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Topline results for dapagliflozin in HFpEF: DELIVER
Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.
The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.
“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.
The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.
The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.
A version of this article first appeared on Medscape.com.
Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.
The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.
“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.
The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.
The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.
A version of this article first appeared on Medscape.com.
Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.
The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.
“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.
The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.
The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.
A version of this article first appeared on Medscape.com.
Bone, breath, heart, guts: Eight essential papers in primary care
1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study
Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.
Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.
To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.
The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.
A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.
“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”
At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.
“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis
The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.
However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.
To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.
The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study
Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”
The study authors posed two questions:
- How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?
- Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?
During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.
“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study
The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.
The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.
Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.
“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial
This study assessed the effects of four doses of vitamin D3 supplements on the risk of falls.
The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.
“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study
This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.
The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events
This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.
Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.
“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review
Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.
It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.
As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.
“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.
Dr. Wee and Dr. Chang disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study
Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.
Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.
To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.
The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.
A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.
“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”
At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.
“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis
The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.
However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.
To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.
The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study
Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”
The study authors posed two questions:
- How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?
- Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?
During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.
“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study
The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.
The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.
Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.
“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial
This study assessed the effects of four doses of vitamin D3 supplements on the risk of falls.
The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.
“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study
This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.
The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events
This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.
Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.
“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review
Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.
It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.
As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.
“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.
Dr. Wee and Dr. Chang disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study
Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.
Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.
To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.
The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.
A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.
“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”
At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.
“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis
The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.
However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.
To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.
The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study
Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”
The study authors posed two questions:
- How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?
- Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?
During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.
“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study
The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.
The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.
Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.
“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial
This study assessed the effects of four doses of vitamin D3 supplements on the risk of falls.
The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.
“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study
This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.
The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events
This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.
Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.
“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review
Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.
It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.
As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.
“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.
Dr. Wee and Dr. Chang disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM INTERNAL MEDICINE 2022
Adherence to ADHD meds may lower unemployment risk
Investigators analyzed data for almost 13,000 working-age adults with ADHD and found ADHD medication use during the previous 2 years was associated with a 10% lower risk for long-term unemployment in the following year.
In addition, among the female participants, longer treatment duration was associated with a lower risk for subsequent long-term unemployment. In both genders, within-individual comparisons showed long-term unemployment was lower during periods of ADHD medication treatment, compared with nontreatment periods.
“This evidence should be considered together with the existing knowledge of risks and benefits of ADHD medications when developing treatment plans for working-aged adults,” lead author Lin Li, MSc, a doctoral candidate at the School of Medical Science, Örebro University, Sweden, told this news organization.
“However, the effect size is relatively small in magnitude, indicating that other treatment programs, such as psychotherapy, are also needed to help individuals with ADHD in work-related settings,” Ms. Li said.
The findings were published online in JAMA Network Open.
Evidence gap
Adults with ADHD “have occupational impairments, such as poor work performance, less job stability, financial problems, and increased risk for unemployment,” the investigators write.
However, “less is known about the extent to which pharmacological treatment of ADHD is associated with reductions in unemployment rates,” they add.
“People with ADHD have been reported to have problems in work-related performance,” Ms. Li noted. “ADHD medications could reduce ADHD symptoms and also help with academic achievement, but there is limited evidence on the association between ADHD medication and occupational outcomes.”
To address this gap in evidence, the researchers turned to several major Swedish registries to identify 25,358 individuals with ADHD born between 1958 and 1978 who were aged 30 to 55 years during the study period of Jan. 1, 2008, through Dec. 31, 2013).
Of these, 12,875 (41.5% women; mean age, 37.9 years) were included in the analysis. Most participants (81.19%) had more than 9 years of education.
The registers provided information not only about diagnosis, but also about prescription medications these individuals took for ADHD, including methylphenidate, amphetamine, dexamphetamine, lisdexamfetamine, and atomoxetine.
Administrative records provided data about yearly accumulated unemployment days, with long-term unemployment defined as having at least 90 days of unemployment in a calendar year.
Covariates included age at baseline, sex, country of birth, highest educational level, crime records, and psychiatric comorbidities.
Most patients (69.34%) had at least one psychiatric comorbidity, with depressive, anxiety, and substance use disorders being the most common (in 40.28%, 35.27%, and 28.77%, respectively).
Symptom reduction
The mean length of medication use was 49 days (range, 0-366 days) per year. Of participants in whom these data were available, 31.29% of women and 31.03% of men never used ADHD medications. Among participants treated with ADHD medication (68.71%), only 3.23% of the women and 3.46% of the men had persistent use during the follow-up period.
Among women and men in whom these data were available, (38.85% of the total sample), 35.70% and 41.08%, respectively, were recorded as having one or more long-term unemployment stretches across the study period. In addition, 0.15% and 0.4%, respectively, had long-term unemployment during each of those years.
Use of ADHD medications during the previous 2 years was associated with a 10% lower risk for long-term unemployment in the following year (adjusted relative risk, 0.90; 95% confidence interval, 0.87-0.95).
The researchers also found an association between use of ADHD medications and long-term unemployment among women (RR, 0.82; 95% CI, 0.76-0.89) but not among men (RR, 0.96; 95% CI, 0.91-1.01).
Among women in particular, longer treatment duration was associated with a lower risk of subsequent long-term unemployment (P < .001 for trend).
Within-individual comparisons showed the long-term unemployment rate was lower during periods when individuals were being treated with ADHD medication vs. periods of nontreatment (RR, 0.89; 95% CI, 0.85-0.94).
“Among 12,875 working-aged adults with ADHD in Sweden, we found the use of ADHD medication is associated with a lower risk of long-term unemployment, especially for women,” Ms. Li said.
“The hypothesis of this study is that ADHD medications are effective in reducing ADHD symptoms, which may in turn help to improve work performance among individuals with ADHD,” she added.
However, Ms. Li cautioned, “the information on ADHD symptoms is not available in Swedish National Registers, so more research is needed to test the hypothesis.”
The investigators also suggest that future research “should further explore the effectiveness of stimulant and nonstimulant ADHD medications” and replicate their findings in other settings.
Findings ‘make sense’
Commenting on the study, Ari Tuckman PsyD, expert spokesman for Children and Adults with Attention-Deficit/Hyperactivity Disorder, said, there is “a lot to like about this study, specifically the large sample size and within-individual comparisons that the Scandinavians’ databases allow.”
“We know that ADHD can impact both finding and keeping a job, so it absolutely makes sense that medication use would reduce duration of unemployment,” said Dr. Tuckman, who is in private practice in West Chester, Pa., and was not involved with the research.
However, “I would venture that the results would have been more robust if the authors had been able to only look at those on optimized medication regimens, which is far too few,” he added. “This lack of optimization would have been even more true 10 years ago, which is when the data was from.”
The study was supported by a grant from the Swedish Council for Health, Working Life, and Welfare, an award from the Swedish Research Council, and a grant from Shire International GmbH, a member of the Takeda group of companies. Ms. Li and Dr. Tuckman have disclosed no relevant financial relationships. The other authors’ disclosures are listed in the original paper.
A version of this article first appeared on Medscape.com.
Investigators analyzed data for almost 13,000 working-age adults with ADHD and found ADHD medication use during the previous 2 years was associated with a 10% lower risk for long-term unemployment in the following year.
