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Biosimilar matches rituximab in large follicular lymphoma trial
MADRID – The biosimilar GP2013 met the criteria for therapeutic equivalence to rituximab in a large comparator trial of previously untreated patients with aggressive follicular lymphoma.
Based on results presented at the European Society for Medical Oncology Congress, “there is absolutely no difference in the objective response rates for GP2013 and rituximab,” the primary endpoint of the trial, reported Wojciech Jurczak, MD, PhD, head of lymphoma, department of hematology, Jagiellonian University, Krakow, Poland.
Dr. Jurczak characterized the double-blind, randomized phase 3 trial ASSIST_FL (NCT01419665) as the “largest biosimilar trial in hematology.” For the study, 629 patients with previously untreated, advanced-stage follicular lymphoma were randomized to GP2013 and the conventional regimen of cyclophosphamide, vincristine, and prednisone (G-CVP) or rituximab and the same three-agent regimen (R-CVP). Each regimen was given for eight cycles followed by maintenance monotherapy with the assigned monoclonal antibody for up to 2 years.
The primary endpoint, objective response rate (ORR), was 87.1% and 87.5% for G-CVP and R-CVP, respectively. There were no differences in ORR among the subgroups evaluated, which included patients aged 60 years and older vs. younger patients, presence or absence of bulky disease, high or low FLIPI (Follicular Lymphoma International Prognostic Index) score, gender, and the geographic region where treatment was given.
Safety was a secondary endpoint evaluated at the end of eight cycles and again after a year of maintenance therapy. The proportion of patients with any adverse event and the proportion with grade 3 or greater adverse events were not statistically different at any time point. There were also no significant differences in any of the other secondary endpoints evaluated, which included pharmacokinetic, pharmacodynamic, and immune measures.
The results are consistent with those of a related randomized bioequivalence trial comparing GP2013 and rituximab in 312 patients with rheumatoid arthritis (Ann Rheum Dis. 2017;76:1598-1602). The primary endpoint in that trial was area-under-the-curve serum concentration time.
The two studies are mutually reinforcing, and “the ASSIST_FL trial ends the story. We have the totality of evidence that GP2013 can be considered a biosimilar,” said Dr. Jurczak, who anticipates “major price differences” for this agent relative to rituximab.
“We may, based on the results of the follicular lymphoma trial, use the biosimilar in all registered indications for rituximab,” said Dr. Jurczak. This is also the conclusion of the European Medicine Agency, which approved this agent in June 2017 for all rituximab indications.
In explaining the process for approval of biosimilars, Dr. Jurczak emphasized that demonstrating bioequivalence is not the same as the approval process for a new therapeutic agent, for which regulatory agents require a demonstration of efficacy on a meaningful clinical endpoint, such as progression-free survival. For biosimilars, it is not necessary to show clinical benefits. Biosimilars must demonstrate the same biological activity, and ORR is considered an acceptable measure.
The ESMO-invited discussant, Michele Ghielmini, MD, PhD, medical director at the Oncology Institute of Southern Switzerland, Bellinzona, agreed. “We can reasonably speculate that (when rituximab and the biosimilar are associated with the same) response rate, they will lead to the same clinical benefits.”
MADRID – The biosimilar GP2013 met the criteria for therapeutic equivalence to rituximab in a large comparator trial of previously untreated patients with aggressive follicular lymphoma.
Based on results presented at the European Society for Medical Oncology Congress, “there is absolutely no difference in the objective response rates for GP2013 and rituximab,” the primary endpoint of the trial, reported Wojciech Jurczak, MD, PhD, head of lymphoma, department of hematology, Jagiellonian University, Krakow, Poland.
Dr. Jurczak characterized the double-blind, randomized phase 3 trial ASSIST_FL (NCT01419665) as the “largest biosimilar trial in hematology.” For the study, 629 patients with previously untreated, advanced-stage follicular lymphoma were randomized to GP2013 and the conventional regimen of cyclophosphamide, vincristine, and prednisone (G-CVP) or rituximab and the same three-agent regimen (R-CVP). Each regimen was given for eight cycles followed by maintenance monotherapy with the assigned monoclonal antibody for up to 2 years.
The primary endpoint, objective response rate (ORR), was 87.1% and 87.5% for G-CVP and R-CVP, respectively. There were no differences in ORR among the subgroups evaluated, which included patients aged 60 years and older vs. younger patients, presence or absence of bulky disease, high or low FLIPI (Follicular Lymphoma International Prognostic Index) score, gender, and the geographic region where treatment was given.
Safety was a secondary endpoint evaluated at the end of eight cycles and again after a year of maintenance therapy. The proportion of patients with any adverse event and the proportion with grade 3 or greater adverse events were not statistically different at any time point. There were also no significant differences in any of the other secondary endpoints evaluated, which included pharmacokinetic, pharmacodynamic, and immune measures.
The results are consistent with those of a related randomized bioequivalence trial comparing GP2013 and rituximab in 312 patients with rheumatoid arthritis (Ann Rheum Dis. 2017;76:1598-1602). The primary endpoint in that trial was area-under-the-curve serum concentration time.
The two studies are mutually reinforcing, and “the ASSIST_FL trial ends the story. We have the totality of evidence that GP2013 can be considered a biosimilar,” said Dr. Jurczak, who anticipates “major price differences” for this agent relative to rituximab.
“We may, based on the results of the follicular lymphoma trial, use the biosimilar in all registered indications for rituximab,” said Dr. Jurczak. This is also the conclusion of the European Medicine Agency, which approved this agent in June 2017 for all rituximab indications.
In explaining the process for approval of biosimilars, Dr. Jurczak emphasized that demonstrating bioequivalence is not the same as the approval process for a new therapeutic agent, for which regulatory agents require a demonstration of efficacy on a meaningful clinical endpoint, such as progression-free survival. For biosimilars, it is not necessary to show clinical benefits. Biosimilars must demonstrate the same biological activity, and ORR is considered an acceptable measure.
The ESMO-invited discussant, Michele Ghielmini, MD, PhD, medical director at the Oncology Institute of Southern Switzerland, Bellinzona, agreed. “We can reasonably speculate that (when rituximab and the biosimilar are associated with the same) response rate, they will lead to the same clinical benefits.”
MADRID – The biosimilar GP2013 met the criteria for therapeutic equivalence to rituximab in a large comparator trial of previously untreated patients with aggressive follicular lymphoma.
Based on results presented at the European Society for Medical Oncology Congress, “there is absolutely no difference in the objective response rates for GP2013 and rituximab,” the primary endpoint of the trial, reported Wojciech Jurczak, MD, PhD, head of lymphoma, department of hematology, Jagiellonian University, Krakow, Poland.
Dr. Jurczak characterized the double-blind, randomized phase 3 trial ASSIST_FL (NCT01419665) as the “largest biosimilar trial in hematology.” For the study, 629 patients with previously untreated, advanced-stage follicular lymphoma were randomized to GP2013 and the conventional regimen of cyclophosphamide, vincristine, and prednisone (G-CVP) or rituximab and the same three-agent regimen (R-CVP). Each regimen was given for eight cycles followed by maintenance monotherapy with the assigned monoclonal antibody for up to 2 years.
The primary endpoint, objective response rate (ORR), was 87.1% and 87.5% for G-CVP and R-CVP, respectively. There were no differences in ORR among the subgroups evaluated, which included patients aged 60 years and older vs. younger patients, presence or absence of bulky disease, high or low FLIPI (Follicular Lymphoma International Prognostic Index) score, gender, and the geographic region where treatment was given.
Safety was a secondary endpoint evaluated at the end of eight cycles and again after a year of maintenance therapy. The proportion of patients with any adverse event and the proportion with grade 3 or greater adverse events were not statistically different at any time point. There were also no significant differences in any of the other secondary endpoints evaluated, which included pharmacokinetic, pharmacodynamic, and immune measures.
The results are consistent with those of a related randomized bioequivalence trial comparing GP2013 and rituximab in 312 patients with rheumatoid arthritis (Ann Rheum Dis. 2017;76:1598-1602). The primary endpoint in that trial was area-under-the-curve serum concentration time.
The two studies are mutually reinforcing, and “the ASSIST_FL trial ends the story. We have the totality of evidence that GP2013 can be considered a biosimilar,” said Dr. Jurczak, who anticipates “major price differences” for this agent relative to rituximab.
“We may, based on the results of the follicular lymphoma trial, use the biosimilar in all registered indications for rituximab,” said Dr. Jurczak. This is also the conclusion of the European Medicine Agency, which approved this agent in June 2017 for all rituximab indications.
In explaining the process for approval of biosimilars, Dr. Jurczak emphasized that demonstrating bioequivalence is not the same as the approval process for a new therapeutic agent, for which regulatory agents require a demonstration of efficacy on a meaningful clinical endpoint, such as progression-free survival. For biosimilars, it is not necessary to show clinical benefits. Biosimilars must demonstrate the same biological activity, and ORR is considered an acceptable measure.
The ESMO-invited discussant, Michele Ghielmini, MD, PhD, medical director at the Oncology Institute of Southern Switzerland, Bellinzona, agreed. “We can reasonably speculate that (when rituximab and the biosimilar are associated with the same) response rate, they will lead to the same clinical benefits.”
AT ESMO 2017
Key clinical point:
Major finding: The objective response rates were 87.1% and 87.5% for G-CVP and R-CVP.
Data source: Double-blind, multicenter randomized trial of 629 patients with previously untreated, advanced-stage follicular lymphoma.
Disclosures: Dr. Jurczak reported financial relationships with Sandoz.
Analysis: Actual cancer drug R&D costs are far less than widely publicized sum
Research and development costs for cancer drugs are far lower than previous estimates, according to a new analysis, casting doubt on the common justifications by drug companies for the high prices of such medications.
The median cost to develop a cancer drug was $648 million, compared with the widely publicized figure of $2.7 billion, the study’s researchers said.
Lead investigator Vinay Prasad, MD, of Oregon Health and Science University in Portland, and Sham Mailankody, MBBS, of Memorial Sloan Kettering Cancer Center in New York, studied U.S. Securities and Exchange Commission filings for drug companies with no drugs on the market that received Food and Drug Administration approval for a cancer drug from Jan. 1, 2006, through Dec. 31, 2015. Researchers estimated cumulative research and development spending from initiation of drug development activity to date of approval. Earnings were identified from the time of approval to the present. Ten drugs and companies were included in the analysis.
Investigators found that the median time to develop a drug was 7.3 years. Five companies (50%) developed drugs that received accelerated approval from the FDA, and five drugs (50%) received regular approval. Five of the 10 drugs (50%) act on a novel target (ibrutinib, brentuximab vedotin, ruxolitinib, cabozantinib, and eculizumab), whereas the other five drugs (50%) are next-in-class drugs with a mechanism of action similar to that of a previously approved drug.
Results showed the median cost of developing a single drug in 2017 U.S. dollars was $648 million (range, $157.3 million to $1.95 billion), and the mean development cost was $719.8 million (JAMA Intern Med. 2017 Sep 11 doi: 10.1001/jamainternmed.2017.3601).
Drugs that received accelerated approval cost less to develop than did those that received regular approval, although that finding was not statistically significant, according to the study. From the time of approval to December 2016 – or until the company sold or licensed the compound to another company – the total revenue of the 10 drugs was $67 billion. The median revenue for these companies was $1.66 billion (range, $204.1 million to $22.3 billion), and the average revenue was $6.7 billion. Nine of the 10 drugs had revenues greater than their research and development spending. Revenue from sales of four drugs (ponatinib, ibrutinib, enzalutamide, and eculizumab) was more than 10-fold higher than research and development spending.
The analysis offers a transparent estimate of research and development spending on cancer drugs, the study authors said, and has implications for the current debate on drug pricing. They noted that prior estimates for the cost to develop one new drug range from $320 million to $2.7 billion, markedly lower than the study’s $648 million finding.
“In a short period, development cost is more than recouped, and some companies boast more than a 10-fold higher revenue than [research and development] spending – a sum not seen in other sectors of the economy,” the researchers explained. “Future work regarding the cost of cancer drugs may be facilitated by more, not less, transparency in the biopharmaceutical industry.”
Regarding their work, the authors noted that the data set is small, the filings studied are subject to strict guidelines and regulation, the analysis pertains only to cancer drugs, and potential tax breaks applied to research and development costs for drug companies are not accounted for.
Dr. Mailankody reported serving as a principal investigator for clinical trials with research funding from Juno Therapeutics and Takeda Oncology. He also reported receiving personal fees for speaking at the Wedbush Pacgrow Healthcare Conference 2016. No other disclosures were reported.
[email protected]
On Twitter @legal_med
To counter increasing public alarm over high drug prices, industry leaders regularly assert that the substantial investment in researching and developing new products, and the riskiness of that enterprise, justify charging Americans the highest prices in the world for medicines.
To support the assertion, the industry’s trade group relies on an industry-funded study first produced in 1979 by the Tufts University Center for the Study of Drug Development. The most recent iteration of the study, updated in 2014, claims it takes more than 10 years and nearly $2.7 billion in capital to develop a single drug. In inflation-adjusted dollars, the study’s estimate for developing a new drug has more than doubled in the past decade and is more than 10 times the original 1979 figure.
In this issue of JAMA Internal Medicine, study authors Vinay Prasad, MD, MPH, and Sham Mailankody, MBBS, report that the actual cost of developing a new drug is approximately one-fourth the Tufts study estimate. The implications of the present study seem clear. Current pharmaceutical industry pricing policies are unrelated to the cost of research and development. Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation.
Merrill Goozner is editor emeritus for Modern Healthcare in Chicago. He is also author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs.” He made these remarks in an invited commentary accompanying the study (JAMA Intern Med. 2017 Sep 11 doi: 10.1001/jamainternmed.2017.4997).
To counter increasing public alarm over high drug prices, industry leaders regularly assert that the substantial investment in researching and developing new products, and the riskiness of that enterprise, justify charging Americans the highest prices in the world for medicines.
