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Observational data can’t answer question of inhibiting ankylosing spondylitis progression
AMSTERDAM – The attempt to determine whether biologics such as tumor necrosis factor inhibitors (TNFi) inhibit progression of ankylosing spondylitis has been pursued with observational studies, but these types of studies will never definitively answer the question, according to Robert B.M. Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.
“The methodology is sensitive to a lot of measurement error, making the results spurious,” Dr. Landewé said in an interview, recapping remarks he made in a presentation at the European Congress of Rheumatology.
This was disappointing to many investigators, including several speaking in the same symposium where Dr. Landewé made his remarks. Randomized, controlled trials that employ serial radiographs to document changes in ankylosing spondylitis are expensive, making observational studies an attractive surrogate, but Dr. Landewé said such studies are associated with an inherent risk of residual confounding.
In addition, he believes the effect size of biologics on progression, if it exists at all, is likely to be subtle. In the observational studies that have concluded that there is protection, complicated statistical analyses have been typically employed to produce a significant finding.
Observational studies do have hypothesis-generating value, according to Dr. Landewé, but he cautioned that they produce “more questions than answers.” He also emphasized that the inflammation-related progression that leads to bone growth in ankylosing spondylitis is different than it is in the destructive inflammatory diseases, such as rheumatoid arthritis, where the issue is bone loss.
It is rational to assume that effective anti-inflammatory therapy would prevent progression of inflammatory diseases, but Dr. Landewé said in his presentation that this is the type of bias that undermines the value of observational studies for reaching objective conclusions. Unlike the results of a registered randomized, controlled trial, which will be known to be consistent or not with the underlying hypothesis, there is a strong risk that data in an observational study will be reworked until they produce the desired result.
AMSTERDAM – The attempt to determine whether biologics such as tumor necrosis factor inhibitors (TNFi) inhibit progression of ankylosing spondylitis has been pursued with observational studies, but these types of studies will never definitively answer the question, according to Robert B.M. Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.
“The methodology is sensitive to a lot of measurement error, making the results spurious,” Dr. Landewé said in an interview, recapping remarks he made in a presentation at the European Congress of Rheumatology.
This was disappointing to many investigators, including several speaking in the same symposium where Dr. Landewé made his remarks. Randomized, controlled trials that employ serial radiographs to document changes in ankylosing spondylitis are expensive, making observational studies an attractive surrogate, but Dr. Landewé said such studies are associated with an inherent risk of residual confounding.
In addition, he believes the effect size of biologics on progression, if it exists at all, is likely to be subtle. In the observational studies that have concluded that there is protection, complicated statistical analyses have been typically employed to produce a significant finding.
Observational studies do have hypothesis-generating value, according to Dr. Landewé, but he cautioned that they produce “more questions than answers.” He also emphasized that the inflammation-related progression that leads to bone growth in ankylosing spondylitis is different than it is in the destructive inflammatory diseases, such as rheumatoid arthritis, where the issue is bone loss.
It is rational to assume that effective anti-inflammatory therapy would prevent progression of inflammatory diseases, but Dr. Landewé said in his presentation that this is the type of bias that undermines the value of observational studies for reaching objective conclusions. Unlike the results of a registered randomized, controlled trial, which will be known to be consistent or not with the underlying hypothesis, there is a strong risk that data in an observational study will be reworked until they produce the desired result.
AMSTERDAM – The attempt to determine whether biologics such as tumor necrosis factor inhibitors (TNFi) inhibit progression of ankylosing spondylitis has been pursued with observational studies, but these types of studies will never definitively answer the question, according to Robert B.M. Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.
“The methodology is sensitive to a lot of measurement error, making the results spurious,” Dr. Landewé said in an interview, recapping remarks he made in a presentation at the European Congress of Rheumatology.
This was disappointing to many investigators, including several speaking in the same symposium where Dr. Landewé made his remarks. Randomized, controlled trials that employ serial radiographs to document changes in ankylosing spondylitis are expensive, making observational studies an attractive surrogate, but Dr. Landewé said such studies are associated with an inherent risk of residual confounding.
In addition, he believes the effect size of biologics on progression, if it exists at all, is likely to be subtle. In the observational studies that have concluded that there is protection, complicated statistical analyses have been typically employed to produce a significant finding.
Observational studies do have hypothesis-generating value, according to Dr. Landewé, but he cautioned that they produce “more questions than answers.” He also emphasized that the inflammation-related progression that leads to bone growth in ankylosing spondylitis is different than it is in the destructive inflammatory diseases, such as rheumatoid arthritis, where the issue is bone loss.
