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VIDEO: IL-23 inhibitors on the upswing
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Acne and Antiaging: Is There a Connection?
As a chronic inflammatory skin disease well known for its poor cosmesis including scarring, residual macular erythema, and postinflammatory pigment alteration, acne vulgaris may, according to recent research, confer some antiaging benefits to affected patients. In a research letter published online on September 27 in the Journal of Investigative Dermatology, Ribero et al analyzed white blood cells and found that women who said they had acne had longer telomeres (the "caps" at the end of chromosomes that protect them from deteriorating following repeated cell replication). Telomere length, or rather shortening, has been correlated with age-related degenerative change, according to Saum et al (Exp Gerontol. 2014;58:250-255), and therefore the thinking is that in women with acne, something is going on that maintains the length of the cellular guardians. Let's clarify a couple things to help us all understand the why and what.
The impetus of this study, according to Ribero et al, was the observation that women with acne show signs of aging later than those who have never had acne. I personally have not witnessed this finding in my patients, and given that acne in its essence is a disease of chronic inflammation resulting from, for example, persistent activation of toll-like receptor 2 (TLR2) and NOD-like receptor family pyrin domain containing 3 (NLRP3) pattern recognition receptors, one would think the skin damage accrued would make these individuals look older, right? Last I checked, pitted scarring does not make one immediately think of the fountain of youth.
The results from the study show that there is a link between acne and longer telomeres, but the study did not show that telomere length is a cause of acne, that women with longer telomeres had fewer signs of skin aging, or that women with acne lived longer.
Given these points, Ribero et al concluded that "delayed skin aging may be due to reduced senescence," which means that skin aging may be delayed because the longer telomeres in the cells protect them from deterioration. They did find that the expression of one gene in particular was reduced in women with acne--the regulatory gene zinc finger protein 420, ZNF420--suggesting that those without acne may produce more of a particular protein linked to that gene, though the significance is unclear.
What's the issue?
This study is interesting, but it is important not to make any broad conclusions, such as those who get acne will live longer or look younger longer regardless of other factors such as acne treatment, comorbidities, or even environmental factors. This study may give more support for the genetic contribution of acne, but much more work is needed to determine the clinical relevance. For starters, what about men?
Would you assure your acne patients that their disease may be for their own cosmetic good?
As a chronic inflammatory skin disease well known for its poor cosmesis including scarring, residual macular erythema, and postinflammatory pigment alteration, acne vulgaris may, according to recent research, confer some antiaging benefits to affected patients. In a research letter published online on September 27 in the Journal of Investigative Dermatology, Ribero et al analyzed white blood cells and found that women who said they had acne had longer telomeres (the "caps" at the end of chromosomes that protect them from deteriorating following repeated cell replication). Telomere length, or rather shortening, has been correlated with age-related degenerative change, according to Saum et al (Exp Gerontol. 2014;58:250-255), and therefore the thinking is that in women with acne, something is going on that maintains the length of the cellular guardians. Let's clarify a couple things to help us all understand the why and what.
The impetus of this study, according to Ribero et al, was the observation that women with acne show signs of aging later than those who have never had acne. I personally have not witnessed this finding in my patients, and given that acne in its essence is a disease of chronic inflammation resulting from, for example, persistent activation of toll-like receptor 2 (TLR2) and NOD-like receptor family pyrin domain containing 3 (NLRP3) pattern recognition receptors, one would think the skin damage accrued would make these individuals look older, right? Last I checked, pitted scarring does not make one immediately think of the fountain of youth.
The results from the study show that there is a link between acne and longer telomeres, but the study did not show that telomere length is a cause of acne, that women with longer telomeres had fewer signs of skin aging, or that women with acne lived longer.
Given these points, Ribero et al concluded that "delayed skin aging may be due to reduced senescence," which means that skin aging may be delayed because the longer telomeres in the cells protect them from deterioration. They did find that the expression of one gene in particular was reduced in women with acne--the regulatory gene zinc finger protein 420, ZNF420--suggesting that those without acne may produce more of a particular protein linked to that gene, though the significance is unclear.
What's the issue?
This study is interesting, but it is important not to make any broad conclusions, such as those who get acne will live longer or look younger longer regardless of other factors such as acne treatment, comorbidities, or even environmental factors. This study may give more support for the genetic contribution of acne, but much more work is needed to determine the clinical relevance. For starters, what about men?
Would you assure your acne patients that their disease may be for their own cosmetic good?
As a chronic inflammatory skin disease well known for its poor cosmesis including scarring, residual macular erythema, and postinflammatory pigment alteration, acne vulgaris may, according to recent research, confer some antiaging benefits to affected patients. In a research letter published online on September 27 in the Journal of Investigative Dermatology, Ribero et al analyzed white blood cells and found that women who said they had acne had longer telomeres (the "caps" at the end of chromosomes that protect them from deteriorating following repeated cell replication). Telomere length, or rather shortening, has been correlated with age-related degenerative change, according to Saum et al (Exp Gerontol. 2014;58:250-255), and therefore the thinking is that in women with acne, something is going on that maintains the length of the cellular guardians. Let's clarify a couple things to help us all understand the why and what.
The impetus of this study, according to Ribero et al, was the observation that women with acne show signs of aging later than those who have never had acne. I personally have not witnessed this finding in my patients, and given that acne in its essence is a disease of chronic inflammation resulting from, for example, persistent activation of toll-like receptor 2 (TLR2) and NOD-like receptor family pyrin domain containing 3 (NLRP3) pattern recognition receptors, one would think the skin damage accrued would make these individuals look older, right? Last I checked, pitted scarring does not make one immediately think of the fountain of youth.
The results from the study show that there is a link between acne and longer telomeres, but the study did not show that telomere length is a cause of acne, that women with longer telomeres had fewer signs of skin aging, or that women with acne lived longer.
Given these points, Ribero et al concluded that "delayed skin aging may be due to reduced senescence," which means that skin aging may be delayed because the longer telomeres in the cells protect them from deterioration. They did find that the expression of one gene in particular was reduced in women with acne--the regulatory gene zinc finger protein 420, ZNF420--suggesting that those without acne may produce more of a particular protein linked to that gene, though the significance is unclear.
What's the issue?
This study is interesting, but it is important not to make any broad conclusions, such as those who get acne will live longer or look younger longer regardless of other factors such as acne treatment, comorbidities, or even environmental factors. This study may give more support for the genetic contribution of acne, but much more work is needed to determine the clinical relevance. For starters, what about men?
Would you assure your acne patients that their disease may be for their own cosmetic good?
Thyroid disease does not affect primary biliary cholangitis complications
While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.
“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).
Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.
“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”
No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.
While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.
“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).
Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.
“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”
No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.
While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.
“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).
Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.
“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”
No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.
Key clinical point:
Major finding: 150 of 921 PBC patients had TD (16.3%), but there was no correlation between PBC patients who had TD and their histologic stage either at diagnosis, hepatic decompensation events, occurrence of hepatocelluler carcinoma, or liver transplantation rates.
Data source: Prospective study of 921 PBC patients in Padua and Barcelona from 1975 to 2015.
Disclosures: No funding source was disclosed; authors reported no relevant financial disclosures.
Capturing the Big Picture in DCB studies
Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.
Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.
“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.
Dr. Brodmann said that investigators need to look beyond the usual measures, such as late lumen loss, which prove only that the drug is working in the vessel – and toward outcomes that better reflect a patient’s real-world quality of life after the intervention.
“The first time you have a DCB or other technology, you’re really proving efficacy just in terms of treating the stenosis or the occlusion,” she said. “But for the larger RCTs or the registries, you have to not just prove efficacy, you have to go into other endpoints, and that’s something we have to change when we look at these devices,” she said.
“For example, take a patient with intermittent claudication. If you keep that patient mobile and he’s able to walk and do regular daily activity, that’s one of the things we should look at in the future when we design trials and registries. Because if this patient, after the intervention, is able to resume his daily exercise routine and activities without feeling limited, he is also going to be reducing his cardiovascular morbidity and mortality,” Dr. Brodmann said.
Similarly, future studies should take a closer look at re-intervention as an outcome measure. “One of the most important things we can do for our patients is not have to bring them back into the cath lab,” Dr. Brodmann said. “It may not carry the same risk as surgery, but each endovascular procedure you perform still has risks – bleeding at the puncture site, allergic reactions to contrast media. Reducing the patient’s likelihood of going back is another quality-of-life improvement.”
Right now, “quality of life measures are insufficiently captured” in randomized controlled trials (RTCs). “There’s only one DCB trial that’s looked at it. But its increasingly being discussed in expert circles that it’s more and more necessary to focus on quality of life, and to expand our endpoints. We may find we do see something good for our patients beyond the endpoints we have right now,” Dr. Brodmann said.
To understand the full efficacy picture with DCBs, Dr. Brodmann said, it’s important to look both at registry and RCT evidence. “The large RCTs we have establish proof of efficacy but then I would highlight the manufacturer registries, because these registries represent the real-world scenarios you see when you treat patients with a DCB.”
Session 99: New Developments in the Treatment of Diseases of the Lower Extremities
Grand Ballroom East, 3rd Floor
Differences and Similarities in all the DCB Registries and RCTs: All DCBs and All Studies Are Not Equal
Saturday 7:58 .m. – 8:03 a.m.
Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.
Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.
“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.
Dr. Brodmann said that investigators need to look beyond the usual measures, such as late lumen loss, which prove only that the drug is working in the vessel – and toward outcomes that better reflect a patient’s real-world quality of life after the intervention.
“The first time you have a DCB or other technology, you’re really proving efficacy just in terms of treating the stenosis or the occlusion,” she said. “But for the larger RCTs or the registries, you have to not just prove efficacy, you have to go into other endpoints, and that’s something we have to change when we look at these devices,” she said.
“For example, take a patient with intermittent claudication. If you keep that patient mobile and he’s able to walk and do regular daily activity, that’s one of the things we should look at in the future when we design trials and registries. Because if this patient, after the intervention, is able to resume his daily exercise routine and activities without feeling limited, he is also going to be reducing his cardiovascular morbidity and mortality,” Dr. Brodmann said.
Similarly, future studies should take a closer look at re-intervention as an outcome measure. “One of the most important things we can do for our patients is not have to bring them back into the cath lab,” Dr. Brodmann said. “It may not carry the same risk as surgery, but each endovascular procedure you perform still has risks – bleeding at the puncture site, allergic reactions to contrast media. Reducing the patient’s likelihood of going back is another quality-of-life improvement.”
Right now, “quality of life measures are insufficiently captured” in randomized controlled trials (RTCs). “There’s only one DCB trial that’s looked at it. But its increasingly being discussed in expert circles that it’s more and more necessary to focus on quality of life, and to expand our endpoints. We may find we do see something good for our patients beyond the endpoints we have right now,” Dr. Brodmann said.
To understand the full efficacy picture with DCBs, Dr. Brodmann said, it’s important to look both at registry and RCT evidence. “The large RCTs we have establish proof of efficacy but then I would highlight the manufacturer registries, because these registries represent the real-world scenarios you see when you treat patients with a DCB.”
Session 99: New Developments in the Treatment of Diseases of the Lower Extremities
Grand Ballroom East, 3rd Floor
Differences and Similarities in all the DCB Registries and RCTs: All DCBs and All Studies Are Not Equal
Saturday 7:58 .m. – 8:03 a.m.
Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.
Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.
“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.
Dr. Brodmann said that investigators need to look beyond the usual measures, such as late lumen loss, which prove only that the drug is working in the vessel – and toward outcomes that better reflect a patient’s real-world quality of life after the intervention.
“The first time you have a DCB or other technology, you’re really proving efficacy just in terms of treating the stenosis or the occlusion,” she said. “But for the larger RCTs or the registries, you have to not just prove efficacy, you have to go into other endpoints, and that’s something we have to change when we look at these devices,” she said.
“For example, take a patient with intermittent claudication. If you keep that patient mobile and he’s able to walk and do regular daily activity, that’s one of the things we should look at in the future when we design trials and registries. Because if this patient, after the intervention, is able to resume his daily exercise routine and activities without feeling limited, he is also going to be reducing his cardiovascular morbidity and mortality,” Dr. Brodmann said.
Similarly, future studies should take a closer look at re-intervention as an outcome measure. “One of the most important things we can do for our patients is not have to bring them back into the cath lab,” Dr. Brodmann said. “It may not carry the same risk as surgery, but each endovascular procedure you perform still has risks – bleeding at the puncture site, allergic reactions to contrast media. Reducing the patient’s likelihood of going back is another quality-of-life improvement.”
Right now, “quality of life measures are insufficiently captured” in randomized controlled trials (RTCs). “There’s only one DCB trial that’s looked at it. But its increasingly being discussed in expert circles that it’s more and more necessary to focus on quality of life, and to expand our endpoints. We may find we do see something good for our patients beyond the endpoints we have right now,” Dr. Brodmann said.
To understand the full efficacy picture with DCBs, Dr. Brodmann said, it’s important to look both at registry and RCT evidence. “The large RCTs we have establish proof of efficacy but then I would highlight the manufacturer registries, because these registries represent the real-world scenarios you see when you treat patients with a DCB.”