To support the assertion, the industry’s trade group relies on an industry-funded study first produced in 1979 by the Tufts University Center for the Study of Drug Development. The most recent iteration of the study, updated in 2014, claims it takes more than 10 years and nearly $2.7 billion in capital to develop a single drug. In inflation-adjusted dollars, the study’s estimate for developing a new drug has more than doubled in the past decade and is more than 10 times the original 1979 figure.
In this issue of JAMA Internal Medicine, study authors Vinay Prasad, MD, MPH, and Sham Mailankody, MBBS, report that the actual cost of developing a new drug is approximately one-fourth the Tufts study estimate. The implications of the present study seem clear. Current pharmaceutical industry pricing policies are unrelated to the cost of research and development. Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation.
Merrill Goozner is editor emeritus for Modern Healthcare in Chicago. He is also author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs.” He made these remarks in an invited commentary accompanying the study (JAMA Intern Med. 2017 Sep 11 doi: 10.1001/jamainternmed.2017.4997).
To counter increasing public alarm over high drug prices, industry leaders regularly assert that the substantial investment in researching and developing new products, and the riskiness of that enterprise, justify charging Americans the highest prices in the world for medicines.
To support the assertion, the industry’s trade group relies on an industry-funded study first produced in 1979 by the Tufts University Center for the Study of Drug Development. The most recent iteration of the study, updated in 2014, claims it takes more than 10 years and nearly $2.7 billion in capital to develop a single drug. In inflation-adjusted dollars, the study’s estimate for developing a new drug has more than doubled in the past decade and is more than 10 times the original 1979 figure.
In this issue of JAMA Internal Medicine, study authors Vinay Prasad, MD, MPH, and Sham Mailankody, MBBS, report that the actual cost of developing a new drug is approximately one-fourth the Tufts study estimate. The implications of the present study seem clear. Current pharmaceutical industry pricing policies are unrelated to the cost of research and development. Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation.
Merrill Goozner is editor emeritus for Modern Healthcare in Chicago. He is also author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs.” He made these remarks in an invited commentary accompanying the study (JAMA Intern Med. 2017 Sep 11 doi: 10.1001/jamainternmed.2017.4997).
Research and development costs for cancer drugs are far lower than previous estimates, according to a new analysis, casting doubt on the common justifications by drug companies for the high prices of such medications.
The median cost to develop a cancer drug was $648 million, compared with the widely publicized figure of $2.7 billion, the study’s researchers said.
Lead investigator Vinay Prasad, MD, of Oregon Health and Science University in Portland, and Sham Mailankody, MBBS, of Memorial Sloan Kettering Cancer Center in New York, studied U.S. Securities and Exchange Commission filings for drug companies with no drugs on the market that received Food and Drug Administration approval for a cancer drug from Jan. 1, 2006, through Dec. 31, 2015. Researchers estimated cumulative research and development spending from initiation of drug development activity to date of approval. Earnings were identified from the time of approval to the present. Ten drugs and companies were included in the analysis.
Investigators found that the median time to develop a drug was 7.3 years. Five companies (50%) developed drugs that received accelerated approval from the FDA, and five drugs (50%) received regular approval. Five of the 10 drugs (50%) act on a novel target (ibrutinib, brentuximab vedotin, ruxolitinib, cabozantinib, and eculizumab), whereas the other five drugs (50%) are next-in-class drugs with a mechanism of action similar to that of a previously approved drug.
Results showed the median cost of developing a single drug in 2017 U.S. dollars was $648 million (range, $157.3 million to $1.95 billion), and the mean development cost was $719.8 million (JAMA Intern Med. 2017 Sep 11 doi: 10.1001/jamainternmed.2017.3601).
Drugs that received accelerated approval cost less to develop than did those that received regular approval, although that finding was not statistically significant, according to the study. From the time of approval to December 2016 – or until the company sold or licensed the compound to another company – the total revenue of the 10 drugs was $67 billion. The median revenue for these companies was $1.66 billion (range, $204.1 million to $22.3 billion), and the average revenue was $6.7 billion. Nine of the 10 drugs had revenues greater than their research and development spending. Revenue from sales of four drugs (ponatinib, ibrutinib, enzalutamide, and eculizumab) was more than 10-fold higher than research and development spending.
The analysis offers a transparent estimate of research and development spending on cancer drugs, the study authors said, and has implications for the current debate on drug pricing. They noted that prior estimates for the cost to develop one new drug range from $320 million to $2.7 billion, markedly lower than the study’s $648 million finding.
“In a short period, development cost is more than recouped, and some companies boast more than a 10-fold higher revenue than [research and development] spending – a sum not seen in other sectors of the economy,” the researchers explained. “Future work regarding the cost of cancer drugs may be facilitated by more, not less, transparency in the biopharmaceutical industry.”
Regarding their work, the authors noted that the data set is small, the filings studied are subject to strict guidelines and regulation, the analysis pertains only to cancer drugs, and potential tax breaks applied to research and development costs for drug companies are not accounted for.
Dr. Mailankody reported serving as a principal investigator for clinical trials with research funding from Juno Therapeutics and Takeda Oncology. He also reported receiving personal fees for speaking at the Wedbush Pacgrow Healthcare Conference 2016. No other disclosures were reported.
[email protected]
On Twitter @legal_med
Research and development costs for cancer drugs are far lower than previous estimates, according to a new analysis, casting doubt on the common justifications by drug companies for the high prices of such medications.
The median cost to develop a cancer drug was $648 million, compared with the widely publicized figure of $2.7 billion, the study’s researchers said.
Lead investigator Vinay Prasad, MD, of Oregon Health and Science University in Portland, and Sham Mailankody, MBBS, of Memorial Sloan Kettering Cancer Center in New York, studied U.S. Securities and Exchange Commission filings for drug companies with no drugs on the market that received Food and Drug Administration approval for a cancer drug from Jan. 1, 2006, through Dec. 31, 2015. Researchers estimated cumulative research and development spending from initiation of drug development activity to date of approval. Earnings were identified from the time of approval to the present. Ten drugs and companies were included in the analysis.
Investigators found that the median time to develop a drug was 7.3 years. Five companies (50%) developed drugs that received accelerated approval from the FDA, and five drugs (50%) received regular approval. Five of the 10 drugs (50%) act on a novel target (ibrutinib, brentuximab vedotin, ruxolitinib, cabozantinib, and eculizumab), whereas the other five drugs (50%) are next-in-class drugs with a mechanism of action similar to that of a previously approved drug.
Results showed the median cost of developing a single drug in 2017 U.S. dollars was $648 million (range, $157.3 million to $1.95 billion), and the mean development cost was $719.8 million (JAMA Intern Med. 2017 Sep 11 doi: 10.1001/jamainternmed.2017.3601).
Drugs that received accelerated approval cost less to develop than did those that received regular approval, although that finding was not statistically significant, according to the study. From the time of approval to December 2016 – or until the company sold or licensed the compound to another company – the total revenue of the 10 drugs was $67 billion. The median revenue for these companies was $1.66 billion (range, $204.1 million to $22.3 billion), and the average revenue was $6.7 billion. Nine of the 10 drugs had revenues greater than their research and development spending. Revenue from sales of four drugs (ponatinib, ibrutinib, enzalutamide, and eculizumab) was more than 10-fold higher than research and development spending.
The analysis offers a transparent estimate of research and development spending on cancer drugs, the study authors said, and has implications for the current debate on drug pricing. They noted that prior estimates for the cost to develop one new drug range from $320 million to $2.7 billion, markedly lower than the study’s $648 million finding.
“In a short period, development cost is more than recouped, and some companies boast more than a 10-fold higher revenue than [research and development] spending – a sum not seen in other sectors of the economy,” the researchers explained. “Future work regarding the cost of cancer drugs may be facilitated by more, not less, transparency in the biopharmaceutical industry.”
Regarding their work, the authors noted that the data set is small, the filings studied are subject to strict guidelines and regulation, the analysis pertains only to cancer drugs, and potential tax breaks applied to research and development costs for drug companies are not accounted for.
Dr. Mailankody reported serving as a principal investigator for clinical trials with research funding from Juno Therapeutics and Takeda Oncology. He also reported receiving personal fees for speaking at the Wedbush Pacgrow Healthcare Conference 2016. No other disclosures were reported.
[email protected]
On Twitter @legal_med
FROM JAMA INTERNAL MEDICINE
Key clinical point:
Major finding: The median cost to develop a cancer drug was $648 million, compared with the widely publicized figure of $2.7 billion.
Data source: A case study of U.S. Securities and Exchange Commission filings for drug companies that received approval by the Food and Drug Administration for a cancer drug from Jan. 1, 2006, through Dec. 31, 2015.
Disclosures: Dr. Mailankody reported serving as principal investigator for clinical trials with research funding from Juno Therapeutics and Takeda Oncology. He also reported receiving personal fees for speaking at the Wedbush PacGrow Healthcare Conference 2016. No other disclosures were reported.
WHI hormone trials offer reassurance on long-term mortality risk
Postmenopausal women treated with conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) for a median of 5.6 years, or with CEE alone for a median of 7.2 years had no increased risk of all-cause, cardiovascular, or cancer mortality over a cumulative follow-up of 18 years, according to the latest report from the Women’s Health Initiative hormone therapy trials.
All-cause mortality among the 27,347 participants in the two randomized, double-blind, placebo-controlled trials was 27.1% in the hormone therapy group versus 27.6% in the placebo group (hazard ratio, 0.99), JoAnn E. Manson, MD, Harvard Medical School, Boston, and her colleagues reported.
For those who received CEE plus MPA, the hazard ratio was 1.02, while for CEE alone the hazard ratio was 0.94 (JAMA. 2017 Sep;318[10]:927-38).
Cardiovascular mortality among the pooled cohort was 8.9% with hormone therapy and 9.0% with placebo (HR, 1.00), and total cancer mortality was 8.2% and 8.0%, respectively (HR, 1.03). Mortality from other causes was 10.0% with hormone therapy, compared with 10.7% with placebo (HR, 0.95). The results did not differ significantly between the trials, the investigators noted.
An analysis by age showed that women aged 50-59 years tended to have lower hazard ratios for mortality from cardiovascular disease, cancer, and other causes during the intervention phases of the trials, but only the difference for “other” causes in the CEE-alone trial showed a statistically significant trend with age. This was influenced in part by adverse effects of the treatment in women aged 70-79 years. During cumulative follow-up, trends related to mortality across age groups were not statistically significantly different.
The trials included women aged 50-79 years who were enrolled between 1993 and 1998 and followed through 2014. Given the hormone-therapy-related risks identified in the CEE plus MPA and CEE-alone trials – which were stopped early because of increased risk of breast cancer/overall risks exceeding benefits, and for increased stroke risk, respectively – the absence of an increase in all-cause mortality during the intervention and cumulative follow-up phases of the trials is noteworthy, the investigators wrote.
“Although these findings lend support to practice guidelines endorsing use of hormone therapy for recently menopausal women with moderate to severe symptoms, in the absence of contraindications, the attenuation of age differences with longer follow-up and potential health risks of treatment would not support use of hormone therapy for reducing chronic disease or mortality,” they wrote. “Moreover, it is unclear whether benefits would outweigh risks with longer duration of treatment.”
They added that “in clinical decision making, these considerations must be weighed against the evidence linking untreated vasomotor symptoms in midlife women to impaired health and quality of life, disrupted sleep, reduced work productivity, and increased health care expenditures.”
The Women’s Health Initiative is funded by the U.S. Department of Health & Human Services. Study drugs were donated by Wyeth Ayerst. Dr. Manson reported having no financial disclosures. Several of her coauthors reported receiving grants and research funding from the National Institutes of Health, and receiving personal fees, speaking fees, and honoraria from various pharmaceutical companies.
The findings from the Women’s Health Initiative hormone therapy trials as reported by Dr. Manson and her colleagues expand the understanding of the long-term risks and benefits of hormone therapy, which is an important issue for women around the world, Melissa A. McNeil, MD, wrote in an editorial.
The information will be helpful for counseling women considering whether to start hormone therapy, and “hopefully will alleviate concerns that many patients and physicians have about the initiation of hormone therapy,” she said, explaining that the effect of hormone therapy on cancer mortality, and especially on breast cancer mortality, has generated concern and reluctance to prescribe and take hormone therapy for troubling menopausal symptoms.
“The current report ... provides substantial reassurance for patients and physicians about this issue,” she said. “For women with troubling vasomotor symptoms, premature menopause, or early-onset osteoporosis, hormone therapy appears to be both safe and efficacious.”
While several questions remain, including about optimal duration of therapy, whether there is a difference in mortality by age and menopausal status at hormone therapy initiation, and if earlier initiation would provide additional benefits, the data “fully support the newly released 2017 hormone therapy position statement of the North American Menopause Society and are a welcome addition to current knowledge regarding hormone therapy administration,” she wrote.
Dr. McNeil is with the University of Pittsburgh. She reported having no financial disclosures. Her comments come from an accompanying editorial (JAMA. 2017 Sep;318[10]:911-13).
The findings from the Women’s Health Initiative hormone therapy trials as reported by Dr. Manson and her colleagues expand the understanding of the long-term risks and benefits of hormone therapy, which is an important issue for women around the world, Melissa A. McNeil, MD, wrote in an editorial.
The information will be helpful for counseling women considering whether to start hormone therapy, and “hopefully will alleviate concerns that many patients and physicians have about the initiation of hormone therapy,” she said, explaining that the effect of hormone therapy on cancer mortality, and especially on breast cancer mortality, has generated concern and reluctance to prescribe and take hormone therapy for troubling menopausal symptoms.
“The current report ... provides substantial reassurance for patients and physicians about this issue,” she said. “For women with troubling vasomotor symptoms, premature menopause, or early-onset osteoporosis, hormone therapy appears to be both safe and efficacious.”
While several questions remain, including about optimal duration of therapy, whether there is a difference in mortality by age and menopausal status at hormone therapy initiation, and if earlier initiation would provide additional benefits, the data “fully support the newly released 2017 hormone therapy position statement of the North American Menopause Society and are a welcome addition to current knowledge regarding hormone therapy administration,” she wrote.
