User login
M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.
Young patients suffer most from PBC
Youth is no ally when it comes to primary biliary cholangitis, according to a review of 1,990 patients in the United Kingdom–PBC cohort, the largest primary biliary cholangitis cohort in the world.
The investigators previously found that younger patients are less likely to respond to the mainstay treatment, ursodeoxycholic acid (UDCA), and more likely to eventually need a liver transplant and die from the chronic autoimmune disease. Their new study found that they also suffer most from symptoms and have the lowest quality of life.
There was a linear relationship between age and quality of life (QoL) in this study of 1,990 primary biliary cholangitis patients; people who presented at age 20 had more than a 50% chance of reporting a poor QoL, while those presenting at age 70 had less than a 30% chance.
Overall perception of primary biliary cholangitis (PBC)-related QoL and individual severity of all symptoms, as is true with UDCA response, were strongly related to the age of onset of disease, with younger presenting patients experiencing the greatest impact. Each 10-year increase in presentation age was associated with a 14% decrease in the risk of poor QoL (OR, 0.86; 95% CI, 0.75–0.98; P less than .05), after adjustment for gender, disease severity, UDCA response, and disease duration. Presentations before the age of, perhaps, 50 years signal the need for greater vigilance (Aliment Pharmacol Ther. 2016 Nov;44[10]:1039-50).
The findings challenge “the view that PBC is a relatively benign condition of typically older people with limited clinical impact.” The biology “or natural history of PBC may differ between different patient groups, with younger-presenting patients having a more aggressive or materially different form of the disease.” Alternatively, the “enhanced symptom impact in younger patients may be [due to] age-related differences in [the expectation] of chronic disease, personal coping skills, and support networks,” said Jessica Dyson, MBBS, of Newcastle University, Newcastle upon Tyne (England), and her associates.
QoL was most affected by social isolation. “Addressing and treating this single aspect could improve global quality of life significantly... Approaches could range from simple counseling to alert patients to the potential for social isolation, to the development of support groups, to the development of newer digital approaches to social networking through social media,” Dr. Dyson and her colleagues said.
Fatigue, anxiety, and depression also were especially vexing for younger patients, and could “be related to fear of the future and ability to cope, uncertainty as to disease prognosis, and frustration at limitations to life quality,” they said.
“Specifically targeting fatigue is likely to pay dividends,” but “there are currently no therapies able to do that.” However, “a more sociological approach targeting social isolation and the depression and anxiety which may accompany it are very viable approaches.” The findings should help guide future intervention trials, the team said.
QoL was assessed by the PBC-40, a 40 item questionnaire about fatigue; itch; and emotional, social, cognitive, and general symptoms. Each item is scored from 1 to 5, with higher scores indicating greater symptom severity.
The team used the results to assign patients a global QoL score from 1-5 points; scores of 1-3 indicated neutral or good QoL, while 4-5 signaled poor QoL. Overall, two-thirds of patients reported neutral/good scores, and a third had poor scores.
Meanwhile, patients doing well had a median of 18 of 50 possible points on the PBC-40 social score, while those not doing well had a median score of 34 points.
Patients in the study, 91% of whom were women, presented at a median age of 55 years, but 493 presented before the age of 50.
This research was supported by the British Medical Research Council and the National Institute for Health Research, among others. Dr. Dyson had no disclosures, but other authors reported relationships with a range of pharmaceutical companies, including Abbvie, GSK, Intercept, Novartis, and Pfizer.
Youth is no ally when it comes to primary biliary cholangitis, according to a review of 1,990 patients in the United Kingdom–PBC cohort, the largest primary biliary cholangitis cohort in the world.
The investigators previously found that younger patients are less likely to respond to the mainstay treatment, ursodeoxycholic acid (UDCA), and more likely to eventually need a liver transplant and die from the chronic autoimmune disease. Their new study found that they also suffer most from symptoms and have the lowest quality of life.
There was a linear relationship between age and quality of life (QoL) in this study of 1,990 primary biliary cholangitis patients; people who presented at age 20 had more than a 50% chance of reporting a poor QoL, while those presenting at age 70 had less than a 30% chance.
Overall perception of primary biliary cholangitis (PBC)-related QoL and individual severity of all symptoms, as is true with UDCA response, were strongly related to the age of onset of disease, with younger presenting patients experiencing the greatest impact. Each 10-year increase in presentation age was associated with a 14% decrease in the risk of poor QoL (OR, 0.86; 95% CI, 0.75–0.98; P less than .05), after adjustment for gender, disease severity, UDCA response, and disease duration. Presentations before the age of, perhaps, 50 years signal the need for greater vigilance (Aliment Pharmacol Ther. 2016 Nov;44[10]:1039-50).
The findings challenge “the view that PBC is a relatively benign condition of typically older people with limited clinical impact.” The biology “or natural history of PBC may differ between different patient groups, with younger-presenting patients having a more aggressive or materially different form of the disease.” Alternatively, the “enhanced symptom impact in younger patients may be [due to] age-related differences in [the expectation] of chronic disease, personal coping skills, and support networks,” said Jessica Dyson, MBBS, of Newcastle University, Newcastle upon Tyne (England), and her associates.
QoL was most affected by social isolation. “Addressing and treating this single aspect could improve global quality of life significantly... Approaches could range from simple counseling to alert patients to the potential for social isolation, to the development of support groups, to the development of newer digital approaches to social networking through social media,” Dr. Dyson and her colleagues said.
Fatigue, anxiety, and depression also were especially vexing for younger patients, and could “be related to fear of the future and ability to cope, uncertainty as to disease prognosis, and frustration at limitations to life quality,” they said.
“Specifically targeting fatigue is likely to pay dividends,” but “there are currently no therapies able to do that.” However, “a more sociological approach targeting social isolation and the depression and anxiety which may accompany it are very viable approaches.” The findings should help guide future intervention trials, the team said.
QoL was assessed by the PBC-40, a 40 item questionnaire about fatigue; itch; and emotional, social, cognitive, and general symptoms. Each item is scored from 1 to 5, with higher scores indicating greater symptom severity.
The team used the results to assign patients a global QoL score from 1-5 points; scores of 1-3 indicated neutral or good QoL, while 4-5 signaled poor QoL. Overall, two-thirds of patients reported neutral/good scores, and a third had poor scores.
Meanwhile, patients doing well had a median of 18 of 50 possible points on the PBC-40 social score, while those not doing well had a median score of 34 points.
Patients in the study, 91% of whom were women, presented at a median age of 55 years, but 493 presented before the age of 50.
This research was supported by the British Medical Research Council and the National Institute for Health Research, among others. Dr. Dyson had no disclosures, but other authors reported relationships with a range of pharmaceutical companies, including Abbvie, GSK, Intercept, Novartis, and Pfizer.
Youth is no ally when it comes to primary biliary cholangitis, according to a review of 1,990 patients in the United Kingdom–PBC cohort, the largest primary biliary cholangitis cohort in the world.
The investigators previously found that younger patients are less likely to respond to the mainstay treatment, ursodeoxycholic acid (UDCA), and more likely to eventually need a liver transplant and die from the chronic autoimmune disease. Their new study found that they also suffer most from symptoms and have the lowest quality of life.
There was a linear relationship between age and quality of life (QoL) in this study of 1,990 primary biliary cholangitis patients; people who presented at age 20 had more than a 50% chance of reporting a poor QoL, while those presenting at age 70 had less than a 30% chance.
Overall perception of primary biliary cholangitis (PBC)-related QoL and individual severity of all symptoms, as is true with UDCA response, were strongly related to the age of onset of disease, with younger presenting patients experiencing the greatest impact. Each 10-year increase in presentation age was associated with a 14% decrease in the risk of poor QoL (OR, 0.86; 95% CI, 0.75–0.98; P less than .05), after adjustment for gender, disease severity, UDCA response, and disease duration. Presentations before the age of, perhaps, 50 years signal the need for greater vigilance (Aliment Pharmacol Ther. 2016 Nov;44[10]:1039-50).
The findings challenge “the view that PBC is a relatively benign condition of typically older people with limited clinical impact.” The biology “or natural history of PBC may differ between different patient groups, with younger-presenting patients having a more aggressive or materially different form of the disease.” Alternatively, the “enhanced symptom impact in younger patients may be [due to] age-related differences in [the expectation] of chronic disease, personal coping skills, and support networks,” said Jessica Dyson, MBBS, of Newcastle University, Newcastle upon Tyne (England), and her associates.
QoL was most affected by social isolation. “Addressing and treating this single aspect could improve global quality of life significantly... Approaches could range from simple counseling to alert patients to the potential for social isolation, to the development of support groups, to the development of newer digital approaches to social networking through social media,” Dr. Dyson and her colleagues said.
Fatigue, anxiety, and depression also were especially vexing for younger patients, and could “be related to fear of the future and ability to cope, uncertainty as to disease prognosis, and frustration at limitations to life quality,” they said.
“Specifically targeting fatigue is likely to pay dividends,” but “there are currently no therapies able to do that.” However, “a more sociological approach targeting social isolation and the depression and anxiety which may accompany it are very viable approaches.” The findings should help guide future intervention trials, the team said.
QoL was assessed by the PBC-40, a 40 item questionnaire about fatigue; itch; and emotional, social, cognitive, and general symptoms. Each item is scored from 1 to 5, with higher scores indicating greater symptom severity.
The team used the results to assign patients a global QoL score from 1-5 points; scores of 1-3 indicated neutral or good QoL, while 4-5 signaled poor QoL. Overall, two-thirds of patients reported neutral/good scores, and a third had poor scores.
Meanwhile, patients doing well had a median of 18 of 50 possible points on the PBC-40 social score, while those not doing well had a median score of 34 points.
Patients in the study, 91% of whom were women, presented at a median age of 55 years, but 493 presented before the age of 50.
This research was supported by the British Medical Research Council and the National Institute for Health Research, among others. Dr. Dyson had no disclosures, but other authors reported relationships with a range of pharmaceutical companies, including Abbvie, GSK, Intercept, Novartis, and Pfizer.