Session 99: New Developments in the Treatment of Diseases of the Lower Extremities
Grand Ballroom East, 3rd Floor
Differences and Similarities in all the DCB Registries and RCTs: All DCBs and All Studies Are Not Equal
Saturday 7:58 .m. – 8:03 a.m.
FDA approves nivolumab for advanced squamous cell carcinoma of the head and neck
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
NCCN: Deliver vincristine by mini IV drip bag
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference. 
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference.
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference.
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
One psychiatrist’s take on election anxiety
I have to start this column with a disclaimer: I live in Maryland, and like most Marylanders, I am a Democrat. We’re one of the bluest states – today, you’re welcome to give that statement two meanings – and as such, I live in what today has been somewhat pejoratively called the educated, liberal, elitist, East Coast, “Hillary bubble,” where I can be one of the first to admit that I’m not in touch with the country as a whole. I’ll add one more disclaimer: I married a man I fell in love with during my freshman year of college.
As a teenager, I didn’t care much about politics, but my then-boyfriend was a political science major who was a Republican and spent a summer on Capitol Hill. So my blue world is just a bit influenced by decades of living, quite happily, in a bipartisan household. The adult children seem to have settled in as Democrats; the dogs have split parties.
“I thought Donald Trump was a joke, a reality TV thing.”
I hadn’t been paying much attention, and my husband, who remains calm and wise, reassured me that it was months until the primaries, and that Trump would not be the Republican nominee.
Time went on, and my anxiety grew. I found myself caught up in Facebook posts, and I mostly read like-minded rhetoric. In March, I was on vacation and found myself terribly distraught about a colleague’s post. He talked about his anxiety about the election, likened Trump to Hitler or Stalin, and asked what people would do if they found out their friends supported Trump. Should one end their friendship? I have strong viewpoints, and if I limited my friends only to those who agree with me on controversial issues, I would be rather lonely. I started to argue with my colleague’s friends – they likened voting for Trump to being anti-Semitic, and many felt one should end friendships with people who supported him. I decided I didn’t want to be Facebook friends with people who made their friendships contingent on how I vote. This was different, I was told, because of Trump’s xenophobia, and I ended up “unfriending” my colleague (only on Facebook), and turning off all my social media for a while.
When Trump won the Republican nomination, my husband told me I should be happy: This ensured that Hillary Clinton would win the election. He would not vote for Trump; our Republican governor, Larry Hogan, was not supporting Trump; it seemed that neither the Republicans nor the Democrats were enthusiastic about his nomination, and my anxiety waned.
A colleague noted he was having trouble listening to Trump supporters in therapy sessions. In my entire practice, only one patient mentioned being a Trump supporter, a transplant from a Southern state. It was not a major focus of therapy, except that he used it as an example of how he felt out of place in Maryland, and I had sympathy for his sense of isolation here.
My anxiety waned in the weeks before the election, though my patients talked more and more about it. I posted a countdown on Facebook – this nightmare of an election has divided our country, and given a voice to vulgarity and hate speech. While I still would not end a good friendship over a vote, I see Trump as unkind and undignified. He invests energy in being purposely cruel. And since I apparently don’t understand the “non-elitist” voter, it doesn’t make sense to me that disenfranchised blue collar workers hope a privileged billionaire with a history of deceit and mistreating others will be anyone’s savior. At one point, The New York Times’ The Upshot gave Trump a 9% chance of winning. If you are a Trump supporter, please don’t feel insulted, and I would be happy to try to understand your enthusiasm for his presidency.
On Tuesday night, my husband had to be out of town. My friend, psychiatrist Anne Hanson, came to “babysit” me as I didn’t want to be alone as the returns came in – perhaps I had some sense that Clinton could possibly lose. We ordered Indian food, and together, we sat in front of the television, completely dumbfounded.
The morning after came, and Maryland psychiatrists started posting about their despair on our listserv. Others offered support; one suggested that Trump might be just what our country needs; and numerous psychiatrists have said this a call to action, a time to get more involved. On Thursday morning, one psychiatrist noted: “Seeing my patients the day after the election this week felt very much like seeing patients the day after 9/11. What was different though was that on 9/11, we were all in high distress, sadness, and fear. However, unlike 9/11, this time I have the uncanny experience of a few patients that were rejoicing or simply glad that Trump had won.”
My social media sites looked the same – disbelief, distress, obscenities, words of comfort, calls to action. Journalist Andrew Solomon posted on Twitter this morning: “It’s begun. A friend was walking in NYC and someone driving a U-Haul yelled, ‘Hey, homo. So what do you think of President Donald Trump?’” Meanwhile, Trump supporters were reportedly attacked with punches, eggs, and bottles at a protest rally in California. The country remains divided: President Obama and Hillary Clinton remind us that we should give Mr. Trump a chance and support his efforts as we are all one country, while thousands protest his victory in cities across the country.
What will President Trump’s election mean for psychiatry? The American Psychiatric Association gave money to support both candidates, and in the spirit of working together, President Maria A. Oquendo has sent him a letter of congratulations. There is nothing to be gained by having an antagonistic relationship with our country’s leader.
Trump has promised to repeal the Affordable Care Act on his first day in office. What will that mean? Will those covered by ACA policies suddenly lose their coverage? I can’t imagine that would be the case, or at least I hope not. And what about all the time, money, and effort that have been invested in Meaningful Use and the planned transition to MACRA to collect data? Do those systems vanish? I have a son who is about to turn 26 and works as a freelance writer for a fantasy sports website. Will he be able to get health insurance?
And Mr. Trump is a bit unpredictable. He has changed his political party affiliation seven times over the last 2 decades, and until 3 years ago, he was a registered Democrat. Perhaps he won’t repeal the ACA on day 1. Or day 2. We’ll have to wait and see, but in the long run, I think we all have to worry that there might be people with health insurance now who won’t have it in the future.
The mystery of Trump is that he ran a campaign without exposing any strategies. His health care plan boiled down to, We’ll get rid of the lines around the states; there will be open competition with health insurers; and it will be a beautiful thing. (My quote may be inexact, but I took careful note of it during one of the debates.)
Finally, we can ask what will happen with the Mental Health Reform Act of 2016, originally known as the Murphy bill or The Helping Families in Mental Health Crisis Act. The bill, calling for major mental health reforms, passed in the House by a vote of 422-2, and awaits a vote in the Senate during the lame duck session. While the APA supports passage of the bill, there is a great deal of controversy surrounding it, and in a Politico article, former congressman and current mental advocate Patrick Kennedy is quoted as saying that in its current form, the bill should not be passed. The latest version is “‘watered down’ and does nothing more than ‘reallocate money around block grants’ when it should instead ‘try for higher reimbursement rates’ for behavioral health providers. ‘Passing that bill will take the wind out of the sails for real reform,’” he added. “‘Kick it to the next Congress and the new administration to do this the right way.’” How the new administration will react to mental health reform is anyone’s guess.