In addition, among the female participants, longer treatment duration was associated with a lower risk for subsequent long-term unemployment. In both genders, within-individual comparisons showed long-term unemployment was lower during periods of ADHD medication treatment, compared with nontreatment periods.
“This evidence should be considered together with the existing knowledge of risks and benefits of ADHD medications when developing treatment plans for working-aged adults,” lead author Lin Li, MSc, a doctoral candidate at the School of Medical Science, Örebro University, Sweden, told this news organization.
“However, the effect size is relatively small in magnitude, indicating that other treatment programs, such as psychotherapy, are also needed to help individuals with ADHD in work-related settings,” Ms. Li said.
The findings were published online in JAMA Network Open.
Evidence gap
Adults with ADHD “have occupational impairments, such as poor work performance, less job stability, financial problems, and increased risk for unemployment,” the investigators write.
However, “less is known about the extent to which pharmacological treatment of ADHD is associated with reductions in unemployment rates,” they add.
“People with ADHD have been reported to have problems in work-related performance,” Ms. Li noted. “ADHD medications could reduce ADHD symptoms and also help with academic achievement, but there is limited evidence on the association between ADHD medication and occupational outcomes.”
To address this gap in evidence, the researchers turned to several major Swedish registries to identify 25,358 individuals with ADHD born between 1958 and 1978 who were aged 30 to 55 years during the study period of Jan. 1, 2008, through Dec. 31, 2013).
Of these, 12,875 (41.5% women; mean age, 37.9 years) were included in the analysis. Most participants (81.19%) had more than 9 years of education.
The registers provided information not only about diagnosis, but also about prescription medications these individuals took for ADHD, including methylphenidate, amphetamine, dexamphetamine, lisdexamfetamine, and atomoxetine.
Administrative records provided data about yearly accumulated unemployment days, with long-term unemployment defined as having at least 90 days of unemployment in a calendar year.
Covariates included age at baseline, sex, country of birth, highest educational level, crime records, and psychiatric comorbidities.
Most patients (69.34%) had at least one psychiatric comorbidity, with depressive, anxiety, and substance use disorders being the most common (in 40.28%, 35.27%, and 28.77%, respectively).
Symptom reduction
The mean length of medication use was 49 days (range, 0-366 days) per year. Of participants in whom these data were available, 31.29% of women and 31.03% of men never used ADHD medications. Among participants treated with ADHD medication (68.71%), only 3.23% of the women and 3.46% of the men had persistent use during the follow-up period.
Among women and men in whom these data were available, (38.85% of the total sample), 35.70% and 41.08%, respectively, were recorded as having one or more long-term unemployment stretches across the study period. In addition, 0.15% and 0.4%, respectively, had long-term unemployment during each of those years.
Use of ADHD medications during the previous 2 years was associated with a 10% lower risk for long-term unemployment in the following year (adjusted relative risk, 0.90; 95% confidence interval, 0.87-0.95).
The researchers also found an association between use of ADHD medications and long-term unemployment among women (RR, 0.82; 95% CI, 0.76-0.89) but not among men (RR, 0.96; 95% CI, 0.91-1.01).
Among women in particular, longer treatment duration was associated with a lower risk of subsequent long-term unemployment (P < .001 for trend).
Within-individual comparisons showed the long-term unemployment rate was lower during periods when individuals were being treated with ADHD medication vs. periods of nontreatment (RR, 0.89; 95% CI, 0.85-0.94).
“Among 12,875 working-aged adults with ADHD in Sweden, we found the use of ADHD medication is associated with a lower risk of long-term unemployment, especially for women,” Ms. Li said.
“The hypothesis of this study is that ADHD medications are effective in reducing ADHD symptoms, which may in turn help to improve work performance among individuals with ADHD,” she added.
However, Ms. Li cautioned, “the information on ADHD symptoms is not available in Swedish National Registers, so more research is needed to test the hypothesis.”
The investigators also suggest that future research “should further explore the effectiveness of stimulant and nonstimulant ADHD medications” and replicate their findings in other settings.
Findings ‘make sense’
Commenting on the study, Ari Tuckman PsyD, expert spokesman for Children and Adults with Attention-Deficit/Hyperactivity Disorder, said, there is “a lot to like about this study, specifically the large sample size and within-individual comparisons that the Scandinavians’ databases allow.”
“We know that ADHD can impact both finding and keeping a job, so it absolutely makes sense that medication use would reduce duration of unemployment,” said Dr. Tuckman, who is in private practice in West Chester, Pa., and was not involved with the research.
However, “I would venture that the results would have been more robust if the authors had been able to only look at those on optimized medication regimens, which is far too few,” he added. “This lack of optimization would have been even more true 10 years ago, which is when the data was from.”
The study was supported by a grant from the Swedish Council for Health, Working Life, and Welfare, an award from the Swedish Research Council, and a grant from Shire International GmbH, a member of the Takeda group of companies. Ms. Li and Dr. Tuckman have disclosed no relevant financial relationships. The other authors’ disclosures are listed in the original paper.
A version of this article first appeared on Medscape.com.
Investigators analyzed data for almost 13,000 working-age adults with ADHD and found ADHD medication use during the previous 2 years was associated with a 10% lower risk for long-term unemployment in the following year.
In addition, among the female participants, longer treatment duration was associated with a lower risk for subsequent long-term unemployment. In both genders, within-individual comparisons showed long-term unemployment was lower during periods of ADHD medication treatment, compared with nontreatment periods.
“This evidence should be considered together with the existing knowledge of risks and benefits of ADHD medications when developing treatment plans for working-aged adults,” lead author Lin Li, MSc, a doctoral candidate at the School of Medical Science, Örebro University, Sweden, told this news organization.
“However, the effect size is relatively small in magnitude, indicating that other treatment programs, such as psychotherapy, are also needed to help individuals with ADHD in work-related settings,” Ms. Li said.
The findings were published online in JAMA Network Open.
Evidence gap
Adults with ADHD “have occupational impairments, such as poor work performance, less job stability, financial problems, and increased risk for unemployment,” the investigators write.
However, “less is known about the extent to which pharmacological treatment of ADHD is associated with reductions in unemployment rates,” they add.
“People with ADHD have been reported to have problems in work-related performance,” Ms. Li noted. “ADHD medications could reduce ADHD symptoms and also help with academic achievement, but there is limited evidence on the association between ADHD medication and occupational outcomes.”
To address this gap in evidence, the researchers turned to several major Swedish registries to identify 25,358 individuals with ADHD born between 1958 and 1978 who were aged 30 to 55 years during the study period of Jan. 1, 2008, through Dec. 31, 2013).
Of these, 12,875 (41.5% women; mean age, 37.9 years) were included in the analysis. Most participants (81.19%) had more than 9 years of education.
The registers provided information not only about diagnosis, but also about prescription medications these individuals took for ADHD, including methylphenidate, amphetamine, dexamphetamine, lisdexamfetamine, and atomoxetine.
Administrative records provided data about yearly accumulated unemployment days, with long-term unemployment defined as having at least 90 days of unemployment in a calendar year.
Covariates included age at baseline, sex, country of birth, highest educational level, crime records, and psychiatric comorbidities.
Most patients (69.34%) had at least one psychiatric comorbidity, with depressive, anxiety, and substance use disorders being the most common (in 40.28%, 35.27%, and 28.77%, respectively).