Dr. McNeil is with the University of Pittsburgh. She reported having no financial disclosures. Her comments come from an accompanying editorial (JAMA. 2017 Sep;318[10]:911-13).
The findings from the Women’s Health Initiative hormone therapy trials as reported by Dr. Manson and her colleagues expand the understanding of the long-term risks and benefits of hormone therapy, which is an important issue for women around the world, Melissa A. McNeil, MD, wrote in an editorial.
The information will be helpful for counseling women considering whether to start hormone therapy, and “hopefully will alleviate concerns that many patients and physicians have about the initiation of hormone therapy,” she said, explaining that the effect of hormone therapy on cancer mortality, and especially on breast cancer mortality, has generated concern and reluctance to prescribe and take hormone therapy for troubling menopausal symptoms.
“The current report ... provides substantial reassurance for patients and physicians about this issue,” she said. “For women with troubling vasomotor symptoms, premature menopause, or early-onset osteoporosis, hormone therapy appears to be both safe and efficacious.”
While several questions remain, including about optimal duration of therapy, whether there is a difference in mortality by age and menopausal status at hormone therapy initiation, and if earlier initiation would provide additional benefits, the data “fully support the newly released 2017 hormone therapy position statement of the North American Menopause Society and are a welcome addition to current knowledge regarding hormone therapy administration,” she wrote.
Dr. McNeil is with the University of Pittsburgh. She reported having no financial disclosures. Her comments come from an accompanying editorial (JAMA. 2017 Sep;318[10]:911-13).
Postmenopausal women treated with conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) for a median of 5.6 years, or with CEE alone for a median of 7.2 years had no increased risk of all-cause, cardiovascular, or cancer mortality over a cumulative follow-up of 18 years, according to the latest report from the Women’s Health Initiative hormone therapy trials.
All-cause mortality among the 27,347 participants in the two randomized, double-blind, placebo-controlled trials was 27.1% in the hormone therapy group versus 27.6% in the placebo group (hazard ratio, 0.99), JoAnn E. Manson, MD, Harvard Medical School, Boston, and her colleagues reported.
For those who received CEE plus MPA, the hazard ratio was 1.02, while for CEE alone the hazard ratio was 0.94 (JAMA. 2017 Sep;318[10]:927-38).
Cardiovascular mortality among the pooled cohort was 8.9% with hormone therapy and 9.0% with placebo (HR, 1.00), and total cancer mortality was 8.2% and 8.0%, respectively (HR, 1.03). Mortality from other causes was 10.0% with hormone therapy, compared with 10.7% with placebo (HR, 0.95). The results did not differ significantly between the trials, the investigators noted.
An analysis by age showed that women aged 50-59 years tended to have lower hazard ratios for mortality from cardiovascular disease, cancer, and other causes during the intervention phases of the trials, but only the difference for “other” causes in the CEE-alone trial showed a statistically significant trend with age. This was influenced in part by adverse effects of the treatment in women aged 70-79 years. During cumulative follow-up, trends related to mortality across age groups were not statistically significantly different.
The trials included women aged 50-79 years who were enrolled between 1993 and 1998 and followed through 2014. Given the hormone-therapy-related risks identified in the CEE plus MPA and CEE-alone trials – which were stopped early because of increased risk of breast cancer/overall risks exceeding benefits, and for increased stroke risk, respectively – the absence of an increase in all-cause mortality during the intervention and cumulative follow-up phases of the trials is noteworthy, the investigators wrote.
“Although these findings lend support to practice guidelines endorsing use of hormone therapy for recently menopausal women with moderate to severe symptoms, in the absence of contraindications, the attenuation of age differences with longer follow-up and potential health risks of treatment would not support use of hormone therapy for reducing chronic disease or mortality,” they wrote. “Moreover, it is unclear whether benefits would outweigh risks with longer duration of treatment.”
They added that “in clinical decision making, these considerations must be weighed against the evidence linking untreated vasomotor symptoms in midlife women to impaired health and quality of life, disrupted sleep, reduced work productivity, and increased health care expenditures.”
The Women’s Health Initiative is funded by the U.S. Department of Health & Human Services. Study drugs were donated by Wyeth Ayerst. Dr. Manson reported having no financial disclosures. Several of her coauthors reported receiving grants and research funding from the National Institutes of Health, and receiving personal fees, speaking fees, and honoraria from various pharmaceutical companies.
Postmenopausal women treated with conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) for a median of 5.6 years, or with CEE alone for a median of 7.2 years had no increased risk of all-cause, cardiovascular, or cancer mortality over a cumulative follow-up of 18 years, according to the latest report from the Women’s Health Initiative hormone therapy trials.
All-cause mortality among the 27,347 participants in the two randomized, double-blind, placebo-controlled trials was 27.1% in the hormone therapy group versus 27.6% in the placebo group (hazard ratio, 0.99), JoAnn E. Manson, MD, Harvard Medical School, Boston, and her colleagues reported.
For those who received CEE plus MPA, the hazard ratio was 1.02, while for CEE alone the hazard ratio was 0.94 (JAMA. 2017 Sep;318[10]:927-38).
Cardiovascular mortality among the pooled cohort was 8.9% with hormone therapy and 9.0% with placebo (HR, 1.00), and total cancer mortality was 8.2% and 8.0%, respectively (HR, 1.03). Mortality from other causes was 10.0% with hormone therapy, compared with 10.7% with placebo (HR, 0.95). The results did not differ significantly between the trials, the investigators noted.
An analysis by age showed that women aged 50-59 years tended to have lower hazard ratios for mortality from cardiovascular disease, cancer, and other causes during the intervention phases of the trials, but only the difference for “other” causes in the CEE-alone trial showed a statistically significant trend with age. This was influenced in part by adverse effects of the treatment in women aged 70-79 years. During cumulative follow-up, trends related to mortality across age groups were not statistically significantly different.
The trials included women aged 50-79 years who were enrolled between 1993 and 1998 and followed through 2014. Given the hormone-therapy-related risks identified in the CEE plus MPA and CEE-alone trials – which were stopped early because of increased risk of breast cancer/overall risks exceeding benefits, and for increased stroke risk, respectively – the absence of an increase in all-cause mortality during the intervention and cumulative follow-up phases of the trials is noteworthy, the investigators wrote.
“Although these findings lend support to practice guidelines endorsing use of hormone therapy for recently menopausal women with moderate to severe symptoms, in the absence of contraindications, the attenuation of age differences with longer follow-up and potential health risks of treatment would not support use of hormone therapy for reducing chronic disease or mortality,” they wrote. “Moreover, it is unclear whether benefits would outweigh risks with longer duration of treatment.”
They added that “in clinical decision making, these considerations must be weighed against the evidence linking untreated vasomotor symptoms in midlife women to impaired health and quality of life, disrupted sleep, reduced work productivity, and increased health care expenditures.”
The Women’s Health Initiative is funded by the U.S. Department of Health & Human Services. Study drugs were donated by Wyeth Ayerst. Dr. Manson reported having no financial disclosures. Several of her coauthors reported receiving grants and research funding from the National Institutes of Health, and receiving personal fees, speaking fees, and honoraria from various pharmaceutical companies.
FROM JAMA
Key clinical point:
Major finding: All-cause mortality was 27.1% in the hormone therapy group versus 27.6% in the placebo group (hazard ratio, 0.99).
Data source: The randomized, double-blind, placebo-controlled Women’s Health Initiative hormone therapy trials of 27,347 women.
Disclosures: The Women’s Health Initiative is funded by the U.S. Department of Health & Human Services. Study drugs were donated by Wyeth Ayerst. Dr. Manson reported having no disclosures. Several of her coauthors reported receiving grants and research funding from the National Institutes of Health, and receiving personal fees, speaking fees, and honoraria from various pharmaceutical companies.
Blood Test Accurately Detects GLUT1 Deficiency Syndrome
A blood test can detect glucose transporter type 1 (GLUT1) deficiency syndrome accurately and rapidly, according to a brief communication published in the July issue of Annals of Neurology. The new test has a diagnostic rate comparable to that of CSF glucose and may be more cost-effective than the combination of lumbar puncture and genetic testing, according to the researchers.
To confirm the diagnosis in a patient whose phenotype suggests GLUT1 deficiency syndrome, neurologists traditionally measure CSF glucose concentration and perform SLC2A1 molecular analysis. Lumbar puncture requires fasting and may entail complications, however, and analysis of the coding regions of SLC2A1 can be tedious and may fail to identify variants.
Analysis of Red Blood Cells
Domitille Gras, MD, a neurologist at Robert-Debré University Hospital in Paris, and colleagues tested a novel diagnostic method based on flow cytometry analysis of red blood cells. For their proof-of-concept study, the researchers enrolled 30 patients (13 females) between ages 2 and 50 with GLUT1 deficiency syndrome. They also enrolled 18 patients (six females) with paroxysmal movement disorders attributed to genetic defects other than in SLC2A1. Finally, the investigators examined 346 healthy controls.
For all participants, Dr. Gras and colleagues measured CSF glucose concentration, performed SLC2A1 molecular analysis, and used flow cytometry to analyze GLUT1 surface expression on circulating red blood cells. To perform the latter method, researchers who were blinded to patients’ disease condition collected at least 0.5 mL of nonfasted venous blood from each participant. Results were available within 24 hours.
Age Did Not Affect Test Results
GLUT1 expression on red blood cells varied by 15% among healthy controls. The blood test identified 23 (78%) of the patients with GLUT1 deficiency syndrome who had a decrease in GLUT1 expression of at least 20%. Dr. Gras and colleagues saw no overlap between the test results of patients and those of controls. The new test detected three patients with GLUT1 deficiency syndrome who had a CSF glucose concentration greater than 2.2 mM, which is the most commonly used cutoff. Two patients with a presentation suggestive of GLUT1 deficiency syndrome and low CSF glucose and lactate, but no SLC2A1 mutation, had an abnormal blood test.
The blood test detected GLUT1 deficiency syndrome regardless of the patient’s age and disease severity. Patients not detected by the test may have mutations that mildly affect glucose uptake, but not GLUT1 expression, or may have a GLUT1 deficiency restricted to the brain. Most patients were analyzed at least twice, and blood test results were consistent for each patient.
Measuring GLUT1 at the surface of red blood cells could avoid diagnostic delays that currently are considerable, said Dr. Gras and colleagues. “Although more studies are required to establish the diagnostic gain of the red blood cell test on a larger cohort, such a simple diagnostic test, readily available in clinical practice, ought to greatly enlarge the screening of GLUT1 deficiency syndrome in any patient, child, or adult presenting with cognitive impairment, epilepsy, ataxia and/or dystonia, or paroxysmal movement disorder,” they concluded.
—Erik Greb
Suggested Reading
Gras D, Cousin C, Kappeler C, et al. A simple blood test expedites the diagnosis of glucose transporter type 1 deficiency syndrome. Ann Neurol. 2017;82(1):133-138.
A blood test can detect glucose transporter type 1 (GLUT1) deficiency syndrome accurately and rapidly, according to a brief communication published in the July issue of Annals of Neurology. The new test has a diagnostic rate comparable to that of CSF glucose and may be more cost-effective than the combination of lumbar puncture and genetic testing, according to the researchers.
To confirm the diagnosis in a patient whose phenotype suggests GLUT1 deficiency syndrome, neurologists traditionally measure CSF glucose concentration and perform SLC2A1 molecular analysis. Lumbar puncture requires fasting and may entail complications, however, and analysis of the coding regions of SLC2A1 can be tedious and may fail to identify variants.
Analysis of Red Blood Cells
Domitille Gras, MD, a neurologist at Robert-Debré University Hospital in Paris, and colleagues tested a novel diagnostic method based on flow cytometry analysis of red blood cells. For their proof-of-concept study, the researchers enrolled 30 patients (13 females) between ages 2 and 50 with GLUT1 deficiency syndrome. They also enrolled 18 patients (six females) with paroxysmal movement disorders attributed to genetic defects other than in SLC2A1. Finally, the investigators examined 346 healthy controls.
For all participants, Dr. Gras and colleagues measured CSF glucose concentration, performed SLC2A1 molecular analysis, and used flow cytometry to analyze GLUT1 surface expression on circulating red blood cells. To perform the latter method, researchers who were blinded to patients’ disease condition collected at least 0.5 mL of nonfasted venous blood from each participant. Results were available within 24 hours.
Age Did Not Affect Test Results
GLUT1 expression on red blood cells varied by 15% among healthy controls. The blood test identified 23 (78%) of the patients with GLUT1 deficiency syndrome who had a decrease in GLUT1 expression of at least 20%. Dr. Gras and colleagues saw no overlap between the test results of patients and those of controls. The new test detected three patients with GLUT1 deficiency syndrome who had a CSF glucose concentration greater than 2.2 mM, which is the most commonly used cutoff. Two patients with a presentation suggestive of GLUT1 deficiency syndrome and low CSF glucose and lactate, but no SLC2A1 mutation, had an abnormal blood test.
The blood test detected GLUT1 deficiency syndrome regardless of the patient’s age and disease severity. Patients not detected by the test may have mutations that mildly affect glucose uptake, but not GLUT1 expression, or may have a GLUT1 deficiency restricted to the brain. Most patients were analyzed at least twice, and blood test results were consistent for each patient.
Measuring GLUT1 at the surface of red blood cells could avoid diagnostic delays that currently are considerable, said Dr. Gras and colleagues. “Although more studies are required to establish the diagnostic gain of the red blood cell test on a larger cohort, such a simple diagnostic test, readily available in clinical practice, ought to greatly enlarge the screening of GLUT1 deficiency syndrome in any patient, child, or adult presenting with cognitive impairment, epilepsy, ataxia and/or dystonia, or paroxysmal movement disorder,” they concluded.
—Erik Greb
Suggested Reading
Gras D, Cousin C, Kappeler C, et al. A simple blood test expedites the diagnosis of glucose transporter type 1 deficiency syndrome. Ann Neurol. 2017;82(1):133-138.