Anne and I were scheduled to be on NPR’s Diane Rehm radio show this morning to talk about our new book; the unexpected election results led to a postponement while coverage of the election continues. My countdown until the end of this nightmare election reached 0, and I had planned to extend a Facebook re-friend request to my colleague and see if he’d have me back, but election coverage and speculation continue. It may be time for me to take another social media break.
The sun is shining in Baltimore today, and we certainly live in interesting times.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” which was released Nov. 1 by Johns Hopkins University Press.
I have to start this column with a disclaimer: I live in Maryland, and like most Marylanders, I am a Democrat. We’re one of the bluest states – today, you’re welcome to give that statement two meanings – and as such, I live in what today has been somewhat pejoratively called the educated, liberal, elitist, East Coast, “Hillary bubble,” where I can be one of the first to admit that I’m not in touch with the country as a whole. I’ll add one more disclaimer: I married a man I fell in love with during my freshman year of college.
As a teenager, I didn’t care much about politics, but my then-boyfriend was a political science major who was a Republican and spent a summer on Capitol Hill. So my blue world is just a bit influenced by decades of living, quite happily, in a bipartisan household. The adult children seem to have settled in as Democrats; the dogs have split parties.
“I thought Donald Trump was a joke, a reality TV thing.”
I hadn’t been paying much attention, and my husband, who remains calm and wise, reassured me that it was months until the primaries, and that Trump would not be the Republican nominee.
Time went on, and my anxiety grew. I found myself caught up in Facebook posts, and I mostly read like-minded rhetoric. In March, I was on vacation and found myself terribly distraught about a colleague’s post. He talked about his anxiety about the election, likened Trump to Hitler or Stalin, and asked what people would do if they found out their friends supported Trump. Should one end their friendship? I have strong viewpoints, and if I limited my friends only to those who agree with me on controversial issues, I would be rather lonely. I started to argue with my colleague’s friends – they likened voting for Trump to being anti-Semitic, and many felt one should end friendships with people who supported him. I decided I didn’t want to be Facebook friends with people who made their friendships contingent on how I vote. This was different, I was told, because of Trump’s xenophobia, and I ended up “unfriending” my colleague (only on Facebook), and turning off all my social media for a while.
When Trump won the Republican nomination, my husband told me I should be happy: This ensured that Hillary Clinton would win the election. He would not vote for Trump; our Republican governor, Larry Hogan, was not supporting Trump; it seemed that neither the Republicans nor the Democrats were enthusiastic about his nomination, and my anxiety waned.
A colleague noted he was having trouble listening to Trump supporters in therapy sessions. In my entire practice, only one patient mentioned being a Trump supporter, a transplant from a Southern state. It was not a major focus of therapy, except that he used it as an example of how he felt out of place in Maryland, and I had sympathy for his sense of isolation here.
My anxiety waned in the weeks before the election, though my patients talked more and more about it. I posted a countdown on Facebook – this nightmare of an election has divided our country, and given a voice to vulgarity and hate speech. While I still would not end a good friendship over a vote, I see Trump as unkind and undignified. He invests energy in being purposely cruel. And since I apparently don’t understand the “non-elitist” voter, it doesn’t make sense to me that disenfranchised blue collar workers hope a privileged billionaire with a history of deceit and mistreating others will be anyone’s savior. At one point, The New York Times’ The Upshot gave Trump a 9% chance of winning. If you are a Trump supporter, please don’t feel insulted, and I would be happy to try to understand your enthusiasm for his presidency.
On Tuesday night, my husband had to be out of town. My friend, psychiatrist Anne Hanson, came to “babysit” me as I didn’t want to be alone as the returns came in – perhaps I had some sense that Clinton could possibly lose. We ordered Indian food, and together, we sat in front of the television, completely dumbfounded.
The morning after came, and Maryland psychiatrists started posting about their despair on our listserv. Others offered support; one suggested that Trump might be just what our country needs; and numerous psychiatrists have said this a call to action, a time to get more involved. On Thursday morning, one psychiatrist noted: “Seeing my patients the day after the election this week felt very much like seeing patients the day after 9/11. What was different though was that on 9/11, we were all in high distress, sadness, and fear. However, unlike 9/11, this time I have the uncanny experience of a few patients that were rejoicing or simply glad that Trump had won.”
My social media sites looked the same – disbelief, distress, obscenities, words of comfort, calls to action. Journalist Andrew Solomon posted on Twitter this morning: “It’s begun. A friend was walking in NYC and someone driving a U-Haul yelled, ‘Hey, homo. So what do you think of President Donald Trump?’” Meanwhile, Trump supporters were reportedly attacked with punches, eggs, and bottles at a protest rally in California. The country remains divided: President Obama and Hillary Clinton remind us that we should give Mr. Trump a chance and support his efforts as we are all one country, while thousands protest his victory in cities across the country.
What will President Trump’s election mean for psychiatry? The American Psychiatric Association gave money to support both candidates, and in the spirit of working together, President Maria A. Oquendo has sent him a letter of congratulations. There is nothing to be gained by having an antagonistic relationship with our country’s leader.
Trump has promised to repeal the Affordable Care Act on his first day in office. What will that mean? Will those covered by ACA policies suddenly lose their coverage? I can’t imagine that would be the case, or at least I hope not. And what about all the time, money, and effort that have been invested in Meaningful Use and the planned transition to MACRA to collect data? Do those systems vanish? I have a son who is about to turn 26 and works as a freelance writer for a fantasy sports website. Will he be able to get health insurance?
And Mr. Trump is a bit unpredictable. He has changed his political party affiliation seven times over the last 2 decades, and until 3 years ago, he was a registered Democrat. Perhaps he won’t repeal the ACA on day 1. Or day 2. We’ll have to wait and see, but in the long run, I think we all have to worry that there might be people with health insurance now who won’t have it in the future.
The mystery of Trump is that he ran a campaign without exposing any strategies. His health care plan boiled down to, We’ll get rid of the lines around the states; there will be open competition with health insurers; and it will be a beautiful thing. (My quote may be inexact, but I took careful note of it during one of the debates.)