Symptom reduction
The mean length of medication use was 49 days (range, 0-366 days) per year. Of participants in whom these data were available, 31.29% of women and 31.03% of men never used ADHD medications. Among participants treated with ADHD medication (68.71%), only 3.23% of the women and 3.46% of the men had persistent use during the follow-up period.
Among women and men in whom these data were available, (38.85% of the total sample), 35.70% and 41.08%, respectively, were recorded as having one or more long-term unemployment stretches across the study period. In addition, 0.15% and 0.4%, respectively, had long-term unemployment during each of those years.
Use of ADHD medications during the previous 2 years was associated with a 10% lower risk for long-term unemployment in the following year (adjusted relative risk, 0.90; 95% confidence interval, 0.87-0.95).
The researchers also found an association between use of ADHD medications and long-term unemployment among women (RR, 0.82; 95% CI, 0.76-0.89) but not among men (RR, 0.96; 95% CI, 0.91-1.01).
Among women in particular, longer treatment duration was associated with a lower risk of subsequent long-term unemployment (P < .001 for trend).
Within-individual comparisons showed the long-term unemployment rate was lower during periods when individuals were being treated with ADHD medication vs. periods of nontreatment (RR, 0.89; 95% CI, 0.85-0.94).
“Among 12,875 working-aged adults with ADHD in Sweden, we found the use of ADHD medication is associated with a lower risk of long-term unemployment, especially for women,” Ms. Li said.
“The hypothesis of this study is that ADHD medications are effective in reducing ADHD symptoms, which may in turn help to improve work performance among individuals with ADHD,” she added.
However, Ms. Li cautioned, “the information on ADHD symptoms is not available in Swedish National Registers, so more research is needed to test the hypothesis.”
The investigators also suggest that future research “should further explore the effectiveness of stimulant and nonstimulant ADHD medications” and replicate their findings in other settings.
Findings ‘make sense’
Commenting on the study, Ari Tuckman PsyD, expert spokesman for Children and Adults with Attention-Deficit/Hyperactivity Disorder, said, there is “a lot to like about this study, specifically the large sample size and within-individual comparisons that the Scandinavians’ databases allow.”
“We know that ADHD can impact both finding and keeping a job, so it absolutely makes sense that medication use would reduce duration of unemployment,” said Dr. Tuckman, who is in private practice in West Chester, Pa., and was not involved with the research.
However, “I would venture that the results would have been more robust if the authors had been able to only look at those on optimized medication regimens, which is far too few,” he added. “This lack of optimization would have been even more true 10 years ago, which is when the data was from.”
The study was supported by a grant from the Swedish Council for Health, Working Life, and Welfare, an award from the Swedish Research Council, and a grant from Shire International GmbH, a member of the Takeda group of companies. Ms. Li and Dr. Tuckman have disclosed no relevant financial relationships. The other authors’ disclosures are listed in the original paper.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Porcine virus a suspect in man’s death after pig heart transplant
A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.
“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.
As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.
Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.
“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.
Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”
The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.
“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”
That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”
A version of this article first appeared on Medscape.com.
A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.
“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.
As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.
Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.
“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.
Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”
The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.
“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”
That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”
A version of this article first appeared on Medscape.com.
A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.
“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.
As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.
Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.
“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.
Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”
The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.
“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”
That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”
A version of this article first appeared on Medscape.com.
FROM MIT TECHNOLOGY REVIEW
Q&A with Hubert (Hugh) Greenway, MD
American College of Mohs Surgery.
who was also recently selected as program director for cutaneous oncology at Scripps MD Anderson Cancer Center in San Diego. He is also a former president of theAfter earning his medical degree from the Medical College of Georgia, Augusta, in 1974, Dr. Greenway was fellowship trained in Mohs skin cancer surgery by Frederic E. Mohs, MD, at the University of Wisconsin–Madison. He completed his dermatology residency at the Naval Medical Center San Diego and joined Scripps Clinic in 1983, where he launched the institution’s first Mohs surgery program, as well as a popular annual intensive course in superficial anatomy and cutaneous surgery that bears his name. He was also the first physician in the world to use interferon as a nonsurgical treatment of basal cell carcinoma.
To date, Dr. Greenway has performed more than 41,000 Mohs surgery cases and has trained 61 fellows who practice in academic and clinical settings. In 2017, he received the Frederic E. Mohs Award from the ACMS at the college’s annual meeting. He is also a past CEO of Scripps Clinic. In this Q&A, Dr. Greenway opens up about what it was like to train with Dr. Mohs, what makes a good Mohs surgeon, and why he’s excited about the future of dermatology.
I understand that you first became interested in a medical career after meeting Dr. Carl Jones, a friend of your father who was your Scoutmaster in the Boy Scouts in Georgia. What about Dr. Jones inspired you to pursue a career in medicine?
Dr. Jones was an internist/allergist in Atlanta, where I grew up. His three sons and I were friends. My dad had dealt with several medical problems being injured in World War II and subsequently undergoing a couple of kidney transplantations, so I developed an interest in medicine personally. Even though Dr. Jones was a specialist, he started out as a family doctor like I did, so he was interested in the whole person and all of his or her medical problems as opposed to those related to his specialty only. I traveled with the Boy Scouts to camp at places like Valley Forge in Pennsylvania, and Dr. Jones was involved with the medical set-ups of those large events. That also contributed to my interest in medicine.
As part of your 9-year service in the U.S. Navy, you spent 2 years as the flight surgeon at NAS Atlanta/Dobbins Air Force Base. What was your most memorable experience from that assignment?
Dobbins is a large facility with two Lockheed plants, and the Air Force had built the medical clinic, which was staffed by the Navy. Getting to know some of the active-duty members of the Air Force, the Navy, and the National Guard, and their commitment to our country, was memorable. Jimmy Carter was the president in those days. When he would fly in Dobbins, one of my jobs as the flight surgeon was to be on base when Air Force One landed or departed. One night, we had a DC-9 commercial aircraft coming from Huntsville, Ala., to Atlanta that got caught in a thunderstorm a little above 30,000 feet. Both engines went out and the aircraft essentially became a glider. The pilots tried to land on our runway but unfortunately, they ended up 4 miles short. We were heavily involved in responding to the crash, which was a tragic event. I also learned to fly (second seat) different types of aircraft during my assignment at NAS Atlanta/Dobbins Air Force Base, everything from the large C-5s to Navy fighter jets and helicopters. Coincidentally, Dr. Jones was involved with a couple of free health clinics in Atlanta when I was stationed there. Every Tuesday night, my wife (who is a nurse) and I would volunteer at a clinic in Cabbagetown, which was one of the poorer areas of Atlanta. It was a chance to give back to a group of people who didn’t have a whole lot.
In the middle your dermatology residency at Naval Medical Center San Diego, you were selected by Dr. Mohs for fellowship training in Mohs skin cancer surgery at the University of Wisconsin–Madison. What do you remember most about your training with Dr. Mohs?