It is rational to assume that effective anti-inflammatory therapy would prevent progression of inflammatory diseases, but Dr. Landewé said in his presentation that this is the type of bias that undermines the value of observational studies for reaching objective conclusions. Unlike the results of a registered randomized, controlled trial, which will be known to be consistent or not with the underlying hypothesis, there is a strong risk that data in an observational study will be reworked until they produce the desired result.
REPORTING FROM THE EULAR 2018 CONGRESS
TNF inhibitor may protect against axSpA sacroiliac joint progression
AMSTERDAM – In patients with axial spondyloarthritis, new evidence presented at the European Congress of Rheumatology associated tumor necrosis factor inhibitor therapy with prevention of sacroiliac joint progression.
“We already know that biologics can decelerate progression in the spine. The goal of this analysis was to determine whether there is also reduced risk of progression in the sacroiliac joints,” reported Valeria Rios-Rodríguez, MD, of Charité University Clinic in Berlin.
The patients were drawn from the ESTHER trial (Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1), which established the efficacy of the tumor necrosis factor (TNF) inhibitor etanercept over sulfasalazine in patients with early axSpA (Ann Rheum Dis. 2011 Jul;70:590-6). In ESTHER, all patients not in remission after 1 year continued on or were switched to maintenance etanercept. These patients provided the basis for Dr. Rios-Rodriguez and her colleagues’ analysis.
In this study of patients who remained on therapy, two blinded and experienced readers scored the radiographs for sacroiliac joint damage. A standardized modified New York grading system was employed. In addition, blinded readers graded MRI scans with the Berlin MRI Scoring System for inflammatory changes. Only 35% of patients had radiographic axSpA at baseline, reflecting the fact that ESTHER enrolled patients with early-stage axSpA.
A variety of factors were evaluated for their association with progression, including age, symptom duration, treatment duration, and HLA-B27 positivity. Of these factors, elevated C-reactive protein, defined as more than 5 mg/L, and the presence of sacroiliac joint osteitis on MRI emerged as predictive factors on univariate analysis.
“Evaluated with two different analyses, both of these factors were found to be independently associated with radiographic progression,” Dr. Rios-Rodriguez said. However, she reiterated that these factors were meaningful only at year 2 and 4 when progression was seen.
“Our results show a deceleration of progression of structural damage in sacroiliac joints in patients under long-term TNF inhibitor therapy. These findings match the deceleration of spine progression observed in previous studies under similar conditions,” she said, noting that the predictors for structural damage in sacroiliac joints identified in this study are similar to the ones identified for the progression in the spine.
“To our knowledge, our data on sacroiliac joints is unique and will continue to be so in the coming years,” she said.
Pfizer provided funding for the study. Dr. Rios-Rodriguez reported financial relationships with AbbVie and Novartis.
SOURCE: Rios-Rodriguez V et al. Ann Rheum Dis. 2018;77(Suppl 2):62-3. Abstract OP0025.
AMSTERDAM – In patients with axial spondyloarthritis, new evidence presented at the European Congress of Rheumatology associated tumor necrosis factor inhibitor therapy with prevention of sacroiliac joint progression.
“We already know that biologics can decelerate progression in the spine. The goal of this analysis was to determine whether there is also reduced risk of progression in the sacroiliac joints,” reported Valeria Rios-Rodríguez, MD, of Charité University Clinic in Berlin.
The patients were drawn from the ESTHER trial (Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1), which established the efficacy of the tumor necrosis factor (TNF) inhibitor etanercept over sulfasalazine in patients with early axSpA (Ann Rheum Dis. 2011 Jul;70:590-6). In ESTHER, all patients not in remission after 1 year continued on or were switched to maintenance etanercept. These patients provided the basis for Dr. Rios-Rodriguez and her colleagues’ analysis.
In this study of patients who remained on therapy, two blinded and experienced readers scored the radiographs for sacroiliac joint damage. A standardized modified New York grading system was employed. In addition, blinded readers graded MRI scans with the Berlin MRI Scoring System for inflammatory changes. Only 35% of patients had radiographic axSpA at baseline, reflecting the fact that ESTHER enrolled patients with early-stage axSpA.
A variety of factors were evaluated for their association with progression, including age, symptom duration, treatment duration, and HLA-B27 positivity. Of these factors, elevated C-reactive protein, defined as more than 5 mg/L, and the presence of sacroiliac joint osteitis on MRI emerged as predictive factors on univariate analysis.