Finally, we can ask what will happen with the Mental Health Reform Act of 2016, originally known as the Murphy bill or The Helping Families in Mental Health Crisis Act. The bill, calling for major mental health reforms, passed in the House by a vote of 422-2, and awaits a vote in the Senate during the lame duck session. While the APA supports passage of the bill, there is a great deal of controversy surrounding it, and in a Politico article, former congressman and current mental advocate Patrick Kennedy is quoted as saying that in its current form, the bill should not be passed. The latest version is “‘watered down’ and does nothing more than ‘reallocate money around block grants’ when it should instead ‘try for higher reimbursement rates’ for behavioral health providers. ‘Passing that bill will take the wind out of the sails for real reform,’” he added. “‘Kick it to the next Congress and the new administration to do this the right way.’” How the new administration will react to mental health reform is anyone’s guess.
Anne and I were scheduled to be on NPR’s Diane Rehm radio show this morning to talk about our new book; the unexpected election results led to a postponement while coverage of the election continues. My countdown until the end of this nightmare election reached 0, and I had planned to extend a Facebook re-friend request to my colleague and see if he’d have me back, but election coverage and speculation continue. It may be time for me to take another social media break.
The sun is shining in Baltimore today, and we certainly live in interesting times.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” which was released Nov. 1 by Johns Hopkins University Press.
I have to start this column with a disclaimer: I live in Maryland, and like most Marylanders, I am a Democrat. We’re one of the bluest states – today, you’re welcome to give that statement two meanings – and as such, I live in what today has been somewhat pejoratively called the educated, liberal, elitist, East Coast, “Hillary bubble,” where I can be one of the first to admit that I’m not in touch with the country as a whole. I’ll add one more disclaimer: I married a man I fell in love with during my freshman year of college.
As a teenager, I didn’t care much about politics, but my then-boyfriend was a political science major who was a Republican and spent a summer on Capitol Hill. So my blue world is just a bit influenced by decades of living, quite happily, in a bipartisan household. The adult children seem to have settled in as Democrats; the dogs have split parties.
“I thought Donald Trump was a joke, a reality TV thing.”
I hadn’t been paying much attention, and my husband, who remains calm and wise, reassured me that it was months until the primaries, and that Trump would not be the Republican nominee.
Time went on, and my anxiety grew. I found myself caught up in Facebook posts, and I mostly read like-minded rhetoric. In March, I was on vacation and found myself terribly distraught about a colleague’s post. He talked about his anxiety about the election, likened Trump to Hitler or Stalin, and asked what people would do if they found out their friends supported Trump. Should one end their friendship? I have strong viewpoints, and if I limited my friends only to those who agree with me on controversial issues, I would be rather lonely. I started to argue with my colleague’s friends – they likened voting for Trump to being anti-Semitic, and many felt one should end friendships with people who supported him. I decided I didn’t want to be Facebook friends with people who made their friendships contingent on how I vote. This was different, I was told, because of Trump’s xenophobia, and I ended up “unfriending” my colleague (only on Facebook), and turning off all my social media for a while.
When Trump won the Republican nomination, my husband told me I should be happy: This ensured that Hillary Clinton would win the election. He would not vote for Trump; our Republican governor, Larry Hogan, was not supporting Trump; it seemed that neither the Republicans nor the Democrats were enthusiastic about his nomination, and my anxiety waned.
A colleague noted he was having trouble listening to Trump supporters in therapy sessions. In my entire practice, only one patient mentioned being a Trump supporter, a transplant from a Southern state. It was not a major focus of therapy, except that he used it as an example of how he felt out of place in Maryland, and I had sympathy for his sense of isolation here.
My anxiety waned in the weeks before the election, though my patients talked more and more about it. I posted a countdown on Facebook – this nightmare of an election has divided our country, and given a voice to vulgarity and hate speech. While I still would not end a good friendship over a vote, I see Trump as unkind and undignified. He invests energy in being purposely cruel. And since I apparently don’t understand the “non-elitist” voter, it doesn’t make sense to me that disenfranchised blue collar workers hope a privileged billionaire with a history of deceit and mistreating others will be anyone’s savior. At one point, The New York Times’ The Upshot gave Trump a 9% chance of winning. If you are a Trump supporter, please don’t feel insulted, and I would be happy to try to understand your enthusiasm for his presidency.
On Tuesday night, my husband had to be out of town. My friend, psychiatrist Anne Hanson, came to “babysit” me as I didn’t want to be alone as the returns came in – perhaps I had some sense that Clinton could possibly lose. We ordered Indian food, and together, we sat in front of the television, completely dumbfounded.
The morning after came, and Maryland psychiatrists started posting about their despair on our listserv. Others offered support; one suggested that Trump might be just what our country needs; and numerous psychiatrists have said this a call to action, a time to get more involved. On Thursday morning, one psychiatrist noted: “Seeing my patients the day after the election this week felt very much like seeing patients the day after 9/11. What was different though was that on 9/11, we were all in high distress, sadness, and fear. However, unlike 9/11, this time I have the uncanny experience of a few patients that were rejoicing or simply glad that Trump had won.”
My social media sites looked the same – disbelief, distress, obscenities, words of comfort, calls to action. Journalist Andrew Solomon posted on Twitter this morning: “It’s begun. A friend was walking in NYC and someone driving a U-Haul yelled, ‘Hey, homo. So what do you think of President Donald Trump?’” Meanwhile, Trump supporters were reportedly attacked with punches, eggs, and bottles at a protest rally in California. The country remains divided: President Obama and Hillary Clinton remind us that we should give Mr. Trump a chance and support his efforts as we are all one country, while thousands protest his victory in cities across the country.
What will President Trump’s election mean for psychiatry? The American Psychiatric Association gave money to support both candidates, and in the spirit of working together, President Maria A. Oquendo has sent him a letter of congratulations. There is nothing to be gained by having an antagonistic relationship with our country’s leader.
Trump has promised to repeal the Affordable Care Act on his first day in office. What will that mean? Will those covered by ACA policies suddenly lose their coverage? I can’t imagine that would be the case, or at least I hope not. And what about all the time, money, and effort that have been invested in Meaningful Use and the planned transition to MACRA to collect data? Do those systems vanish? I have a son who is about to turn 26 and works as a freelance writer for a fantasy sports website. Will he be able to get health insurance?
And Mr. Trump is a bit unpredictable. He has changed his political party affiliation seven times over the last 2 decades, and until 3 years ago, he was a registered Democrat. Perhaps he won’t repeal the ACA on day 1. Or day 2. We’ll have to wait and see, but in the long run, I think we all have to worry that there might be people with health insurance now who won’t have it in the future.
The mystery of Trump is that he ran a campaign without exposing any strategies. His health care plan boiled down to, We’ll get rid of the lines around the states; there will be open competition with health insurers; and it will be a beautiful thing. (My quote may be inexact, but I took careful note of it during one of the debates.)