Dr. Mohs was a kind, humble man who had this great idea about skin cancer. He was not a dermatologist; he was a general surgeon. The technique he developed was originally called chemosurgery because he put a chemical onto the skin. This was known as the fixed-tissue technique. Then we had a fresh-tissue technique, where we did not use the chemical, but we were able to use local anesthesia right away. That developed into the Mohs surgery we know today. Dr. Mohs did not name it that; he was very humble, but he was very proud of his technique. He was also a very hard worker. On the first day of my fellowship, I started at 7 in the morning and ended at 7 at night. It was the same for the last day of my fellowship. He also had an excellent office staff, many of whom had worked with him for many years. Patients with difficult skin cancers traveled to Madison from all over the world because there weren’t that many Mohs surgery clinics in those days. During the latter part of my fellowship, Michael McCall, MD, and I had the opportunity to remove a skin cancer from the nose of Dr. Mohs. We presented the case at a national conference, and I titled the talk “Mohs Surgery for Mohs’ Nose.”
Early in your career Dr. Mohs asked you to take over his practice, but you accepted an offer to establish the first Mohs surgery office at Scripps in San Diego instead. What convinced you to head West?
After my fellowship, I returned to San Diego to complete my residency with the Navy, where we opened a Mohs surgery clinic. Dr. Mohs came out for the ribbon cutting. During that time, I was taking care of several patients that he had treated in Wisconsin. Through that my wife and I ended up going to dinner with Cecil and Ida Green, philanthropists who made several financial gifts to Scripps Clinic – and for whom Scripps Green Hospital is named. Cecil cofounded Texas Instruments and was knighted by Queen Elizabeth. During dinner, he suggested that I stay in San Diego for a year and work at Scripps after my residency assignment with the Navy. I agreed and have been here ever since.
What do you find most interesting about Mohs surgery?
In Mohs surgery, you’re able to provide not only surgical care to eliminate the tumor, but also the pathology and the reconstruction. That was interesting to me. Dr. Mohs was not that interested in reconstruction. He was more focused on the tumor, in part because with the original fixed-tissue technique you could not do the reconstruction. You had to wait for an extra layer of tissue to separate. But with the fresh-tissue technique, you were able to provide the reconstruction that day. Mohs surgery deals with a subset of tumors that are challenging to treat. That also spiked my academic and clinical interest.
In your opinion, what’s been the most important advance in Mohs surgery to date?
In recent years, immunology has come into play, so now we have teams of clinicians in dermatology, medical oncology, surgery, and other subspecialties providing patients the best of care. In the arena of Mohs surgery itself, in the 1980s, the American College of Mohs Surgery developed a 1-year fellowship program, which enabled us to train many men and women to practice Mohs surgery. Most of them are dermatologists.
Please complete the sentence: “You can tell a good Mohs surgeon by the way he/she ...”
Treats patients, is willing to spend time with them, and shows an interest in them. One of the things we should strive for is to let patients know that they as a person are important; it’s not just the melanoma on their nose. We’re not only dealing with a skin cancer; we’re dealing with a patient who has skin cancer.
For the past 39 years, you have led Hugh Greenway’s Superficial Anatomy and Cutaneous Surgery course, which takes place every January in San Diego. What’s been key to sustaining this training course for nearly 4 decades?
There have been many people involved in its success, so it’s not just me. When I first started my practice, there really was not a focus on anatomy in the general dermatologic community. Dermatologic surgery textbooks contained very little content on surgical anatomy so I developed an interest a putting together a course that would cover some of this material. I met with Terence Davidson, MD, an otolaryngologist who was dean of continuing medical education at the University of California, San Diego. The course includes lectures from experts in many subspecialties and hands-on laboratories using cadavers to work on anatomy and surgical techniques. After about 16 years of doing the course Dr. Davidson told me: “When we started this course, as a group, the head and neck surgeons were the best to do the reconstructions on the face with skin flaps and grafts and layered closures. But now, as a group, the dermatologists are best at doing that.” That’s what we want to hear in medical education.
During the peak of the COVID-19 pandemic, what were your most significant challenges from both a clinical and a personal standpoint?
I’m fortunate to practice at a place like Scripps, where there are many resources to look at what was happening with COVID-19. Clinically, we had to put a lot of things on hold, but we tried our best to keep our cancer patients in particular in the forefront of care. It has been a challenge, but fortunately we have been able to take care of patients after a brief timeout. Many of us remember the polio vaccine back in the 1950s. Having worked overseas and at missionary hospital where we had children die of measles because they were not vaccinated gave me a larger appreciation for the importance of vaccines. I recommend all young physicians who work with me to read, “The Great Influenza: The Story of the Deadliest Pandemic in History,” by John M. Barry, which recounts the 1918 flu epidemic.
Who inspires you most in your work today?
I don’t view what I do as work. Dr. Jones and Dr. Mohs continue to inspire me with what they accomplished during their careers. You have to love people and love patients. Every patient who comes to see me has a story, so I try to understand their story. One of the things I really enjoy is training the young fellows. We train three Mohs fellows per year at Scripps, and it’s a great challenge every day.
What development in dermatology are you most excited about in the next 5 years?
Dermatology will continue to evolve just like all other medical specialties. We’re going to see a large growth in telemedicine, and immunotherapy is playing a key role in dermatologic oncology. What excites me the most in medicine is the young people who enter the field willing to contribute their lives to helping others.
American College of Mohs Surgery.
who was also recently selected as program director for cutaneous oncology at Scripps MD Anderson Cancer Center in San Diego. He is also a former president of theAfter earning his medical degree from the Medical College of Georgia, Augusta, in 1974, Dr. Greenway was fellowship trained in Mohs skin cancer surgery by Frederic E. Mohs, MD, at the University of Wisconsin–Madison. He completed his dermatology residency at the Naval Medical Center San Diego and joined Scripps Clinic in 1983, where he launched the institution’s first Mohs surgery program, as well as a popular annual intensive course in superficial anatomy and cutaneous surgery that bears his name. He was also the first physician in the world to use interferon as a nonsurgical treatment of basal cell carcinoma.
To date, Dr. Greenway has performed more than 41,000 Mohs surgery cases and has trained 61 fellows who practice in academic and clinical settings. In 2017, he received the Frederic E. Mohs Award from the ACMS at the college’s annual meeting. He is also a past CEO of Scripps Clinic. In this Q&A, Dr. Greenway opens up about what it was like to train with Dr. Mohs, what makes a good Mohs surgeon, and why he’s excited about the future of dermatology.
I understand that you first became interested in a medical career after meeting Dr. Carl Jones, a friend of your father who was your Scoutmaster in the Boy Scouts in Georgia. What about Dr. Jones inspired you to pursue a career in medicine?
Dr. Jones was an internist/allergist in Atlanta, where I grew up. His three sons and I were friends. My dad had dealt with several medical problems being injured in World War II and subsequently undergoing a couple of kidney transplantations, so I developed an interest in medicine personally. Even though Dr. Jones was a specialist, he started out as a family doctor like I did, so he was interested in the whole person and all of his or her medical problems as opposed to those related to his specialty only. I traveled with the Boy Scouts to camp at places like Valley Forge in Pennsylvania, and Dr. Jones was involved with the medical set-ups of those large events. That also contributed to my interest in medicine.
As part of your 9-year service in the U.S. Navy, you spent 2 years as the flight surgeon at NAS Atlanta/Dobbins Air Force Base. What was your most memorable experience from that assignment?
