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California Opens Treatment Center for Native Youth
The IHS announced the opening of another youth regional treatment center (YRTC) to provide culturally centered, evidence-based substance use disorder services to Native youth.
Desert Sage Youth Wellness Center in Hemet is the first federally owned and operated health care facility in California to serve American Indians and Alaska Natives (AI/AN). Although California has the largest population of AI/AN in the country, IHS says, teens were usually sent out of state to non-IHS or nontribal facilities that do not always meet their “unique cultural needs.”
Desert Sage is 1 of 11 YRTCs funded by IHS across the country. The YRTCs provide comprehensive, holistic care, including mental health assessments, individualized treatment plans, academic education, vocational and life-skills training, and activities to meet the spiritual and cultural needs of Native American youth.
The Desert Sage center, which includes 3 buildings with 32 beds and 5 family suites, will employ 70 full-time employees and treat about 100 tribal youth annually.
Sacred Oaks Healing Center in Davis, the next YRTC planned for California, is expected to be completed in 2019.
The IHS announced the opening of another youth regional treatment center (YRTC) to provide culturally centered, evidence-based substance use disorder services to Native youth.
Desert Sage Youth Wellness Center in Hemet is the first federally owned and operated health care facility in California to serve American Indians and Alaska Natives (AI/AN). Although California has the largest population of AI/AN in the country, IHS says, teens were usually sent out of state to non-IHS or nontribal facilities that do not always meet their “unique cultural needs.”
Desert Sage is 1 of 11 YRTCs funded by IHS across the country. The YRTCs provide comprehensive, holistic care, including mental health assessments, individualized treatment plans, academic education, vocational and life-skills training, and activities to meet the spiritual and cultural needs of Native American youth.
The Desert Sage center, which includes 3 buildings with 32 beds and 5 family suites, will employ 70 full-time employees and treat about 100 tribal youth annually.
Sacred Oaks Healing Center in Davis, the next YRTC planned for California, is expected to be completed in 2019.
The IHS announced the opening of another youth regional treatment center (YRTC) to provide culturally centered, evidence-based substance use disorder services to Native youth.
Desert Sage Youth Wellness Center in Hemet is the first federally owned and operated health care facility in California to serve American Indians and Alaska Natives (AI/AN). Although California has the largest population of AI/AN in the country, IHS says, teens were usually sent out of state to non-IHS or nontribal facilities that do not always meet their “unique cultural needs.”
Desert Sage is 1 of 11 YRTCs funded by IHS across the country. The YRTCs provide comprehensive, holistic care, including mental health assessments, individualized treatment plans, academic education, vocational and life-skills training, and activities to meet the spiritual and cultural needs of Native American youth.
The Desert Sage center, which includes 3 buildings with 32 beds and 5 family suites, will employ 70 full-time employees and treat about 100 tribal youth annually.
Sacred Oaks Healing Center in Davis, the next YRTC planned for California, is expected to be completed in 2019.
Why fewer blood cancer patients receive hospice care
New research provides an explanation for the fact that US patients with hematologic malignancies are less likely to enroll in hospice care than patients with solid tumor malignancies.
Results of a national survey suggest that concerns about the adequacy of hospice may prevent hematologic oncologists from referring their patients.
Researchers say this finding, published in Cancer, points to potential means of improving end-of-life care for patients with hematologic malignancies.
Oreofe Odejide, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues carried out this study.
The team conducted a survey of a national sample of hematologic oncologists listed in the publicly available clinical directory of the American Society of Hematology.
More than 57% of physicians who were contacted provided responses, for a total of 349 respondents.
The survey included questions about views regarding the helpfulness and adequacy of home hospice services for patients with hematologic malignancies, as well as factors that would impact oncologists’ likelihood of referring patients to hospice.
More than 68% of hematologic oncologists strongly agreed that hospice care is “helpful” for patients with hematologic malignancies.
However, 46% of the oncologists felt that home hospice is “inadequate” for the needs of patients with hematologic malignancies, when compared to inpatient hospice.
Still, most of the respondents who believed home hospice is inadequate said they would be more likely to refer patients if platelet and red blood cell transfusions were readily available.
“Our findings are important as they shed light on factors that are potential barriers to hospice referrals,” Dr Odejide said. “These findings can be employed to develop targeted interventions to address hospice underuse for patients with blood cancers.”
New research provides an explanation for the fact that US patients with hematologic malignancies are less likely to enroll in hospice care than patients with solid tumor malignancies.
Results of a national survey suggest that concerns about the adequacy of hospice may prevent hematologic oncologists from referring their patients.
Researchers say this finding, published in Cancer, points to potential means of improving end-of-life care for patients with hematologic malignancies.
Oreofe Odejide, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues carried out this study.
The team conducted a survey of a national sample of hematologic oncologists listed in the publicly available clinical directory of the American Society of Hematology.
More than 57% of physicians who were contacted provided responses, for a total of 349 respondents.
The survey included questions about views regarding the helpfulness and adequacy of home hospice services for patients with hematologic malignancies, as well as factors that would impact oncologists’ likelihood of referring patients to hospice.
More than 68% of hematologic oncologists strongly agreed that hospice care is “helpful” for patients with hematologic malignancies.
However, 46% of the oncologists felt that home hospice is “inadequate” for the needs of patients with hematologic malignancies, when compared to inpatient hospice.
Still, most of the respondents who believed home hospice is inadequate said they would be more likely to refer patients if platelet and red blood cell transfusions were readily available.
“Our findings are important as they shed light on factors that are potential barriers to hospice referrals,” Dr Odejide said. “These findings can be employed to develop targeted interventions to address hospice underuse for patients with blood cancers.”
New research provides an explanation for the fact that US patients with hematologic malignancies are less likely to enroll in hospice care than patients with solid tumor malignancies.
Results of a national survey suggest that concerns about the adequacy of hospice may prevent hematologic oncologists from referring their patients.
Researchers say this finding, published in Cancer, points to potential means of improving end-of-life care for patients with hematologic malignancies.
Oreofe Odejide, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues carried out this study.
The team conducted a survey of a national sample of hematologic oncologists listed in the publicly available clinical directory of the American Society of Hematology.
More than 57% of physicians who were contacted provided responses, for a total of 349 respondents.
The survey included questions about views regarding the helpfulness and adequacy of home hospice services for patients with hematologic malignancies, as well as factors that would impact oncologists’ likelihood of referring patients to hospice.
More than 68% of hematologic oncologists strongly agreed that hospice care is “helpful” for patients with hematologic malignancies.
However, 46% of the oncologists felt that home hospice is “inadequate” for the needs of patients with hematologic malignancies, when compared to inpatient hospice.
Still, most of the respondents who believed home hospice is inadequate said they would be more likely to refer patients if platelet and red blood cell transfusions were readily available.
“Our findings are important as they shed light on factors that are potential barriers to hospice referrals,” Dr Odejide said. “These findings can be employed to develop targeted interventions to address hospice underuse for patients with blood cancers.”
Global study reveals healthcare inequity, preventable deaths
A global study has revealed inequity of access to and quality of healthcare among and within countries and suggests people are dying from causes with well-known treatments.
“What we have found about healthcare access and quality is disturbing,” said Christopher Murray, MD, DPhil, of the University of Washington in Seattle.
“Having a strong economy does not guarantee good healthcare. Having great medical technology doesn’t either. We know this because people are not getting the care that should be expected for diseases with established treatments.”
Dr Murray and his colleagues reported these findings in The Lancet.
For this study, the researchers assessed access to and quality of healthcare services in 195 countries from 1990 to 2015.
The group used the Healthcare Access and Quality Index, a summary measure based on 32 causes* that, in the presence of high-quality healthcare, should not result in death. Leukemia and Hodgkin lymphoma are among these causes.
Countries were assigned scores for each of the causes, based on estimates from the annual Global Burden of Diseases, Injuries, and Risk Factors study (GBD), a systematic, scientific effort to quantify the magnitude of health loss from all major diseases, injuries, and risk factors by age, sex, and population.
In addition, data were extracted from the most recent GBD update and evaluated using a Socio-demographic Index based on rates of education, fertility, and income.
Results
The 195 countries were assigned scores on a scale of 1 to 100 for healthcare access and quality. They received scores for the 32 causes as well as overall scores.
In 2015, the top-ranked nation was Andorra, with an overall score of 95. Its lowest treatment score was 70, for Hodgkin lymphoma.
The lowest-ranked nation was Central African Republic, with a score of 29. Its highest treatment score was 65, for diphtheria.