Finally, we can ask what will happen with the Mental Health Reform Act of 2016, originally known as the Murphy bill or The Helping Families in Mental Health Crisis Act. The bill, calling for major mental health reforms, passed in the House by a vote of 422-2, and awaits a vote in the Senate during the lame duck session. While the APA supports passage of the bill, there is a great deal of controversy surrounding it, and in a Politico article, former congressman and current mental advocate Patrick Kennedy is quoted as saying that in its current form, the bill should not be passed. The latest version is “‘watered down’ and does nothing more than ‘reallocate money around block grants’ when it should instead ‘try for higher reimbursement rates’ for behavioral health providers. ‘Passing that bill will take the wind out of the sails for real reform,’” he added. “‘Kick it to the next Congress and the new administration to do this the right way.’” How the new administration will react to mental health reform is anyone’s guess.
Anne and I were scheduled to be on NPR’s Diane Rehm radio show this morning to talk about our new book; the unexpected election results led to a postponement while coverage of the election continues. My countdown until the end of this nightmare election reached 0, and I had planned to extend a Facebook re-friend request to my colleague and see if he’d have me back, but election coverage and speculation continue. It may be time for me to take another social media break.
The sun is shining in Baltimore today, and we certainly live in interesting times.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” which was released Nov. 1 by Johns Hopkins University Press.
Friday/Saturday Debates
FRIDAY
Session 75: More Carotid Disease And Treatment Related Topics And Controversies; Transcervical Cas (Tcar) And New Mesh Covered Carotid Stents
1:18 p.m. – 1:23 p.m.
Debate: Early CEA After Symptom Onset Is Beneficial To Patients: The Earlier The Better After Certain Requirements Are Met
Presenter: Ross Naylor, MD, FRCS
1:24 p.m. – 1:29 p.m.
Debate: Early CEA after Symptoms (TIA or Small Stroke):
Timing is Everything: Within 48 Hours is Bad:
Within 3-14 Days is Good: Why
Presenter: Ian Loftus, MD
1:30 p.m. – 1:35 p.m.
Presenter: Laura Capoccia, MD, PhD
1:36 p.m. – 1:41 p.m.
Debate: Another Balanced View: When is Early CEA after Symptom Onset in Patients with Carotid Stenosis Safe and Beneficial and When is It Not
Presenter: Martin Bjorck, MD, PhD
Session 77: New Carotid Concepts and Updates
4:12 p.m. – 4:17 p.m.
Debate: CAS Has No Increased Cost Consequences Compared to CEA
Presenters: Brajesh K. Lal, MD / Thomas G. Brott, MD
4:18 p.m. – 4:23 p.m.
Debate: Not So: CEA Costs Less Than CAS: Why the Discrepancy
Presenter: Kosmas I. Paraskevas, MD
Session 79: New Developments in the Treatment of Aneurysms and Other Diseases Involving the Popliteal Artery
6:52 a.m. – 6:57 a.m.
Debate: Endovascular Repair of Popliteal Aneurysms is Less Risky Than Open Repair and Should Be the Procedure of Choice: What Percent of Patients Should Be Treated Endo
Presenter: Irwin V. Mohan, MBBS, MD, FRCS, FEBVS, FRACS
6:58 a.m. – 7:03 a.m.
Debate: Not So: Open Repair is Better for Most Popliteal Aneurysm Patients: Endo Repair Is Sometimes a Failed Experiment
Presenter: Martin Bjorck, MD, PhD
Session 80: Infected Arteries and Arterial Grafts and Their Treatment: Infected EVARs; Mycotic AAAs; Infected Aortic/Arterial Prosthetic Grafts; Treatment Of Aorto-Esophageal Fistula
7:40 a.m. – 7:45 a.m.
Debate: Update on Treatment of Infected Aortic Endografts: Open Surgical Graft Excision is Always Indicated
Presenter: Kamphol Laohapensang, MD
7:46 a.m. – 7:51 a.m.
Debate: Not So: Semi-Conservative Treatment Without Graft Excision and with Drainage and Antibiotic Irrigation of AAA Sac Can be Effective Treatment: Longer-Term Results Prove It
Presenter: Martin Malina, MD, PhD
Session 87: Venous Cross-Sectional Imaging Techniques, Pelvic Venous Disorders
8:35 a.m. – 8:40 a.m.
Debate: Renal Vein Transposition (with Patch) is the Ideal Treatment for Nutcracker Syndrome, Not Stenting
Presenter: Olivier Hartung, MD
8:41 a.m. – 8:46 a.m.
Debate: Gonadal Vein Transposition is the Ideal Treatment for Nutcracker Syndrome
Presenter: Cynthia K. Shortell, MD
8:47 a.m. – 8:52 a.m.
Debate: Stenting is the Ideal Treatment or Nutcracker Syndrome
Presenter: Thomas S. Maldonado, MD
8:53 a.m. – 8:58 a.m.
Debate: Hybrid Endo-Open Surgery is the Ideal Treatment for Nutcracker Syndrome
Manju Kalra, MBBS
Session 88: Femoro-Iliocaval Interventional Strategies to Reduce Venous Hypertension, Hot Ideas for Recanalizing Chronic Total Occlusions
9:11 a.m. – 9:16 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is of Limited Value in the Endovascular Era
Presenter: Jose I. Almeida, MD, FACS, RPVI, RVT
9:17 a.m. – 9:22 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is Standard of Care
Presenter: Cees H.A. Wittens, MD, PhD
FRIDAY
Session 75: More Carotid Disease And Treatment Related Topics And Controversies; Transcervical Cas (Tcar) And New Mesh Covered Carotid Stents
1:18 p.m. – 1:23 p.m.
Debate: Early CEA After Symptom Onset Is Beneficial To Patients: The Earlier The Better After Certain Requirements Are Met
Presenter: Ross Naylor, MD, FRCS
1:24 p.m. – 1:29 p.m.
Debate: Early CEA after Symptoms (TIA or Small Stroke):
Timing is Everything: Within 48 Hours is Bad:
Within 3-14 Days is Good: Why
Presenter: Ian Loftus, MD
1:30 p.m. – 1:35 p.m.
Presenter: Laura Capoccia, MD, PhD
1:36 p.m. – 1:41 p.m.
Debate: Another Balanced View: When is Early CEA after Symptom Onset in Patients with Carotid Stenosis Safe and Beneficial and When is It Not
Presenter: Martin Bjorck, MD, PhD
Session 77: New Carotid Concepts and Updates
4:12 p.m. – 4:17 p.m.
Debate: CAS Has No Increased Cost Consequences Compared to CEA
Presenters: Brajesh K. Lal, MD / Thomas G. Brott, MD
4:18 p.m. – 4:23 p.m.