Dobbins is a large facility with two Lockheed plants, and the Air Force had built the medical clinic, which was staffed by the Navy. Getting to know some of the active-duty members of the Air Force, the Navy, and the National Guard, and their commitment to our country, was memorable. Jimmy Carter was the president in those days. When he would fly in Dobbins, one of my jobs as the flight surgeon was to be on base when Air Force One landed or departed. One night, we had a DC-9 commercial aircraft coming from Huntsville, Ala., to Atlanta that got caught in a thunderstorm a little above 30,000 feet. Both engines went out and the aircraft essentially became a glider. The pilots tried to land on our runway but unfortunately, they ended up 4 miles short. We were heavily involved in responding to the crash, which was a tragic event. I also learned to fly (second seat) different types of aircraft during my assignment at NAS Atlanta/Dobbins Air Force Base, everything from the large C-5s to Navy fighter jets and helicopters. Coincidentally, Dr. Jones was involved with a couple of free health clinics in Atlanta when I was stationed there. Every Tuesday night, my wife (who is a nurse) and I would volunteer at a clinic in Cabbagetown, which was one of the poorer areas of Atlanta. It was a chance to give back to a group of people who didn’t have a whole lot.
In the middle your dermatology residency at Naval Medical Center San Diego, you were selected by Dr. Mohs for fellowship training in Mohs skin cancer surgery at the University of Wisconsin–Madison. What do you remember most about your training with Dr. Mohs?
Dr. Mohs was a kind, humble man who had this great idea about skin cancer. He was not a dermatologist; he was a general surgeon. The technique he developed was originally called chemosurgery because he put a chemical onto the skin. This was known as the fixed-tissue technique. Then we had a fresh-tissue technique, where we did not use the chemical, but we were able to use local anesthesia right away. That developed into the Mohs surgery we know today. Dr. Mohs did not name it that; he was very humble, but he was very proud of his technique. He was also a very hard worker. On the first day of my fellowship, I started at 7 in the morning and ended at 7 at night. It was the same for the last day of my fellowship. He also had an excellent office staff, many of whom had worked with him for many years. Patients with difficult skin cancers traveled to Madison from all over the world because there weren’t that many Mohs surgery clinics in those days. During the latter part of my fellowship, Michael McCall, MD, and I had the opportunity to remove a skin cancer from the nose of Dr. Mohs. We presented the case at a national conference, and I titled the talk “Mohs Surgery for Mohs’ Nose.”
Early in your career Dr. Mohs asked you to take over his practice, but you accepted an offer to establish the first Mohs surgery office at Scripps in San Diego instead. What convinced you to head West?
After my fellowship, I returned to San Diego to complete my residency with the Navy, where we opened a Mohs surgery clinic. Dr. Mohs came out for the ribbon cutting. During that time, I was taking care of several patients that he had treated in Wisconsin. Through that my wife and I ended up going to dinner with Cecil and Ida Green, philanthropists who made several financial gifts to Scripps Clinic – and for whom Scripps Green Hospital is named. Cecil cofounded Texas Instruments and was knighted by Queen Elizabeth. During dinner, he suggested that I stay in San Diego for a year and work at Scripps after my residency assignment with the Navy. I agreed and have been here ever since.
What do you find most interesting about Mohs surgery?
In Mohs surgery, you’re able to provide not only surgical care to eliminate the tumor, but also the pathology and the reconstruction. That was interesting to me. Dr. Mohs was not that interested in reconstruction. He was more focused on the tumor, in part because with the original fixed-tissue technique you could not do the reconstruction. You had to wait for an extra layer of tissue to separate. But with the fresh-tissue technique, you were able to provide the reconstruction that day. Mohs surgery deals with a subset of tumors that are challenging to treat. That also spiked my academic and clinical interest.
In your opinion, what’s been the most important advance in Mohs surgery to date?
In recent years, immunology has come into play, so now we have teams of clinicians in dermatology, medical oncology, surgery, and other subspecialties providing patients the best of care. In the arena of Mohs surgery itself, in the 1980s, the American College of Mohs Surgery developed a 1-year fellowship program, which enabled us to train many men and women to practice Mohs surgery. Most of them are dermatologists.
Please complete the sentence: “You can tell a good Mohs surgeon by the way he/she ...”
Treats patients, is willing to spend time with them, and shows an interest in them. One of the things we should strive for is to let patients know that they as a person are important; it’s not just the melanoma on their nose. We’re not only dealing with a skin cancer; we’re dealing with a patient who has skin cancer.
For the past 39 years, you have led Hugh Greenway’s Superficial Anatomy and Cutaneous Surgery course, which takes place every January in San Diego. What’s been key to sustaining this training course for nearly 4 decades?
There have been many people involved in its success, so it’s not just me. When I first started my practice, there really was not a focus on anatomy in the general dermatologic community. Dermatologic surgery textbooks contained very little content on surgical anatomy so I developed an interest a putting together a course that would cover some of this material. I met with Terence Davidson, MD, an otolaryngologist who was dean of continuing medical education at the University of California, San Diego. The course includes lectures from experts in many subspecialties and hands-on laboratories using cadavers to work on anatomy and surgical techniques. After about 16 years of doing the course Dr. Davidson told me: “When we started this course, as a group, the head and neck surgeons were the best to do the reconstructions on the face with skin flaps and grafts and layered closures. But now, as a group, the dermatologists are best at doing that.” That’s what we want to hear in medical education.
During the peak of the COVID-19 pandemic, what were your most significant challenges from both a clinical and a personal standpoint?
I’m fortunate to practice at a place like Scripps, where there are many resources to look at what was happening with COVID-19. Clinically, we had to put a lot of things on hold, but we tried our best to keep our cancer patients in particular in the forefront of care. It has been a challenge, but fortunately we have been able to take care of patients after a brief timeout. Many of us remember the polio vaccine back in the 1950s. Having worked overseas and at missionary hospital where we had children die of measles because they were not vaccinated gave me a larger appreciation for the importance of vaccines. I recommend all young physicians who work with me to read, “The Great Influenza: The Story of the Deadliest Pandemic in History,” by John M. Barry, which recounts the 1918 flu epidemic.
Who inspires you most in your work today?
I don’t view what I do as work. Dr. Jones and Dr. Mohs continue to inspire me with what they accomplished during their careers. You have to love people and love patients. Every patient who comes to see me has a story, so I try to understand their story. One of the things I really enjoy is training the young fellows. We train three Mohs fellows per year at Scripps, and it’s a great challenge every day.
What development in dermatology are you most excited about in the next 5 years?
Dermatology will continue to evolve just like all other medical specialties. We’re going to see a large growth in telemedicine, and immunotherapy is playing a key role in dermatologic oncology. What excites me the most in medicine is the young people who enter the field willing to contribute their lives to helping others.
American College of Mohs Surgery.
who was also recently selected as program director for cutaneous oncology at Scripps MD Anderson Cancer Center in San Diego. He is also a former president of theAfter earning his medical degree from the Medical College of Georgia, Augusta, in 1974, Dr. Greenway was fellowship trained in Mohs skin cancer surgery by Frederic E. Mohs, MD, at the University of Wisconsin–Madison. He completed his dermatology residency at the Naval Medical Center San Diego and joined Scripps Clinic in 1983, where he launched the institution’s first Mohs surgery program, as well as a popular annual intensive course in superficial anatomy and cutaneous surgery that bears his name. He was also the first physician in the world to use interferon as a nonsurgical treatment of basal cell carcinoma.