A blood test can detect glucose transporter type 1 (GLUT1) deficiency syndrome accurately and rapidly, according to a brief communication published in the July issue of Annals of Neurology. The new test has a diagnostic rate comparable to that of CSF glucose and may be more cost-effective than the combination of lumbar puncture and genetic testing, according to the researchers.
To confirm the diagnosis in a patient whose phenotype suggests GLUT1 deficiency syndrome, neurologists traditionally measure CSF glucose concentration and perform SLC2A1 molecular analysis. Lumbar puncture requires fasting and may entail complications, however, and analysis of the coding regions of SLC2A1 can be tedious and may fail to identify variants.
Analysis of Red Blood Cells
Domitille Gras, MD, a neurologist at Robert-Debré University Hospital in Paris, and colleagues tested a novel diagnostic method based on flow cytometry analysis of red blood cells. For their proof-of-concept study, the researchers enrolled 30 patients (13 females) between ages 2 and 50 with GLUT1 deficiency syndrome. They also enrolled 18 patients (six females) with paroxysmal movement disorders attributed to genetic defects other than in SLC2A1. Finally, the investigators examined 346 healthy controls.
For all participants, Dr. Gras and colleagues measured CSF glucose concentration, performed SLC2A1 molecular analysis, and used flow cytometry to analyze GLUT1 surface expression on circulating red blood cells. To perform the latter method, researchers who were blinded to patients’ disease condition collected at least 0.5 mL of nonfasted venous blood from each participant. Results were available within 24 hours.
Age Did Not Affect Test Results
GLUT1 expression on red blood cells varied by 15% among healthy controls. The blood test identified 23 (78%) of the patients with GLUT1 deficiency syndrome who had a decrease in GLUT1 expression of at least 20%. Dr. Gras and colleagues saw no overlap between the test results of patients and those of controls. The new test detected three patients with GLUT1 deficiency syndrome who had a CSF glucose concentration greater than 2.2 mM, which is the most commonly used cutoff. Two patients with a presentation suggestive of GLUT1 deficiency syndrome and low CSF glucose and lactate, but no SLC2A1 mutation, had an abnormal blood test.
The blood test detected GLUT1 deficiency syndrome regardless of the patient’s age and disease severity. Patients not detected by the test may have mutations that mildly affect glucose uptake, but not GLUT1 expression, or may have a GLUT1 deficiency restricted to the brain. Most patients were analyzed at least twice, and blood test results were consistent for each patient.
Measuring GLUT1 at the surface of red blood cells could avoid diagnostic delays that currently are considerable, said Dr. Gras and colleagues. “Although more studies are required to establish the diagnostic gain of the red blood cell test on a larger cohort, such a simple diagnostic test, readily available in clinical practice, ought to greatly enlarge the screening of GLUT1 deficiency syndrome in any patient, child, or adult presenting with cognitive impairment, epilepsy, ataxia and/or dystonia, or paroxysmal movement disorder,” they concluded.
—Erik Greb
Suggested Reading
Gras D, Cousin C, Kappeler C, et al. A simple blood test expedites the diagnosis of glucose transporter type 1 deficiency syndrome. Ann Neurol. 2017;82(1):133-138.
FDA advisory committee rejects opioids in children’s cough syrup
ROCKVILLE, MD – The majority of
The voting was broken into multiple votes based on age range of patients and the specific opioid present in the cough syrup. Unlike other advisory committee meetings, this meeting did not focus on a the treatment of a disease state, but rather on the treatment of a symptom.
On Sept. 11, 2017, the FDA’s Pediatric Advisory Committee voted 21 no, 2 yes, with one abstention, that the benefit versus the risk of opioid cough suppressants for pediatric patients was not favorable.
This vote was preceded by two previous votes specifically questioning the use of codeine and hydrocodone in medications for pediatric patients. For codeine, the committee voted unanimously with 24 against that the benefit versus risk was not favorable in pediatric patients aged 12 years to less than 18 years. 
For hydrocodone, the committee asked two questions: 1) Was the benefit versus risk favorable for pediatric patients aged 6 years to less than 12 years? and 2) Was the benefit versus risk favorable for pediatric patients aged 12 years to less than 18 years? On the vote for patients aged 6 years to less than 12 years, the committee voted 23 no, 1 yes with no abstention. For the patients aged 12 years to less than 18, the committee voted 23 no, 1 yes, with no abstention.
According to Sharon Levy, MD, MPH, adolescents are the most at-risk population for opioid misuse. This susceptibility is due to the developmental neurobiology of adolescent brains. A region of the brain associated with the reward pathway, nucleus accumbens, is developing in adolescents and plays a role in salience. Salience, or the differentiation between important vs. unimportant rewards, varies widely by age group. Young children show little salience with rewards, and treat rewards equivocally. Adults have a proportional response to rewards with accurate salience. Adolescents, on the other hand, are unhappy with small rewards, but receive a massive return with large rewards. This type of neurobiological feedback makes adolescents “vulnerable to develop substance use disorders.”
Dr. Levy also noted a correlation between prescribed opioid use and alcohol, marijuana, and tobacco use as contributing factors to opioid misuse. When opioids are prescribed for pain management, there is an adjusted odds ratio (AOR) of 1.33, indicating a high likelihood of misuse. Similar AORs are seen in adolescents who have used marijuana, cigarettes, and alcohol: 2.44, 1.25, and 1.23, respectively.
Sovereign pharmaceuticals representative Leonard Lawrence presented the findings of a pharmacokinetic study for hydrocodone and guaifenesin in 25-35 pediatric patients evenly divided into groups aged 6 years to less than 12 years, and 12 years to less than 18 years. According to Mr. Lawrence, codeine appears “to be a greater risk in children younger than 12 years, and should not be used” because of difficulty breathing. Mr Lawrence went on to say that these effects were exacerbated in obese children with lung disease or obstructive sleep apnea.
Victor S. Sloan, MD, of UCB in Brussels, presented an internal review of Tussionex, a combination cough medicine (hydrocodone/chlorpheniramine). This review took into account modern pharmacovigilance methods, changes in clinical practice, and a literature review. “Upon annual review, UCB determined that benefit risk balance for use of Tussionex for cough in children was no longer favorable,” said Dr. Sloan. Based on the results of the review, UCB has filed a label supplement to limit use of Tussionex to patients aged 18 years or older.
“Codeine, in particular, is an antiquated drug,” said Kathleen Neville, MD, pediatrics and clinical pharmacology section chief of Arkansas Children’s Hospital, Little Rock. Many of the committee members echoed Dr. Neville’s opinion.
The committee members had no relevant financial disclosures.
[email protected]
On Twitter @ilacy_19
ROCKVILLE, MD – The majority of
The voting was broken into multiple votes based on age range of patients and the specific opioid present in the cough syrup. Unlike other advisory committee meetings, this meeting did not focus on a the treatment of a disease state, but rather on the treatment of a symptom.
On Sept. 11, 2017, the FDA’s Pediatric Advisory Committee voted 21 no, 2 yes, with one abstention, that the benefit versus the risk of opioid cough suppressants for pediatric patients was not favorable.
This vote was preceded by two previous votes specifically questioning the use of codeine and hydrocodone in medications for pediatric patients. For codeine, the committee voted unanimously with 24 against that the benefit versus risk was not favorable in pediatric patients aged 12 years to less than 18 years.
For hydrocodone, the committee asked two questions: 1) Was the benefit versus risk favorable for pediatric patients aged 6 years to less than 12 years? and 2) Was the benefit versus risk favorable for pediatric patients aged 12 years to less than 18 years? On the vote for patients aged 6 years to less than 12 years, the committee voted 23 no, 1 yes with no abstention. For the patients aged 12 years to less than 18, the committee voted 23 no, 1 yes, with no abstention.
According to Sharon Levy, MD, MPH, adolescents are the most at-risk population for opioid misuse. This susceptibility is due to the developmental neurobiology of adolescent brains. A region of the brain associated with the reward pathway, nucleus accumbens, is developing in adolescents and plays a role in salience. Salience, or the differentiation between important vs. unimportant rewards, varies widely by age group. Young children show little salience with rewards, and treat rewards equivocally. Adults have a proportional response to rewards with accurate salience. Adolescents, on the other hand, are unhappy with small rewards, but receive a massive return with large rewards. This type of neurobiological feedback makes adolescents “vulnerable to develop substance use disorders.”
Dr. Levy also noted a correlation between prescribed opioid use and alcohol, marijuana, and tobacco use as contributing factors to opioid misuse. When opioids are prescribed for pain management, there is an adjusted odds ratio (AOR) of 1.33, indicating a high likelihood of misuse. Similar AORs are seen in adolescents who have used marijuana, cigarettes, and alcohol: 2.44, 1.25, and 1.23, respectively.
Sovereign pharmaceuticals representative Leonard Lawrence presented the findings of a pharmacokinetic study for hydrocodone and guaifenesin in 25-35 pediatric patients evenly divided into groups aged 6 years to less than 12 years, and 12 years to less than 18 years. According to Mr. Lawrence, codeine appears “to be a greater risk in children younger than 12 years, and should not be used” because of difficulty breathing. Mr Lawrence went on to say that these effects were exacerbated in obese children with lung disease or obstructive sleep apnea.
Victor S. Sloan, MD, of UCB in Brussels, presented an internal review of Tussionex, a combination cough medicine (hydrocodone/chlorpheniramine). This review took into account modern pharmacovigilance methods, changes in clinical practice, and a literature review. “Upon annual review, UCB determined that benefit risk balance for use of Tussionex for cough in children was no longer favorable,” said Dr. Sloan. Based on the results of the review, UCB has filed a label supplement to limit use of Tussionex to patients aged 18 years or older.
“Codeine, in particular, is an antiquated drug,” said Kathleen Neville, MD, pediatrics and clinical pharmacology section chief of Arkansas Children’s Hospital, Little Rock. Many of the committee members echoed Dr. Neville’s opinion.
The committee members had no relevant financial disclosures.
[email protected]
On Twitter @ilacy_19
ROCKVILLE, MD – The majority of
The voting was broken into multiple votes based on age range of patients and the specific opioid present in the cough syrup. Unlike other advisory committee meetings, this meeting did not focus on a the treatment of a disease state, but rather on the treatment of a symptom.
On Sept. 11, 2017, the FDA’s Pediatric Advisory Committee voted 21 no, 2 yes, with one abstention, that the benefit versus the risk of opioid cough suppressants for pediatric patients was not favorable.
This vote was preceded by two previous votes specifically questioning the use of codeine and hydrocodone in medications for pediatric patients. For codeine, the committee voted unanimously with 24 against that the benefit versus risk was not favorable in pediatric patients aged 12 years to less than 18 years.
For hydrocodone, the committee asked two questions: 1) Was the benefit versus risk favorable for pediatric patients aged 6 years to less than 12 years? and 2) Was the benefit versus risk favorable for pediatric patients aged 12 years to less than 18 years? On the vote for patients aged 6 years to less than 12 years, the committee voted 23 no, 1 yes with no abstention. For the patients aged 12 years to less than 18, the committee voted 23 no, 1 yes, with no abstention.
According to Sharon Levy, MD, MPH, adolescents are the most at-risk population for opioid misuse. This susceptibility is due to the developmental neurobiology of adolescent brains. A region of the brain associated with the reward pathway, nucleus accumbens, is developing in adolescents and plays a role in salience. Salience, or the differentiation between important vs. unimportant rewards, varies widely by age group. Young children show little salience with rewards, and treat rewards equivocally. Adults have a proportional response to rewards with accurate salience. Adolescents, on the other hand, are unhappy with small rewards, but receive a massive return with large rewards. This type of neurobiological feedback makes adolescents “vulnerable to develop substance use disorders.”
Dr. Levy also noted a correlation between prescribed opioid use and alcohol, marijuana, and tobacco use as contributing factors to opioid misuse. When opioids are prescribed for pain management, there is an adjusted odds ratio (AOR) of 1.33, indicating a high likelihood of misuse. Similar AORs are seen in adolescents who have used marijuana, cigarettes, and alcohol: 2.44, 1.25, and 1.23, respectively.
Sovereign pharmaceuticals representative Leonard Lawrence presented the findings of a pharmacokinetic study for hydrocodone and guaifenesin in 25-35 pediatric patients evenly divided into groups aged 6 years to less than 12 years, and 12 years to less than 18 years. According to Mr. Lawrence, codeine appears “to be a greater risk in children younger than 12 years, and should not be used” because of difficulty breathing. Mr Lawrence went on to say that these effects were exacerbated in obese children with lung disease or obstructive sleep apnea.
Victor S. Sloan, MD, of UCB in Brussels, presented an internal review of Tussionex, a combination cough medicine (hydrocodone/chlorpheniramine). This review took into account modern pharmacovigilance methods, changes in clinical practice, and a literature review. “Upon annual review, UCB determined that benefit risk balance for use of Tussionex for cough in children was no longer favorable,” said Dr. Sloan. Based on the results of the review, UCB has filed a label supplement to limit use of Tussionex to patients aged 18 years or older.
“Codeine, in particular, is an antiquated drug,” said Kathleen Neville, MD, pediatrics and clinical pharmacology section chief of Arkansas Children’s Hospital, Little Rock. Many of the committee members echoed Dr. Neville’s opinion.
The committee members had no relevant financial disclosures.
[email protected]
On Twitter @ilacy_19
AT AN FDA PEDIATRIC ADVISORY COMMITTEE MEETING
Ten-year outcomes support skipping axillary lymph node dissection with positive sentinel nodes
A follow-up to a study showing the noninferiority of sentinel lymph node dissection to axillary lymph node dissection for breast cancer in overall and disease-free survival at a median of 6.3 years found similar noninferiority in overall survival at 10 years.
Axillary lymph node dissection has a risk of complications including lymphedema, numbness, axillary web syndrome, and decreased upper-extremity range of motion. The American College of Surgeons Oncology Group Z0011 trial sought to determine if the procedure could be avoided without inferior survival outcomes.