FROM ALIMENTARY PHARMACOLOGY AND THERAPEUTICS
Key clinical point:
Major finding: There was a linear relationship between age and quality of life (QoL) in patients with primary biliary cholangitis, with younger presenting patients having the poorest QoL. Each 10-year increase in presentation age was associated with a 14% decrease in the risk of poor QoL.
Data source: Review of 1,990 patients in the United Kingdom–PBC cohort.
Disclosures: The work was funded by the British Medical Research Council and the National Institute for Health Research, among others. Dr. Dyson had no disclosures, but other authors reported relationships with a range of pharmaceutical companies, including Abbvie, GSK, Intercept, and Novartis.
ADT may increase dementia risk in prostate CA
Prostate cancer patients treated with androgen deprivation therapy are more than twice as likely as those who were not to develop dementia, according to a review of 9,272 prostate cancer cases at Stanford (Calif.) University.
Almost 8% of the 1,826 men treated with androgen deprivation therapy (ADT), a mainstay against prostate cancer, were diagnosed with dementia at 5 years, versus 3.5% of the 7,446 men not treated with ADT (JAMA Oncol. 2016 Oct 13. doi: 10.1001/jamaoncol.2016.3662).
“Our study extends previous work supporting an association between use of ADT and Alzheimer disease and suggests that ADT may more broadly affect neurocognitive function,” said the investigators, led by Kevin Nead, MD, formerly at Stanford but now a radiation oncology resident at the University of Pennsylvania, Philadelphia.
New-onset senile dementia, vascular dementia, frontotemporal dementia, and Alzheimer dementia were linked to ADT in both a propensity score-matched analysis (HR, 2.17; 95% CI, 1.58-2.99; P < .001) and multivariate analysis (adjusted HR, 2.21; 95% CI, 1.72-2.83; P < .001). The results held up when Alzheimer disease, just 30% of the 314 dementia cases, was excluded.
Men with at least 12 months of ADT had the greatest increased risk of dementia (HR, 2.36; 95% CI, 1.64-3.38; P < .001), suggesting a dose-response relationship; men on ADT who were at least 70 years old had the lowest cumulative probability of not developing dementia.
The link, the team said, is biologically plausible. Androgens have a role in neuron health and growth, and testosterone analogues have neuroprotective effects. Testosterone may be converted to estrogen, which is also neuroprotective. Low testosterone levels and ADT, meanwhile, have been shown to increase the risk of cardiometabolic diseases, which increase the risk of dementia.
The analyses controlled for age at prostate cancer diagnosis; race; smoking status; use of antiplatelet, anticoagulant, antihypertensive, and statin medications; and histories of cardiovascular disease, type 1 or 2 diabetes, stroke, and malignant neoplasms.
The men were treated at Stanford from 1994-2013. ADT patients tended to be older than their peers (70 versus 66 years), less likely to white (54% versus 60%), more likely to have smoked (44% versus 38%), and more likely to have other health problems.
More than 20 medications in the study were used for ADT, including leuprolide, goserelin, and triptorelin. Data were collectedd from electronic health records, and included diagnostic codes, medication lists, and clinical notes.
The work was funded by the National Institutes of Health. The senior author, Nigam Shah, PhD, has patents pending on the data-mining methods used in the study.
Prostate cancer patients treated with androgen deprivation therapy are more than twice as likely as those who were not to develop dementia, according to a review of 9,272 prostate cancer cases at Stanford (Calif.) University.
Almost 8% of the 1,826 men treated with androgen deprivation therapy (ADT), a mainstay against prostate cancer, were diagnosed with dementia at 5 years, versus 3.5% of the 7,446 men not treated with ADT (JAMA Oncol. 2016 Oct 13. doi: 10.1001/jamaoncol.2016.3662).
“Our study extends previous work supporting an association between use of ADT and Alzheimer disease and suggests that ADT may more broadly affect neurocognitive function,” said the investigators, led by Kevin Nead, MD, formerly at Stanford but now a radiation oncology resident at the University of Pennsylvania, Philadelphia.
New-onset senile dementia, vascular dementia, frontotemporal dementia, and Alzheimer dementia were linked to ADT in both a propensity score-matched analysis (HR, 2.17; 95% CI, 1.58-2.99; P < .001) and multivariate analysis (adjusted HR, 2.21; 95% CI, 1.72-2.83; P < .001). The results held up when Alzheimer disease, just 30% of the 314 dementia cases, was excluded.
Men with at least 12 months of ADT had the greatest increased risk of dementia (HR, 2.36; 95% CI, 1.64-3.38; P < .001), suggesting a dose-response relationship; men on ADT who were at least 70 years old had the lowest cumulative probability of not developing dementia.
The link, the team said, is biologically plausible. Androgens have a role in neuron health and growth, and testosterone analogues have neuroprotective effects. Testosterone may be converted to estrogen, which is also neuroprotective. Low testosterone levels and ADT, meanwhile, have been shown to increase the risk of cardiometabolic diseases, which increase the risk of dementia.
The analyses controlled for age at prostate cancer diagnosis; race; smoking status; use of antiplatelet, anticoagulant, antihypertensive, and statin medications; and histories of cardiovascular disease, type 1 or 2 diabetes, stroke, and malignant neoplasms.
The men were treated at Stanford from 1994-2013. ADT patients tended to be older than their peers (70 versus 66 years), less likely to white (54% versus 60%), more likely to have smoked (44% versus 38%), and more likely to have other health problems.
More than 20 medications in the study were used for ADT, including leuprolide, goserelin, and triptorelin. Data were collectedd from electronic health records, and included diagnostic codes, medication lists, and clinical notes.
The work was funded by the National Institutes of Health. The senior author, Nigam Shah, PhD, has patents pending on the data-mining methods used in the study.
Prostate cancer patients treated with androgen deprivation therapy are more than twice as likely as those who were not to develop dementia, according to a review of 9,272 prostate cancer cases at Stanford (Calif.) University.
Almost 8% of the 1,826 men treated with androgen deprivation therapy (ADT), a mainstay against prostate cancer, were diagnosed with dementia at 5 years, versus 3.5% of the 7,446 men not treated with ADT (JAMA Oncol. 2016 Oct 13. doi: 10.1001/jamaoncol.2016.3662).
“Our study extends previous work supporting an association between use of ADT and Alzheimer disease and suggests that ADT may more broadly affect neurocognitive function,” said the investigators, led by Kevin Nead, MD, formerly at Stanford but now a radiation oncology resident at the University of Pennsylvania, Philadelphia.
New-onset senile dementia, vascular dementia, frontotemporal dementia, and Alzheimer dementia were linked to ADT in both a propensity score-matched analysis (HR, 2.17; 95% CI, 1.58-2.99; P < .001) and multivariate analysis (adjusted HR, 2.21; 95% CI, 1.72-2.83; P < .001). The results held up when Alzheimer disease, just 30% of the 314 dementia cases, was excluded.
Men with at least 12 months of ADT had the greatest increased risk of dementia (HR, 2.36; 95% CI, 1.64-3.38; P < .001), suggesting a dose-response relationship; men on ADT who were at least 70 years old had the lowest cumulative probability of not developing dementia.
The link, the team said, is biologically plausible. Androgens have a role in neuron health and growth, and testosterone analogues have neuroprotective effects. Testosterone may be converted to estrogen, which is also neuroprotective. Low testosterone levels and ADT, meanwhile, have been shown to increase the risk of cardiometabolic diseases, which increase the risk of dementia.
The analyses controlled for age at prostate cancer diagnosis; race; smoking status; use of antiplatelet, anticoagulant, antihypertensive, and statin medications; and histories of cardiovascular disease, type 1 or 2 diabetes, stroke, and malignant neoplasms.
The men were treated at Stanford from 1994-2013. ADT patients tended to be older than their peers (70 versus 66 years), less likely to white (54% versus 60%), more likely to have smoked (44% versus 38%), and more likely to have other health problems.
More than 20 medications in the study were used for ADT, including leuprolide, goserelin, and triptorelin. Data were collectedd from electronic health records, and included diagnostic codes, medication lists, and clinical notes.
The work was funded by the National Institutes of Health. The senior author, Nigam Shah, PhD, has patents pending on the data-mining methods used in the study.
FROM JAMA ONCOLOGY
Key clinical point:
Major finding: New-onset senile dementia, vascular dementia, frontotemporal dementia, and Alzheimer dementia were linked to ADT in both a propensity score-matched analysis (HR, 2.17; 95% CI, 1.58-2.99; P < .001) and multivariate analysis (adjusted HR, 2.21; 95% CI, 1.72-2.83; P < .001).
Data source: Review of 9,272 prostate cancer cases at Stanford (Calif.) University.
Disclosures: The work was funded by the National Institutes of Health. The senior author, Nigam Shah, PhD, has patents pending on the data-mining methods used in the study.
Depression drops COPD medication adherence
Chronic obstructive pulmonary disease (COPD) patients with depression are less likely to take their maintenance medications, according to a review of Medicare claims by the University of Maryland, Baltimore.
“Clinicians who treat older adults newly diagnosed with COPD should be aware of the development of depression, especially during the first 6 months. As such, clinicians should consider the need to monitor their patients with COPD for … depression [treatment], as well as use of and adherence to prescribed COPD medications. Close management of these and other aspects of newly diagnosed older adults with COPD will help to ensure optimal clinical outcomes,” said the investigators, led by Jennifer Albrecht, PhD, of the department of epidemiology and public health at the University of Maryland.
The researchers ran a random sampling of Medicare data and identified 31,033 beneficiaries diagnosed with COPD between 2006 and 2010; 6,227 patients (20% of the study sample) were diagnosed with depression within 2 years of being diagnosed with COPD.
The investigators found that depression reduced the likelihood of chronic obstructive pulmonary disease patients filling their prescriptions. Maintenance medication adherence was low overall, peaking at 57% in the month after the first fill and decreasing every month for the next 9 months for both the patients with depression and those patients who had not been diagnosed with the condition. Depression made things worse; 20% of depressed patients filled 80% or more of their medications at the pharmacy, vs. 22% of nondepressed patients. Patients with newly diagnosed depression were about 7% less likely to have good adherence (odds ratio, 0.93; 95% confidence interval, 0.89-0.98). Women – 65% of the study sample and 75% of those with depression – were less likely than men to fill their scripts.
Meanwhile, adherence to COPD maintenance medication was more likely among patients on short-term inhalers and supplemental oxygen, as well as among nursing home patients and those with low-income subsidies.
Patients were 83% white. Those diagnosed with depression were slightly younger on average than those who were not (67 vs. 69 years old) and were more likely to have more than three comorbid conditions (33% vs. 23%). With the exception of asthma, comorbid conditions made adherence worse. Depressed patients also had more severe COPD symptoms, based on their higher rates of oxygen use (10% vs. 8%).
Dr. Albrecht reported receiving grants from the National Institutes of Health during the conduct of the study.
Chronic obstructive pulmonary disease (COPD) patients with depression are less likely to take their maintenance medications, according to a review of Medicare claims by the University of Maryland, Baltimore.
“Clinicians who treat older adults newly diagnosed with COPD should be aware of the development of depression, especially during the first 6 months. As such, clinicians should consider the need to monitor their patients with COPD for … depression [treatment], as well as use of and adherence to prescribed COPD medications. Close management of these and other aspects of newly diagnosed older adults with COPD will help to ensure optimal clinical outcomes,” said the investigators, led by Jennifer Albrecht, PhD, of the department of epidemiology and public health at the University of Maryland.
The researchers ran a random sampling of Medicare data and identified 31,033 beneficiaries diagnosed with COPD between 2006 and 2010; 6,227 patients (20% of the study sample) were diagnosed with depression within 2 years of being diagnosed with COPD.
The investigators found that depression reduced the likelihood of chronic obstructive pulmonary disease patients filling their prescriptions. Maintenance medication adherence was low overall, peaking at 57% in the month after the first fill and decreasing every month for the next 9 months for both the patients with depression and those patients who had not been diagnosed with the condition. Depression made things worse; 20% of depressed patients filled 80% or more of their medications at the pharmacy, vs. 22% of nondepressed patients. Patients with newly diagnosed depression were about 7% less likely to have good adherence (odds ratio, 0.93; 95% confidence interval, 0.89-0.98). Women – 65% of the study sample and 75% of those with depression – were less likely than men to fill their scripts.
Meanwhile, adherence to COPD maintenance medication was more likely among patients on short-term inhalers and supplemental oxygen, as well as among nursing home patients and those with low-income subsidies.
Patients were 83% white. Those diagnosed with depression were slightly younger on average than those who were not (67 vs. 69 years old) and were more likely to have more than three comorbid conditions (33% vs. 23%). With the exception of asthma, comorbid conditions made adherence worse. Depressed patients also had more severe COPD symptoms, based on their higher rates of oxygen use (10% vs. 8%).
Dr. Albrecht reported receiving grants from the National Institutes of Health during the conduct of the study.
Chronic obstructive pulmonary disease (COPD) patients with depression are less likely to take their maintenance medications, according to a review of Medicare claims by the University of Maryland, Baltimore.
“Clinicians who treat older adults newly diagnosed with COPD should be aware of the development of depression, especially during the first 6 months. As such, clinicians should consider the need to monitor their patients with COPD for … depression [treatment], as well as use of and adherence to prescribed COPD medications. Close management of these and other aspects of newly diagnosed older adults with COPD will help to ensure optimal clinical outcomes,” said the investigators, led by Jennifer Albrecht, PhD, of the department of epidemiology and public health at the University of Maryland.
The researchers ran a random sampling of Medicare data and identified 31,033 beneficiaries diagnosed with COPD between 2006 and 2010; 6,227 patients (20% of the study sample) were diagnosed with depression within 2 years of being diagnosed with COPD.
The investigators found that depression reduced the likelihood of chronic obstructive pulmonary disease patients filling their prescriptions. Maintenance medication adherence was low overall, peaking at 57% in the month after the first fill and decreasing every month for the next 9 months for both the patients with depression and those patients who had not been diagnosed with the condition. Depression made things worse; 20% of depressed patients filled 80% or more of their medications at the pharmacy, vs. 22% of nondepressed patients. Patients with newly diagnosed depression were about 7% less likely to have good adherence (odds ratio, 0.93; 95% confidence interval, 0.89-0.98). Women – 65% of the study sample and 75% of those with depression – were less likely than men to fill their scripts.
Meanwhile, adherence to COPD maintenance medication was more likely among patients on short-term inhalers and supplemental oxygen, as well as among nursing home patients and those with low-income subsidies.
Patients were 83% white. Those diagnosed with depression were slightly younger on average than those who were not (67 vs. 69 years old) and were more likely to have more than three comorbid conditions (33% vs. 23%). With the exception of asthma, comorbid conditions made adherence worse. Depressed patients also had more severe COPD symptoms, based on their higher rates of oxygen use (10% vs. 8%).
Dr. Albrecht reported receiving grants from the National Institutes of Health during the conduct of the study.
FROM THE ANNALS OF THE AMERICAN THORACIC SOCIETY
Key clinical point:
Major finding: Patients with newly diagnosed depression were about 7% less likely to have good adherence to their medications (OR 0.93; 95% CI, 0.89–0.98).
Data source: A review of 31,033 Medicare COPD patients, who had filled their COPD maintenance medication at least twice.
Disclosures: Dr. Albrecht reported receiving grants from the National Institutes of Health during the conduct of the study.
Open Payments: Few dermatologists have significant conflicts of interest
A total of 8,333 dermatologists – 73% of those practicing in the United States – received $34.8 million from industry in 2014, mostly from pharmaceutical companies, according to an Oct. 5 report in JAMA Dermatology.
The bulk of the money went to a fraction of the dermatologists. Just 10% – 833 – collected $31.2 million. Eighty-three dermatologists – 1% of the total – pulled in about $15 million, each receiving at least $93,622. The 10 highest-paid dermatologists were mostly in private practice, not academia, and three were women (JAMA Dermatol. 2016 Oct 5. doi: 10.1001/jamadermatol.2016.3037).
Speaker fees accounted for 32% of the total payment amount, consulting fees for 22%, research payments for 17%, and food and beverage payments for 13%. Lesser amounts went towards travel and honoraria, among other things.
Almost $29 million came from pharmaceutical companies. AbbVie and Allergan led the way with payments of nearly $6 million each. Pharmaceutical company largesse is “not surprising” since companies have “financial incentives to promote their medications,” and having “thought leaders being advocates and spokespersons may help shift clinical practices,” said lead investigator Hao Feng, MD, a dermatology resident at New York University, and his colleagues. Recent studies “show that receipt of industry payments and industry-sponsored meals was associated with an increased rate of prescribing several class[es] of brand-name medications.”
The data come from the CMS Open Payments database, which records industry payments to physicians and is searchable by name. The investigators analyzed data from 2014 because it was the first year with a full 12 months of data.
For most dermatologists, industry payments didn’t amount to much: the overall median payment was $298, and 63% received less than $500. Almost 80% of the 208,613 payments in 2014 were for $50 or less.
The investigators were careful to note that industry payments are common in other specialties as well, with most of the money going to a select few. Dermatologists received 0.5% of the $6.5 billion that companies paid to U.S. physicians in 2014. Companies paid U.S. physicians $7.52 billion in 2015, according to CMS.
The Open Payments database was launched as part of the Affordable Care Act in the belief that transparency would combat the untoward effects of commercial interests and conflicts of interest on patient care, but it doesn’t catch everything. CMS only requires companies that make government-reimbursed products to report payments. For dermatologists, that means, for example, laser and other cosmetic device companies are exempt. Physicians also can direct payments to third parties. Such issues led Dr. Feng and his associates to conclude that CMS captures “only a fraction of … physician-industry financial relationships.”
Another problem, they said, is that CMS does not judge between industry payments that advance science and help patients and those that are “harmful,” so the database does little to counter public concerns about “dishonesty and selfishness” when doctors deal with industry. “Ultimately, the impact of financial disclosure from industry to dermatologists, and physicians in general, remains to be seen,” they wrote.
The investigators did not report any conflicts of interest.
Transparency for physician interactions with industry is important, especially given the findings showing individual consulting payments to dermatologists are as high as $249,643. However, the roll out of the Open Payments program has frustrated physicians and failed to provide the public with information of sufficient accuracy and meaning to use to make fair conclusions.
Some straightforward changes would substantially improve the situation. Physicians should have the opportunity to preview data before manufacturers transmit it to the CMS. The administrative burden inherent in the current CMS data review portal and the dispute process should be reduced. A common reporting method, including very clear definitions of meaningful categories of payments, should be standardized across companies. The CMS should issue clear guidance that reduces fear among manufacturers and decreases overreporting.
Jack Resneck Jr., MD, is professor and vice-chair of dermatology at the University of California, San Francisco. He serves on the American Medical Association Board of Trustees and made his comments in an editorial (JAMA Dermatol. 5 Oct. 2016).
Transparency for physician interactions with industry is important, especially given the findings showing individual consulting payments to dermatologists are as high as $249,643. However, the roll out of the Open Payments program has frustrated physicians and failed to provide the public with information of sufficient accuracy and meaning to use to make fair conclusions.
Some straightforward changes would substantially improve the situation. Physicians should have the opportunity to preview data before manufacturers transmit it to the CMS. The administrative burden inherent in the current CMS data review portal and the dispute process should be reduced. A common reporting method, including very clear definitions of meaningful categories of payments, should be standardized across companies. The CMS should issue clear guidance that reduces fear among manufacturers and decreases overreporting.
Jack Resneck Jr., MD, is professor and vice-chair of dermatology at the University of California, San Francisco. He serves on the American Medical Association Board of Trustees and made his comments in an editorial (JAMA Dermatol. 5 Oct. 2016).
Transparency for physician interactions with industry is important, especially given the findings showing individual consulting payments to dermatologists are as high as $249,643. However, the roll out of the Open Payments program has frustrated physicians and failed to provide the public with information of sufficient accuracy and meaning to use to make fair conclusions.
Some straightforward changes would substantially improve the situation. Physicians should have the opportunity to preview data before manufacturers transmit it to the CMS. The administrative burden inherent in the current CMS data review portal and the dispute process should be reduced. A common reporting method, including very clear definitions of meaningful categories of payments, should be standardized across companies. The CMS should issue clear guidance that reduces fear among manufacturers and decreases overreporting.