To date, Dr. Greenway has performed more than 41,000 Mohs surgery cases and has trained 61 fellows who practice in academic and clinical settings. In 2017, he received the Frederic E. Mohs Award from the ACMS at the college’s annual meeting. He is also a past CEO of Scripps Clinic. In this Q&A, Dr. Greenway opens up about what it was like to train with Dr. Mohs, what makes a good Mohs surgeon, and why he’s excited about the future of dermatology.
I understand that you first became interested in a medical career after meeting Dr. Carl Jones, a friend of your father who was your Scoutmaster in the Boy Scouts in Georgia. What about Dr. Jones inspired you to pursue a career in medicine?
Dr. Jones was an internist/allergist in Atlanta, where I grew up. His three sons and I were friends. My dad had dealt with several medical problems being injured in World War II and subsequently undergoing a couple of kidney transplantations, so I developed an interest in medicine personally. Even though Dr. Jones was a specialist, he started out as a family doctor like I did, so he was interested in the whole person and all of his or her medical problems as opposed to those related to his specialty only. I traveled with the Boy Scouts to camp at places like Valley Forge in Pennsylvania, and Dr. Jones was involved with the medical set-ups of those large events. That also contributed to my interest in medicine.
As part of your 9-year service in the U.S. Navy, you spent 2 years as the flight surgeon at NAS Atlanta/Dobbins Air Force Base. What was your most memorable experience from that assignment?
Dobbins is a large facility with two Lockheed plants, and the Air Force had built the medical clinic, which was staffed by the Navy. Getting to know some of the active-duty members of the Air Force, the Navy, and the National Guard, and their commitment to our country, was memorable. Jimmy Carter was the president in those days. When he would fly in Dobbins, one of my jobs as the flight surgeon was to be on base when Air Force One landed or departed. One night, we had a DC-9 commercial aircraft coming from Huntsville, Ala., to Atlanta that got caught in a thunderstorm a little above 30,000 feet. Both engines went out and the aircraft essentially became a glider. The pilots tried to land on our runway but unfortunately, they ended up 4 miles short. We were heavily involved in responding to the crash, which was a tragic event. I also learned to fly (second seat) different types of aircraft during my assignment at NAS Atlanta/Dobbins Air Force Base, everything from the large C-5s to Navy fighter jets and helicopters. Coincidentally, Dr. Jones was involved with a couple of free health clinics in Atlanta when I was stationed there. Every Tuesday night, my wife (who is a nurse) and I would volunteer at a clinic in Cabbagetown, which was one of the poorer areas of Atlanta. It was a chance to give back to a group of people who didn’t have a whole lot.
In the middle your dermatology residency at Naval Medical Center San Diego, you were selected by Dr. Mohs for fellowship training in Mohs skin cancer surgery at the University of Wisconsin–Madison. What do you remember most about your training with Dr. Mohs?
Dr. Mohs was a kind, humble man who had this great idea about skin cancer. He was not a dermatologist; he was a general surgeon. The technique he developed was originally called chemosurgery because he put a chemical onto the skin. This was known as the fixed-tissue technique. Then we had a fresh-tissue technique, where we did not use the chemical, but we were able to use local anesthesia right away. That developed into the Mohs surgery we know today. Dr. Mohs did not name it that; he was very humble, but he was very proud of his technique. He was also a very hard worker. On the first day of my fellowship, I started at 7 in the morning and ended at 7 at night. It was the same for the last day of my fellowship. He also had an excellent office staff, many of whom had worked with him for many years. Patients with difficult skin cancers traveled to Madison from all over the world because there weren’t that many Mohs surgery clinics in those days. During the latter part of my fellowship, Michael McCall, MD, and I had the opportunity to remove a skin cancer from the nose of Dr. Mohs. We presented the case at a national conference, and I titled the talk “Mohs Surgery for Mohs’ Nose.”
Early in your career Dr. Mohs asked you to take over his practice, but you accepted an offer to establish the first Mohs surgery office at Scripps in San Diego instead. What convinced you to head West?
After my fellowship, I returned to San Diego to complete my residency with the Navy, where we opened a Mohs surgery clinic. Dr. Mohs came out for the ribbon cutting. During that time, I was taking care of several patients that he had treated in Wisconsin. Through that my wife and I ended up going to dinner with Cecil and Ida Green, philanthropists who made several financial gifts to Scripps Clinic – and for whom Scripps Green Hospital is named. Cecil cofounded Texas Instruments and was knighted by Queen Elizabeth. During dinner, he suggested that I stay in San Diego for a year and work at Scripps after my residency assignment with the Navy. I agreed and have been here ever since.
What do you find most interesting about Mohs surgery?
In Mohs surgery, you’re able to provide not only surgical care to eliminate the tumor, but also the pathology and the reconstruction. That was interesting to me. Dr. Mohs was not that interested in reconstruction. He was more focused on the tumor, in part because with the original fixed-tissue technique you could not do the reconstruction. You had to wait for an extra layer of tissue to separate. But with the fresh-tissue technique, you were able to provide the reconstruction that day. Mohs surgery deals with a subset of tumors that are challenging to treat. That also spiked my academic and clinical interest.
In your opinion, what’s been the most important advance in Mohs surgery to date?
In recent years, immunology has come into play, so now we have teams of clinicians in dermatology, medical oncology, surgery, and other subspecialties providing patients the best of care. In the arena of Mohs surgery itself, in the 1980s, the American College of Mohs Surgery developed a 1-year fellowship program, which enabled us to train many men and women to practice Mohs surgery. Most of them are dermatologists.
Please complete the sentence: “You can tell a good Mohs surgeon by the way he/she ...”
Treats patients, is willing to spend time with them, and shows an interest in them. One of the things we should strive for is to let patients know that they as a person are important; it’s not just the melanoma on their nose. We’re not only dealing with a skin cancer; we’re dealing with a patient who has skin cancer.
For the past 39 years, you have led Hugh Greenway’s Superficial Anatomy and Cutaneous Surgery course, which takes place every January in San Diego. What’s been key to sustaining this training course for nearly 4 decades?
There have been many people involved in its success, so it’s not just me. When I first started my practice, there really was not a focus on anatomy in the general dermatologic community. Dermatologic surgery textbooks contained very little content on surgical anatomy so I developed an interest a putting together a course that would cover some of this material. I met with Terence Davidson, MD, an otolaryngologist who was dean of continuing medical education at the University of California, San Diego. The course includes lectures from experts in many subspecialties and hands-on laboratories using cadavers to work on anatomy and surgical techniques. After about 16 years of doing the course Dr. Davidson told me: “When we started this course, as a group, the head and neck surgeons were the best to do the reconstructions on the face with skin flaps and grafts and layered closures. But now, as a group, the dermatologists are best at doing that.” That’s what we want to hear in medical education.
During the peak of the COVID-19 pandemic, what were your most significant challenges from both a clinical and a personal standpoint?