“Evaluated with two different analyses, both of these factors were found to be independently associated with radiographic progression,” Dr. Rios-Rodriguez said. However, she reiterated that these factors were meaningful only at year 2 and 4 when progression was seen.
“Our results show a deceleration of progression of structural damage in sacroiliac joints in patients under long-term TNF inhibitor therapy. These findings match the deceleration of spine progression observed in previous studies under similar conditions,” she said, noting that the predictors for structural damage in sacroiliac joints identified in this study are similar to the ones identified for the progression in the spine.
“To our knowledge, our data on sacroiliac joints is unique and will continue to be so in the coming years,” she said.
Pfizer provided funding for the study. Dr. Rios-Rodriguez reported financial relationships with AbbVie and Novartis.
SOURCE: Rios-Rodriguez V et al. Ann Rheum Dis. 2018;77(Suppl 2):62-3. Abstract OP0025.
AMSTERDAM – In patients with axial spondyloarthritis, new evidence presented at the European Congress of Rheumatology associated tumor necrosis factor inhibitor therapy with prevention of sacroiliac joint progression.
“We already know that biologics can decelerate progression in the spine. The goal of this analysis was to determine whether there is also reduced risk of progression in the sacroiliac joints,” reported Valeria Rios-Rodríguez, MD, of Charité University Clinic in Berlin.
The patients were drawn from the ESTHER trial (Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1), which established the efficacy of the tumor necrosis factor (TNF) inhibitor etanercept over sulfasalazine in patients with early axSpA (Ann Rheum Dis. 2011 Jul;70:590-6). In ESTHER, all patients not in remission after 1 year continued on or were switched to maintenance etanercept. These patients provided the basis for Dr. Rios-Rodriguez and her colleagues’ analysis.
In this study of patients who remained on therapy, two blinded and experienced readers scored the radiographs for sacroiliac joint damage. A standardized modified New York grading system was employed. In addition, blinded readers graded MRI scans with the Berlin MRI Scoring System for inflammatory changes. Only 35% of patients had radiographic axSpA at baseline, reflecting the fact that ESTHER enrolled patients with early-stage axSpA.
A variety of factors were evaluated for their association with progression, including age, symptom duration, treatment duration, and HLA-B27 positivity. Of these factors, elevated C-reactive protein, defined as more than 5 mg/L, and the presence of sacroiliac joint osteitis on MRI emerged as predictive factors on univariate analysis.
“Evaluated with two different analyses, both of these factors were found to be independently associated with radiographic progression,” Dr. Rios-Rodriguez said. However, she reiterated that these factors were meaningful only at year 2 and 4 when progression was seen.
“Our results show a deceleration of progression of structural damage in sacroiliac joints in patients under long-term TNF inhibitor therapy. These findings match the deceleration of spine progression observed in previous studies under similar conditions,” she said, noting that the predictors for structural damage in sacroiliac joints identified in this study are similar to the ones identified for the progression in the spine.
“To our knowledge, our data on sacroiliac joints is unique and will continue to be so in the coming years,” she said.
Pfizer provided funding for the study. Dr. Rios-Rodriguez reported financial relationships with AbbVie and Novartis.
SOURCE: Rios-Rodriguez V et al. Ann Rheum Dis. 2018;77(Suppl 2):62-3. Abstract OP0025.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point:
Major finding: Sacroiliac joint progression was seen in 18% of patients at year 2, 4.1% at year 4, and 0% at year 6.
Study details: A post hoc analysis of a subset of 42 patients in the randomized ESTHER trial.
Disclosures: Pfizer provided funding for the study. Dr. Rios-Rodriguez reported financial relationships with AbbVie and Novartis.
Source: Rios-Rodriguez V et al. Ann Rheum Dis. 2018;77(Suppl 2):62-3. Abstract OP0025.
FDA database reveals many rheumatic and musculoskeletal adverse events on immunotherapies
AMSTERDAM – Mining of the Food and Drug Administration adverse events database revealed a more substantial risk of rheumatic and musculoskeletal events on checkpoint inhibitor therapy than has been previously reported, according to Xerxes N. Pundole, PhD, an instructor in the research faculty at the University of Texas MD Anderson Cancer Center, Houston.
In a video interview, Dr. Pundole summarized data he presented at the European Congress of Rheumatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
So far, according to Dr. Pundole, there have been a relatively limited number of reports in the medical literature of inflammatory rheumatic or musculoskeletal events from checkpoint inhibitors. However, other inflammatory conditions, such as colitis and pneumonitis, are known to occur commonly with these agents. The FDA adverse event database provided an opportunity to evaluate how often rheumatic and musculoskeletal events are reported in the real world.
In this interview, Dr. Pundole explained that rheumatic and musculoskeletal events do occur at higher rates than would be expected in patients not treated with a checkpoint inhibitor. With data from more than 30,000 unique patients, the relative risks of some of these adverse events, such as polymyositis, were more than doubled, although the event rates were not evenly distributed.
Specifically, rheumatic and musculoskeletal adverse events were far less common with the cytotoxic T-lymphocyte antigen 4 checkpoint inhibitor ipilimumab (Yervoy) relative to programmed cell death protein 1 inhibitors, particularly nivolumab (Opdivo).
In another notable finding, a demographic stratification of the FDA database found elderly men to be overrepresented among patients developing adverse events related to musculoskeletal inflammation.
Overall, his data do support a relationship between checkpoint inhibitors and a greater risk of rheumatic and musculoskeletal adverse events than has been previously reported, but he noted that these data provide no specific guidance for those who already have RA or another inflammatory condition.
“Can you identify these adverse events early on to keep the patients on immune checkpoint inhibitor therapy and not have to stop their cancer treatment? That’s a question,” Dr. Pundole said. However, he suggested that the FDA data support clinician awareness of the problem and the studies that will establish strategies for preserving the benefit-to-risk ratio of checkpoint inhibitors in patients who are at greater risk of adverse events relative to immune function because of a preexisting inflammatory condition.
SOURCE: Pundole XN et al. Ann Rheum Dis. 2018;77(Suppl 2):147-148. Abstract OP0197.
AMSTERDAM – Mining of the Food and Drug Administration adverse events database revealed a more substantial risk of rheumatic and musculoskeletal events on checkpoint inhibitor therapy than has been previously reported, according to Xerxes N. Pundole, PhD, an instructor in the research faculty at the University of Texas MD Anderson Cancer Center, Houston.
In a video interview, Dr. Pundole summarized data he presented at the European Congress of Rheumatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
So far, according to Dr. Pundole, there have been a relatively limited number of reports in the medical literature of inflammatory rheumatic or musculoskeletal events from checkpoint inhibitors. However, other inflammatory conditions, such as colitis and pneumonitis, are known to occur commonly with these agents. The FDA adverse event database provided an opportunity to evaluate how often rheumatic and musculoskeletal events are reported in the real world.
In this interview, Dr. Pundole explained that rheumatic and musculoskeletal events do occur at higher rates than would be expected in patients not treated with a checkpoint inhibitor. With data from more than 30,000 unique patients, the relative risks of some of these adverse events, such as polymyositis, were more than doubled, although the event rates were not evenly distributed.
Specifically, rheumatic and musculoskeletal adverse events were far less common with the cytotoxic T-lymphocyte antigen 4 checkpoint inhibitor ipilimumab (Yervoy) relative to programmed cell death protein 1 inhibitors, particularly nivolumab (Opdivo).
In another notable finding, a demographic stratification of the FDA database found elderly men to be overrepresented among patients developing adverse events related to musculoskeletal inflammation.
Overall, his data do support a relationship between checkpoint inhibitors and a greater risk of rheumatic and musculoskeletal adverse events than has been previously reported, but he noted that these data provide no specific guidance for those who already have RA or another inflammatory condition.
“Can you identify these adverse events early on to keep the patients on immune checkpoint inhibitor therapy and not have to stop their cancer treatment? That’s a question,” Dr. Pundole said. However, he suggested that the FDA data support clinician awareness of the problem and the studies that will establish strategies for preserving the benefit-to-risk ratio of checkpoint inhibitors in patients who are at greater risk of adverse events relative to immune function because of a preexisting inflammatory condition.
SOURCE: Pundole XN et al. Ann Rheum Dis. 2018;77(Suppl 2):147-148. Abstract OP0197.
AMSTERDAM – Mining of the Food and Drug Administration adverse events database revealed a more substantial risk of rheumatic and musculoskeletal events on checkpoint inhibitor therapy than has been previously reported, according to Xerxes N. Pundole, PhD, an instructor in the research faculty at the University of Texas MD Anderson Cancer Center, Houston.
In a video interview, Dr. Pundole summarized data he presented at the European Congress of Rheumatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
So far, according to Dr. Pundole, there have been a relatively limited number of reports in the medical literature of inflammatory rheumatic or musculoskeletal events from checkpoint inhibitors. However, other inflammatory conditions, such as colitis and pneumonitis, are known to occur commonly with these agents. The FDA adverse event database provided an opportunity to evaluate how often rheumatic and musculoskeletal events are reported in the real world.