Debate: Not So: CEA Costs Less Than CAS: Why the Discrepancy
Presenter: Kosmas I. Paraskevas, MD
Session 79: New Developments in the Treatment of Aneurysms and Other Diseases Involving the Popliteal Artery
6:52 a.m. – 6:57 a.m.
Debate: Endovascular Repair of Popliteal Aneurysms is Less Risky Than Open Repair and Should Be the Procedure of Choice: What Percent of Patients Should Be Treated Endo
Presenter: Irwin V. Mohan, MBBS, MD, FRCS, FEBVS, FRACS
6:58 a.m. – 7:03 a.m.
Debate: Not So: Open Repair is Better for Most Popliteal Aneurysm Patients: Endo Repair Is Sometimes a Failed Experiment
Presenter: Martin Bjorck, MD, PhD
Session 80: Infected Arteries and Arterial Grafts and Their Treatment: Infected EVARs; Mycotic AAAs; Infected Aortic/Arterial Prosthetic Grafts; Treatment Of Aorto-Esophageal Fistula
7:40 a.m. – 7:45 a.m.
Debate: Update on Treatment of Infected Aortic Endografts: Open Surgical Graft Excision is Always Indicated
Presenter: Kamphol Laohapensang, MD
7:46 a.m. – 7:51 a.m.
Debate: Not So: Semi-Conservative Treatment Without Graft Excision and with Drainage and Antibiotic Irrigation of AAA Sac Can be Effective Treatment: Longer-Term Results Prove It
Presenter: Martin Malina, MD, PhD
Session 87: Venous Cross-Sectional Imaging Techniques, Pelvic Venous Disorders
8:35 a.m. – 8:40 a.m.
Debate: Renal Vein Transposition (with Patch) is the Ideal Treatment for Nutcracker Syndrome, Not Stenting
Presenter: Olivier Hartung, MD
8:41 a.m. – 8:46 a.m.
Debate: Gonadal Vein Transposition is the Ideal Treatment for Nutcracker Syndrome
Presenter: Cynthia K. Shortell, MD
8:47 a.m. – 8:52 a.m.
Debate: Stenting is the Ideal Treatment or Nutcracker Syndrome
Presenter: Thomas S. Maldonado, MD
8:53 a.m. – 8:58 a.m.
Debate: Hybrid Endo-Open Surgery is the Ideal Treatment for Nutcracker Syndrome
Manju Kalra, MBBS
Session 88: Femoro-Iliocaval Interventional Strategies to Reduce Venous Hypertension, Hot Ideas for Recanalizing Chronic Total Occlusions
9:11 a.m. – 9:16 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is of Limited Value in the Endovascular Era
Presenter: Jose I. Almeida, MD, FACS, RPVI, RVT
9:17 a.m. – 9:22 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is Standard of Care
Presenter: Cees H.A. Wittens, MD, PhD
FRIDAY
Session 75: More Carotid Disease And Treatment Related Topics And Controversies; Transcervical Cas (Tcar) And New Mesh Covered Carotid Stents
1:18 p.m. – 1:23 p.m.
Debate: Early CEA After Symptom Onset Is Beneficial To Patients: The Earlier The Better After Certain Requirements Are Met
Presenter: Ross Naylor, MD, FRCS
1:24 p.m. – 1:29 p.m.
Debate: Early CEA after Symptoms (TIA or Small Stroke):
Timing is Everything: Within 48 Hours is Bad:
Within 3-14 Days is Good: Why
Presenter: Ian Loftus, MD
1:30 p.m. – 1:35 p.m.
Presenter: Laura Capoccia, MD, PhD
1:36 p.m. – 1:41 p.m.
Debate: Another Balanced View: When is Early CEA after Symptom Onset in Patients with Carotid Stenosis Safe and Beneficial and When is It Not
Presenter: Martin Bjorck, MD, PhD
Session 77: New Carotid Concepts and Updates
4:12 p.m. – 4:17 p.m.
Debate: CAS Has No Increased Cost Consequences Compared to CEA
Presenters: Brajesh K. Lal, MD / Thomas G. Brott, MD
4:18 p.m. – 4:23 p.m.
Debate: Not So: CEA Costs Less Than CAS: Why the Discrepancy
Presenter: Kosmas I. Paraskevas, MD
Session 79: New Developments in the Treatment of Aneurysms and Other Diseases Involving the Popliteal Artery
6:52 a.m. – 6:57 a.m.
Debate: Endovascular Repair of Popliteal Aneurysms is Less Risky Than Open Repair and Should Be the Procedure of Choice: What Percent of Patients Should Be Treated Endo
Presenter: Irwin V. Mohan, MBBS, MD, FRCS, FEBVS, FRACS
6:58 a.m. – 7:03 a.m.
Debate: Not So: Open Repair is Better for Most Popliteal Aneurysm Patients: Endo Repair Is Sometimes a Failed Experiment
Presenter: Martin Bjorck, MD, PhD
Session 80: Infected Arteries and Arterial Grafts and Their Treatment: Infected EVARs; Mycotic AAAs; Infected Aortic/Arterial Prosthetic Grafts; Treatment Of Aorto-Esophageal Fistula
7:40 a.m. – 7:45 a.m.
Debate: Update on Treatment of Infected Aortic Endografts: Open Surgical Graft Excision is Always Indicated
Presenter: Kamphol Laohapensang, MD
7:46 a.m. – 7:51 a.m.
Debate: Not So: Semi-Conservative Treatment Without Graft Excision and with Drainage and Antibiotic Irrigation of AAA Sac Can be Effective Treatment: Longer-Term Results Prove It
Presenter: Martin Malina, MD, PhD
Session 87: Venous Cross-Sectional Imaging Techniques, Pelvic Venous Disorders
8:35 a.m. – 8:40 a.m.
Debate: Renal Vein Transposition (with Patch) is the Ideal Treatment for Nutcracker Syndrome, Not Stenting
Presenter: Olivier Hartung, MD
8:41 a.m. – 8:46 a.m.
Debate: Gonadal Vein Transposition is the Ideal Treatment for Nutcracker Syndrome
Presenter: Cynthia K. Shortell, MD
8:47 a.m. – 8:52 a.m.
Debate: Stenting is the Ideal Treatment or Nutcracker Syndrome
Presenter: Thomas S. Maldonado, MD
8:53 a.m. – 8:58 a.m.