Nations in much of sub-Saharan Africa, as well as in south Asia and several countries in Latin America and the Caribbean, also had low rankings.
However, many countries in these regions, including China (score: 74) and Ethiopia (score: 44), have seen sizeable gains since 1990.
‘Developed’ nations falling short
The US had an overall score of 81 (in 2015), tied with Estonia and Montenegro. As with many other nations, the US scored 100 in treating common vaccine-preventable diseases, such as diphtheria, tetanus, and measles.
However, the US had 9 treatment categories in which it scored in the 60s: lower respiratory infections (60), neonatal disorders (69), non-melanoma skin cancer (68), Hodgkin lymphoma (67), ischemic heart disease (62), hypertensive heart disease (64), diabetes (67), chronic kidney disease (62), and the adverse effects of medical treatment itself (68).
“America’s ranking is an embarrassment, especially considering the US spends more than $9000 per person on healthcare annually, more than any other country,” Dr Murray said.
“Anyone with a stake in the current healthcare debate, including elected officials at the federal, state, and local levels, should take a look at where the US is falling short.”
Other nations with strong economies and advanced medical technology are falling short in some areas as well.
For example, Norway and Australia each scored 90 overall, among the highest in the world. However, Norway scored 65 in its treatment for testicular cancer, and Australia scored 52 for treating non-melanoma skin cancer.
“In the majority of cases, both of these cancers can be treated effectively,” Dr Murray said. “Shouldn’t it cause serious concern that people are dying of these causes in countries that have the resources to address them?”
*The 32 causes are:
- Adverse effects of medical treatment
- Appendicitis
- Breast cancer
- Cerebrovascular disease (stroke)
- Cervical cancer
- Chronic kidney disease
- Chronic respiratory diseases
- Colon and rectum cancer
- Congenital anomalies
- Diabetes mellitus
- Diarrhea-related diseases
- Diphtheria
- Epilepsy
- Gallbladder and biliary diseases
- Hodgkin lymphoma
- Hypertensive heart disease
- Inguinal, femoral, and abdominal hernia
- Ischemic heart disease
- Leukemia
- Lower respiratory infections
- Maternal disorders
- Measles
- Neonatal disorders
- Non-melanoma skin cancer
- Peptic ulcer disease
- Rheumatic heart disease
- Testicular cancer
- Tetanus
- Tuberculosis
- Upper respiratory infections
- Uterine cancer
- Whooping cough.
A global study has revealed inequity of access to and quality of healthcare among and within countries and suggests people are dying from causes with well-known treatments.
“What we have found about healthcare access and quality is disturbing,” said Christopher Murray, MD, DPhil, of the University of Washington in Seattle.
“Having a strong economy does not guarantee good healthcare. Having great medical technology doesn’t either. We know this because people are not getting the care that should be expected for diseases with established treatments.”
Dr Murray and his colleagues reported these findings in The Lancet.
For this study, the researchers assessed access to and quality of healthcare services in 195 countries from 1990 to 2015.
The group used the Healthcare Access and Quality Index, a summary measure based on 32 causes* that, in the presence of high-quality healthcare, should not result in death. Leukemia and Hodgkin lymphoma are among these causes.
Countries were assigned scores for each of the causes, based on estimates from the annual Global Burden of Diseases, Injuries, and Risk Factors study (GBD), a systematic, scientific effort to quantify the magnitude of health loss from all major diseases, injuries, and risk factors by age, sex, and population.
In addition, data were extracted from the most recent GBD update and evaluated using a Socio-demographic Index based on rates of education, fertility, and income.
Results
The 195 countries were assigned scores on a scale of 1 to 100 for healthcare access and quality. They received scores for the 32 causes as well as overall scores.
In 2015, the top-ranked nation was Andorra, with an overall score of 95. Its lowest treatment score was 70, for Hodgkin lymphoma.
The lowest-ranked nation was Central African Republic, with a score of 29. Its highest treatment score was 65, for diphtheria.
Nations in much of sub-Saharan Africa, as well as in south Asia and several countries in Latin America and the Caribbean, also had low rankings.
However, many countries in these regions, including China (score: 74) and Ethiopia (score: 44), have seen sizeable gains since 1990.
‘Developed’ nations falling short
The US had an overall score of 81 (in 2015), tied with Estonia and Montenegro. As with many other nations, the US scored 100 in treating common vaccine-preventable diseases, such as diphtheria, tetanus, and measles.
However, the US had 9 treatment categories in which it scored in the 60s: lower respiratory infections (60), neonatal disorders (69), non-melanoma skin cancer (68), Hodgkin lymphoma (67), ischemic heart disease (62), hypertensive heart disease (64), diabetes (67), chronic kidney disease (62), and the adverse effects of medical treatment itself (68).
“America’s ranking is an embarrassment, especially considering the US spends more than $9000 per person on healthcare annually, more than any other country,” Dr Murray said.
“Anyone with a stake in the current healthcare debate, including elected officials at the federal, state, and local levels, should take a look at where the US is falling short.”
Other nations with strong economies and advanced medical technology are falling short in some areas as well.
For example, Norway and Australia each scored 90 overall, among the highest in the world. However, Norway scored 65 in its treatment for testicular cancer, and Australia scored 52 for treating non-melanoma skin cancer.
“In the majority of cases, both of these cancers can be treated effectively,” Dr Murray said. “Shouldn’t it cause serious concern that people are dying of these causes in countries that have the resources to address them?”
*The 32 causes are:
- Adverse effects of medical treatment
- Appendicitis
- Breast cancer
- Cerebrovascular disease (stroke)
- Cervical cancer
- Chronic kidney disease
- Chronic respiratory diseases
- Colon and rectum cancer
- Congenital anomalies
- Diabetes mellitus
- Diarrhea-related diseases
- Diphtheria
- Epilepsy
- Gallbladder and biliary diseases
- Hodgkin lymphoma
- Hypertensive heart disease
- Inguinal, femoral, and abdominal hernia
- Ischemic heart disease
- Leukemia
- Lower respiratory infections
- Maternal disorders
- Measles
- Neonatal disorders
- Non-melanoma skin cancer
- Peptic ulcer disease
- Rheumatic heart disease
- Testicular cancer
- Tetanus
- Tuberculosis
- Upper respiratory infections
- Uterine cancer
- Whooping cough.
A global study has revealed inequity of access to and quality of healthcare among and within countries and suggests people are dying from causes with well-known treatments.
“What we have found about healthcare access and quality is disturbing,” said Christopher Murray, MD, DPhil, of the University of Washington in Seattle.
“Having a strong economy does not guarantee good healthcare. Having great medical technology doesn’t either. We know this because people are not getting the care that should be expected for diseases with established treatments.”
Dr Murray and his colleagues reported these findings in The Lancet.
For this study, the researchers assessed access to and quality of healthcare services in 195 countries from 1990 to 2015.
The group used the Healthcare Access and Quality Index, a summary measure based on 32 causes* that, in the presence of high-quality healthcare, should not result in death. Leukemia and Hodgkin lymphoma are among these causes.
Countries were assigned scores for each of the causes, based on estimates from the annual Global Burden of Diseases, Injuries, and Risk Factors study (GBD), a systematic, scientific effort to quantify the magnitude of health loss from all major diseases, injuries, and risk factors by age, sex, and population.
In addition, data were extracted from the most recent GBD update and evaluated using a Socio-demographic Index based on rates of education, fertility, and income.
Results
The 195 countries were assigned scores on a scale of 1 to 100 for healthcare access and quality. They received scores for the 32 causes as well as overall scores.
In 2015, the top-ranked nation was Andorra, with an overall score of 95. Its lowest treatment score was 70, for Hodgkin lymphoma.
The lowest-ranked nation was Central African Republic, with a score of 29. Its highest treatment score was 65, for diphtheria.
Nations in much of sub-Saharan Africa, as well as in south Asia and several countries in Latin America and the Caribbean, also had low rankings.
However, many countries in these regions, including China (score: 74) and Ethiopia (score: 44), have seen sizeable gains since 1990.
‘Developed’ nations falling short
The US had an overall score of 81 (in 2015), tied with Estonia and Montenegro. As with many other nations, the US scored 100 in treating common vaccine-preventable diseases, such as diphtheria, tetanus, and measles.
However, the US had 9 treatment categories in which it scored in the 60s: lower respiratory infections (60), neonatal disorders (69), non-melanoma skin cancer (68), Hodgkin lymphoma (67), ischemic heart disease (62), hypertensive heart disease (64), diabetes (67), chronic kidney disease (62), and the adverse effects of medical treatment itself (68).
“America’s ranking is an embarrassment, especially considering the US spends more than $9000 per person on healthcare annually, more than any other country,” Dr Murray said.
“Anyone with a stake in the current healthcare debate, including elected officials at the federal, state, and local levels, should take a look at where the US is falling short.”
Other nations with strong economies and advanced medical technology are falling short in some areas as well.
For example, Norway and Australia each scored 90 overall, among the highest in the world. However, Norway scored 65 in its treatment for testicular cancer, and Australia scored 52 for treating non-melanoma skin cancer.
“In the majority of cases, both of these cancers can be treated effectively,” Dr Murray said. “Shouldn’t it cause serious concern that people are dying of these causes in countries that have the resources to address them?”
*The 32 causes are:
- Adverse effects of medical treatment
- Appendicitis
- Breast cancer
- Cerebrovascular disease (stroke)
- Cervical cancer
- Chronic kidney disease
- Chronic respiratory diseases
- Colon and rectum cancer
- Congenital anomalies
- Diabetes mellitus
- Diarrhea-related diseases
- Diphtheria
- Epilepsy
- Gallbladder and biliary diseases
- Hodgkin lymphoma
- Hypertensive heart disease
- Inguinal, femoral, and abdominal hernia
- Ischemic heart disease
- Leukemia
- Lower respiratory infections
- Maternal disorders
- Measles
- Neonatal disorders
- Non-melanoma skin cancer
- Peptic ulcer disease
- Rheumatic heart disease
- Testicular cancer
- Tetanus
- Tuberculosis
- Upper respiratory infections
- Uterine cancer
- Whooping cough.
FDA supports continued, cautious use of GBCAs
The US Food and Drug Administration (FDA) said it has not found any evidence of adverse health effects from gadolinium retention in the brain following the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
The agency noted that all GBCAs may be associated with some gadolinium retention in the brain and other body tissues.
However, an FDA review showed no evidence that gadolinium retention in the brain is harmful.
Therefore, the FDA said it will not restrict GBCA use, although the agency will continue to assess the safety of GBCAs and plans to have a public meeting on the issue in the future.
The manufacturer of OptiMARK (gadoversetamide), a linear GBCA, updated its label with information about gadolinium retention. The FDA said it is reviewing the labels of other GBCAs to determine if changes are needed.
Recommendations
The FDA said its recommendations regarding GBCAs have not changed.
The agency advises healthcare professionals to limit GBCA use to circumstances in which the contrast agent can provide necessary information. Professionals should also consider the necessity of repetitive MRIs with GBCAs.
Patients, parents, and caregivers with any questions or concerns about GBCAs should discuss the agents with their healthcare professionals.
The FDA is also urging patients and healthcare professionals to report side effects involving GBCAs to the agency’s MedWatch program.
About the FDA review
For its review, the FDA looked at scientific publications and adverse event reports submitted to agency.
These data showed that gadolinium is retained in organs and suggested that linear GBCAs cause retention of more gadolinium in the brain than macrocyclic GBCAs. However, the data did not show adverse health effects related to this brain retention.
The only known adverse health effect related to gadolinium retention is nephrogenic systemic fibrosis (NSF), a disease characterized by thickening of the skin, which can involve the joints and limit motion.
NSF is known to occur in patients with pre-existing kidney failure. However, recent publications have shown reactions involving thickening and hardening of the skin and other tissues in patients with normal kidney function who received GBCAs and did not have NSF. Some of these patients also had evidence of gadolinium retention.
The FDA said it is evaluating such reports to determine if these fibrotic reactions are an adverse health effect of retained gadolinium.
The agency is also continuing its assessment of GBCAs, investigating how gadolinium is retained in the body. And the FDA’s National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats.
PRAC review
A recent review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) suggested there are no adverse health effects associated with gadolinium retention in the brain.
However, the PRAC recommended suspending the marketing authorization of certain linear GBCAs because they cause greater retention of gadolinium in the brain than macrocyclic GBCAs.
The PRAC’s recommendation is undergoing an appeal, which will be further reviewed by the PRAC and the Committee for Medicinal Products for Human Use.
The US Food and Drug Administration (FDA) said it has not found any evidence of adverse health effects from gadolinium retention in the brain following the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
The agency noted that all GBCAs may be associated with some gadolinium retention in the brain and other body tissues.
However, an FDA review showed no evidence that gadolinium retention in the brain is harmful.
Therefore, the FDA said it will not restrict GBCA use, although the agency will continue to assess the safety of GBCAs and plans to have a public meeting on the issue in the future.
The manufacturer of OptiMARK (gadoversetamide), a linear GBCA, updated its label with information about gadolinium retention. The FDA said it is reviewing the labels of other GBCAs to determine if changes are needed.
Recommendations
The FDA said its recommendations regarding GBCAs have not changed.
The agency advises healthcare professionals to limit GBCA use to circumstances in which the contrast agent can provide necessary information. Professionals should also consider the necessity of repetitive MRIs with GBCAs.
Patients, parents, and caregivers with any questions or concerns about GBCAs should discuss the agents with their healthcare professionals.
The FDA is also urging patients and healthcare professionals to report side effects involving GBCAs to the agency’s MedWatch program.
About the FDA review
For its review, the FDA looked at scientific publications and adverse event reports submitted to agency.
These data showed that gadolinium is retained in organs and suggested that linear GBCAs cause retention of more gadolinium in the brain than macrocyclic GBCAs. However, the data did not show adverse health effects related to this brain retention.
The only known adverse health effect related to gadolinium retention is nephrogenic systemic fibrosis (NSF), a disease characterized by thickening of the skin, which can involve the joints and limit motion.
NSF is known to occur in patients with pre-existing kidney failure. However, recent publications have shown reactions involving thickening and hardening of the skin and other tissues in patients with normal kidney function who received GBCAs and did not have NSF. Some of these patients also had evidence of gadolinium retention.
The FDA said it is evaluating such reports to determine if these fibrotic reactions are an adverse health effect of retained gadolinium.
The agency is also continuing its assessment of GBCAs, investigating how gadolinium is retained in the body. And the FDA’s National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats.
PRAC review
A recent review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) suggested there are no adverse health effects associated with gadolinium retention in the brain.
However, the PRAC recommended suspending the marketing authorization of certain linear GBCAs because they cause greater retention of gadolinium in the brain than macrocyclic GBCAs.
The PRAC’s recommendation is undergoing an appeal, which will be further reviewed by the PRAC and the Committee for Medicinal Products for Human Use.
The US Food and Drug Administration (FDA) said it has not found any evidence of adverse health effects from gadolinium retention in the brain following the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
The agency noted that all GBCAs may be associated with some gadolinium retention in the brain and other body tissues.
However, an FDA review showed no evidence that gadolinium retention in the brain is harmful.
Therefore, the FDA said it will not restrict GBCA use, although the agency will continue to assess the safety of GBCAs and plans to have a public meeting on the issue in the future.
The manufacturer of OptiMARK (gadoversetamide), a linear GBCA, updated its label with information about gadolinium retention. The FDA said it is reviewing the labels of other GBCAs to determine if changes are needed.
Recommendations
The FDA said its recommendations regarding GBCAs have not changed.
The agency advises healthcare professionals to limit GBCA use to circumstances in which the contrast agent can provide necessary information. Professionals should also consider the necessity of repetitive MRIs with GBCAs.
Patients, parents, and caregivers with any questions or concerns about GBCAs should discuss the agents with their healthcare professionals.
The FDA is also urging patients and healthcare professionals to report side effects involving GBCAs to the agency’s MedWatch program.
About the FDA review
For its review, the FDA looked at scientific publications and adverse event reports submitted to agency.
These data showed that gadolinium is retained in organs and suggested that linear GBCAs cause retention of more gadolinium in the brain than macrocyclic GBCAs. However, the data did not show adverse health effects related to this brain retention.
The only known adverse health effect related to gadolinium retention is nephrogenic systemic fibrosis (NSF), a disease characterized by thickening of the skin, which can involve the joints and limit motion.
NSF is known to occur in patients with pre-existing kidney failure. However, recent publications have shown reactions involving thickening and hardening of the skin and other tissues in patients with normal kidney function who received GBCAs and did not have NSF. Some of these patients also had evidence of gadolinium retention.
The FDA said it is evaluating such reports to determine if these fibrotic reactions are an adverse health effect of retained gadolinium.