In this interview, Dr. Pundole explained that rheumatic and musculoskeletal events do occur at higher rates than would be expected in patients not treated with a checkpoint inhibitor. With data from more than 30,000 unique patients, the relative risks of some of these adverse events, such as polymyositis, were more than doubled, although the event rates were not evenly distributed.
Specifically, rheumatic and musculoskeletal adverse events were far less common with the cytotoxic T-lymphocyte antigen 4 checkpoint inhibitor ipilimumab (Yervoy) relative to programmed cell death protein 1 inhibitors, particularly nivolumab (Opdivo).
In another notable finding, a demographic stratification of the FDA database found elderly men to be overrepresented among patients developing adverse events related to musculoskeletal inflammation.
Overall, his data do support a relationship between checkpoint inhibitors and a greater risk of rheumatic and musculoskeletal adverse events than has been previously reported, but he noted that these data provide no specific guidance for those who already have RA or another inflammatory condition.
“Can you identify these adverse events early on to keep the patients on immune checkpoint inhibitor therapy and not have to stop their cancer treatment? That’s a question,” Dr. Pundole said. However, he suggested that the FDA data support clinician awareness of the problem and the studies that will establish strategies for preserving the benefit-to-risk ratio of checkpoint inhibitors in patients who are at greater risk of adverse events relative to immune function because of a preexisting inflammatory condition.
SOURCE: Pundole XN et al. Ann Rheum Dis. 2018;77(Suppl 2):147-148. Abstract OP0197.
REPORTING FROM THE EULAR 2018 CONGRESS
Malignancy risk of tocilizumab and TNF inhibitors found similar
AMSTERDAM – , according to an analysis of three large databases presented at the European Congress of Rheumatology.
“When we combined the databases, the incidence of any malignancy excluding nonmelanoma skin cancer was 13.09 per 1,000 patient years in the tocilizumab group and 13.46 in the TNF-inhibitor group,” reported Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology & pharmacoeconomics at Brigham and Women’s Hospital, Boston.
The study was conducted with data from 10,393 adult RA patients treated with tocilizumab and 26,357 patients treated with TNFi in the Medicare, QuintilesIMS PharMetrics Plus, and Truven Health MarketScan databases. All patients were new starts on tocilizumab or the TNFi on which they were evaluated, but all were required to have been exposed to at least one different biologic prior to starting the treatment. A diagnosis of RA at least 365 days prior to inclusion in this analysis was required to rule out prevalent cancers, which was an exclusion criterion.
More than 60 covariates were employed in the analysis to minimize the risk of confounders. These included demographics, RA characteristics, comorbidities, and other medications.
There also was no difference in the rates of the 12 most common cancer types when those exposed to tocilizumab were compared with those exposed to TNFi in a secondary analysis of these data, according to Dr. Kim. When expressed as hazard ratios, there were some numerical differences in relative risk among these cancers on both as-treated and intention-to-treat analyses, but confidence intervals were large, and none approached significance.
RA itself has been associated with an increased risk of some malignancies, such as lung cancer, but the relationship between the proinflammatory state of RA, its treatments, and the risk of cancer has been unclear, according to Dr. Kim. She said, “There is some concern relative to use of TNFi or other biologics in regard to developing malignancy, but studies have been inconsistent.”
Dr. Kim conceded that a lack of data on patients’ disease duration or activity is one limitation of this analysis. Another is that residual confounding can never be ruled out from a retrospective analysis. However, she said that, because the two biologics were compared for the same indication in patients exposed to at least one previous biologic, the confounding may be less than it would be if tocilizumab was compared with a conventional synthetic disease modifying antirheumatic drug (csDMARD), such as methotrexate. Again, there also was a requirement for exposure to at least one prior biologic, and this also is reassuring for the final conclusion.
“In other words, even among RA patients who were exposed to more than one biologic, the risk of cancer was similar between tocilizumab and TNF-inhibitor initiators,” Dr. Kim reported.
Roche provided funding for the study. Dr. Kim reports financial relationships with Bristol-Myers Squibb, Pfizer, and Roche.
AMSTERDAM – , according to an analysis of three large databases presented at the European Congress of Rheumatology.