I’m fortunate to practice at a place like Scripps, where there are many resources to look at what was happening with COVID-19. Clinically, we had to put a lot of things on hold, but we tried our best to keep our cancer patients in particular in the forefront of care. It has been a challenge, but fortunately we have been able to take care of patients after a brief timeout. Many of us remember the polio vaccine back in the 1950s. Having worked overseas and at missionary hospital where we had children die of measles because they were not vaccinated gave me a larger appreciation for the importance of vaccines. I recommend all young physicians who work with me to read, “The Great Influenza: The Story of the Deadliest Pandemic in History,” by John M. Barry, which recounts the 1918 flu epidemic.
Who inspires you most in your work today?
I don’t view what I do as work. Dr. Jones and Dr. Mohs continue to inspire me with what they accomplished during their careers. You have to love people and love patients. Every patient who comes to see me has a story, so I try to understand their story. One of the things I really enjoy is training the young fellows. We train three Mohs fellows per year at Scripps, and it’s a great challenge every day.
What development in dermatology are you most excited about in the next 5 years?
Dermatology will continue to evolve just like all other medical specialties. We’re going to see a large growth in telemedicine, and immunotherapy is playing a key role in dermatologic oncology. What excites me the most in medicine is the young people who enter the field willing to contribute their lives to helping others.
‘Unprecedented crisis’: Hodgkin drug shortage persists
The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.
In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.
“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.
Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.
Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.
In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.
“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.
According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
Finding a substitute
In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.
The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.
The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?
For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.
The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.
For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.
Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.
For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.
The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).
For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).
For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.
Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”
To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.
For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.
Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.
The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.
No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.
In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.
“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.
Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.
Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.
In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.
“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.
According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
Finding a substitute
In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.
The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.
The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?
For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.
The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.
For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.
Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.
For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.
The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).
For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).
For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.
Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”
To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.
For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.
Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.
The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.
No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.
In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.
“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.
Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.
Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.
In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.
“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.
According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
Finding a substitute
In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.
The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.
The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?
For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.
The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.
For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.
Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.
For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.
The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).
For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).
For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.
Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”
To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.
For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.
Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.
The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.
No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many state cancer plans drift from USPSTF breast cancer recommendations
When it comes to mammography recommendations state comprehensive cancer control (CCC) plans vary considerably and don’t always closely match the U.S. Preventive Services Task Force (USPSTF) recommendations for mammography frequency in women at average risk for breast cancer, according to a new cross-sectional study of CCC plans in all 50 states and the District of Columbia. The recommended age for initiation varied widely among CCC plans, and nearly one in five bore little resemblance at all to the USPTF recommendations.
According to the authors of the study, the variation among suggested ages of initiation may indicate a lack of consensus among state agencies. “For a recommendation tied to service coverage, this is a serious gap in public health policy,” they wrote in the study published online in JAMA Network Open.
CCC plans include goals, measurable objectives, and evidence-based strategies to combat cancers that are both common and preventable. They include input from multiple groups, frequently take 4-6 years to create, and should be updated regularly. Funding from the Centers for Disease Control and Prevention requires that the plans include data cancer screening prevalence rates and specific objectives and strategies.
Breast cancer is the most common cancer in women in the United States, and the second highest cause of cancer death. Regular, high-quality screening reduces breast cancer mortality by 25%-31% among women aged 50-69. As a result, the American Cancer Society, the USPSTF, the American College of Physicians, and the American Academy of Family Physicians have produced guidelines for mammography screening in women at average risk of breast cancer.
Although the benefits of screening are widely accepted, there is disagreement about the ages it should be initiated and ended. These inconsistencies stem from different evidence used to support recommendations, as well as different standards for benefits and harms from screening. Common concerns include overdiagnosis, false-positive results, and radiation damage from mammography.
Because these benefits and harms can vary based on age and values, there is an emphasis on shared decision-making between clinicians and women, especially those aged 40-49.
The most recent USPTF recommendation, issued in 2016, states that women aged 50-74 with average risk should be screened with mammography every 2 years. The choice of mammography in average-risk women under 50 should be approached on an individual basis. USPTF defines average risk as having no signs, symptoms, or previous diagnosis of breast cancer, and no family history or genetic causes for concern.
In the new study, researchers conducted a point-in-time evaluation of CCC plans from 50 states and the District of Columbia, between Nov. 1, 2019, and June 30, 2021.
Thirty-one percent of the plans included the complete USPTF recommendations of biennial mammography between ages 50 and 74; 51% included some, but not all of the USPTF recommendations; and 18% were not consistent at all with USPTF recommendations.
Overall, 59% of plans recommended initiation at age 50 and 37% at age 40, which is consistent with the older 2009 USPSTF recommendation. Eight percent of plans recommended starting at both 40 and 50, and 20% of plans had no recommended age of initiation.
Among the plans that were partially consistent with USPTF, 73% recommended initiation of mammography at age 40 and 31% at age 50. Eighty-five percent did not include an age to stop mammography; 15% did not include a recommended frequency; and 15% had an initiation age other than 40 or 50. Eighty-five percent of plans partially consistent with USPSTF included a recommendation that mammography should be conducted biennially.
The authors state that CCC plans could be improved by a unified emphasis on biennial screening of the general population of women aged 50-74, as well as clear differentiation between women at average risk and those at high risk, who could be screened at ages younger than 50 in consultation with their physician.
The study is limited by the fact that plans were reviewed a single time, while state CCC plans are updated with varying periodicity. The authors agree that implementation of population-based screening should be tailored to individual states and health care systems.
When it comes to mammography recommendations state comprehensive cancer control (CCC) plans vary considerably and don’t always closely match the U.S. Preventive Services Task Force (USPSTF) recommendations for mammography frequency in women at average risk for breast cancer, according to a new cross-sectional study of CCC plans in all 50 states and the District of Columbia. The recommended age for initiation varied widely among CCC plans, and nearly one in five bore little resemblance at all to the USPTF recommendations.
According to the authors of the study, the variation among suggested ages of initiation may indicate a lack of consensus among state agencies. “For a recommendation tied to service coverage, this is a serious gap in public health policy,” they wrote in the study published online in JAMA Network Open.
CCC plans include goals, measurable objectives, and evidence-based strategies to combat cancers that are both common and preventable. They include input from multiple groups, frequently take 4-6 years to create, and should be updated regularly. Funding from the Centers for Disease Control and Prevention requires that the plans include data cancer screening prevalence rates and specific objectives and strategies.
Breast cancer is the most common cancer in women in the United States, and the second highest cause of cancer death. Regular, high-quality screening reduces breast cancer mortality by 25%-31% among women aged 50-69. As a result, the American Cancer Society, the USPSTF, the American College of Physicians, and the American Academy of Family Physicians have produced guidelines for mammography screening in women at average risk of breast cancer.
Although the benefits of screening are widely accepted, there is disagreement about the ages it should be initiated and ended. These inconsistencies stem from different evidence used to support recommendations, as well as different standards for benefits and harms from screening. Common concerns include overdiagnosis, false-positive results, and radiation damage from mammography.
Because these benefits and harms can vary based on age and values, there is an emphasis on shared decision-making between clinicians and women, especially those aged 40-49.
The most recent USPTF recommendation, issued in 2016, states that women aged 50-74 with average risk should be screened with mammography every 2 years. The choice of mammography in average-risk women under 50 should be approached on an individual basis. USPTF defines average risk as having no signs, symptoms, or previous diagnosis of breast cancer, and no family history or genetic causes for concern.
In the new study, researchers conducted a point-in-time evaluation of CCC plans from 50 states and the District of Columbia, between Nov. 1, 2019, and June 30, 2021.
Thirty-one percent of the plans included the complete USPTF recommendations of biennial mammography between ages 50 and 74; 51% included some, but not all of the USPTF recommendations; and 18% were not consistent at all with USPTF recommendations.
Overall, 59% of plans recommended initiation at age 50 and 37% at age 40, which is consistent with the older 2009 USPSTF recommendation. Eight percent of plans recommended starting at both 40 and 50, and 20% of plans had no recommended age of initiation.
Among the plans that were partially consistent with USPTF, 73% recommended initiation of mammography at age 40 and 31% at age 50. Eighty-five percent did not include an age to stop mammography; 15% did not include a recommended frequency; and 15% had an initiation age other than 40 or 50. Eighty-five percent of plans partially consistent with USPSTF included a recommendation that mammography should be conducted biennially.
The authors state that CCC plans could be improved by a unified emphasis on biennial screening of the general population of women aged 50-74, as well as clear differentiation between women at average risk and those at high risk, who could be screened at ages younger than 50 in consultation with their physician.
The study is limited by the fact that plans were reviewed a single time, while state CCC plans are updated with varying periodicity. The authors agree that implementation of population-based screening should be tailored to individual states and health care systems.
When it comes to mammography recommendations state comprehensive cancer control (CCC) plans vary considerably and don’t always closely match the U.S. Preventive Services Task Force (USPSTF) recommendations for mammography frequency in women at average risk for breast cancer, according to a new cross-sectional study of CCC plans in all 50 states and the District of Columbia. The recommended age for initiation varied widely among CCC plans, and nearly one in five bore little resemblance at all to the USPTF recommendations.
According to the authors of the study, the variation among suggested ages of initiation may indicate a lack of consensus among state agencies. “For a recommendation tied to service coverage, this is a serious gap in public health policy,” they wrote in the study published online in JAMA Network Open.
CCC plans include goals, measurable objectives, and evidence-based strategies to combat cancers that are both common and preventable. They include input from multiple groups, frequently take 4-6 years to create, and should be updated regularly. Funding from the Centers for Disease Control and Prevention requires that the plans include data cancer screening prevalence rates and specific objectives and strategies.
Breast cancer is the most common cancer in women in the United States, and the second highest cause of cancer death. Regular, high-quality screening reduces breast cancer mortality by 25%-31% among women aged 50-69. As a result, the American Cancer Society, the USPSTF, the American College of Physicians, and the American Academy of Family Physicians have produced guidelines for mammography screening in women at average risk of breast cancer.
Although the benefits of screening are widely accepted, there is disagreement about the ages it should be initiated and ended. These inconsistencies stem from different evidence used to support recommendations, as well as different standards for benefits and harms from screening. Common concerns include overdiagnosis, false-positive results, and radiation damage from mammography.
Because these benefits and harms can vary based on age and values, there is an emphasis on shared decision-making between clinicians and women, especially those aged 40-49.
The most recent USPTF recommendation, issued in 2016, states that women aged 50-74 with average risk should be screened with mammography every 2 years. The choice of mammography in average-risk women under 50 should be approached on an individual basis. USPTF defines average risk as having no signs, symptoms, or previous diagnosis of breast cancer, and no family history or genetic causes for concern.
In the new study, researchers conducted a point-in-time evaluation of CCC plans from 50 states and the District of Columbia, between Nov. 1, 2019, and June 30, 2021.
Thirty-one percent of the plans included the complete USPTF recommendations of biennial mammography between ages 50 and 74; 51% included some, but not all of the USPTF recommendations; and 18% were not consistent at all with USPTF recommendations.
Overall, 59% of plans recommended initiation at age 50 and 37% at age 40, which is consistent with the older 2009 USPSTF recommendation. Eight percent of plans recommended starting at both 40 and 50, and 20% of plans had no recommended age of initiation.
Among the plans that were partially consistent with USPTF, 73% recommended initiation of mammography at age 40 and 31% at age 50. Eighty-five percent did not include an age to stop mammography; 15% did not include a recommended frequency; and 15% had an initiation age other than 40 or 50. Eighty-five percent of plans partially consistent with USPSTF included a recommendation that mammography should be conducted biennially.
The authors state that CCC plans could be improved by a unified emphasis on biennial screening of the general population of women aged 50-74, as well as clear differentiation between women at average risk and those at high risk, who could be screened at ages younger than 50 in consultation with their physician.
The study is limited by the fact that plans were reviewed a single time, while state CCC plans are updated with varying periodicity. The authors agree that implementation of population-based screening should be tailored to individual states and health care systems.
FROM JAMA NETWORK OPEN
Roe v. Wade reversal would rock ob.gyn. residencies
A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.
On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.
Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.
Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”
The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”
Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.
Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.
Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
A glimpse at the future
The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.
The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.
“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”
But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”
She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available.
Spillover effect
Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.
“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”
Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.
“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.
Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.
“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”
Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.
Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
A looming ‘pipeline problem’
There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.
Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.
Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.
“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”
States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.
As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”
A version of this article first appeared on Medscape.com.
A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.
On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.
Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.
Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”
The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”
Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.
Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.
Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
A glimpse at the future
The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.
The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.
“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”
But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”
She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available.
Spillover effect
Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.
“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”
Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.
“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.
Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.
“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”
Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.
Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
A looming ‘pipeline problem’
There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.
Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.
Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.
“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”
States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.
As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”
A version of this article first appeared on Medscape.com.
A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.
On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.
Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.
Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”
The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”
Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.
Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.
Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
A glimpse at the future
The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.
The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.
“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”
But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”
She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available.
Spillover effect
Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.
“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”
Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.
“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.
Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.
“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”
Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.
Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
A looming ‘pipeline problem’
There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.
Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.
Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.
“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”
States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.
As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”
A version of this article first appeared on Medscape.com.
Multistate opioid crackdown nets indictment against seven physicians
In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.
The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.
“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
Medical professionals, others across six states charged
One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:
- Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
- Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
- Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
- Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
- Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
- Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
- Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
- Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
- Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.
Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.
The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.
“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.
“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.
A version of this article first appeared on Medscape.com.
In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.
The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.
“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
Medical professionals, others across six states charged
One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:
- Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
- Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
- Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
- Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
- Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
- Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
- Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
- Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
- Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.
Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.
The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.
“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.
“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.
A version of this article first appeared on Medscape.com.
In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.
The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.
“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
Medical professionals, others across six states charged
One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:
- Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
- Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
- Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
- Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
- Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
- Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
- Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
- Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
- Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.
Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.
The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.
“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.
“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.
A version of this article first appeared on Medscape.com.
Takotsubo syndrome also linked to happy life events
, a new study suggests.
The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”
In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.
Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.
The results were published online in JACC: Heart Failure.
Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.
A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.
“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.
But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”
For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.
The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.
There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.
Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.
Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.
Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.
“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.
Dr. Stiermaier reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new study suggests.
The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”
In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.
Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.
The results were published online in JACC: Heart Failure.
Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.
A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.
“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.
But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”
For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.
The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.
There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.
Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.
Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.
Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.
“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.
Dr. Stiermaier reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new study suggests.
The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”
In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.
Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.
The results were published online in JACC: Heart Failure.
Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.
A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.
“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.
But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”
For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.
The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.
There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.
Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.
Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.
Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.
“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.
Dr. Stiermaier reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
JACC: HEART FAILURE