The agency is also continuing its assessment of GBCAs, investigating how gadolinium is retained in the body. And the FDA’s National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats.
PRAC review
A recent review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) suggested there are no adverse health effects associated with gadolinium retention in the brain.
However, the PRAC recommended suspending the marketing authorization of certain linear GBCAs because they cause greater retention of gadolinium in the brain than macrocyclic GBCAs.
The PRAC’s recommendation is undergoing an appeal, which will be further reviewed by the PRAC and the Committee for Medicinal Products for Human Use.
PREMM5: Updated Lynch syndrome test available
An updated Lynch syndrome (LS) prediction model improves accuracy and may be used to assess individuals who are currently unaffected by cancer. The model predicts an individual’s risk of carrying one of five known gene mutations associated with LS. It could be applied to individuals with a suspicious family history of cancer, as well as to colon cancer patients who may not have tumor immunohistochemical and microsatellite instability testing results that can spot potential LS patients based on specific tumor characteristics.
LS is linked to a 40%-80% lifetime risk of colorectal cancer and heightened risk of gynecologic cancer in women, as well as gastrointestinal, genitourinary, and additional cancers.
Addition of the PMS2 gene is important because there is some evidence that it is the most prevalent gene in LS, although it has a weaker phenotype, with cancer diagnoses at older ages and less striking family histories. Still, its higher frequency makes it an important player. “It’s a big deal. We originally thought the majority of LS was caused by MLH1 and MSH2 gene alterations, but that is no longer the case,” said lead author Fay Kastrinos, MD, MPH, director of the hereditary GI cancer risk and prevention program at New York–Presbyterian Hospital/Columbia University Medical Center.
The researchers recommend that anyone with a probability over 2.5% should be referred to evaluation for genetic testing, which could include germline genetic testing, microsatellite instability, or immunohistochemistry testing of a colorectal cancer tumor.
The new model is a successor to PRMM1,2,6, which evaluated a patient’s risk of a mutation in MLH1, MLH2, or MLH6. That model was developed from a population predominantly composed of colon cancer patients.
The researchers expanded the population for the PREMM5 model to include a total of 18,734 subjects who were evaluated for a wide range of clinical characteristics, as well as personal and family cancer history, and were tested for mutations in all five genes.
Of that population, 5% had mutations in one of the LS genes, and the model distinguished mutation carriers from noncarriers with an area under the curve of 0.81 (95% confidence interval, 0.79-0.82).
When the team applied the model to a validation cohort of 1,058 patients with colorectal cancer, it achieved a similar level of accuracy (AUC, 0.83; 95% CI, 0.75-0.92). When looking at the prediction of each specific gene, the model fared worse in predicting PMS2 mutations (AUC, 0.64; 95% CI, 0.60-0.68) than for other genes.
When applied to the PREMM5 development cohort, PREMM1,2,6 over-predicted mutation-positive status. (For MLH1, MSH2, and MSH6, it predicted a prevalence of 8.0%, compared with an observed frequency of 4.5%.)
Dr. Kastrinos stressed the potential use of the model among individuals unaffected by cancer. She noted that over 46% of the derivation cohort had no personal cancer history, only family histories of LS-associated cancers. “So, there is the potential for this model to be used in preventive health settings to assess familial cancer risk in someone who doesn’t have cancer but may be discovered to be at increased risk during a routine medical evaluation,” she said.
Gastroenterologists could also employ it with patients presenting for screening colonoscopy to assess for personal or family cancer history suggestive of LS. Patients ultimately found to have LS can be followed more closely, and close relatives can also be considered for testing. “If we can promote the identification of those with LS who are unaffected by cancer, we can make a tremendous impact in the prevention of malignancies associated with Lynch syndrome,” said Dr. Kastrinos.
Dr. Kastrinos reported having no financial disclosures.
An updated Lynch syndrome (LS) prediction model improves accuracy and may be used to assess individuals who are currently unaffected by cancer. The model predicts an individual’s risk of carrying one of five known gene mutations associated with LS. It could be applied to individuals with a suspicious family history of cancer, as well as to colon cancer patients who may not have tumor immunohistochemical and microsatellite instability testing results that can spot potential LS patients based on specific tumor characteristics.
LS is linked to a 40%-80% lifetime risk of colorectal cancer and heightened risk of gynecologic cancer in women, as well as gastrointestinal, genitourinary, and additional cancers.
Addition of the PMS2 gene is important because there is some evidence that it is the most prevalent gene in LS, although it has a weaker phenotype, with cancer diagnoses at older ages and less striking family histories. Still, its higher frequency makes it an important player. “It’s a big deal. We originally thought the majority of LS was caused by MLH1 and MSH2 gene alterations, but that is no longer the case,” said lead author Fay Kastrinos, MD, MPH, director of the hereditary GI cancer risk and prevention program at New York–Presbyterian Hospital/Columbia University Medical Center.
The researchers recommend that anyone with a probability over 2.5% should be referred to evaluation for genetic testing, which could include germline genetic testing, microsatellite instability, or immunohistochemistry testing of a colorectal cancer tumor.
The new model is a successor to PRMM1,2,6, which evaluated a patient’s risk of a mutation in MLH1, MLH2, or MLH6. That model was developed from a population predominantly composed of colon cancer patients.
The researchers expanded the population for the PREMM5 model to include a total of 18,734 subjects who were evaluated for a wide range of clinical characteristics, as well as personal and family cancer history, and were tested for mutations in all five genes.
Of that population, 5% had mutations in one of the LS genes, and the model distinguished mutation carriers from noncarriers with an area under the curve of 0.81 (95% confidence interval, 0.79-0.82).
When the team applied the model to a validation cohort of 1,058 patients with colorectal cancer, it achieved a similar level of accuracy (AUC, 0.83; 95% CI, 0.75-0.92). When looking at the prediction of each specific gene, the model fared worse in predicting PMS2 mutations (AUC, 0.64; 95% CI, 0.60-0.68) than for other genes.
When applied to the PREMM5 development cohort, PREMM1,2,6 over-predicted mutation-positive status. (For MLH1, MSH2, and MSH6, it predicted a prevalence of 8.0%, compared with an observed frequency of 4.5%.)
Dr. Kastrinos stressed the potential use of the model among individuals unaffected by cancer. She noted that over 46% of the derivation cohort had no personal cancer history, only family histories of LS-associated cancers. “So, there is the potential for this model to be used in preventive health settings to assess familial cancer risk in someone who doesn’t have cancer but may be discovered to be at increased risk during a routine medical evaluation,” she said.
Gastroenterologists could also employ it with patients presenting for screening colonoscopy to assess for personal or family cancer history suggestive of LS. Patients ultimately found to have LS can be followed more closely, and close relatives can also be considered for testing. “If we can promote the identification of those with LS who are unaffected by cancer, we can make a tremendous impact in the prevention of malignancies associated with Lynch syndrome,” said Dr. Kastrinos.
Dr. Kastrinos reported having no financial disclosures.
An updated Lynch syndrome (LS) prediction model improves accuracy and may be used to assess individuals who are currently unaffected by cancer. The model predicts an individual’s risk of carrying one of five known gene mutations associated with LS. It could be applied to individuals with a suspicious family history of cancer, as well as to colon cancer patients who may not have tumor immunohistochemical and microsatellite instability testing results that can spot potential LS patients based on specific tumor characteristics.
LS is linked to a 40%-80% lifetime risk of colorectal cancer and heightened risk of gynecologic cancer in women, as well as gastrointestinal, genitourinary, and additional cancers.
Addition of the PMS2 gene is important because there is some evidence that it is the most prevalent gene in LS, although it has a weaker phenotype, with cancer diagnoses at older ages and less striking family histories. Still, its higher frequency makes it an important player. “It’s a big deal. We originally thought the majority of LS was caused by MLH1 and MSH2 gene alterations, but that is no longer the case,” said lead author Fay Kastrinos, MD, MPH, director of the hereditary GI cancer risk and prevention program at New York–Presbyterian Hospital/Columbia University Medical Center.
The researchers recommend that anyone with a probability over 2.5% should be referred to evaluation for genetic testing, which could include germline genetic testing, microsatellite instability, or immunohistochemistry testing of a colorectal cancer tumor.
The new model is a successor to PRMM1,2,6, which evaluated a patient’s risk of a mutation in MLH1, MLH2, or MLH6. That model was developed from a population predominantly composed of colon cancer patients.