Debate: Hybrid Endo-Open Surgery is the Ideal Treatment for Nutcracker Syndrome
Manju Kalra, MBBS
Session 88: Femoro-Iliocaval Interventional Strategies to Reduce Venous Hypertension, Hot Ideas for Recanalizing Chronic Total Occlusions
9:11 a.m. – 9:16 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is of Limited Value in the Endovascular Era
Presenter: Jose I. Almeida, MD, FACS, RPVI, RVT
9:17 a.m. – 9:22 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is Standard of Care
Presenter: Cees H.A. Wittens, MD, PhD
Session Tackles Vascular Malformations
A session on Friday morning entitled “Introduction to Vascular Malformations” will consider the classification, imaging, and surgical approaches to the congenital anomalies that occur in veins, lymph nodes, both, or in arteries and veins. The session will be co-moderated by Dr. Krassi Ivancev, University Hospital Hamburg-Eppendorf, Hamburg, Germany, and Dr. Furuzan Numan, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey.
Vascular malformations are present at birth and become apparent sometime later in life. Surgery often does not completely remove a malformation, which can lead to recurrence.
“Vascular malformations constitute the most difficult challenge in the world of vascular medicine and as a group are the most challenging of all vascular disease entities. Compounding their inherent difficulty in clinical management is the extreme rarity of these complex vascular lesions. Most malformations are in surgically difficult anatomies and many are impossible to resect, save by amputation,” said Dr. Ivancev.
Since vascular anomalies represent a spectrum of disorders, incorrect identification and misdiagnosis can occur, which can lead clinicians in the wrong direction when treating patients. As will be discussed by Dr. Leo J. Schultze Kool of Radboud University Nijmegen in the Netherlands, the International Society for the Study of Vascular Anomalies (ISSVA) classification system stratifies vascular lesions into vascular malformations and proliferative vascular lesions.
Dr. Wayne Yakes of the Yakes Vascular Malformation Center, will discuss an arteriovenous malformation (AVM) classification system he pioneered that defines all the angioarchitectures and their associated treatment strategies. Dr. Yakes will also talk about the therapeutic implications of the AVM classification when confronting challenging cases.
Diagnostic classification of vascular anomalies based on their visual appearance has been an area of innovation and invention in recent years. Imaging of congenital vascular malformations using magnetic resonance and using this information as a guide to treatment will be addressed by Dr. R. Sean Pakbaz of Scripps Healthcare.
Embolization techniques began to be used about 30 years ago, and have proven to be effective. Dr. James Donaldson of Northwestern University Feinberg School of Medicine will discuss endovascular access and embolization in neonates and children.
Session 92: Introduction to Vascular Malformations
Friday 6:45 a.m. – 7:30 a.m.
Gramercy Suites East and West, 2nd Floor
A session on Friday morning entitled “Introduction to Vascular Malformations” will consider the classification, imaging, and surgical approaches to the congenital anomalies that occur in veins, lymph nodes, both, or in arteries and veins. The session will be co-moderated by Dr. Krassi Ivancev, University Hospital Hamburg-Eppendorf, Hamburg, Germany, and Dr. Furuzan Numan, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey.
Vascular malformations are present at birth and become apparent sometime later in life. Surgery often does not completely remove a malformation, which can lead to recurrence.
“Vascular malformations constitute the most difficult challenge in the world of vascular medicine and as a group are the most challenging of all vascular disease entities. Compounding their inherent difficulty in clinical management is the extreme rarity of these complex vascular lesions. Most malformations are in surgically difficult anatomies and many are impossible to resect, save by amputation,” said Dr. Ivancev.
Since vascular anomalies represent a spectrum of disorders, incorrect identification and misdiagnosis can occur, which can lead clinicians in the wrong direction when treating patients. As will be discussed by Dr. Leo J. Schultze Kool of Radboud University Nijmegen in the Netherlands, the International Society for the Study of Vascular Anomalies (ISSVA) classification system stratifies vascular lesions into vascular malformations and proliferative vascular lesions.
Dr. Wayne Yakes of the Yakes Vascular Malformation Center, will discuss an arteriovenous malformation (AVM) classification system he pioneered that defines all the angioarchitectures and their associated treatment strategies. Dr. Yakes will also talk about the therapeutic implications of the AVM classification when confronting challenging cases.
Diagnostic classification of vascular anomalies based on their visual appearance has been an area of innovation and invention in recent years. Imaging of congenital vascular malformations using magnetic resonance and using this information as a guide to treatment will be addressed by Dr. R. Sean Pakbaz of Scripps Healthcare.
Embolization techniques began to be used about 30 years ago, and have proven to be effective. Dr. James Donaldson of Northwestern University Feinberg School of Medicine will discuss endovascular access and embolization in neonates and children.
Session 92: Introduction to Vascular Malformations
Friday 6:45 a.m. – 7:30 a.m.
Gramercy Suites East and West, 2nd Floor
A session on Friday morning entitled “Introduction to Vascular Malformations” will consider the classification, imaging, and surgical approaches to the congenital anomalies that occur in veins, lymph nodes, both, or in arteries and veins. The session will be co-moderated by Dr. Krassi Ivancev, University Hospital Hamburg-Eppendorf, Hamburg, Germany, and Dr. Furuzan Numan, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey.
Vascular malformations are present at birth and become apparent sometime later in life. Surgery often does not completely remove a malformation, which can lead to recurrence.
“Vascular malformations constitute the most difficult challenge in the world of vascular medicine and as a group are the most challenging of all vascular disease entities. Compounding their inherent difficulty in clinical management is the extreme rarity of these complex vascular lesions. Most malformations are in surgically difficult anatomies and many are impossible to resect, save by amputation,” said Dr. Ivancev.
Since vascular anomalies represent a spectrum of disorders, incorrect identification and misdiagnosis can occur, which can lead clinicians in the wrong direction when treating patients. As will be discussed by Dr. Leo J. Schultze Kool of Radboud University Nijmegen in the Netherlands, the International Society for the Study of Vascular Anomalies (ISSVA) classification system stratifies vascular lesions into vascular malformations and proliferative vascular lesions.
Dr. Wayne Yakes of the Yakes Vascular Malformation Center, will discuss an arteriovenous malformation (AVM) classification system he pioneered that defines all the angioarchitectures and their associated treatment strategies. Dr. Yakes will also talk about the therapeutic implications of the AVM classification when confronting challenging cases.
Diagnostic classification of vascular anomalies based on their visual appearance has been an area of innovation and invention in recent years. Imaging of congenital vascular malformations using magnetic resonance and using this information as a guide to treatment will be addressed by Dr. R. Sean Pakbaz of Scripps Healthcare.
Embolization techniques began to be used about 30 years ago, and have proven to be effective. Dr. James Donaldson of Northwestern University Feinberg School of Medicine will discuss endovascular access and embolization in neonates and children.
Session 92: Introduction to Vascular Malformations
Friday 6:45 a.m. – 7:30 a.m.
Gramercy Suites East and West, 2nd Floor
Include quality of life measures in evaluating treatment success of psoriasis
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
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EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR