action” on syphilis, the Centers for Disease Control and Prevention cited several practical ways that clinicians can combat the spread of congenital syphilis (CS).

1. Complete a sexual history for your patients. The CDC recommends following this with STD counseling for those at risk and contraception counseling for women at risk of unintended pregnancy.

2. Test all pregnant women for syphilis. This should be done at the first prenatal visit, with repeat screening for pregnant women at high risk and in areas of high prevalence at the beginning of the third trimester and again at delivery.

3. Treat women infected with syphilis immediately. If a woman has syphilis or suspected syphilis, she should be treated with long-acting penicillin G, especially if she is pregnant. CDC also calls for testing and treating the infected woman’s sex partner(s) to avoid reinfection.

4. Confirm syphilis testing at delivery. Before discharging the mother or infant from the hospital, check that the mother has been tested for syphilis at least once during pregnancy or at delivery. All women who deliver a stillborn infant should be tested for syphilis.

5. Report CS cases to the local or state health department within 24 hours.

[email protected]