The researchers expanded the population for the PREMM5 model to include a total of 18,734 subjects who were evaluated for a wide range of clinical characteristics, as well as personal and family cancer history, and were tested for mutations in all five genes.
Of that population, 5% had mutations in one of the LS genes, and the model distinguished mutation carriers from noncarriers with an area under the curve of 0.81 (95% confidence interval, 0.79-0.82).
When the team applied the model to a validation cohort of 1,058 patients with colorectal cancer, it achieved a similar level of accuracy (AUC, 0.83; 95% CI, 0.75-0.92). When looking at the prediction of each specific gene, the model fared worse in predicting PMS2 mutations (AUC, 0.64; 95% CI, 0.60-0.68) than for other genes.
When applied to the PREMM5 development cohort, PREMM1,2,6 over-predicted mutation-positive status. (For MLH1, MSH2, and MSH6, it predicted a prevalence of 8.0%, compared with an observed frequency of 4.5%.)
Dr. Kastrinos stressed the potential use of the model among individuals unaffected by cancer. She noted that over 46% of the derivation cohort had no personal cancer history, only family histories of LS-associated cancers. “So, there is the potential for this model to be used in preventive health settings to assess familial cancer risk in someone who doesn’t have cancer but may be discovered to be at increased risk during a routine medical evaluation,” she said.
Gastroenterologists could also employ it with patients presenting for screening colonoscopy to assess for personal or family cancer history suggestive of LS. Patients ultimately found to have LS can be followed more closely, and close relatives can also be considered for testing. “If we can promote the identification of those with LS who are unaffected by cancer, we can make a tremendous impact in the prevention of malignancies associated with Lynch syndrome,” said Dr. Kastrinos.
Dr. Kastrinos reported having no financial disclosures.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: The researchers recommend testing for patients who score a probability greater than or equal to 2.5%.
Major finding: The model distinguished carriers from noncarriers with an AUC of 0.81.
Data source: Development cohort of 18,734 and validation cohort of 1,058.
Disclosures: No source of funding was disclosed. Dr. Kastrinos reported having no financial disclosures.
Elderly black individuals at higher risk of colorectal cancer
Elderly black patients on Medicare are at a 31% higher risk for colorectal cancer (CRC) than white patients, according to a study done by Stacey A. Fedewa, PhD, MPH, and her colleagues at the American Cancer Society.
There were 2,735 cases of interval CRC identified between 2002 and 2011 for this study. The patients studied were between 66 and 75 years of age and were all enrolled in Medicare. A higher proportion of black individuals, 52.8%, received a colonoscopy from physicians with a lower polyp detection rate (PDR, a proxy for adenoma detection rate), compared with whites at 46.2%. The PDR, the number of patients in whom a polypectomy is performed divided by the number of colonoscopies performed in a 5-year period, is significantly associated with interval CRC risk (Ann Intern Med. 2017. doi: 10.7326/M16-1154).
Interval CRC, defined as cancer that develops after a negative result on colonoscopy but before the next recommended test, accounts for 3%-8% of CRC cases in the United States. These cases of CRC develop in certain populations because they were missed at the time of screening or between recommended screenings or surveillance intervals.
Results showed that the probability of interval CRC by the end of follow-up was 7.1% in blacks, 5.8% in whites, 4.4% in Hispanics, and 3.8% in Asians. Of the 79,396 Medicare patients that met enrollment criteria, 61,433 were included in the study. The average age of index colonoscopy was 70 years, and 2,735 cases of interval CRC were identified.
“Future studies examining this issue are warranted, given the higher overall risk for interval CRC in black populations as well as the larger disease burden in this group,” Dr. Fedewa said.
Medicare patient data were gathered from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program (SEER), a data collection of 18 cancer registries across the United States. Claims data were used to identify receipt and dates of patient colonoscopies and polypectomies, as well as the PDR of administering physicians. Data from SEER was used to identify cases of interval CRC. Medicare Enrollment data were used to determine patients’ ethnicities.
The primary exposures were ethnicity and physician PDR, a relative measure of colonoscopy quality. Ethnicities were categorized as non-Hispanic white, black, Hispanic, Asian, and other. Patients were followed until they died, were no longer enrolled in Medicare, or experienced interval CRC defined as a first case of primary invasive CRC diagnosed 6-59 months after the colonoscopy.
Elderly black patients on Medicare are at a 31% higher risk for colorectal cancer (CRC) than white patients, according to a study done by Stacey A. Fedewa, PhD, MPH, and her colleagues at the American Cancer Society.
There were 2,735 cases of interval CRC identified between 2002 and 2011 for this study. The patients studied were between 66 and 75 years of age and were all enrolled in Medicare. A higher proportion of black individuals, 52.8%, received a colonoscopy from physicians with a lower polyp detection rate (PDR, a proxy for adenoma detection rate), compared with whites at 46.2%. The PDR, the number of patients in whom a polypectomy is performed divided by the number of colonoscopies performed in a 5-year period, is significantly associated with interval CRC risk (Ann Intern Med. 2017. doi: 10.7326/M16-1154).
Interval CRC, defined as cancer that develops after a negative result on colonoscopy but before the next recommended test, accounts for 3%-8% of CRC cases in the United States. These cases of CRC develop in certain populations because they were missed at the time of screening or between recommended screenings or surveillance intervals.
Results showed that the probability of interval CRC by the end of follow-up was 7.1% in blacks, 5.8% in whites, 4.4% in Hispanics, and 3.8% in Asians. Of the 79,396 Medicare patients that met enrollment criteria, 61,433 were included in the study. The average age of index colonoscopy was 70 years, and 2,735 cases of interval CRC were identified.
“Future studies examining this issue are warranted, given the higher overall risk for interval CRC in black populations as well as the larger disease burden in this group,” Dr. Fedewa said.
Medicare patient data were gathered from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program (SEER), a data collection of 18 cancer registries across the United States. Claims data were used to identify receipt and dates of patient colonoscopies and polypectomies, as well as the PDR of administering physicians. Data from SEER was used to identify cases of interval CRC. Medicare Enrollment data were used to determine patients’ ethnicities.
The primary exposures were ethnicity and physician PDR, a relative measure of colonoscopy quality. Ethnicities were categorized as non-Hispanic white, black, Hispanic, Asian, and other. Patients were followed until they died, were no longer enrolled in Medicare, or experienced interval CRC defined as a first case of primary invasive CRC diagnosed 6-59 months after the colonoscopy.
Elderly black patients on Medicare are at a 31% higher risk for colorectal cancer (CRC) than white patients, according to a study done by Stacey A. Fedewa, PhD, MPH, and her colleagues at the American Cancer Society.
There were 2,735 cases of interval CRC identified between 2002 and 2011 for this study. The patients studied were between 66 and 75 years of age and were all enrolled in Medicare. A higher proportion of black individuals, 52.8%, received a colonoscopy from physicians with a lower polyp detection rate (PDR, a proxy for adenoma detection rate), compared with whites at 46.2%. The PDR, the number of patients in whom a polypectomy is performed divided by the number of colonoscopies performed in a 5-year period, is significantly associated with interval CRC risk (Ann Intern Med. 2017. doi: 10.7326/M16-1154).
Interval CRC, defined as cancer that develops after a negative result on colonoscopy but before the next recommended test, accounts for 3%-8% of CRC cases in the United States. These cases of CRC develop in certain populations because they were missed at the time of screening or between recommended screenings or surveillance intervals.
Results showed that the probability of interval CRC by the end of follow-up was 7.1% in blacks, 5.8% in whites, 4.4% in Hispanics, and 3.8% in Asians. Of the 79,396 Medicare patients that met enrollment criteria, 61,433 were included in the study. The average age of index colonoscopy was 70 years, and 2,735 cases of interval CRC were identified.
“Future studies examining this issue are warranted, given the higher overall risk for interval CRC in black populations as well as the larger disease burden in this group,” Dr. Fedewa said.
Medicare patient data were gathered from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program (SEER), a data collection of 18 cancer registries across the United States. Claims data were used to identify receipt and dates of patient colonoscopies and polypectomies, as well as the PDR of administering physicians. Data from SEER was used to identify cases of interval CRC. Medicare Enrollment data were used to determine patients’ ethnicities.
The primary exposures were ethnicity and physician PDR, a relative measure of colonoscopy quality. Ethnicities were categorized as non-Hispanic white, black, Hispanic, Asian, and other. Patients were followed until they died, were no longer enrolled in Medicare, or experienced interval CRC defined as a first case of primary invasive CRC diagnosed 6-59 months after the colonoscopy.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point:
Major finding: The risk of interval colorectal cancer was 7.1% in blacks, 5.8% in whites, 4.4% in Hispanics, and 3.8% in Asians.
Data source: A population-based cohort study involving 2,735 cases of interval colorectal cancer identified between 2002 and 2011.
Disclosures: The study was funded by the American Cancer Society and approved by the Institutional review board at Emory University. Data analysis for this research was supported by the American Cancer Society. Dr. Doubeni’s contribution was supported by an award from the United States National Cancer Institute of the National Institutes of Health. Authors have declared no conflicts of interest.
Republicans race the clock on health care, but the calendar is not helping
Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.
In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.
One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.
Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.
“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.
“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”
In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”
CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.
“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”
“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”
But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.
That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.
There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.
And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”
That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.
There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”
So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.
At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.
Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.
In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.
One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.
Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.
“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.
“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”
In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”
CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.
“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”
“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”
But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.
That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.
There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.
And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”
That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.
There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”
So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.
At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.
Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.
In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.
One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.
Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.
“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.
“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”
In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”
CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.
“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”
“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”
But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.
That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.
There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.
And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”
That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.
There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”
So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.
At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.
HM17 plenaries: Hospital medicine leading health care shift to value, quality
LAS VEGAS – The path to improved health care in the U.S. may never be straight – and it certainly won’t be easy – but the three plenary speakers at HM17 think its destination is pretty clear: a system that increasingly rewards quality care delivered at lower costs.
And the three experts agreed that there may be “no finer group” than hospitalists to continue leading the charge.
Hospitalists “have been at the center of change, not only in building a new field and showing us that medicine doesn’t have to be the way it always was,” said Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health in the U.S. Department of Health and Human Services. “You have been at the forefront of seeing that we’re getting better value out of our health care system.”
Dr. DeSalvo believes HM’s scope of practice must evolve to include a focus on social determinants – such as economic stability, neighborhood and physical environment, education, and access to healthy options for food – because they have “direct relationships with mortality and morbidity and cost.”
In other words, Dr. DeSalvo wondered aloud, what good is treating a grandmother’s heart failure over and over if she’s always going to return to the hospital because her home, her neighborhood, or her finances mean she is unable to prevent recurring issues?
“If you listen to the hoof-beats that are coming, there is definitely a financial imprimatur to do this,” Dr. DeSalvo said. “There is going to be an expectation from public and private payers... that we are going to be taking into account and addressing social factors. Just look at the data from the people of this country – they are shouting loudly to you that they need help.”
“I can tell you our system still does not have a highly reliable, whole health system for those children and their families,” he said. “Every weekend, I have a family that I can’t discharge because they don’t have the social and home-based supports for them to go home. So they literally sit in the hospital until Monday. That makes no sense for our overall health system.”
Dr. Conway assured attendees that health system transformation is a bipartisan ideal and that for all the tumult in Washington, the progress of testing new payment- and service-delivery models will move forward.
The work “on value, the work on accountability, the work on bundled payments... will continue and will continue to be important to you and the patients you serve,” he said.
Robert Wachter, MD, MHM, concluded the meeting – as is tradition – by telling hospitalists the field remains positioned to take the lead for hospital transformation. And technology, despite its myriad frustrations, is still the tool that will get the field there.
“Digital is really important here, because it becomes an enabler for those stakeholders who care about what we do to measure what we do, and our ability to change what we do in a far more robust way than we could ever do before, if we get our acts together,” Dr. Wachter said. “We’re well past the time where you can nibble around the edges here, you can get this done with little mini projects. You really have to remake your whole delivery system, the way you do your work in order to succeed in this environment.”
Dr. Wachter agreed that social determinants must be addressed. He said HM might do better to partner with folks handling those issues, rather than tackling them head on. Instead, HM needs to be “focusing on the right things” amid mounting pressures from digitization, consolidation of everything from health systems to insurance companies to HM companies, and the gravitation toward population health.
“We have successfully positioned ourselves as the people who are leaders in this work,” Dr. Wachter said, “and it is increasingly important that we continue to do that as we go forward.”
LAS VEGAS – The path to improved health care in the U.S. may never be straight – and it certainly won’t be easy – but the three plenary speakers at HM17 think its destination is pretty clear: a system that increasingly rewards quality care delivered at lower costs.
And the three experts agreed that there may be “no finer group” than hospitalists to continue leading the charge.
Hospitalists “have been at the center of change, not only in building a new field and showing us that medicine doesn’t have to be the way it always was,” said Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health in the U.S. Department of Health and Human Services. “You have been at the forefront of seeing that we’re getting better value out of our health care system.”
Dr. DeSalvo believes HM’s scope of practice must evolve to include a focus on social determinants – such as economic stability, neighborhood and physical environment, education, and access to healthy options for food – because they have “direct relationships with mortality and morbidity and cost.”
In other words, Dr. DeSalvo wondered aloud, what good is treating a grandmother’s heart failure over and over if she’s always going to return to the hospital because her home, her neighborhood, or her finances mean she is unable to prevent recurring issues?
“If you listen to the hoof-beats that are coming, there is definitely a financial imprimatur to do this,” Dr. DeSalvo said. “There is going to be an expectation from public and private payers... that we are going to be taking into account and addressing social factors. Just look at the data from the people of this country – they are shouting loudly to you that they need help.”
“I can tell you our system still does not have a highly reliable, whole health system for those children and their families,” he said. “Every weekend, I have a family that I can’t discharge because they don’t have the social and home-based supports for them to go home. So they literally sit in the hospital until Monday. That makes no sense for our overall health system.”
Dr. Conway assured attendees that health system transformation is a bipartisan ideal and that for all the tumult in Washington, the progress of testing new payment- and service-delivery models will move forward.
The work “on value, the work on accountability, the work on bundled payments... will continue and will continue to be important to you and the patients you serve,” he said.
Robert Wachter, MD, MHM, concluded the meeting – as is tradition – by telling hospitalists the field remains positioned to take the lead for hospital transformation. And technology, despite its myriad frustrations, is still the tool that will get the field there.
“Digital is really important here, because it becomes an enabler for those stakeholders who care about what we do to measure what we do, and our ability to change what we do in a far more robust way than we could ever do before, if we get our acts together,” Dr. Wachter said. “We’re well past the time where you can nibble around the edges here, you can get this done with little mini projects. You really have to remake your whole delivery system, the way you do your work in order to succeed in this environment.”
Dr. Wachter agreed that social determinants must be addressed. He said HM might do better to partner with folks handling those issues, rather than tackling them head on. Instead, HM needs to be “focusing on the right things” amid mounting pressures from digitization, consolidation of everything from health systems to insurance companies to HM companies, and the gravitation toward population health.
“We have successfully positioned ourselves as the people who are leaders in this work,” Dr. Wachter said, “and it is increasingly important that we continue to do that as we go forward.”
LAS VEGAS – The path to improved health care in the U.S. may never be straight – and it certainly won’t be easy – but the three plenary speakers at HM17 think its destination is pretty clear: a system that increasingly rewards quality care delivered at lower costs.
And the three experts agreed that there may be “no finer group” than hospitalists to continue leading the charge.
Hospitalists “have been at the center of change, not only in building a new field and showing us that medicine doesn’t have to be the way it always was,” said Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health in the U.S. Department of Health and Human Services. “You have been at the forefront of seeing that we’re getting better value out of our health care system.”
Dr. DeSalvo believes HM’s scope of practice must evolve to include a focus on social determinants – such as economic stability, neighborhood and physical environment, education, and access to healthy options for food – because they have “direct relationships with mortality and morbidity and cost.”
In other words, Dr. DeSalvo wondered aloud, what good is treating a grandmother’s heart failure over and over if she’s always going to return to the hospital because her home, her neighborhood, or her finances mean she is unable to prevent recurring issues?
“If you listen to the hoof-beats that are coming, there is definitely a financial imprimatur to do this,” Dr. DeSalvo said. “There is going to be an expectation from public and private payers... that we are going to be taking into account and addressing social factors. Just look at the data from the people of this country – they are shouting loudly to you that they need help.”
“I can tell you our system still does not have a highly reliable, whole health system for those children and their families,” he said. “Every weekend, I have a family that I can’t discharge because they don’t have the social and home-based supports for them to go home. So they literally sit in the hospital until Monday. That makes no sense for our overall health system.”
Dr. Conway assured attendees that health system transformation is a bipartisan ideal and that for all the tumult in Washington, the progress of testing new payment- and service-delivery models will move forward.
The work “on value, the work on accountability, the work on bundled payments... will continue and will continue to be important to you and the patients you serve,” he said.
Robert Wachter, MD, MHM, concluded the meeting – as is tradition – by telling hospitalists the field remains positioned to take the lead for hospital transformation. And technology, despite its myriad frustrations, is still the tool that will get the field there.
“Digital is really important here, because it becomes an enabler for those stakeholders who care about what we do to measure what we do, and our ability to change what we do in a far more robust way than we could ever do before, if we get our acts together,” Dr. Wachter said. “We’re well past the time where you can nibble around the edges here, you can get this done with little mini projects. You really have to remake your whole delivery system, the way you do your work in order to succeed in this environment.”
Dr. Wachter agreed that social determinants must be addressed. He said HM might do better to partner with folks handling those issues, rather than tackling them head on. Instead, HM needs to be “focusing on the right things” amid mounting pressures from digitization, consolidation of everything from health systems to insurance companies to HM companies, and the gravitation toward population health.
“We have successfully positioned ourselves as the people who are leaders in this work,” Dr. Wachter said, “and it is increasingly important that we continue to do that as we go forward.”
Recurrent acute pancreatitis significantly impairs both mental and physical quality of life
CHICAGO – Despite its intermittent and unpredictable nature, recurrent acute pancreatitis exacts a significant toll on patients’ physical and mental quality of life.
It is well-known that patients with chronic pancreatitis suffer physically and emotionally. However, the same understanding has not been engendered for those who experience recurrent acute pancreatitis (RAP), Gregory A. Cote, MD, said at the annual Digestive Disease Week®. Sporadic episodes of acute pancreatitis may cause persistent declines in quality of life.
“RAP clearly leads to a significant reduction in physical and mental quality of life, despite its erratic and sporadic nature,” Dr. Cote said. “Smoking and self-reported disability are very important drivers of these reductions, and a concomitant diagnosis of diabetes exacerbates that even further.”
To explore RAP’s impact on mental and physical quality of life, Dr. Cote examined data from three related cross-sectional North American Pancreatitis Studies (NAPS): the NAPS2, NAPS2-CV (Continuation and Validation), and NAPS2-AS (Ancillary Study).
These studies comprised 2,619 subjects who were enrolled at 27 U.S. sites from 2000 to 2014. Both patients and their physicians completed detailed baseline questionnaires that included personal and family history, risk factors, symptoms, and the 12-Item Short Form Health Survey (SF-12), a detailed quality of life measure.
A score of 50 is the mean for the U.S. general population, and a difference of 3 points or more is considered clinically relevant, Dr. Cote noted.
He parsed the cohort into three groups: those with RAP (508), those with chronic pancreatitis (1,086), and a reference group of healthy controls who were also in the database (1,025).
Some significant between-group differences were immediately obvious, Dr. Cote said. Patients with RAP were significantly younger than both chronic pancreatitis patients (CP) and controls (45 vs. 51 and 49 years, respectively). They also experienced their first bout of acute pancreatitis sooner than CP patients became symptomatic (40 vs. 44 years). Gender was a factor as well: CP patients were more often men (55% vs. 46%).
The pattern of alcohol use between the groups was difficult to interpret, he said. About one-quarter of RAP patients abstained, another fourth were light drinkers, and another fourth moderate drinkers – 12% drank heavily and 7% very heavily. In contrast, frequent drinking was more common among CP patients, with 12% reporting that they drank heavily and 33% very heavily.
CP patients were significantly more likely to be smokers, with 75% reporting current or past tobacco use, compared with 55% of RAP patients. More RAP patients reported never smoking (44% vs. 25%).
RAP patients fell between CP patients and controls in terms of medical comorbidities, including diabetes, renal disease or kidney failure, heart disease, and liver disease.
On the SF-12 physical component section, RAP patients scored a mean of 41 points – significantly worse than controls (51) but significantly better than CP patients (37). The findings were similar for the mental component score: RAP patients scored a mean of 45, compared with 52 in controls and 43 in CP patients.
Dr. Cote performed a multivariate analysis that controlled for age, sex, tobacco and alcohol use, and diabetes. Again, he found that, compared with controls, RAP was associated with significantly reduced scores on both the physical and mental components (mean 8.5 and 6.5 points, respectively).
“The magnitude of reduction was even greater for chronic pancreatitis, with an 11-point reduction on the physical component score and a 7.6-point reduction on the mental component score.
He then sought to identify which clinical characteristics most contributed to this impact on quality of life.
On the physical component score, several were significant, including female sex, which was associated with a 4.4-point decrease; prior pancreatic surgery (–3.3); endocrine insufficiency (–4.6); past smoking (–2.5); current smoking (–3.6); and self-reported physical disability (–9.5).
The mental component score breakdown echoed some of these. Self-reported disability exerted the largest impact, bringing the mental score down by a mean of 5.4 points. Other significant factors were smoking less than a pack a day (–2.5) and smoking more than a pack a day (–4.6). Any suspicion of chronic pancreatitis by the treating physician was associated with a 2.9-point decrease on the score.
“Our findings stress that this is not a disease that can be followed conservatively. We have to investigate interventions that will attenuate it, not only because these patients may go on to develop chronic pancreatitis but because, in their current state, most are experiencing significant reductions in their quality of life.”
Dr Cote had no financial disclosures.
[email protected]
On Twitter @alz_gal
CHICAGO – Despite its intermittent and unpredictable nature, recurrent acute pancreatitis exacts a significant toll on patients’ physical and mental quality of life.
It is well-known that patients with chronic pancreatitis suffer physically and emotionally. However, the same understanding has not been engendered for those who experience recurrent acute pancreatitis (RAP), Gregory A. Cote, MD, said at the annual Digestive Disease Week®. Sporadic episodes of acute pancreatitis may cause persistent declines in quality of life.
“RAP clearly leads to a significant reduction in physical and mental quality of life, despite its erratic and sporadic nature,” Dr. Cote said. “Smoking and self-reported disability are very important drivers of these reductions, and a concomitant diagnosis of diabetes exacerbates that even further.”
To explore RAP’s impact on mental and physical quality of life, Dr. Cote examined data from three related cross-sectional North American Pancreatitis Studies (NAPS): the NAPS2, NAPS2-CV (Continuation and Validation), and NAPS2-AS (Ancillary Study).
These studies comprised 2,619 subjects who were enrolled at 27 U.S. sites from 2000 to 2014. Both patients and their physicians completed detailed baseline questionnaires that included personal and family history, risk factors, symptoms, and the 12-Item Short Form Health Survey (SF-12), a detailed quality of life measure.
A score of 50 is the mean for the U.S. general population, and a difference of 3 points or more is considered clinically relevant, Dr. Cote noted.
He parsed the cohort into three groups: those with RAP (508), those with chronic pancreatitis (1,086), and a reference group of healthy controls who were also in the database (1,025).
Some significant between-group differences were immediately obvious, Dr. Cote said. Patients with RAP were significantly younger than both chronic pancreatitis patients (CP) and controls (45 vs. 51 and 49 years, respectively). They also experienced their first bout of acute pancreatitis sooner than CP patients became symptomatic (40 vs. 44 years). Gender was a factor as well: CP patients were more often men (55% vs. 46%).
The pattern of alcohol use between the groups was difficult to interpret, he said. About one-quarter of RAP patients abstained, another fourth were light drinkers, and another fourth moderate drinkers – 12% drank heavily and 7% very heavily. In contrast, frequent drinking was more common among CP patients, with 12% reporting that they drank heavily and 33% very heavily.
CP patients were significantly more likely to be smokers, with 75% reporting current or past tobacco use, compared with 55% of RAP patients. More RAP patients reported never smoking (44% vs. 25%).
RAP patients fell between CP patients and controls in terms of medical comorbidities, including diabetes, renal disease or kidney failure, heart disease, and liver disease.
On the SF-12 physical component section, RAP patients scored a mean of 41 points – significantly worse than controls (51) but significantly better than CP patients (37). The findings were similar for the mental component score: RAP patients scored a mean of 45, compared with 52 in controls and 43 in CP patients.
Dr. Cote performed a multivariate analysis that controlled for age, sex, tobacco and alcohol use, and diabetes. Again, he found that, compared with controls, RAP was associated with significantly reduced scores on both the physical and mental components (mean 8.5 and 6.5 points, respectively).
“The magnitude of reduction was even greater for chronic pancreatitis, with an 11-point reduction on the physical component score and a 7.6-point reduction on the mental component score.
He then sought to identify which clinical characteristics most contributed to this impact on quality of life.
On the physical component score, several were significant, including female sex, which was associated with a 4.4-point decrease; prior pancreatic surgery (–3.3); endocrine insufficiency (–4.6); past smoking (–2.5); current smoking (–3.6); and self-reported physical disability (–9.5).
The mental component score breakdown echoed some of these. Self-reported disability exerted the largest impact, bringing the mental score down by a mean of 5.4 points. Other significant factors were smoking less than a pack a day (–2.5) and smoking more than a pack a day (–4.6). Any suspicion of chronic pancreatitis by the treating physician was associated with a 2.9-point decrease on the score.
“Our findings stress that this is not a disease that can be followed conservatively. We have to investigate interventions that will attenuate it, not only because these patients may go on to develop chronic pancreatitis but because, in their current state, most are experiencing significant reductions in their quality of life.”
Dr Cote had no financial disclosures.
[email protected]
On Twitter @alz_gal
CHICAGO – Despite its intermittent and unpredictable nature, recurrent acute pancreatitis exacts a significant toll on patients’ physical and mental quality of life.
It is well-known that patients with chronic pancreatitis suffer physically and emotionally. However, the same understanding has not been engendered for those who experience recurrent acute pancreatitis (RAP), Gregory A. Cote, MD, said at the annual Digestive Disease Week®. Sporadic episodes of acute pancreatitis may cause persistent declines in quality of life.
“RAP clearly leads to a significant reduction in physical and mental quality of life, despite its erratic and sporadic nature,” Dr. Cote said. “Smoking and self-reported disability are very important drivers of these reductions, and a concomitant diagnosis of diabetes exacerbates that even further.”
To explore RAP’s impact on mental and physical quality of life, Dr. Cote examined data from three related cross-sectional North American Pancreatitis Studies (NAPS): the NAPS2, NAPS2-CV (Continuation and Validation), and NAPS2-AS (Ancillary Study).
These studies comprised 2,619 subjects who were enrolled at 27 U.S. sites from 2000 to 2014. Both patients and their physicians completed detailed baseline questionnaires that included personal and family history, risk factors, symptoms, and the 12-Item Short Form Health Survey (SF-12), a detailed quality of life measure.
A score of 50 is the mean for the U.S. general population, and a difference of 3 points or more is considered clinically relevant, Dr. Cote noted.
He parsed the cohort into three groups: those with RAP (508), those with chronic pancreatitis (1,086), and a reference group of healthy controls who were also in the database (1,025).
Some significant between-group differences were immediately obvious, Dr. Cote said. Patients with RAP were significantly younger than both chronic pancreatitis patients (CP) and controls (45 vs. 51 and 49 years, respectively). They also experienced their first bout of acute pancreatitis sooner than CP patients became symptomatic (40 vs. 44 years). Gender was a factor as well: CP patients were more often men (55% vs. 46%).
The pattern of alcohol use between the groups was difficult to interpret, he said. About one-quarter of RAP patients abstained, another fourth were light drinkers, and another fourth moderate drinkers – 12% drank heavily and 7% very heavily. In contrast, frequent drinking was more common among CP patients, with 12% reporting that they drank heavily and 33% very heavily.
CP patients were significantly more likely to be smokers, with 75% reporting current or past tobacco use, compared with 55% of RAP patients. More RAP patients reported never smoking (44% vs. 25%).
RAP patients fell between CP patients and controls in terms of medical comorbidities, including diabetes, renal disease or kidney failure, heart disease, and liver disease.
On the SF-12 physical component section, RAP patients scored a mean of 41 points – significantly worse than controls (51) but significantly better than CP patients (37). The findings were similar for the mental component score: RAP patients scored a mean of 45, compared with 52 in controls and 43 in CP patients.
Dr. Cote performed a multivariate analysis that controlled for age, sex, tobacco and alcohol use, and diabetes. Again, he found that, compared with controls, RAP was associated with significantly reduced scores on both the physical and mental components (mean 8.5 and 6.5 points, respectively).
“The magnitude of reduction was even greater for chronic pancreatitis, with an 11-point reduction on the physical component score and a 7.6-point reduction on the mental component score.
He then sought to identify which clinical characteristics most contributed to this impact on quality of life.
On the physical component score, several were significant, including female sex, which was associated with a 4.4-point decrease; prior pancreatic surgery (–3.3); endocrine insufficiency (–4.6); past smoking (–2.5); current smoking (–3.6); and self-reported physical disability (–9.5).
The mental component score breakdown echoed some of these. Self-reported disability exerted the largest impact, bringing the mental score down by a mean of 5.4 points. Other significant factors were smoking less than a pack a day (–2.5) and smoking more than a pack a day (–4.6). Any suspicion of chronic pancreatitis by the treating physician was associated with a 2.9-point decrease on the score.
“Our findings stress that this is not a disease that can be followed conservatively. We have to investigate interventions that will attenuate it, not only because these patients may go on to develop chronic pancreatitis but because, in their current state, most are experiencing significant reductions in their quality of life.”
Dr Cote had no financial disclosures.
[email protected]
On Twitter @alz_gal
AT DDW
Key clinical point:
Major finding: On a physical QOL scale, patients scored a mean of 41 points – 10 points lower than controls. The mental QOL score was 7 points lower.
Data source: The database review comprised 2,619 subjects.
Disclosures: Dr. Cote had no financial disclosures.
FDA approves first specific treatment for giant cell arteritis
The Food and Drug Administration has approved subcutaneous tocilizumab (Actemra) for the treatment of giant cell arteritis, according to a May 22 announcement from the agency.
Giant cell arteritis is a type of vasculitis that inflames blood vessels in the head, causing arteries to narrow or become irregular. The temporal arteries are the most commonly affected blood vessels, but giant cell arteritis can also affect other large blood vessels such as the aorta. Tocilizumab is the first drug specifically intended to treat giant cell arteritis. The standard treatment has typically been high doses of corticosteroids, tapered over time.
The FDA’s approval of tocilizumab was based on results from a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. After 1 year, patients who received tocilizumab and tapered prednisone achieved remission at a higher rate than did patients who received placebo and tapered prednisone. Safety was consistent with tocilizumab’s known safety profile.
Subcutaneous tocilizumab is also approved for moderate to severely active rheumatoid arthritis. The intravenous formulation is approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.
The FDA granted both Breakthrough Therapy and Priority Review designations to this supplemental new drug application of tocilizumab.
The Food and Drug Administration has approved subcutaneous tocilizumab (Actemra) for the treatment of giant cell arteritis, according to a May 22 announcement from the agency.
Giant cell arteritis is a type of vasculitis that inflames blood vessels in the head, causing arteries to narrow or become irregular. The temporal arteries are the most commonly affected blood vessels, but giant cell arteritis can also affect other large blood vessels such as the aorta. Tocilizumab is the first drug specifically intended to treat giant cell arteritis. The standard treatment has typically been high doses of corticosteroids, tapered over time.
The FDA’s approval of tocilizumab was based on results from a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. After 1 year, patients who received tocilizumab and tapered prednisone achieved remission at a higher rate than did patients who received placebo and tapered prednisone. Safety was consistent with tocilizumab’s known safety profile.
Subcutaneous tocilizumab is also approved for moderate to severely active rheumatoid arthritis. The intravenous formulation is approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.
The FDA granted both Breakthrough Therapy and Priority Review designations to this supplemental new drug application of tocilizumab.
The Food and Drug Administration has approved subcutaneous tocilizumab (Actemra) for the treatment of giant cell arteritis, according to a May 22 announcement from the agency.
Giant cell arteritis is a type of vasculitis that inflames blood vessels in the head, causing arteries to narrow or become irregular. The temporal arteries are the most commonly affected blood vessels, but giant cell arteritis can also affect other large blood vessels such as the aorta. Tocilizumab is the first drug specifically intended to treat giant cell arteritis. The standard treatment has typically been high doses of corticosteroids, tapered over time.
The FDA’s approval of tocilizumab was based on results from a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. After 1 year, patients who received tocilizumab and tapered prednisone achieved remission at a higher rate than did patients who received placebo and tapered prednisone. Safety was consistent with tocilizumab’s known safety profile.
Subcutaneous tocilizumab is also approved for moderate to severely active rheumatoid arthritis. The intravenous formulation is approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.
The FDA granted both Breakthrough Therapy and Priority Review designations to this supplemental new drug application of tocilizumab.