Criticism of the study focused on the potential for later recurrence, particularly in patients with hormone receptor–positive breast cancer. All enrolled patients had one or two sentinel nodes with metastases. At randomization, 436 received sentinel lymph node dissection alone, and 420 received the additional axillary lymph node dissection. The patients were assessed every 6 months for the first 3 years, then annually.
After a median of 9.3 years, 110 of the patients had died of any cause – 51 in the sentinel lymph node dissection group and 59 in the axillary lymph node dissection group – a 10-year overall survival rate of 86.3% and 83.6%, respectively. This met the study’s primary endpoint of showing noninferior overall survival without the riskier procedure. In the study’s secondary endpoint, disease-free survival, there was not a significant difference either (80.2% vs. 78.2%).
“Axillary dissections are associated with considerable morbidity, and the results of this trial demonstrated that this morbidity can be avoided without decreasing cancer control. … These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes,” wrote Armando E. Guiliano, MD, of Cedars-Sinai Medical, Los Angeles and his coauthors (JAMA. 2017;318[10]:918-26. doi: 10.1001/jama.2017.11470).
A follow-up to a study showing the noninferiority of sentinel lymph node dissection to axillary lymph node dissection for breast cancer in overall and disease-free survival at a median of 6.3 years found similar noninferiority in overall survival at 10 years.
Axillary lymph node dissection has a risk of complications including lymphedema, numbness, axillary web syndrome, and decreased upper-extremity range of motion. The American College of Surgeons Oncology Group Z0011 trial sought to determine if the procedure could be avoided without inferior survival outcomes.
Criticism of the study focused on the potential for later recurrence, particularly in patients with hormone receptor–positive breast cancer. All enrolled patients had one or two sentinel nodes with metastases. At randomization, 436 received sentinel lymph node dissection alone, and 420 received the additional axillary lymph node dissection. The patients were assessed every 6 months for the first 3 years, then annually.
After a median of 9.3 years, 110 of the patients had died of any cause – 51 in the sentinel lymph node dissection group and 59 in the axillary lymph node dissection group – a 10-year overall survival rate of 86.3% and 83.6%, respectively. This met the study’s primary endpoint of showing noninferior overall survival without the riskier procedure. In the study’s secondary endpoint, disease-free survival, there was not a significant difference either (80.2% vs. 78.2%).
“Axillary dissections are associated with considerable morbidity, and the results of this trial demonstrated that this morbidity can be avoided without decreasing cancer control. … These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes,” wrote Armando E. Guiliano, MD, of Cedars-Sinai Medical, Los Angeles and his coauthors (JAMA. 2017;318[10]:918-26. doi: 10.1001/jama.2017.11470).
A follow-up to a study showing the noninferiority of sentinel lymph node dissection to axillary lymph node dissection for breast cancer in overall and disease-free survival at a median of 6.3 years found similar noninferiority in overall survival at 10 years.
Axillary lymph node dissection has a risk of complications including lymphedema, numbness, axillary web syndrome, and decreased upper-extremity range of motion. The American College of Surgeons Oncology Group Z0011 trial sought to determine if the procedure could be avoided without inferior survival outcomes.
Criticism of the study focused on the potential for later recurrence, particularly in patients with hormone receptor–positive breast cancer. All enrolled patients had one or two sentinel nodes with metastases. At randomization, 436 received sentinel lymph node dissection alone, and 420 received the additional axillary lymph node dissection. The patients were assessed every 6 months for the first 3 years, then annually.
After a median of 9.3 years, 110 of the patients had died of any cause – 51 in the sentinel lymph node dissection group and 59 in the axillary lymph node dissection group – a 10-year overall survival rate of 86.3% and 83.6%, respectively. This met the study’s primary endpoint of showing noninferior overall survival without the riskier procedure. In the study’s secondary endpoint, disease-free survival, there was not a significant difference either (80.2% vs. 78.2%).
“Axillary dissections are associated with considerable morbidity, and the results of this trial demonstrated that this morbidity can be avoided without decreasing cancer control. … These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes,” wrote Armando E. Guiliano, MD, of Cedars-Sinai Medical, Los Angeles and his coauthors (JAMA. 2017;318[10]:918-26. doi: 10.1001/jama.2017.11470).
FROM JAMA
Microneedling With Stem Cells
Incidental hip CT scans could serve as osteoporosis screen
DENVER – Computed tomography (CT) scans that were taken for an unrelated purpose could potentially be used to screen for osteoporosis, according to a new study. Researchers analyzed data from CT scans that produced estimates of bone mineral density (BMD) and femoral strength, and these performed similarly to dual-energy X-ray absorptiometry (DXA) in predicting fracture risk.
“The neat thing is that there’s no additional burden to the patients, because they’ve already had the CT scan. There’s no additional radiation exposure, no additional trip to the office. Another advantage to this is there are so many more men who are getting CT scans than there are who are getting DXAs for osteoporosis, so it’s an opportunity to screen more men,” Annette Adams, PhD, research scientist at Kaiser Permanente of Southern California, said in an interview at the annual meeting of the American Society for Bone and Mineral Research.
To test the potential of the CT scans, the researchers conducted a case-control cohort analysis of patients aged 65 and over who were seen at 11 Kaiser Permanente Southern California (KPSC) hospitals. The patients had undergone abdominal or pelvic CT between 2006 and 2014. They had not experienced a fragility hip fracture before the CT scan was taken, but they had to have undergone a DXA within 3 years of the scan.
A total of 1,340 women and 619 men had a first hip fracture during the study period. They were compared to randomly selected subjects without hip fractures.
The researchers found associations between hip fractures and CT-based scores, and the relationships were stronger than those seen with DXA. In women, for each decrease in one standard deviation (SD) in hip BMD T-score, the hazard ratio (HR) for hip fracture was 2.18 (95% confidence interval [CI], 1.87-2.54). In men, the HR was 3.12 (2.35-4.14). The HRs for hip fracture based on DXA hip BMD T-score values were 1.80 (95% CI, 1.53-2.13) for women and 2.74 (95% CI, 2.15-3.49) for men.
CT-derived femoral strength values also performed well. In women, each one SD decrease in femoral strength seen in the CT-based scores was associated with an HR of 2.76 (95% CI, 2.25-3.39). In men, the value was HR 2.84 (95% CI, 2.20-3.66).
In a subanalysis of subjects who had not received osteoporosis treatment, for each one SD decrease in hip BMD T-score, the HR for hip fracture was 2.72 (95% CI, 2.24-3.32) in women and 3.93 (95% CI, 2.46-6.26) in men.
In untreated patients, each increase of one SD in femoral strength was tied to an HR in women of 3.81 (95% CI, 2.90-5.01) and 3.37 (95% CI, 2.27-5.01) in men.
The addition of established thresholds for osteoporosis (BMD T-score –2.5 or less) as well as fragile bone strength (3,000 Newtons or less in women, 3,500 Newtons or less in men) increased the 5-year sensitivity for hip fracture from 0.55 to 0.67 in women, and from 0.43 to 0.54 in men.
The technique is not yet ready for large-scale implementation because the process isn’t yet completely automated – it requires human review to eliminate some glitches, and that is likely to make it cost ineffective for now, Sally Warner, PhD, said in an interview. Dr. Warner is senior director of musculoskeletal imaging at Parexel, and was not involved in the study.
But she was nevertheless enthusiastic. “CT is such a great modality to be able to look at bone and interpret the density, the volume, the quality of the bone. It’s got great potential utility,” she said.
She said she thinks it will become cost-effective in time. “As long as the acquisition is standardized, I’m sure the automation could come a little bit more readily,” Dr. Warner said.
Amgen and Merck funded the study. Dr. Adams has received research funding from both companies. Dr. Warner reported having no financial disclosures.
DENVER – Computed tomography (CT) scans that were taken for an unrelated purpose could potentially be used to screen for osteoporosis, according to a new study. Researchers analyzed data from CT scans that produced estimates of bone mineral density (BMD) and femoral strength, and these performed similarly to dual-energy X-ray absorptiometry (DXA) in predicting fracture risk.
“The neat thing is that there’s no additional burden to the patients, because they’ve already had the CT scan. There’s no additional radiation exposure, no additional trip to the office. Another advantage to this is there are so many more men who are getting CT scans than there are who are getting DXAs for osteoporosis, so it’s an opportunity to screen more men,” Annette Adams, PhD, research scientist at Kaiser Permanente of Southern California, said in an interview at the annual meeting of the American Society for Bone and Mineral Research.
To test the potential of the CT scans, the researchers conducted a case-control cohort analysis of patients aged 65 and over who were seen at 11 Kaiser Permanente Southern California (KPSC) hospitals. The patients had undergone abdominal or pelvic CT between 2006 and 2014. They had not experienced a fragility hip fracture before the CT scan was taken, but they had to have undergone a DXA within 3 years of the scan.
A total of 1,340 women and 619 men had a first hip fracture during the study period. They were compared to randomly selected subjects without hip fractures.
The researchers found associations between hip fractures and CT-based scores, and the relationships were stronger than those seen with DXA. In women, for each decrease in one standard deviation (SD) in hip BMD T-score, the hazard ratio (HR) for hip fracture was 2.18 (95% confidence interval [CI], 1.87-2.54). In men, the HR was 3.12 (2.35-4.14). The HRs for hip fracture based on DXA hip BMD T-score values were 1.80 (95% CI, 1.53-2.13) for women and 2.74 (95% CI, 2.15-3.49) for men.
CT-derived femoral strength values also performed well. In women, each one SD decrease in femoral strength seen in the CT-based scores was associated with an HR of 2.76 (95% CI, 2.25-3.39). In men, the value was HR 2.84 (95% CI, 2.20-3.66).
In a subanalysis of subjects who had not received osteoporosis treatment, for each one SD decrease in hip BMD T-score, the HR for hip fracture was 2.72 (95% CI, 2.24-3.32) in women and 3.93 (95% CI, 2.46-6.26) in men.
In untreated patients, each increase of one SD in femoral strength was tied to an HR in women of 3.81 (95% CI, 2.90-5.01) and 3.37 (95% CI, 2.27-5.01) in men.
The addition of established thresholds for osteoporosis (BMD T-score –2.5 or less) as well as fragile bone strength (3,000 Newtons or less in women, 3,500 Newtons or less in men) increased the 5-year sensitivity for hip fracture from 0.55 to 0.67 in women, and from 0.43 to 0.54 in men.
The technique is not yet ready for large-scale implementation because the process isn’t yet completely automated – it requires human review to eliminate some glitches, and that is likely to make it cost ineffective for now, Sally Warner, PhD, said in an interview. Dr. Warner is senior director of musculoskeletal imaging at Parexel, and was not involved in the study.
But she was nevertheless enthusiastic. “CT is such a great modality to be able to look at bone and interpret the density, the volume, the quality of the bone. It’s got great potential utility,” she said.
She said she thinks it will become cost-effective in time. “As long as the acquisition is standardized, I’m sure the automation could come a little bit more readily,” Dr. Warner said.
Amgen and Merck funded the study. Dr. Adams has received research funding from both companies. Dr. Warner reported having no financial disclosures.
DENVER – Computed tomography (CT) scans that were taken for an unrelated purpose could potentially be used to screen for osteoporosis, according to a new study. Researchers analyzed data from CT scans that produced estimates of bone mineral density (BMD) and femoral strength, and these performed similarly to dual-energy X-ray absorptiometry (DXA) in predicting fracture risk.
“The neat thing is that there’s no additional burden to the patients, because they’ve already had the CT scan. There’s no additional radiation exposure, no additional trip to the office. Another advantage to this is there are so many more men who are getting CT scans than there are who are getting DXAs for osteoporosis, so it’s an opportunity to screen more men,” Annette Adams, PhD, research scientist at Kaiser Permanente of Southern California, said in an interview at the annual meeting of the American Society for Bone and Mineral Research.
To test the potential of the CT scans, the researchers conducted a case-control cohort analysis of patients aged 65 and over who were seen at 11 Kaiser Permanente Southern California (KPSC) hospitals. The patients had undergone abdominal or pelvic CT between 2006 and 2014. They had not experienced a fragility hip fracture before the CT scan was taken, but they had to have undergone a DXA within 3 years of the scan.
A total of 1,340 women and 619 men had a first hip fracture during the study period. They were compared to randomly selected subjects without hip fractures.
The researchers found associations between hip fractures and CT-based scores, and the relationships were stronger than those seen with DXA. In women, for each decrease in one standard deviation (SD) in hip BMD T-score, the hazard ratio (HR) for hip fracture was 2.18 (95% confidence interval [CI], 1.87-2.54). In men, the HR was 3.12 (2.35-4.14). The HRs for hip fracture based on DXA hip BMD T-score values were 1.80 (95% CI, 1.53-2.13) for women and 2.74 (95% CI, 2.15-3.49) for men.
CT-derived femoral strength values also performed well. In women, each one SD decrease in femoral strength seen in the CT-based scores was associated with an HR of 2.76 (95% CI, 2.25-3.39). In men, the value was HR 2.84 (95% CI, 2.20-3.66).
In a subanalysis of subjects who had not received osteoporosis treatment, for each one SD decrease in hip BMD T-score, the HR for hip fracture was 2.72 (95% CI, 2.24-3.32) in women and 3.93 (95% CI, 2.46-6.26) in men.
In untreated patients, each increase of one SD in femoral strength was tied to an HR in women of 3.81 (95% CI, 2.90-5.01) and 3.37 (95% CI, 2.27-5.01) in men.
The addition of established thresholds for osteoporosis (BMD T-score –2.5 or less) as well as fragile bone strength (3,000 Newtons or less in women, 3,500 Newtons or less in men) increased the 5-year sensitivity for hip fracture from 0.55 to 0.67 in women, and from 0.43 to 0.54 in men.
The technique is not yet ready for large-scale implementation because the process isn’t yet completely automated – it requires human review to eliminate some glitches, and that is likely to make it cost ineffective for now, Sally Warner, PhD, said in an interview. Dr. Warner is senior director of musculoskeletal imaging at Parexel, and was not involved in the study.
But she was nevertheless enthusiastic. “CT is such a great modality to be able to look at bone and interpret the density, the volume, the quality of the bone. It’s got great potential utility,” she said.