Jack Resneck Jr., MD, is professor and vice-chair of dermatology at the University of California, San Francisco. He serves on the American Medical Association Board of Trustees and made his comments in an editorial (JAMA Dermatol. 5 Oct. 2016).
A total of 8,333 dermatologists – 73% of those practicing in the United States – received $34.8 million from industry in 2014, mostly from pharmaceutical companies, according to an Oct. 5 report in JAMA Dermatology.
The bulk of the money went to a fraction of the dermatologists. Just 10% – 833 – collected $31.2 million. Eighty-three dermatologists – 1% of the total – pulled in about $15 million, each receiving at least $93,622. The 10 highest-paid dermatologists were mostly in private practice, not academia, and three were women (JAMA Dermatol. 2016 Oct 5. doi: 10.1001/jamadermatol.2016.3037).
Speaker fees accounted for 32% of the total payment amount, consulting fees for 22%, research payments for 17%, and food and beverage payments for 13%. Lesser amounts went towards travel and honoraria, among other things.
Almost $29 million came from pharmaceutical companies. AbbVie and Allergan led the way with payments of nearly $6 million each. Pharmaceutical company largesse is “not surprising” since companies have “financial incentives to promote their medications,” and having “thought leaders being advocates and spokespersons may help shift clinical practices,” said lead investigator Hao Feng, MD, a dermatology resident at New York University, and his colleagues. Recent studies “show that receipt of industry payments and industry-sponsored meals was associated with an increased rate of prescribing several class[es] of brand-name medications.”
The data come from the CMS Open Payments database, which records industry payments to physicians and is searchable by name. The investigators analyzed data from 2014 because it was the first year with a full 12 months of data.
For most dermatologists, industry payments didn’t amount to much: the overall median payment was $298, and 63% received less than $500. Almost 80% of the 208,613 payments in 2014 were for $50 or less.
The investigators were careful to note that industry payments are common in other specialties as well, with most of the money going to a select few. Dermatologists received 0.5% of the $6.5 billion that companies paid to U.S. physicians in 2014. Companies paid U.S. physicians $7.52 billion in 2015, according to CMS.
The Open Payments database was launched as part of the Affordable Care Act in the belief that transparency would combat the untoward effects of commercial interests and conflicts of interest on patient care, but it doesn’t catch everything. CMS only requires companies that make government-reimbursed products to report payments. For dermatologists, that means, for example, laser and other cosmetic device companies are exempt. Physicians also can direct payments to third parties. Such issues led Dr. Feng and his associates to conclude that CMS captures “only a fraction of … physician-industry financial relationships.”
Another problem, they said, is that CMS does not judge between industry payments that advance science and help patients and those that are “harmful,” so the database does little to counter public concerns about “dishonesty and selfishness” when doctors deal with industry. “Ultimately, the impact of financial disclosure from industry to dermatologists, and physicians in general, remains to be seen,” they wrote.
The investigators did not report any conflicts of interest.
A total of 8,333 dermatologists – 73% of those practicing in the United States – received $34.8 million from industry in 2014, mostly from pharmaceutical companies, according to an Oct. 5 report in JAMA Dermatology.
The bulk of the money went to a fraction of the dermatologists. Just 10% – 833 – collected $31.2 million. Eighty-three dermatologists – 1% of the total – pulled in about $15 million, each receiving at least $93,622. The 10 highest-paid dermatologists were mostly in private practice, not academia, and three were women (JAMA Dermatol. 2016 Oct 5. doi: 10.1001/jamadermatol.2016.3037).
Speaker fees accounted for 32% of the total payment amount, consulting fees for 22%, research payments for 17%, and food and beverage payments for 13%. Lesser amounts went towards travel and honoraria, among other things.
Almost $29 million came from pharmaceutical companies. AbbVie and Allergan led the way with payments of nearly $6 million each. Pharmaceutical company largesse is “not surprising” since companies have “financial incentives to promote their medications,” and having “thought leaders being advocates and spokespersons may help shift clinical practices,” said lead investigator Hao Feng, MD, a dermatology resident at New York University, and his colleagues. Recent studies “show that receipt of industry payments and industry-sponsored meals was associated with an increased rate of prescribing several class[es] of brand-name medications.”
The data come from the CMS Open Payments database, which records industry payments to physicians and is searchable by name. The investigators analyzed data from 2014 because it was the first year with a full 12 months of data.
For most dermatologists, industry payments didn’t amount to much: the overall median payment was $298, and 63% received less than $500. Almost 80% of the 208,613 payments in 2014 were for $50 or less.
The investigators were careful to note that industry payments are common in other specialties as well, with most of the money going to a select few. Dermatologists received 0.5% of the $6.5 billion that companies paid to U.S. physicians in 2014. Companies paid U.S. physicians $7.52 billion in 2015, according to CMS.
The Open Payments database was launched as part of the Affordable Care Act in the belief that transparency would combat the untoward effects of commercial interests and conflicts of interest on patient care, but it doesn’t catch everything. CMS only requires companies that make government-reimbursed products to report payments. For dermatologists, that means, for example, laser and other cosmetic device companies are exempt. Physicians also can direct payments to third parties. Such issues led Dr. Feng and his associates to conclude that CMS captures “only a fraction of … physician-industry financial relationships.”
Another problem, they said, is that CMS does not judge between industry payments that advance science and help patients and those that are “harmful,” so the database does little to counter public concerns about “dishonesty and selfishness” when doctors deal with industry. “Ultimately, the impact of financial disclosure from industry to dermatologists, and physicians in general, remains to be seen,” they wrote.
The investigators did not report any conflicts of interest.
Key clinical point:
Major finding: The bulk of the money went to 833 dermatologists who collected $31.2 million in 2014, mostly from pharmaceutical companies.
Data source: Review of the CMS Open Payments database
Disclosures: The investigators had no disclosures.
Strongly recommend HPV vaccine to increase uptake
To convince parents to get their kids vaccinated against human papillomavirus (HPV), tell them “I strongly believe in the importance of this cancer-preventing vaccine for [their child’s name],” researchers concluded after an online survey of 1,504 parents of children aged 11-17 years.
Sixty-five percent of parents agreed it was a persuasive argument, the highest percentage among 15 statements in favor of vaccination; 69% of 776 surveyed physicians said they’d use it in practice, also the highest physician endorsement for the various arguments (Cancer Epidemiol Biomarkers Prev. 2016 Sep 30. doi: 10.1158/1055-9965.EPI-16-0224).
In general, parents disinclined to vaccinate were most receptive to messages about HPV infection being common, cancers caused by HPV, and HPV vaccine effectiveness.
Other persuasive arguments included “[child’s name] can get anal/cervical cancer as an adult, but you can stop that right now;” and “there will be many things in [child’s name]’s life that you can’t control. But you can control whether [he/she] gets some dangerous kinds of HPV.” 
Both “placed the onus of protection on the parent and emphasized the control they possess over their child’s health. This finding is aligned with the tenets of various theories of fear appeals, which posit that fear messages inspire action if the receiver believes he or she has some control over the situation. Parents without prior intentions to vaccinate their child may be particularly receptive to messages that arouse fear while fostering a sense of efficacy,” said Teri Malo, PhD, of the University of North Carolina, Chapel Hill, and associates.
Although almost 60% of parents said they’d pay attention if told they could control if their child gets HPV cancer, only 37% of physicians said they’d use the argument. It’s not clear why, but the team said the finding was “concerning ... given that it was one of the top messages that would persuade parents without prior intentions to vaccinate their child.”
At present, 40% of girls and 22% of boys aged 13-17 years receive all three HPV shots. The goal of the study was to help doctors increase those numbers with persuasive arguments. “Physician communication about human papillomavirus vaccine is a key determinant of uptake,” but not all physicians strongly recommend the vaccine, especially if they anticipate parent resistance. “We sought to identify messages that would motivate HPV vaccination,” the researchers said.
Argument by analogy was the weakest approach. Only 5% of parents found “would you wait until [child’s name] is in a car accident before you tell [him/her] to wear a seatbelt?” persuasive, and only 9% of physicians said they’d use it, which made it the least endorsed statement in the study.
The same arguments seemed to work regardless of parents’ race, education, or income, or their child’s age or sex, which led the team to suggest the messages will work across demographic subgroups.
Slightly more moms than dads filled out the survey, and most were white, with about 9% of parents black and 14% Hispanic. Most parents lived in metropolitan areas, nearly two-thirds had at least some college, and almost half reported an annual household income of at least $75,000. For simplicity, parents limited their responses to their child with the most recent birthday. About half of children were boys, and just over half hadn’t been vaccinated against HPV.
About two-thirds of the physicians were men. Over half had practiced for at least 20 years, just over half were pediatricians, and the rest were family practitioners.
The work was funded by an unrestricted educational grant from Pfizer to senior investigator Noel Brewer, PhD. Dr. Brewer receives commercial research grants from Merck, maker of the HPV vaccine Gardasil, and Pfizer. He is also a Merck consultant and advisory board member. Coauthor Melissa B. Gilkey, PhD, and Dr. Malo were supported by other grants. The report noted that “the costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with” U.S. law.
To convince parents to get their kids vaccinated against human papillomavirus (HPV), tell them “I strongly believe in the importance of this cancer-preventing vaccine for [their child’s name],” researchers concluded after an online survey of 1,504 parents of children aged 11-17 years.
Sixty-five percent of parents agreed it was a persuasive argument, the highest percentage among 15 statements in favor of vaccination; 69% of 776 surveyed physicians said they’d use it in practice, also the highest physician endorsement for the various arguments (Cancer Epidemiol Biomarkers Prev. 2016 Sep 30. doi: 10.1158/1055-9965.EPI-16-0224).
In general, parents disinclined to vaccinate were most receptive to messages about HPV infection being common, cancers caused by HPV, and HPV vaccine effectiveness.
Other persuasive arguments included “[child’s name] can get anal/cervical cancer as an adult, but you can stop that right now;” and “there will be many things in [child’s name]’s life that you can’t control. But you can control whether [he/she] gets some dangerous kinds of HPV.”
Both “placed the onus of protection on the parent and emphasized the control they possess over their child’s health. This finding is aligned with the tenets of various theories of fear appeals, which posit that fear messages inspire action if the receiver believes he or she has some control over the situation. Parents without prior intentions to vaccinate their child may be particularly receptive to messages that arouse fear while fostering a sense of efficacy,” said Teri Malo, PhD, of the University of North Carolina, Chapel Hill, and associates.
Although almost 60% of parents said they’d pay attention if told they could control if their child gets HPV cancer, only 37% of physicians said they’d use the argument. It’s not clear why, but the team said the finding was “concerning ... given that it was one of the top messages that would persuade parents without prior intentions to vaccinate their child.”
At present, 40% of girls and 22% of boys aged 13-17 years receive all three HPV shots. The goal of the study was to help doctors increase those numbers with persuasive arguments. “Physician communication about human papillomavirus vaccine is a key determinant of uptake,” but not all physicians strongly recommend the vaccine, especially if they anticipate parent resistance. “We sought to identify messages that would motivate HPV vaccination,” the researchers said.
Argument by analogy was the weakest approach. Only 5% of parents found “would you wait until [child’s name] is in a car accident before you tell [him/her] to wear a seatbelt?” persuasive, and only 9% of physicians said they’d use it, which made it the least endorsed statement in the study.
The same arguments seemed to work regardless of parents’ race, education, or income, or their child’s age or sex, which led the team to suggest the messages will work across demographic subgroups.
Slightly more moms than dads filled out the survey, and most were white, with about 9% of parents black and 14% Hispanic. Most parents lived in metropolitan areas, nearly two-thirds had at least some college, and almost half reported an annual household income of at least $75,000. For simplicity, parents limited their responses to their child with the most recent birthday. About half of children were boys, and just over half hadn’t been vaccinated against HPV.
About two-thirds of the physicians were men. Over half had practiced for at least 20 years, just over half were pediatricians, and the rest were family practitioners.
The work was funded by an unrestricted educational grant from Pfizer to senior investigator Noel Brewer, PhD. Dr. Brewer receives commercial research grants from Merck, maker of the HPV vaccine Gardasil, and Pfizer. He is also a Merck consultant and advisory board member. Coauthor Melissa B. Gilkey, PhD, and Dr. Malo were supported by other grants. The report noted that “the costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with” U.S. law.
To convince parents to get their kids vaccinated against human papillomavirus (HPV), tell them “I strongly believe in the importance of this cancer-preventing vaccine for [their child’s name],” researchers concluded after an online survey of 1,504 parents of children aged 11-17 years.
Sixty-five percent of parents agreed it was a persuasive argument, the highest percentage among 15 statements in favor of vaccination; 69% of 776 surveyed physicians said they’d use it in practice, also the highest physician endorsement for the various arguments (Cancer Epidemiol Biomarkers Prev. 2016 Sep 30. doi: 10.1158/1055-9965.EPI-16-0224).
In general, parents disinclined to vaccinate were most receptive to messages about HPV infection being common, cancers caused by HPV, and HPV vaccine effectiveness.
Other persuasive arguments included “[child’s name] can get anal/cervical cancer as an adult, but you can stop that right now;” and “there will be many things in [child’s name]’s life that you can’t control. But you can control whether [he/she] gets some dangerous kinds of HPV.”
Both “placed the onus of protection on the parent and emphasized the control they possess over their child’s health. This finding is aligned with the tenets of various theories of fear appeals, which posit that fear messages inspire action if the receiver believes he or she has some control over the situation. Parents without prior intentions to vaccinate their child may be particularly receptive to messages that arouse fear while fostering a sense of efficacy,” said Teri Malo, PhD, of the University of North Carolina, Chapel Hill, and associates.
Although almost 60% of parents said they’d pay attention if told they could control if their child gets HPV cancer, only 37% of physicians said they’d use the argument. It’s not clear why, but the team said the finding was “concerning ... given that it was one of the top messages that would persuade parents without prior intentions to vaccinate their child.”
At present, 40% of girls and 22% of boys aged 13-17 years receive all three HPV shots. The goal of the study was to help doctors increase those numbers with persuasive arguments. “Physician communication about human papillomavirus vaccine is a key determinant of uptake,” but not all physicians strongly recommend the vaccine, especially if they anticipate parent resistance. “We sought to identify messages that would motivate HPV vaccination,” the researchers said.
Argument by analogy was the weakest approach. Only 5% of parents found “would you wait until [child’s name] is in a car accident before you tell [him/her] to wear a seatbelt?” persuasive, and only 9% of physicians said they’d use it, which made it the least endorsed statement in the study.
The same arguments seemed to work regardless of parents’ race, education, or income, or their child’s age or sex, which led the team to suggest the messages will work across demographic subgroups.
Slightly more moms than dads filled out the survey, and most were white, with about 9% of parents black and 14% Hispanic. Most parents lived in metropolitan areas, nearly two-thirds had at least some college, and almost half reported an annual household income of at least $75,000. For simplicity, parents limited their responses to their child with the most recent birthday. About half of children were boys, and just over half hadn’t been vaccinated against HPV.
About two-thirds of the physicians were men. Over half had practiced for at least 20 years, just over half were pediatricians, and the rest were family practitioners.
The work was funded by an unrestricted educational grant from Pfizer to senior investigator Noel Brewer, PhD. Dr. Brewer receives commercial research grants from Merck, maker of the HPV vaccine Gardasil, and Pfizer. He is also a Merck consultant and advisory board member. Coauthor Melissa B. Gilkey, PhD, and Dr. Malo were supported by other grants. The report noted that “the costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with” U.S. law.
Key clinical point:
Major finding: Sixty-five percent of parents agreed it was a persuasive argument, the highest percentage among 15 statements in favor of vaccination; 69% of 776 surveyed physicians said they’d use it in practice.
Data source: Online survey of 1,504 parents of children aged 11-17 years old, and 776 physicians.
Disclosures: The work was funded by an unrestricted educational grant from Pfizer to senior investigator Noel Brewer, PhD. Dr. Brewer receives commercial research grants from Merck, maker of the HPV vaccine Gardasil, and Pfizer. He is also a Merck consultant and advisory board member. Coauthor Melissa B. Gilkey, PhD, and Dr. Malo were supported by other grants. The report noted that “the costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with” U.S. law.
Vitamin D deficiency linked to hepatitis B infection
More than half of hepatitis B patients were vitamin D deficient, and deficiency was associated with worse outcomes, in a Vietnamese study published in BMC Infectious Diseases.
A total of 48% of 165 chronic hepatitis B patients, 54% of 127 hepatitis B virus (HBV)-associated cirrhosis patients, and 55% of 108 virus-associated hepatocellular carcinoma (HCC) patients had levels below 20 ng/mL, compared with 33% of 122 healthy controls.
Vitamin D levels inversely correlated with viral DNA loads, and lower levels were associated with more severe cirrhosis. On multivariate analyses adjusted for age and sex, HBV infection was an independent risk factor for vitamin D inadequacy (BMC Infect Dis. 2016 Sep 23;16[1]:507).
“These findings suggest that serum vitamin D levels contribute significantly to the clinical courses of HBV infection, including the severe consequences of” cirrhosis and HCC. “Our findings allow speculating that vitamin D and its analogs might provide a potential therapeutic addendum in the treatment of chronic liver diseases,” concluded investigators led by Nghiem Xuan Hoan, MD, of the Vietnamese-German Center for Medical Research in Hanoi.
Total vitamin D (25[OH] D2 and D3) levels were measured only once in the study; the cross-sectional design meant that “we could not determine the fluctuation of vitamin D levels over the course of HBV infection as well as the causative association of vitamin D levels and HBV-related liver diseases,” the researchers explained.
Low levels could be caused by impaired hepatic function, because the liver is key to vitamin D metabolism. HBV patients also tended to be older than the healthy controls were, which also might have contributed to the greater likelihood of deficiency.
Even so, a case seems to be building that vitamin D has an active role in HBV liver disease. Other investigations also have found an inverse relationship between viral loads and vitamin D status, and low levels previously have been associated with HCC.
Vitamin D is involved in adaptive and innate immune responses that clear the virus and other infections from the body, or at least keep them in check. Deficiency has been associated with susceptibility to various infections and inflammatory diseases, as well as carcinogenesis.
There was no industry funding for the work, and the authors had no disclosures.
More than half of hepatitis B patients were vitamin D deficient, and deficiency was associated with worse outcomes, in a Vietnamese study published in BMC Infectious Diseases.
A total of 48% of 165 chronic hepatitis B patients, 54% of 127 hepatitis B virus (HBV)-associated cirrhosis patients, and 55% of 108 virus-associated hepatocellular carcinoma (HCC) patients had levels below 20 ng/mL, compared with 33% of 122 healthy controls.
Vitamin D levels inversely correlated with viral DNA loads, and lower levels were associated with more severe cirrhosis. On multivariate analyses adjusted for age and sex, HBV infection was an independent risk factor for vitamin D inadequacy (BMC Infect Dis. 2016 Sep 23;16[1]:507).
“These findings suggest that serum vitamin D levels contribute significantly to the clinical courses of HBV infection, including the severe consequences of” cirrhosis and HCC. “Our findings allow speculating that vitamin D and its analogs might provide a potential therapeutic addendum in the treatment of chronic liver diseases,” concluded investigators led by Nghiem Xuan Hoan, MD, of the Vietnamese-German Center for Medical Research in Hanoi.
Total vitamin D (25[OH] D2 and D3) levels were measured only once in the study; the cross-sectional design meant that “we could not determine the fluctuation of vitamin D levels over the course of HBV infection as well as the causative association of vitamin D levels and HBV-related liver diseases,” the researchers explained.
Low levels could be caused by impaired hepatic function, because the liver is key to vitamin D metabolism. HBV patients also tended to be older than the healthy controls were, which also might have contributed to the greater likelihood of deficiency.
Even so, a case seems to be building that vitamin D has an active role in HBV liver disease. Other investigations also have found an inverse relationship between viral loads and vitamin D status, and low levels previously have been associated with HCC.
Vitamin D is involved in adaptive and innate immune responses that clear the virus and other infections from the body, or at least keep them in check. Deficiency has been associated with susceptibility to various infections and inflammatory diseases, as well as carcinogenesis.