She said she thinks it will become cost-effective in time. “As long as the acquisition is standardized, I’m sure the automation could come a little bit more readily,” Dr. Warner said.
Amgen and Merck funded the study. Dr. Adams has received research funding from both companies. Dr. Warner reported having no financial disclosures.
AT ASBMR
Key clinical point: Use of existing abdominal or pelvic CT scans may serve as a way to screen for osteoporosis without the need for dual-energy x-ray absorptiometry.
Major finding: For each decrease in one standard deviation in CT-derived hip BMD T-score, the hazard ratio for hip fracture was 2.18 in women and 3.12 in men.
Data source: A case-control study of 1,340 women and 619 men at 11 California centers.
Disclosures: Amgen and Merck funded the study. Dr. Adams has received research funding from both companies. Dr. Warner reported having no financial disclosures.
More studies show Medicaid expansion has benefited hospitals
In 2016, a series of studies showed the impact of Medicaid expansion on hospitals.1 The news was good: Hospitals in states that accepted Medicaid expansion through the Affordable Care Act saw dramatic reductions in their uninsured patient populations, increases in their Medicaid stays, and reductions in uncompensated care costs.1,2
In 2017, additional data continue to show that Medicaid expansion has been a boon to hospitals, including an April 2017 report published by the Urban Institute and a May 2017 analysis from The Commonwealth Fund.3,4 Both show that some of the hospitals that need it most are reaping the greatest benefits of expansion.
At the same time, Craig Garthwaite, PhD, MPP, lead author of The Commonwealth Fund report, said Medicaid expansion “wiped out roughly half of the uncompensated care faced by hospitals, with relatively little or no decline in nonexpansion states.” To date, 19 states have not expanded Medicaid.
With Medicaid facing an uncertain future, Dr. Blavin said some experts are concerned about what could happen to vulnerable hospitals if Medicaid expansion is repealed or scaled back. Indeed, President Trump and Congressional Republicans have proposed significantly altering Medicaid by either transitioning it to block grants or by capping federal funding for the entitlement.6,7
“We wanted to give people a sense of the stakes of what you’re talking about with repeal of the Affordable Care Act and go back to a system where patients are able to get emergency care at the hospital but not the complete care they get if they’re insured. We’re not going to be paying hospitals for that care, so the hospital has that coming out of their profit margin,” said Dr. Garthwaite, professor of strategy and codirector of the Health Enterprise Management Program in the Kellogg School of Management at Northwestern University, Evanston, Ill.
The Commonwealth Fund report used data from the Centers for Medicare & Medicaid Services (CMS) Hospital Cost Reports to examine 1,154 hospitals in expansion and nonexpansion states. It built on a Health Affairs study Dr. Garthwaite and his coauthors published in 2016.2 The analysis found that between 2013 and 2014, uncompensated care costs declined dramatically in expansion states and continued into 2015, falling from 3.9% to 2.3% of operating costs. Meanwhile, hospitals in nonexpansion states saw uncompensated care costs drop just 0.3-0.4 percentage points. The largest reductions were seen by hospitals providing the highest proportion of care to low-income and uninsured patients and overall savings to hospitals in expansion states amounted to $6.2 billion.
“Any contraction of the Medicaid expansion will reduce overall health insurance coverage and could have important financial implications for hospitals,” Dr. Blavin said. “We are likely to see large increases in expenses attributable to uninsured patients, declines in Medicaid revenue, and increases in uncompensated care burdens that can be a significant financial strain to hospitals.”
As part of a project supported by the Robert Wood Johnson Foundation, the Urban Institute in May 2011 began to track and study the impact of health reform. The report Dr. Blavin authored is part of this endeavor and utilized data from the American Hospital Association Annual Survey and the CMS Health Care Cost Reports to update the 2016 JAMA study. It compared hospitals in expansion states to those in nonexpansion states between fiscal years 2011 and 2015, excluding hospitals in states that expanded before January 2014. It examined hospital-reported data on uncompensated care, uncompensated care as a percentage of total hospital expenses, Medicaid revenue, Medicaid as a percentage of total revenue, operating margins, and excess margins.
The analysis found that Medicaid expansion resulted in a $3.2 million reduction in uncompensated care and a $5.0 million increase in mean annual Medicaid revenue per hospital. Expansion-state hospitals also saw improvements in excess and operating margins relative to nonexpansion state hospitals.
In Connecticut, Medicaid reimbursement rates are among the lowest in the country.8 The state uses a provider tax to finance Medicaid but, facing a budget deficit, state leaders have dramatically reduced the amount of money returned to hospitals in recent years.9
“Our Medicaid patient volume has gone up but our margins have declined because the return on investment is so low,” added Dr. Kumar, a practicing hospitalist and member of the SHM Public Policy Committee. He is concerned about what happens if Medicaid is capped or transitioned to a block grant, since “block grants have not been favorable so far … It would further squeeze us.”
In Arizona, Steve Narang, MD, MHCM, a hospitalist and CEO of Banner–University Medical Center Phoenix (B-UMCP), already knows what it’s like when Medicaid funding expands and then contracts. In 2001, the state expanded Medicaid to 100% of the federal poverty level for childless adults but then in 2011, in the throes of recession, the state froze its match on federal dollars. Prior to the freeze, charity care and bad debt made up 9% of B-UMCP’s net revenue. After the state cut to Medicaid, the hospital’s uncompensated care doubled; charity care and bad debt spiked to 20% of net revenue. Once the freeze was lifted and the state expanded Medicaid through the ACA in 2014, bad debt and charity care plummeted to 7% of revenue and remains in the single digits, Dr. Narang said.
“You hear a lot, especially in debates, about Medicaid being bad coverage … From a hospital perspective, if you’re taking care of a patient who is uninsured versus a patient with Medicaid coverage, that hospital is likely better off financially treating the patient with Medicaid coverage,” said Dr. Blavin.
“From a basic commitment to our fellow human beings, are we doing the right thing as a country?” he asked, noting that states and the federal government must address the economic realities of health care while also providing safety nets for patients. “We have to do both. But I have faith that the state and federal government will find a model and we will continue to focus on what we can control.”
References
1. Tyrrell K. Benefits of Medicaid Expansion for Hospitalists. The Hospitalist. 2016 March;2016(3). http://www.the-hospitalist.org/hospitalist/article/121832/benefits-medicaid-expansion-hospitalists. Accessed May 25, 2017.
2. Dranove D., Garthwaite C., Ody C. Uncompensated Care Decreased at Hospitals in Medicaid Expansion States but Not at Hospitals in Nonexpansion States. Health Affairs, Aug. 2016 35(8):1471-9. http://content.healthaffairs.org/content/35/8/1471.abstract. Accessed May 25, 2017.
3. Blavin F. How Has the ACA Changed Finances for Different Types of Hospitals? Updated Insights from 2015 Cost Report Data. Urban Institute. Published April 2017. Accessed May 25, 2017. http://www.urban.org/sites/default/files/publication/89446/2001215-how-has-the-aca-changed-finances-for-different-types-of-hospitals.pdf.
4. Dranove D., Garthwaite C., Ody C. The Impact of the ACA’s Medicaid Expansion on Hospitals’ Uncompensated Care Burden and the Potential Effects of Repeal. Published May 3, 2017. Accessed May 25, 2017. http://www.commonwealthfund.org/publications/issue-briefs/2017/may/aca-medicaid-expansion-hospital-uncompensated-care.
5. Blavin F. Association Between the 2014 Medicaid Expansion and US Hospital Finances. http://jamanetwork.com/journals/jama/fullarticle/2565750. JAMA 2016;316(14):1475-1483. doi:10.1001/jama.2016.14765
6. President Trump’s 2018 Budget Proposal Reduces Federal Funding for Coverage of Children in Medicaid and CHIP. Kaiser Family Foundation. Published March 23, 2017. Accessed May 25, 2017. http://kff.org/medicaid/fact-sheet/presidents-2018-budget-proposal-reduces-federal-funding-for-coverage-of-children-in-medicaid-and-chip/
7. Paradise J. Restructuring Medicaid in the American Health Care Act: Five Key Considerations. Kaiser Family Foundation. Published March 15, 2017. Accessed May 25, 2017. http://kff.org/medicaid/issue-brief/restructuring-medicaid-in-the-american-health-care-act-five-key-considerations/
8. Medicaid Hospital Payment: A comparison across states and to Medicare. MACPAC Issue Brief. Published April 2017.
9. Levin Becker A. Hospitals blast Malloy’s proposal to subject them to property taxes. Published Feb. 8, 2017. Accessed May 25, 2017. https://ctmirror.org/2017/02/08/hospitals-blast-malloys-proposal-to-subject-them-to-property-taxes/
In 2016, a series of studies showed the impact of Medicaid expansion on hospitals.1 The news was good: Hospitals in states that accepted Medicaid expansion through the Affordable Care Act saw dramatic reductions in their uninsured patient populations, increases in their Medicaid stays, and reductions in uncompensated care costs.1,2
In 2017, additional data continue to show that Medicaid expansion has been a boon to hospitals, including an April 2017 report published by the Urban Institute and a May 2017 analysis from The Commonwealth Fund.3,4 Both show that some of the hospitals that need it most are reaping the greatest benefits of expansion.
At the same time, Craig Garthwaite, PhD, MPP, lead author of The Commonwealth Fund report, said Medicaid expansion “wiped out roughly half of the uncompensated care faced by hospitals, with relatively little or no decline in nonexpansion states.” To date, 19 states have not expanded Medicaid.
With Medicaid facing an uncertain future, Dr. Blavin said some experts are concerned about what could happen to vulnerable hospitals if Medicaid expansion is repealed or scaled back. Indeed, President Trump and Congressional Republicans have proposed significantly altering Medicaid by either transitioning it to block grants or by capping federal funding for the entitlement.6,7
“We wanted to give people a sense of the stakes of what you’re talking about with repeal of the Affordable Care Act and go back to a system where patients are able to get emergency care at the hospital but not the complete care they get if they’re insured. We’re not going to be paying hospitals for that care, so the hospital has that coming out of their profit margin,” said Dr. Garthwaite, professor of strategy and codirector of the Health Enterprise Management Program in the Kellogg School of Management at Northwestern University, Evanston, Ill.
The Commonwealth Fund report used data from the Centers for Medicare & Medicaid Services (CMS) Hospital Cost Reports to examine 1,154 hospitals in expansion and nonexpansion states. It built on a Health Affairs study Dr. Garthwaite and his coauthors published in 2016.2 The analysis found that between 2013 and 2014, uncompensated care costs declined dramatically in expansion states and continued into 2015, falling from 3.9% to 2.3% of operating costs. Meanwhile, hospitals in nonexpansion states saw uncompensated care costs drop just 0.3-0.4 percentage points. The largest reductions were seen by hospitals providing the highest proportion of care to low-income and uninsured patients and overall savings to hospitals in expansion states amounted to $6.2 billion.
“Any contraction of the Medicaid expansion will reduce overall health insurance coverage and could have important financial implications for hospitals,” Dr. Blavin said. “We are likely to see large increases in expenses attributable to uninsured patients, declines in Medicaid revenue, and increases in uncompensated care burdens that can be a significant financial strain to hospitals.”
As part of a project supported by the Robert Wood Johnson Foundation, the Urban Institute in May 2011 began to track and study the impact of health reform. The report Dr. Blavin authored is part of this endeavor and utilized data from the American Hospital Association Annual Survey and the CMS Health Care Cost Reports to update the 2016 JAMA study. It compared hospitals in expansion states to those in nonexpansion states between fiscal years 2011 and 2015, excluding hospitals in states that expanded before January 2014. It examined hospital-reported data on uncompensated care, uncompensated care as a percentage of total hospital expenses, Medicaid revenue, Medicaid as a percentage of total revenue, operating margins, and excess margins.
The analysis found that Medicaid expansion resulted in a $3.2 million reduction in uncompensated care and a $5.0 million increase in mean annual Medicaid revenue per hospital. Expansion-state hospitals also saw improvements in excess and operating margins relative to nonexpansion state hospitals.
In Connecticut, Medicaid reimbursement rates are among the lowest in the country.8 The state uses a provider tax to finance Medicaid but, facing a budget deficit, state leaders have dramatically reduced the amount of money returned to hospitals in recent years.9
“Our Medicaid patient volume has gone up but our margins have declined because the return on investment is so low,” added Dr. Kumar, a practicing hospitalist and member of the SHM Public Policy Committee. He is concerned about what happens if Medicaid is capped or transitioned to a block grant, since “block grants have not been favorable so far … It would further squeeze us.”
In Arizona, Steve Narang, MD, MHCM, a hospitalist and CEO of Banner–University Medical Center Phoenix (B-UMCP), already knows what it’s like when Medicaid funding expands and then contracts. In 2001, the state expanded Medicaid to 100% of the federal poverty level for childless adults but then in 2011, in the throes of recession, the state froze its match on federal dollars. Prior to the freeze, charity care and bad debt made up 9% of B-UMCP’s net revenue. After the state cut to Medicaid, the hospital’s uncompensated care doubled; charity care and bad debt spiked to 20% of net revenue. Once the freeze was lifted and the state expanded Medicaid through the ACA in 2014, bad debt and charity care plummeted to 7% of revenue and remains in the single digits, Dr. Narang said.
“You hear a lot, especially in debates, about Medicaid being bad coverage … From a hospital perspective, if you’re taking care of a patient who is uninsured versus a patient with Medicaid coverage, that hospital is likely better off financially treating the patient with Medicaid coverage,” said Dr. Blavin.
“From a basic commitment to our fellow human beings, are we doing the right thing as a country?” he asked, noting that states and the federal government must address the economic realities of health care while also providing safety nets for patients. “We have to do both. But I have faith that the state and federal government will find a model and we will continue to focus on what we can control.”
References
1. Tyrrell K. Benefits of Medicaid Expansion for Hospitalists. The Hospitalist. 2016 March;2016(3). http://www.the-hospitalist.org/hospitalist/article/121832/benefits-medicaid-expansion-hospitalists. Accessed May 25, 2017.
2. Dranove D., Garthwaite C., Ody C. Uncompensated Care Decreased at Hospitals in Medicaid Expansion States but Not at Hospitals in Nonexpansion States. Health Affairs, Aug. 2016 35(8):1471-9. http://content.healthaffairs.org/content/35/8/1471.abstract. Accessed May 25, 2017.
3. Blavin F. How Has the ACA Changed Finances for Different Types of Hospitals? Updated Insights from 2015 Cost Report Data. Urban Institute. Published April 2017. Accessed May 25, 2017. http://www.urban.org/sites/default/files/publication/89446/2001215-how-has-the-aca-changed-finances-for-different-types-of-hospitals.pdf.
4. Dranove D., Garthwaite C., Ody C. The Impact of the ACA’s Medicaid Expansion on Hospitals’ Uncompensated Care Burden and the Potential Effects of Repeal. Published May 3, 2017. Accessed May 25, 2017. http://www.commonwealthfund.org/publications/issue-briefs/2017/may/aca-medicaid-expansion-hospital-uncompensated-care.
5. Blavin F. Association Between the 2014 Medicaid Expansion and US Hospital Finances. http://jamanetwork.com/journals/jama/fullarticle/2565750. JAMA 2016;316(14):1475-1483. doi:10.1001/jama.2016.14765
6. President Trump’s 2018 Budget Proposal Reduces Federal Funding for Coverage of Children in Medicaid and CHIP. Kaiser Family Foundation. Published March 23, 2017. Accessed May 25, 2017. http://kff.org/medicaid/fact-sheet/presidents-2018-budget-proposal-reduces-federal-funding-for-coverage-of-children-in-medicaid-and-chip/
7. Paradise J. Restructuring Medicaid in the American Health Care Act: Five Key Considerations. Kaiser Family Foundation. Published March 15, 2017. Accessed May 25, 2017. http://kff.org/medicaid/issue-brief/restructuring-medicaid-in-the-american-health-care-act-five-key-considerations/
8. Medicaid Hospital Payment: A comparison across states and to Medicare. MACPAC Issue Brief. Published April 2017.
9. Levin Becker A. Hospitals blast Malloy’s proposal to subject them to property taxes. Published Feb. 8, 2017. Accessed May 25, 2017. https://ctmirror.org/2017/02/08/hospitals-blast-malloys-proposal-to-subject-them-to-property-taxes/
In 2016, a series of studies showed the impact of Medicaid expansion on hospitals.1 The news was good: Hospitals in states that accepted Medicaid expansion through the Affordable Care Act saw dramatic reductions in their uninsured patient populations, increases in their Medicaid stays, and reductions in uncompensated care costs.1,2
In 2017, additional data continue to show that Medicaid expansion has been a boon to hospitals, including an April 2017 report published by the Urban Institute and a May 2017 analysis from The Commonwealth Fund.3,4 Both show that some of the hospitals that need it most are reaping the greatest benefits of expansion.
At the same time, Craig Garthwaite, PhD, MPP, lead author of The Commonwealth Fund report, said Medicaid expansion “wiped out roughly half of the uncompensated care faced by hospitals, with relatively little or no decline in nonexpansion states.” To date, 19 states have not expanded Medicaid.
With Medicaid facing an uncertain future, Dr. Blavin said some experts are concerned about what could happen to vulnerable hospitals if Medicaid expansion is repealed or scaled back. Indeed, President Trump and Congressional Republicans have proposed significantly altering Medicaid by either transitioning it to block grants or by capping federal funding for the entitlement.6,7
“We wanted to give people a sense of the stakes of what you’re talking about with repeal of the Affordable Care Act and go back to a system where patients are able to get emergency care at the hospital but not the complete care they get if they’re insured. We’re not going to be paying hospitals for that care, so the hospital has that coming out of their profit margin,” said Dr. Garthwaite, professor of strategy and codirector of the Health Enterprise Management Program in the Kellogg School of Management at Northwestern University, Evanston, Ill.
The Commonwealth Fund report used data from the Centers for Medicare & Medicaid Services (CMS) Hospital Cost Reports to examine 1,154 hospitals in expansion and nonexpansion states. It built on a Health Affairs study Dr. Garthwaite and his coauthors published in 2016.2 The analysis found that between 2013 and 2014, uncompensated care costs declined dramatically in expansion states and continued into 2015, falling from 3.9% to 2.3% of operating costs. Meanwhile, hospitals in nonexpansion states saw uncompensated care costs drop just 0.3-0.4 percentage points. The largest reductions were seen by hospitals providing the highest proportion of care to low-income and uninsured patients and overall savings to hospitals in expansion states amounted to $6.2 billion.
“Any contraction of the Medicaid expansion will reduce overall health insurance coverage and could have important financial implications for hospitals,” Dr. Blavin said. “We are likely to see large increases in expenses attributable to uninsured patients, declines in Medicaid revenue, and increases in uncompensated care burdens that can be a significant financial strain to hospitals.”
As part of a project supported by the Robert Wood Johnson Foundation, the Urban Institute in May 2011 began to track and study the impact of health reform. The report Dr. Blavin authored is part of this endeavor and utilized data from the American Hospital Association Annual Survey and the CMS Health Care Cost Reports to update the 2016 JAMA study. It compared hospitals in expansion states to those in nonexpansion states between fiscal years 2011 and 2015, excluding hospitals in states that expanded before January 2014. It examined hospital-reported data on uncompensated care, uncompensated care as a percentage of total hospital expenses, Medicaid revenue, Medicaid as a percentage of total revenue, operating margins, and excess margins.
The analysis found that Medicaid expansion resulted in a $3.2 million reduction in uncompensated care and a $5.0 million increase in mean annual Medicaid revenue per hospital. Expansion-state hospitals also saw improvements in excess and operating margins relative to nonexpansion state hospitals.
In Connecticut, Medicaid reimbursement rates are among the lowest in the country.8 The state uses a provider tax to finance Medicaid but, facing a budget deficit, state leaders have dramatically reduced the amount of money returned to hospitals in recent years.9
“Our Medicaid patient volume has gone up but our margins have declined because the return on investment is so low,” added Dr. Kumar, a practicing hospitalist and member of the SHM Public Policy Committee. He is concerned about what happens if Medicaid is capped or transitioned to a block grant, since “block grants have not been favorable so far … It would further squeeze us.”
In Arizona, Steve Narang, MD, MHCM, a hospitalist and CEO of Banner–University Medical Center Phoenix (B-UMCP), already knows what it’s like when Medicaid funding expands and then contracts. In 2001, the state expanded Medicaid to 100% of the federal poverty level for childless adults but then in 2011, in the throes of recession, the state froze its match on federal dollars. Prior to the freeze, charity care and bad debt made up 9% of B-UMCP’s net revenue. After the state cut to Medicaid, the hospital’s uncompensated care doubled; charity care and bad debt spiked to 20% of net revenue. Once the freeze was lifted and the state expanded Medicaid through the ACA in 2014, bad debt and charity care plummeted to 7% of revenue and remains in the single digits, Dr. Narang said.
“You hear a lot, especially in debates, about Medicaid being bad coverage … From a hospital perspective, if you’re taking care of a patient who is uninsured versus a patient with Medicaid coverage, that hospital is likely better off financially treating the patient with Medicaid coverage,” said Dr. Blavin.
“From a basic commitment to our fellow human beings, are we doing the right thing as a country?” he asked, noting that states and the federal government must address the economic realities of health care while also providing safety nets for patients. “We have to do both. But I have faith that the state and federal government will find a model and we will continue to focus on what we can control.”
References
1. Tyrrell K. Benefits of Medicaid Expansion for Hospitalists. The Hospitalist. 2016 March;2016(3). http://www.the-hospitalist.org/hospitalist/article/121832/benefits-medicaid-expansion-hospitalists. Accessed May 25, 2017.
2. Dranove D., Garthwaite C., Ody C. Uncompensated Care Decreased at Hospitals in Medicaid Expansion States but Not at Hospitals in Nonexpansion States. Health Affairs, Aug. 2016 35(8):1471-9. http://content.healthaffairs.org/content/35/8/1471.abstract. Accessed May 25, 2017.
3. Blavin F. How Has the ACA Changed Finances for Different Types of Hospitals? Updated Insights from 2015 Cost Report Data. Urban Institute. Published April 2017. Accessed May 25, 2017. http://www.urban.org/sites/default/files/publication/89446/2001215-how-has-the-aca-changed-finances-for-different-types-of-hospitals.pdf.
4. Dranove D., Garthwaite C., Ody C. The Impact of the ACA’s Medicaid Expansion on Hospitals’ Uncompensated Care Burden and the Potential Effects of Repeal. Published May 3, 2017. Accessed May 25, 2017. http://www.commonwealthfund.org/publications/issue-briefs/2017/may/aca-medicaid-expansion-hospital-uncompensated-care.
5. Blavin F. Association Between the 2014 Medicaid Expansion and US Hospital Finances. http://jamanetwork.com/journals/jama/fullarticle/2565750. JAMA 2016;316(14):1475-1483. doi:10.1001/jama.2016.14765
6. President Trump’s 2018 Budget Proposal Reduces Federal Funding for Coverage of Children in Medicaid and CHIP. Kaiser Family Foundation. Published March 23, 2017. Accessed May 25, 2017. http://kff.org/medicaid/fact-sheet/presidents-2018-budget-proposal-reduces-federal-funding-for-coverage-of-children-in-medicaid-and-chip/
7. Paradise J. Restructuring Medicaid in the American Health Care Act: Five Key Considerations. Kaiser Family Foundation. Published March 15, 2017. Accessed May 25, 2017. http://kff.org/medicaid/issue-brief/restructuring-medicaid-in-the-american-health-care-act-five-key-considerations/
8. Medicaid Hospital Payment: A comparison across states and to Medicare. MACPAC Issue Brief. Published April 2017.
9. Levin Becker A. Hospitals blast Malloy’s proposal to subject them to property taxes. Published Feb. 8, 2017. Accessed May 25, 2017. https://ctmirror.org/2017/02/08/hospitals-blast-malloys-proposal-to-subject-them-to-property-taxes/
AAP annual meeting sessions you won’t want to miss
- “The preconference program ‘Pediatricians Leading Change in Physician Health and Wellness’ will be something you don’t want to miss. Speakers will address topics such as burnout among physicians and residents, compassion fatigue, and approaches to wellness that target individuals, practices, organizations, and medical education. Physician wellness is essential if we want to provide excellent medical care.” Friday, Sept. 15, 11:30 a.m. – 5:30 p.m. at McCormick Place West, W375 E.
- “Monday’s plenary session, ‘The Heat Is On: Why Climate Change Advocacy Is Essential to Child Health’ by Jonathan Patz, MD, MPH, will be particularly relevant, given recent extreme weather events. Children also are affected by climate change, because infectious diseases patterns are altered and because of changes in plant growth and pollen production. Dr. Patz will discuss how pediatricians and physicians from other specialties need to join together to protect patients from further harm, through education and advocacy.” Monday, Sept. 18, at 12:10 p.m. – 12:30 p.m. at Skyline Ballroom.
- “Tics, CANS, PANS, and Other Movement Disorders” by Joanna Blackburn, MD. “When I was in training, these diagnoses were not really recognized; but from what I have seen in practice, they exist and require support from specialists who are hard to find. Having more knowledge of the disorders would benefit any primary care physician.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W183 C, and Sunday, Sept. 17, at 8:30 a.m. – 9:15 a.m. at McCormick Place West, W185D.
- “Are Vaccines Safe?” by Paul Offit, MD. “As physicians, we know that vaccines are safe; but our patients are very skeptical about this and don’t believe us. I hope this lecture will give us statistics and studies to bring back to our patients.” Saturday, Sept. 16, at 4 p.m. – 4:45 p.m. at McCormick Place West, W183 B, and Sunday, Sept. 17, at 2 p.m. – 2:45 p.m. at McCormick Place West, W183 B.
- “The presentation ‘Bright Futures Update: What Has Changed and Why’ by Joseph Hagan Jr., MD, is always a good guide.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Integrating Mental Health Services in the Primary Care Office” by Jay Rabinowitz, MD. “Pediatricians are increasingly involved in dealing with children and adolescents who have mental health problems. Enhancing their ability to do so in their office can be very beneficial.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W178 B, and Saturday, Sept. 16, at 5:00 p.m. – 5:45 p.m. at McCormick Place West, W176 C.
- “2017 AAP Guidelines for Childhood Hypertension: Highlights” by Joseph Flynn, MD, MS. “New guidelines for diagnosis, evaluation, and management of abnormal blood pressures in the ambulatory setting were issued by the AAP in September. Pediatricians need to be updated on this important disease and incorporate these into their practices.” Tuesday, Sept. 19, at 10:30 a.m. – 10:50 a.m. at Skyline Ballroom.
- “Meet the Redbook Committee.” “This session will include discussions of issues germane to infectious diseases in children. It always includes new information on important topics for practice, including immunizations.” Monday, Sept. 18, at 8 a.m. – 10 a.m. at McCormick Place West, W190 A.
- “Vaccine Update, What’s New and What’s Changed” by Mary Anne Jackson, MD. “Recommendations change yearly, so this session is always important.” Sunday, Sept. 17, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W183 A, and Sunday, Sept. 17, at 4 p.m. – 4:45 p.m. at McCormick Place West, W183 A.
- “The presentation ‘Bright Futures Update: What Has Changed and Why’ by Joseph Hagan Jr., MD, highlights the new recommendations for the new guidelines published this year. There are important changes for all who use Bright Futures for their preventive child health visits (well-child visits).” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Children’s Health – What’s at Stake in the New Administration” by Lynda Young, MD. “Dr. Young has significant experience in the advocacy area, which started for her when she was a young practitioner in Massachusetts and became interested in learning about how to promote the health of her patients through legislative connections and actions. Lynda is now chair of the AAP Committee on Federal Government Affairs, and with the changes in Washington adversely affecting millions of children in our country, it will be crucial for individual pediatricians to advocate in their communities and beyond. This session will share key concepts and tools for child health advocacy.” Saturday, Sept. 16, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “AAP President’s Address.” “The AAP is our voice, our tool to improve the lives of children. I want to know what the AAP thinks is important today, and AAP President Fernando Stein, MD, will provide an update on efforts by the academy to advance the Agenda for Children.” Saturday, Sept. 16, at 10:30 a.m. – 11:15 a.m. at Skyline Ballroom.