There was no industry funding for the work, and the authors had no disclosures.
More than half of hepatitis B patients were vitamin D deficient, and deficiency was associated with worse outcomes, in a Vietnamese study published in BMC Infectious Diseases.
A total of 48% of 165 chronic hepatitis B patients, 54% of 127 hepatitis B virus (HBV)-associated cirrhosis patients, and 55% of 108 virus-associated hepatocellular carcinoma (HCC) patients had levels below 20 ng/mL, compared with 33% of 122 healthy controls.
Vitamin D levels inversely correlated with viral DNA loads, and lower levels were associated with more severe cirrhosis. On multivariate analyses adjusted for age and sex, HBV infection was an independent risk factor for vitamin D inadequacy (BMC Infect Dis. 2016 Sep 23;16[1]:507).
“These findings suggest that serum vitamin D levels contribute significantly to the clinical courses of HBV infection, including the severe consequences of” cirrhosis and HCC. “Our findings allow speculating that vitamin D and its analogs might provide a potential therapeutic addendum in the treatment of chronic liver diseases,” concluded investigators led by Nghiem Xuan Hoan, MD, of the Vietnamese-German Center for Medical Research in Hanoi.
Total vitamin D (25[OH] D2 and D3) levels were measured only once in the study; the cross-sectional design meant that “we could not determine the fluctuation of vitamin D levels over the course of HBV infection as well as the causative association of vitamin D levels and HBV-related liver diseases,” the researchers explained.
Low levels could be caused by impaired hepatic function, because the liver is key to vitamin D metabolism. HBV patients also tended to be older than the healthy controls were, which also might have contributed to the greater likelihood of deficiency.
Even so, a case seems to be building that vitamin D has an active role in HBV liver disease. Other investigations also have found an inverse relationship between viral loads and vitamin D status, and low levels previously have been associated with HCC.
Vitamin D is involved in adaptive and innate immune responses that clear the virus and other infections from the body, or at least keep them in check. Deficiency has been associated with susceptibility to various infections and inflammatory diseases, as well as carcinogenesis.
There was no industry funding for the work, and the authors had no disclosures.
FROM BMC INFECTIOUS DISEASES
Continuous glucose monitoring recommended over finger sticks for type 1 diabetes
“Studies have found that people with type 1 diabetes who use CGMs [continuous glucose monitors] are able to maintain better control of their blood sugar without increasing episodes of hypoglycemia when blood sugar drops to dangerous levels, compared to those who self-monitor blood glucose with periodic finger sticks,” the chair of the guideline task force, Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said in a Sept. 26 statement.
The group recommended CGMs for well-controlled type 1 patients as well as those above hemoglobin A1c (HbA1c) targets, so long as they want and understand how to use the devices. It also suggested short-term, intermittent CGM use to help type 2 patients meet HbA1cgoals. Insulin pumps were recommended over multiple daily injections for type 1 patients above target HbA1clevels, as well as those who meet their target but continue to have severe hypoglycemia or high glucose variability. For patients with type 2 disease, pumps were suggested for cases of poor glycemic control despite intensive insulin therapy, oral agents, and other measures.
The Endocrine Society and others have been pushing Medicare to cover CGMs for a while; the new guideline seems to support the effort. Although the devices are used by type 1 patients and covered by some insurance plans, they are only indicated as finger-stick adjuncts, not replacements. For Medicare coverage, they would “need to serve a primary medical purpose and not be used adjunctively,” according to a recent review by Dexcom, a company seeking a primary monitoring indication for its CGM.
The Endocrine Society noted in its evidence-based guideline that standard capillary blood glucose measurements “offer only a limited perspective on the constant daily changes in blood glucose levels,” and, unlike continuous monitoring, “do not provide alarms that indicate when blood glucose levels are above or below various thresholds, and do not indicate trends in blood glucose levels.”
The society commissioned a pooled analysis of 11 randomized trials that showed a 0.3% reduction in HbA1c with real-time glucose monitoring, mostly in patients 15 years or older. Other studies cited by the group also showed better HbA1c control than with finger sticks, without an increased risk of hypoglycemia.
The guideline also suggested insulin pumps for type 1 patients who want greater flexibility and convenience and that insulin pump therapy should continue during hospitalizations. It also suggested encouraging patients to use the embedded bolus calculators in their pumps so long as they “have appropriate education regarding their use and limitations.”
The Endocrine Society funded the work, with cosponsorship from the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology. Several of the authors have industry ties to companies that make CGMs or insulin pumps. Dr. Peters is an advisor for Abbott, Becton Dickinson, AstraZeneca, Biodel, Medtronic, and other companies, as well as a speaker, investigator, and advisor for Janssen.
“Studies have found that people with type 1 diabetes who use CGMs [continuous glucose monitors] are able to maintain better control of their blood sugar without increasing episodes of hypoglycemia when blood sugar drops to dangerous levels, compared to those who self-monitor blood glucose with periodic finger sticks,” the chair of the guideline task force, Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said in a Sept. 26 statement.
The group recommended CGMs for well-controlled type 1 patients as well as those above hemoglobin A1c (HbA1c) targets, so long as they want and understand how to use the devices. It also suggested short-term, intermittent CGM use to help type 2 patients meet HbA1cgoals. Insulin pumps were recommended over multiple daily injections for type 1 patients above target HbA1clevels, as well as those who meet their target but continue to have severe hypoglycemia or high glucose variability. For patients with type 2 disease, pumps were suggested for cases of poor glycemic control despite intensive insulin therapy, oral agents, and other measures.
The Endocrine Society and others have been pushing Medicare to cover CGMs for a while; the new guideline seems to support the effort. Although the devices are used by type 1 patients and covered by some insurance plans, they are only indicated as finger-stick adjuncts, not replacements. For Medicare coverage, they would “need to serve a primary medical purpose and not be used adjunctively,” according to a recent review by Dexcom, a company seeking a primary monitoring indication for its CGM.
The Endocrine Society noted in its evidence-based guideline that standard capillary blood glucose measurements “offer only a limited perspective on the constant daily changes in blood glucose levels,” and, unlike continuous monitoring, “do not provide alarms that indicate when blood glucose levels are above or below various thresholds, and do not indicate trends in blood glucose levels.”
The society commissioned a pooled analysis of 11 randomized trials that showed a 0.3% reduction in HbA1c with real-time glucose monitoring, mostly in patients 15 years or older. Other studies cited by the group also showed better HbA1c control than with finger sticks, without an increased risk of hypoglycemia.
The guideline also suggested insulin pumps for type 1 patients who want greater flexibility and convenience and that insulin pump therapy should continue during hospitalizations. It also suggested encouraging patients to use the embedded bolus calculators in their pumps so long as they “have appropriate education regarding their use and limitations.”
The Endocrine Society funded the work, with cosponsorship from the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology. Several of the authors have industry ties to companies that make CGMs or insulin pumps. Dr. Peters is an advisor for Abbott, Becton Dickinson, AstraZeneca, Biodel, Medtronic, and other companies, as well as a speaker, investigator, and advisor for Janssen.
“Studies have found that people with type 1 diabetes who use CGMs [continuous glucose monitors] are able to maintain better control of their blood sugar without increasing episodes of hypoglycemia when blood sugar drops to dangerous levels, compared to those who self-monitor blood glucose with periodic finger sticks,” the chair of the guideline task force, Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said in a Sept. 26 statement.
The group recommended CGMs for well-controlled type 1 patients as well as those above hemoglobin A1c (HbA1c) targets, so long as they want and understand how to use the devices. It also suggested short-term, intermittent CGM use to help type 2 patients meet HbA1cgoals. Insulin pumps were recommended over multiple daily injections for type 1 patients above target HbA1clevels, as well as those who meet their target but continue to have severe hypoglycemia or high glucose variability. For patients with type 2 disease, pumps were suggested for cases of poor glycemic control despite intensive insulin therapy, oral agents, and other measures.
The Endocrine Society and others have been pushing Medicare to cover CGMs for a while; the new guideline seems to support the effort. Although the devices are used by type 1 patients and covered by some insurance plans, they are only indicated as finger-stick adjuncts, not replacements. For Medicare coverage, they would “need to serve a primary medical purpose and not be used adjunctively,” according to a recent review by Dexcom, a company seeking a primary monitoring indication for its CGM.
The Endocrine Society noted in its evidence-based guideline that standard capillary blood glucose measurements “offer only a limited perspective on the constant daily changes in blood glucose levels,” and, unlike continuous monitoring, “do not provide alarms that indicate when blood glucose levels are above or below various thresholds, and do not indicate trends in blood glucose levels.”
The society commissioned a pooled analysis of 11 randomized trials that showed a 0.3% reduction in HbA1c with real-time glucose monitoring, mostly in patients 15 years or older. Other studies cited by the group also showed better HbA1c control than with finger sticks, without an increased risk of hypoglycemia.
The guideline also suggested insulin pumps for type 1 patients who want greater flexibility and convenience and that insulin pump therapy should continue during hospitalizations. It also suggested encouraging patients to use the embedded bolus calculators in their pumps so long as they “have appropriate education regarding their use and limitations.”
The Endocrine Society funded the work, with cosponsorship from the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology. Several of the authors have industry ties to companies that make CGMs or insulin pumps. Dr. Peters is an advisor for Abbott, Becton Dickinson, AstraZeneca, Biodel, Medtronic, and other companies, as well as a speaker, investigator, and advisor for Janssen.
Rise in HPV vaccination spurs CIN drop
As human papillomavirus vaccination rates climbed in New Mexico, all grades of cervical intraepithelial neoplasia declined in females aged 15-19 years, and grade 2 neoplasia fell among those who were aged 20-24 years, according to an analysis published online Sept. 29 in JAMA Oncology.
In the 15- to 19-year-old group, the annual incidence of cervical intraepithelial neoplasia (CIN) 1 dropped from 3,468 cases per 100,000 individuals screened in 2007 to 1,591 in 2014, an annual percentage change (APC) of –9.0.
CIN2 cases fell from 896 to 415 (APC, –10.5), and CIN3 from 240 to 0 (APC, –41.3). Among women aged 20-24 years, CIN2 annual incidence fell from 1,028 to 627 cases per 100,000 women screened (APC, –6.3).
The reductions were greater than expected, given that only 40% of females aged 13-17 years had received all three doses in 2014, up from 17% in 2008. It’s likely that herd immunity, benefit from even partial vaccination, and cross-protection against HPV strains not in vaccines contributed to the success, reported Vicki B. Benard, PhD, of the Centers for Disease Control and Prevention, and her colleagues (JAMA Oncol. 2016 Sept. 29. doi: 10.1001/jamaoncol.2016.3609).
The investigators adjusted their findings to account for trends towards longer intervals between cervical screenings and later initiation of screening. Otherwise, the effect of the vaccine would have been overestimated.
The ultimate goal “is a rational integration of HPV vaccination and cervical screening,” they wrote. Current cervical cancer screening guidelines do not differentiate between women who have been vaccinated and those who have not, but this should be reevaluated in light of the study findings, the researchers noted.
“Our data demonstrate that clinical outcomes of CIN will be reduced among cohorts [even] partially vaccinated for HPV,” which will reduce the cost-effectiveness of screening. “A later starting age for cervical screening among partially vaccinated populations of young women ... may be prudent given the already infrequent incidence of invasive cervical cancer for women younger than 25 years” even before the HPV vaccine was introduced in 2007, the investigators wrote.
The study focuses on data from New Mexico because it is the only state that has captured population-based estimates of both screening prevalence and CIN since the introduction of the vaccine.
The National Institute of Allergy and Infectious Diseases funded the work. Dr. Benard reported having no financial disclosures, but other investigators reported ties with HPV vaccine makers Merck and GSK, among other companies.
As human papillomavirus vaccination rates climbed in New Mexico, all grades of cervical intraepithelial neoplasia declined in females aged 15-19 years, and grade 2 neoplasia fell among those who were aged 20-24 years, according to an analysis published online Sept. 29 in JAMA Oncology.
In the 15- to 19-year-old group, the annual incidence of cervical intraepithelial neoplasia (CIN) 1 dropped from 3,468 cases per 100,000 individuals screened in 2007 to 1,591 in 2014, an annual percentage change (APC) of –9.0.
CIN2 cases fell from 896 to 415 (APC, –10.5), and CIN3 from 240 to 0 (APC, –41.3). Among women aged 20-24 years, CIN2 annual incidence fell from 1,028 to 627 cases per 100,000 women screened (APC, –6.3).
The reductions were greater than expected, given that only 40% of females aged 13-17 years had received all three doses in 2014, up from 17% in 2008. It’s likely that herd immunity, benefit from even partial vaccination, and cross-protection against HPV strains not in vaccines contributed to the success, reported Vicki B. Benard, PhD, of the Centers for Disease Control and Prevention, and her colleagues (JAMA Oncol. 2016 Sept. 29. doi: 10.1001/jamaoncol.2016.3609).
The investigators adjusted their findings to account for trends towards longer intervals between cervical screenings and later initiation of screening. Otherwise, the effect of the vaccine would have been overestimated.
The ultimate goal “is a rational integration of HPV vaccination and cervical screening,” they wrote. Current cervical cancer screening guidelines do not differentiate between women who have been vaccinated and those who have not, but this should be reevaluated in light of the study findings, the researchers noted.
“Our data demonstrate that clinical outcomes of CIN will be reduced among cohorts [even] partially vaccinated for HPV,” which will reduce the cost-effectiveness of screening. “A later starting age for cervical screening among partially vaccinated populations of young women ... may be prudent given the already infrequent incidence of invasive cervical cancer for women younger than 25 years” even before the HPV vaccine was introduced in 2007, the investigators wrote.
The study focuses on data from New Mexico because it is the only state that has captured population-based estimates of both screening prevalence and CIN since the introduction of the vaccine.
The National Institute of Allergy and Infectious Diseases funded the work. Dr. Benard reported having no financial disclosures, but other investigators reported ties with HPV vaccine makers Merck and GSK, among other companies.
As human papillomavirus vaccination rates climbed in New Mexico, all grades of cervical intraepithelial neoplasia declined in females aged 15-19 years, and grade 2 neoplasia fell among those who were aged 20-24 years, according to an analysis published online Sept. 29 in JAMA Oncology.
In the 15- to 19-year-old group, the annual incidence of cervical intraepithelial neoplasia (CIN) 1 dropped from 3,468 cases per 100,000 individuals screened in 2007 to 1,591 in 2014, an annual percentage change (APC) of –9.0.
CIN2 cases fell from 896 to 415 (APC, –10.5), and CIN3 from 240 to 0 (APC, –41.3). Among women aged 20-24 years, CIN2 annual incidence fell from 1,028 to 627 cases per 100,000 women screened (APC, –6.3).
The reductions were greater than expected, given that only 40% of females aged 13-17 years had received all three doses in 2014, up from 17% in 2008. It’s likely that herd immunity, benefit from even partial vaccination, and cross-protection against HPV strains not in vaccines contributed to the success, reported Vicki B. Benard, PhD, of the Centers for Disease Control and Prevention, and her colleagues (JAMA Oncol. 2016 Sept. 29. doi: 10.1001/jamaoncol.2016.3609).
The investigators adjusted their findings to account for trends towards longer intervals between cervical screenings and later initiation of screening. Otherwise, the effect of the vaccine would have been overestimated.
The ultimate goal “is a rational integration of HPV vaccination and cervical screening,” they wrote. Current cervical cancer screening guidelines do not differentiate between women who have been vaccinated and those who have not, but this should be reevaluated in light of the study findings, the researchers noted.
“Our data demonstrate that clinical outcomes of CIN will be reduced among cohorts [even] partially vaccinated for HPV,” which will reduce the cost-effectiveness of screening. “A later starting age for cervical screening among partially vaccinated populations of young women ... may be prudent given the already infrequent incidence of invasive cervical cancer for women younger than 25 years” even before the HPV vaccine was introduced in 2007, the investigators wrote.
The study focuses on data from New Mexico because it is the only state that has captured population-based estimates of both screening prevalence and CIN since the introduction of the vaccine.
The National Institute of Allergy and Infectious Diseases funded the work. Dr. Benard reported having no financial disclosures, but other investigators reported ties with HPV vaccine makers Merck and GSK, among other companies.
FROM JAMA ONCOLOGY
Key clinical point: Future cervical cancer screening guidelines may need to differentiate between those who have been vaccinated against HPV and those who have not.
Major finding: As HPV vaccination rates increased in New Mexico, the annual incidence of CIN1 among 15- to 19-year-old females dropped from 3,468 cases per 100,000 individuals screened in 2007 to 1,591 in 2014, an annual percentage change of –9.0.
Data source: An analysis of the New Mexico HPV Pap Registry of 2007-2014.
Disclosures: The National Institute of Allergy and Infectious Diseases funded the work. The lead investigator had no financial disclosures, but others reported ties with HPV vaccine makers Merck and GSK, among other companies.
FDA approves biosimilar adalimumab
There are “no clinically meaningful differences” between Amgen’s biosimilar adalimumab (Amjevita) and AbbVie’s branded product Humira, the Food and Drug Administration noted it its Sept. 23 announcement of Amjevita’s approval.
Although Amjevita (adalimumab-atto) is expected to cost less than Humira, Amgen has not released price information or a launch date pending ongoing litigation with AbbVie over intellectual property rights, an Amgen spokeswoman said.
The products carry an identical black box warning of tuberculosis and other serious infections, as well as lymphoma and other malignancies “reported in children and adolescent patients treated with [tumor necrosis factor] blockers including adalimumab.” As with Humira, “the most common expected adverse reactions with Amjevita are infections and injection site reactions,” the FDA said. Both products are approved in 20 mg/0.4 mL and 40 mg/0.8 mL prefilled injections, but Humira also has a 10 mg/0.2 mL option.
Amjevita was unanimously recommended for approval by an FDA review panel in July. Although “the biosimilar pathway is still a new frontier,” it’s likely to “enhance access to treatment for patients with serious medical conditions,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency statement.
The approval follows the FDA’s approval of biosimilar infliximab (Inflectra) in April 2016 and biosimilar etanercept (Erelzi) in August 2016. Inflectra has not hit the U.S. market yet, but the European experience with biosimilar infliximab – generally positive – may give an indication of how Amjevita will fare in the United States. It’s perhaps a third or more less expensive than the original product (Remicade) and often used for new starts. There is uncertainty, however, about switching patients already established on Remicade, especially when it’s forced by cost issues.
Interchangeability is a concern in the United States as well. The FDA is working on the issue but has not yet released guidance, and the agency was careful to note in its statement that Amjevita was “approved as a biosimilar, not as an interchangeable product.” Biosimilar adalimumab, meanwhile, is under review in Europe, according to an Amgen statement.
The FDA approved Amjevita after reviewing structural and functional characteristics, pharmacokinetics and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrated similarity to Humira, including two phase III trials for plaque psoriasis and rheumatoid arthritis.
An AbbVie spokesperson said the company “anticipated Amgen’s product would be approved,” but noted the ongoing litigation.
There are “no clinically meaningful differences” between Amgen’s biosimilar adalimumab (Amjevita) and AbbVie’s branded product Humira, the Food and Drug Administration noted it its Sept. 23 announcement of Amjevita’s approval.
Although Amjevita (adalimumab-atto) is expected to cost less than Humira, Amgen has not released price information or a launch date pending ongoing litigation with AbbVie over intellectual property rights, an Amgen spokeswoman said.
The products carry an identical black box warning of tuberculosis and other serious infections, as well as lymphoma and other malignancies “reported in children and adolescent patients treated with [tumor necrosis factor] blockers including adalimumab.” As with Humira, “the most common expected adverse reactions with Amjevita are infections and injection site reactions,” the FDA said. Both products are approved in 20 mg/0.4 mL and 40 mg/0.8 mL prefilled injections, but Humira also has a 10 mg/0.2 mL option.
Amjevita was unanimously recommended for approval by an FDA review panel in July. Although “the biosimilar pathway is still a new frontier,” it’s likely to “enhance access to treatment for patients with serious medical conditions,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency statement.
The approval follows the FDA’s approval of biosimilar infliximab (Inflectra) in April 2016 and biosimilar etanercept (Erelzi) in August 2016. Inflectra has not hit the U.S. market yet, but the European experience with biosimilar infliximab – generally positive – may give an indication of how Amjevita will fare in the United States. It’s perhaps a third or more less expensive than the original product (Remicade) and often used for new starts. There is uncertainty, however, about switching patients already established on Remicade, especially when it’s forced by cost issues.
Interchangeability is a concern in the United States as well. The FDA is working on the issue but has not yet released guidance, and the agency was careful to note in its statement that Amjevita was “approved as a biosimilar, not as an interchangeable product.” Biosimilar adalimumab, meanwhile, is under review in Europe, according to an Amgen statement.
The FDA approved Amjevita after reviewing structural and functional characteristics, pharmacokinetics and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrated similarity to Humira, including two phase III trials for plaque psoriasis and rheumatoid arthritis.
An AbbVie spokesperson said the company “anticipated Amgen’s product would be approved,” but noted the ongoing litigation.
There are “no clinically meaningful differences” between Amgen’s biosimilar adalimumab (Amjevita) and AbbVie’s branded product Humira, the Food and Drug Administration noted it its Sept. 23 announcement of Amjevita’s approval.
Although Amjevita (adalimumab-atto) is expected to cost less than Humira, Amgen has not released price information or a launch date pending ongoing litigation with AbbVie over intellectual property rights, an Amgen spokeswoman said.
The products carry an identical black box warning of tuberculosis and other serious infections, as well as lymphoma and other malignancies “reported in children and adolescent patients treated with [tumor necrosis factor] blockers including adalimumab.” As with Humira, “the most common expected adverse reactions with Amjevita are infections and injection site reactions,” the FDA said. Both products are approved in 20 mg/0.4 mL and 40 mg/0.8 mL prefilled injections, but Humira also has a 10 mg/0.2 mL option.
Amjevita was unanimously recommended for approval by an FDA review panel in July. Although “the biosimilar pathway is still a new frontier,” it’s likely to “enhance access to treatment for patients with serious medical conditions,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency statement.
The approval follows the FDA’s approval of biosimilar infliximab (Inflectra) in April 2016 and biosimilar etanercept (Erelzi) in August 2016. Inflectra has not hit the U.S. market yet, but the European experience with biosimilar infliximab – generally positive – may give an indication of how Amjevita will fare in the United States. It’s perhaps a third or more less expensive than the original product (Remicade) and often used for new starts. There is uncertainty, however, about switching patients already established on Remicade, especially when it’s forced by cost issues.
Interchangeability is a concern in the United States as well. The FDA is working on the issue but has not yet released guidance, and the agency was careful to note in its statement that Amjevita was “approved as a biosimilar, not as an interchangeable product.” Biosimilar adalimumab, meanwhile, is under review in Europe, according to an Amgen statement.
The FDA approved Amjevita after reviewing structural and functional characteristics, pharmacokinetics and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrated similarity to Humira, including two phase III trials for plaque psoriasis and rheumatoid arthritis.
An AbbVie spokesperson said the company “anticipated Amgen’s product would be approved,” but noted the ongoing litigation.
OMA publishes pediatric obesity treatment guide
The Pediatric Obesity Algorithm – a free state-of-the-science management review from the Obesity Medicine Association – should help clinicians weed through the options for overweight kids, according to Texas pediatrician and lead author Suzanne Cuda, MD.
The group put the latest thinking into one place to serve as a handy guide, and plans to update it every 2 years. The idea was to present choices, not push particular approaches. “Many of my colleagues have expressed concern [that] they do not have the resources to provide the kind of support these kids need,” said Dr. Cuda, director of the weight management clinic at the Children’s Hospital of San Antonio and associate professor of pediatrics at the Baylor College of Medicine. Clinicians can find the guide at www.PediatricObesityAlgorithm.org.
The effort also will help clinicians prepare for American Board of Obesity Medicine certification, since it was “designed to address the content on the exam. A lot of tools out there for children [emphasize] prevention. Our starting point was children who are already overweight,“ she said.
The document covers risk factors, differential diagnoses, assessment, diet, appropriate activity levels, medications, surgery, comorbidity management, and other issues, often broken down by age and body mass index.
Nothing is particularly controversial, although some clinicians are reluctant to move beyond diet and exercise for kids, Dr. Cuda said.
The Obesity Medicine Association (OMA) was aware of that, and so was careful to note, for instance, which obesity medications are approved for pediatric use – orlistat (Xenical), metformin, and phentermine – and their real-world effect.
“We didn’t cover all the drugs out there” because many haven’t been tested in children, Dr. Cuda said. The group also highlights antiseizure and other drugs that put on weight.
The guide covers birth to adulthood. There can be signs of problems even before the first birthday, such as weight above the 95th percentile. In those cases, evidence supports exclusive breast feeding for as long as possible, and no more than 24 ounces per day in formula-fed children, with no cereal or media watching.
OMA hasn’t submitted its work for endorsement by other groups, so other associations haven’t signed onto it. “We didn’t want to prolong putting it out there to go through that whole process,” Dr. Cuda said.
Even so, some organizations are aware of the contents and support the effort. “It aligns with the resources we have already developed on this topic. These are core competencies ... all physicians should have, regardless of whether they are certified in obesity medicine,” said an American Academy of Pediatrics staff member.
Until recently, OMA was known as the American Society of Bariatric Physicians. It rebranded itself to avoid being mistaken for a bariatric surgery group.
Dr. Cuda and the other authors had no disclosures. There was no industry funding for the work.
The Pediatric Obesity Algorithm – a free state-of-the-science management review from the Obesity Medicine Association – should help clinicians weed through the options for overweight kids, according to Texas pediatrician and lead author Suzanne Cuda, MD.
The group put the latest thinking into one place to serve as a handy guide, and plans to update it every 2 years. The idea was to present choices, not push particular approaches. “Many of my colleagues have expressed concern [that] they do not have the resources to provide the kind of support these kids need,” said Dr. Cuda, director of the weight management clinic at the Children’s Hospital of San Antonio and associate professor of pediatrics at the Baylor College of Medicine. Clinicians can find the guide at www.PediatricObesityAlgorithm.org.
The effort also will help clinicians prepare for American Board of Obesity Medicine certification, since it was “designed to address the content on the exam. A lot of tools out there for children [emphasize] prevention. Our starting point was children who are already overweight,“ she said.
The document covers risk factors, differential diagnoses, assessment, diet, appropriate activity levels, medications, surgery, comorbidity management, and other issues, often broken down by age and body mass index.
Nothing is particularly controversial, although some clinicians are reluctant to move beyond diet and exercise for kids, Dr. Cuda said.
The Obesity Medicine Association (OMA) was aware of that, and so was careful to note, for instance, which obesity medications are approved for pediatric use – orlistat (Xenical), metformin, and phentermine – and their real-world effect.
“We didn’t cover all the drugs out there” because many haven’t been tested in children, Dr. Cuda said. The group also highlights antiseizure and other drugs that put on weight.
The guide covers birth to adulthood. There can be signs of problems even before the first birthday, such as weight above the 95th percentile. In those cases, evidence supports exclusive breast feeding for as long as possible, and no more than 24 ounces per day in formula-fed children, with no cereal or media watching.
OMA hasn’t submitted its work for endorsement by other groups, so other associations haven’t signed onto it. “We didn’t want to prolong putting it out there to go through that whole process,” Dr. Cuda said.
Even so, some organizations are aware of the contents and support the effort. “It aligns with the resources we have already developed on this topic. These are core competencies ... all physicians should have, regardless of whether they are certified in obesity medicine,” said an American Academy of Pediatrics staff member.
Until recently, OMA was known as the American Society of Bariatric Physicians. It rebranded itself to avoid being mistaken for a bariatric surgery group.
Dr. Cuda and the other authors had no disclosures. There was no industry funding for the work.
The Pediatric Obesity Algorithm – a free state-of-the-science management review from the Obesity Medicine Association – should help clinicians weed through the options for overweight kids, according to Texas pediatrician and lead author Suzanne Cuda, MD.
The group put the latest thinking into one place to serve as a handy guide, and plans to update it every 2 years. The idea was to present choices, not push particular approaches. “Many of my colleagues have expressed concern [that] they do not have the resources to provide the kind of support these kids need,” said Dr. Cuda, director of the weight management clinic at the Children’s Hospital of San Antonio and associate professor of pediatrics at the Baylor College of Medicine. Clinicians can find the guide at www.PediatricObesityAlgorithm.org.
The effort also will help clinicians prepare for American Board of Obesity Medicine certification, since it was “designed to address the content on the exam. A lot of tools out there for children [emphasize] prevention. Our starting point was children who are already overweight,“ she said.
The document covers risk factors, differential diagnoses, assessment, diet, appropriate activity levels, medications, surgery, comorbidity management, and other issues, often broken down by age and body mass index.
Nothing is particularly controversial, although some clinicians are reluctant to move beyond diet and exercise for kids, Dr. Cuda said.
The Obesity Medicine Association (OMA) was aware of that, and so was careful to note, for instance, which obesity medications are approved for pediatric use – orlistat (Xenical), metformin, and phentermine – and their real-world effect.
“We didn’t cover all the drugs out there” because many haven’t been tested in children, Dr. Cuda said. The group also highlights antiseizure and other drugs that put on weight.
The guide covers birth to adulthood. There can be signs of problems even before the first birthday, such as weight above the 95th percentile. In those cases, evidence supports exclusive breast feeding for as long as possible, and no more than 24 ounces per day in formula-fed children, with no cereal or media watching.
OMA hasn’t submitted its work for endorsement by other groups, so other associations haven’t signed onto it. “We didn’t want to prolong putting it out there to go through that whole process,” Dr. Cuda said.
Even so, some organizations are aware of the contents and support the effort. “It aligns with the resources we have already developed on this topic. These are core competencies ... all physicians should have, regardless of whether they are certified in obesity medicine,” said an American Academy of Pediatrics staff member.
Until recently, OMA was known as the American Society of Bariatric Physicians. It rebranded itself to avoid being mistaken for a bariatric surgery group.
Dr. Cuda and the other authors had no disclosures. There was no industry funding for the work.
FROM THE OBESITY MEDICINE ASSOCIATION