- “Antimicrobial Update.” “Infectious diseases is a big part of pediatrics. I need to stay current on the latest antibiotic tools.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W179, and Monday, Sept. 18, at 8:30 a.m. – 10 a.m. at McCormick Place West, W180.
- “Teens Gone Wild: Advising Families on Parenting Adolescents.” “Working with parenting issues with teens is fun but complicated. I look forward to the refresher.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W183 A.
- “Social Determinants of Health: Practical and Sensitive Identification and Strategies.” “Yes, but what is our responsibility as pediatricians? Hopefully, I can find out at this session.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “Council on Community Pediatrics Program. The Intersection of Housing, Neighborhood, and Child Health.” “We must never forget that the factors that impact the health and development of our patients often are not medical, but social and environmental. This should be an interesting session.” Monday, Sept. 18, at 8 a.m. – 12 p.m. at McCormick Place West, S105 A.
- “Bright Futures Update: What Has Changed and Why.” “There is nothing more complicated or important than the well-child care we provide. Bright Futures has come out with new changes, and I need to take advantage of having the editor, Joe Hagan, guide me through the changes.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Children’s Health: What’s at Stake in the New Administration.” “These are scary times for children, especially for those who come from disadvantaged backgrounds. I need to prioritize where to take action.” Saturday, Sept. 16, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “Integrating Mental Health Services in the Primary Care Office.” “We see more and more children coming in the office with mental health issues, and I need new skill development to take care of them.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W178 B, and Saturday, Sept. 16, at 5 p.m. – 5:45 p.m. at McCormick Place West, W176 C.
- “The preconference program ‘Pediatricians Leading Change in Physician Health and Wellness’ will be something you don’t want to miss. Speakers will address topics such as burnout among physicians and residents, compassion fatigue, and approaches to wellness that target individuals, practices, organizations, and medical education. Physician wellness is essential if we want to provide excellent medical care.” Friday, Sept. 15, 11:30 a.m. – 5:30 p.m. at McCormick Place West, W375 E.
- “Monday’s plenary session, ‘The Heat Is On: Why Climate Change Advocacy Is Essential to Child Health’ by Jonathan Patz, MD, MPH, will be particularly relevant, given recent extreme weather events. Children also are affected by climate change, because infectious diseases patterns are altered and because of changes in plant growth and pollen production. Dr. Patz will discuss how pediatricians and physicians from other specialties need to join together to protect patients from further harm, through education and advocacy.” Monday, Sept. 18, at 12:10 p.m. – 12:30 p.m. at Skyline Ballroom.
- “Tics, CANS, PANS, and Other Movement Disorders” by Joanna Blackburn, MD. “When I was in training, these diagnoses were not really recognized; but from what I have seen in practice, they exist and require support from specialists who are hard to find. Having more knowledge of the disorders would benefit any primary care physician.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W183 C, and Sunday, Sept. 17, at 8:30 a.m. – 9:15 a.m. at McCormick Place West, W185D.
- “Are Vaccines Safe?” by Paul Offit, MD. “As physicians, we know that vaccines are safe; but our patients are very skeptical about this and don’t believe us. I hope this lecture will give us statistics and studies to bring back to our patients.” Saturday, Sept. 16, at 4 p.m. – 4:45 p.m. at McCormick Place West, W183 B, and Sunday, Sept. 17, at 2 p.m. – 2:45 p.m. at McCormick Place West, W183 B.
- “The presentation ‘Bright Futures Update: What Has Changed and Why’ by Joseph Hagan Jr., MD, is always a good guide.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Integrating Mental Health Services in the Primary Care Office” by Jay Rabinowitz, MD. “Pediatricians are increasingly involved in dealing with children and adolescents who have mental health problems. Enhancing their ability to do so in their office can be very beneficial.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W178 B, and Saturday, Sept. 16, at 5:00 p.m. – 5:45 p.m. at McCormick Place West, W176 C.
- “2017 AAP Guidelines for Childhood Hypertension: Highlights” by Joseph Flynn, MD, MS. “New guidelines for diagnosis, evaluation, and management of abnormal blood pressures in the ambulatory setting were issued by the AAP in September. Pediatricians need to be updated on this important disease and incorporate these into their practices.” Tuesday, Sept. 19, at 10:30 a.m. – 10:50 a.m. at Skyline Ballroom.
- “Meet the Redbook Committee.” “This session will include discussions of issues germane to infectious diseases in children. It always includes new information on important topics for practice, including immunizations.” Monday, Sept. 18, at 8 a.m. – 10 a.m. at McCormick Place West, W190 A.
- “Vaccine Update, What’s New and What’s Changed” by Mary Anne Jackson, MD. “Recommendations change yearly, so this session is always important.” Sunday, Sept. 17, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W183 A, and Sunday, Sept. 17, at 4 p.m. – 4:45 p.m. at McCormick Place West, W183 A.
- “The presentation ‘Bright Futures Update: What Has Changed and Why’ by Joseph Hagan Jr., MD, highlights the new recommendations for the new guidelines published this year. There are important changes for all who use Bright Futures for their preventive child health visits (well-child visits).” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Children’s Health – What’s at Stake in the New Administration” by Lynda Young, MD. “Dr. Young has significant experience in the advocacy area, which started for her when she was a young practitioner in Massachusetts and became interested in learning about how to promote the health of her patients through legislative connections and actions. Lynda is now chair of the AAP Committee on Federal Government Affairs, and with the changes in Washington adversely affecting millions of children in our country, it will be crucial for individual pediatricians to advocate in their communities and beyond. This session will share key concepts and tools for child health advocacy.” Saturday, Sept. 16, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “AAP President’s Address.” “The AAP is our voice, our tool to improve the lives of children. I want to know what the AAP thinks is important today, and AAP President Fernando Stein, MD, will provide an update on efforts by the academy to advance the Agenda for Children.” Saturday, Sept. 16, at 10:30 a.m. – 11:15 a.m. at Skyline Ballroom.
- “Antimicrobial Update.” “Infectious diseases is a big part of pediatrics. I need to stay current on the latest antibiotic tools.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W179, and Monday, Sept. 18, at 8:30 a.m. – 10 a.m. at McCormick Place West, W180.
- “Teens Gone Wild: Advising Families on Parenting Adolescents.” “Working with parenting issues with teens is fun but complicated. I look forward to the refresher.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W183 A.
- “Social Determinants of Health: Practical and Sensitive Identification and Strategies.” “Yes, but what is our responsibility as pediatricians? Hopefully, I can find out at this session.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “Council on Community Pediatrics Program. The Intersection of Housing, Neighborhood, and Child Health.” “We must never forget that the factors that impact the health and development of our patients often are not medical, but social and environmental. This should be an interesting session.” Monday, Sept. 18, at 8 a.m. – 12 p.m. at McCormick Place West, S105 A.
- “Bright Futures Update: What Has Changed and Why.” “There is nothing more complicated or important than the well-child care we provide. Bright Futures has come out with new changes, and I need to take advantage of having the editor, Joe Hagan, guide me through the changes.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Children’s Health: What’s at Stake in the New Administration.” “These are scary times for children, especially for those who come from disadvantaged backgrounds. I need to prioritize where to take action.” Saturday, Sept. 16, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “Integrating Mental Health Services in the Primary Care Office.” “We see more and more children coming in the office with mental health issues, and I need new skill development to take care of them.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W178 B, and Saturday, Sept. 16, at 5 p.m. – 5:45 p.m. at McCormick Place West, W176 C.
- “The preconference program ‘Pediatricians Leading Change in Physician Health and Wellness’ will be something you don’t want to miss. Speakers will address topics such as burnout among physicians and residents, compassion fatigue, and approaches to wellness that target individuals, practices, organizations, and medical education. Physician wellness is essential if we want to provide excellent medical care.” Friday, Sept. 15, 11:30 a.m. – 5:30 p.m. at McCormick Place West, W375 E.
- “Monday’s plenary session, ‘The Heat Is On: Why Climate Change Advocacy Is Essential to Child Health’ by Jonathan Patz, MD, MPH, will be particularly relevant, given recent extreme weather events. Children also are affected by climate change, because infectious diseases patterns are altered and because of changes in plant growth and pollen production. Dr. Patz will discuss how pediatricians and physicians from other specialties need to join together to protect patients from further harm, through education and advocacy.” Monday, Sept. 18, at 12:10 p.m. – 12:30 p.m. at Skyline Ballroom.
- “Tics, CANS, PANS, and Other Movement Disorders” by Joanna Blackburn, MD. “When I was in training, these diagnoses were not really recognized; but from what I have seen in practice, they exist and require support from specialists who are hard to find. Having more knowledge of the disorders would benefit any primary care physician.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W183 C, and Sunday, Sept. 17, at 8:30 a.m. – 9:15 a.m. at McCormick Place West, W185D.
- “Are Vaccines Safe?” by Paul Offit, MD. “As physicians, we know that vaccines are safe; but our patients are very skeptical about this and don’t believe us. I hope this lecture will give us statistics and studies to bring back to our patients.” Saturday, Sept. 16, at 4 p.m. – 4:45 p.m. at McCormick Place West, W183 B, and Sunday, Sept. 17, at 2 p.m. – 2:45 p.m. at McCormick Place West, W183 B.
- “The presentation ‘Bright Futures Update: What Has Changed and Why’ by Joseph Hagan Jr., MD, is always a good guide.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Integrating Mental Health Services in the Primary Care Office” by Jay Rabinowitz, MD. “Pediatricians are increasingly involved in dealing with children and adolescents who have mental health problems. Enhancing their ability to do so in their office can be very beneficial.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W178 B, and Saturday, Sept. 16, at 5:00 p.m. – 5:45 p.m. at McCormick Place West, W176 C.
- “2017 AAP Guidelines for Childhood Hypertension: Highlights” by Joseph Flynn, MD, MS. “New guidelines for diagnosis, evaluation, and management of abnormal blood pressures in the ambulatory setting were issued by the AAP in September. Pediatricians need to be updated on this important disease and incorporate these into their practices.” Tuesday, Sept. 19, at 10:30 a.m. – 10:50 a.m. at Skyline Ballroom.
- “Meet the Redbook Committee.” “This session will include discussions of issues germane to infectious diseases in children. It always includes new information on important topics for practice, including immunizations.” Monday, Sept. 18, at 8 a.m. – 10 a.m. at McCormick Place West, W190 A.
- “Vaccine Update, What’s New and What’s Changed” by Mary Anne Jackson, MD. “Recommendations change yearly, so this session is always important.” Sunday, Sept. 17, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W183 A, and Sunday, Sept. 17, at 4 p.m. – 4:45 p.m. at McCormick Place West, W183 A.
- “The presentation ‘Bright Futures Update: What Has Changed and Why’ by Joseph Hagan Jr., MD, highlights the new recommendations for the new guidelines published this year. There are important changes for all who use Bright Futures for their preventive child health visits (well-child visits).” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Children’s Health – What’s at Stake in the New Administration” by Lynda Young, MD. “Dr. Young has significant experience in the advocacy area, which started for her when she was a young practitioner in Massachusetts and became interested in learning about how to promote the health of her patients through legislative connections and actions. Lynda is now chair of the AAP Committee on Federal Government Affairs, and with the changes in Washington adversely affecting millions of children in our country, it will be crucial for individual pediatricians to advocate in their communities and beyond. This session will share key concepts and tools for child health advocacy.” Saturday, Sept. 16, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “AAP President’s Address.” “The AAP is our voice, our tool to improve the lives of children. I want to know what the AAP thinks is important today, and AAP President Fernando Stein, MD, will provide an update on efforts by the academy to advance the Agenda for Children.” Saturday, Sept. 16, at 10:30 a.m. – 11:15 a.m. at Skyline Ballroom.
- “Antimicrobial Update.” “Infectious diseases is a big part of pediatrics. I need to stay current on the latest antibiotic tools.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W179, and Monday, Sept. 18, at 8:30 a.m. – 10 a.m. at McCormick Place West, W180.
- “Teens Gone Wild: Advising Families on Parenting Adolescents.” “Working with parenting issues with teens is fun but complicated. I look forward to the refresher.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W183 A.
- “Social Determinants of Health: Practical and Sensitive Identification and Strategies.” “Yes, but what is our responsibility as pediatricians? Hopefully, I can find out at this session.” Sunday, Sept. 17, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “Council on Community Pediatrics Program. The Intersection of Housing, Neighborhood, and Child Health.” “We must never forget that the factors that impact the health and development of our patients often are not medical, but social and environmental. This should be an interesting session.” Monday, Sept. 18, at 8 a.m. – 12 p.m. at McCormick Place West, S105 A.
- “Bright Futures Update: What Has Changed and Why.” “There is nothing more complicated or important than the well-child care we provide. Bright Futures has come out with new changes, and I need to take advantage of having the editor, Joe Hagan, guide me through the changes.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W179, and Sunday, Sept. 17, at 9:30 a.m. – 10:15 a.m. at McCormick Place West, W187 A.
- “Children’s Health: What’s at Stake in the New Administration.” “These are scary times for children, especially for those who come from disadvantaged backgrounds. I need to prioritize where to take action.” Saturday, Sept. 16, at 8:30 a.m. – 10 a.m. at McCormick Place West, W181 A.
- “Integrating Mental Health Services in the Primary Care Office.” “We see more and more children coming in the office with mental health issues, and I need new skill development to take care of them.” Saturday, Sept. 16, at 7:30 a.m. – 8:15 a.m. at McCormick Place West, W178 B, and Saturday, Sept. 16, at 5 p.m. – 5:45 p.m. at McCormick Place West, W176 C.