“When we combined the databases, the incidence of any malignancy excluding nonmelanoma skin cancer was 13.09 per 1,000 patient years in the tocilizumab group and 13.46 in the TNF-inhibitor group,” reported Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology & pharmacoeconomics at Brigham and Women’s Hospital, Boston.
The study was conducted with data from 10,393 adult RA patients treated with tocilizumab and 26,357 patients treated with TNFi in the Medicare, QuintilesIMS PharMetrics Plus, and Truven Health MarketScan databases. All patients were new starts on tocilizumab or the TNFi on which they were evaluated, but all were required to have been exposed to at least one different biologic prior to starting the treatment. A diagnosis of RA at least 365 days prior to inclusion in this analysis was required to rule out prevalent cancers, which was an exclusion criterion.
More than 60 covariates were employed in the analysis to minimize the risk of confounders. These included demographics, RA characteristics, comorbidities, and other medications.
There also was no difference in the rates of the 12 most common cancer types when those exposed to tocilizumab were compared with those exposed to TNFi in a secondary analysis of these data, according to Dr. Kim. When expressed as hazard ratios, there were some numerical differences in relative risk among these cancers on both as-treated and intention-to-treat analyses, but confidence intervals were large, and none approached significance.
RA itself has been associated with an increased risk of some malignancies, such as lung cancer, but the relationship between the proinflammatory state of RA, its treatments, and the risk of cancer has been unclear, according to Dr. Kim. She said, “There is some concern relative to use of TNFi or other biologics in regard to developing malignancy, but studies have been inconsistent.”
Dr. Kim conceded that a lack of data on patients’ disease duration or activity is one limitation of this analysis. Another is that residual confounding can never be ruled out from a retrospective analysis. However, she said that, because the two biologics were compared for the same indication in patients exposed to at least one previous biologic, the confounding may be less than it would be if tocilizumab was compared with a conventional synthetic disease modifying antirheumatic drug (csDMARD), such as methotrexate. Again, there also was a requirement for exposure to at least one prior biologic, and this also is reassuring for the final conclusion.
“In other words, even among RA patients who were exposed to more than one biologic, the risk of cancer was similar between tocilizumab and TNF-inhibitor initiators,” Dr. Kim reported.
Roche provided funding for the study. Dr. Kim reports financial relationships with Bristol-Myers Squibb, Pfizer, and Roche.
AMSTERDAM – , according to an analysis of three large databases presented at the European Congress of Rheumatology.
“When we combined the databases, the incidence of any malignancy excluding nonmelanoma skin cancer was 13.09 per 1,000 patient years in the tocilizumab group and 13.46 in the TNF-inhibitor group,” reported Seoyoung C. Kim, MD, ScD, of the division of pharmacoepidemiology & pharmacoeconomics at Brigham and Women’s Hospital, Boston.
The study was conducted with data from 10,393 adult RA patients treated with tocilizumab and 26,357 patients treated with TNFi in the Medicare, QuintilesIMS PharMetrics Plus, and Truven Health MarketScan databases. All patients were new starts on tocilizumab or the TNFi on which they were evaluated, but all were required to have been exposed to at least one different biologic prior to starting the treatment. A diagnosis of RA at least 365 days prior to inclusion in this analysis was required to rule out prevalent cancers, which was an exclusion criterion.
More than 60 covariates were employed in the analysis to minimize the risk of confounders. These included demographics, RA characteristics, comorbidities, and other medications.
There also was no difference in the rates of the 12 most common cancer types when those exposed to tocilizumab were compared with those exposed to TNFi in a secondary analysis of these data, according to Dr. Kim. When expressed as hazard ratios, there were some numerical differences in relative risk among these cancers on both as-treated and intention-to-treat analyses, but confidence intervals were large, and none approached significance.
RA itself has been associated with an increased risk of some malignancies, such as lung cancer, but the relationship between the proinflammatory state of RA, its treatments, and the risk of cancer has been unclear, according to Dr. Kim. She said, “There is some concern relative to use of TNFi or other biologics in regard to developing malignancy, but studies have been inconsistent.”
Dr. Kim conceded that a lack of data on patients’ disease duration or activity is one limitation of this analysis. Another is that residual confounding can never be ruled out from a retrospective analysis. However, she said that, because the two biologics were compared for the same indication in patients exposed to at least one previous biologic, the confounding may be less than it would be if tocilizumab was compared with a conventional synthetic disease modifying antirheumatic drug (csDMARD), such as methotrexate. Again, there also was a requirement for exposure to at least one prior biologic, and this also is reassuring for the final conclusion.
“In other words, even among RA patients who were exposed to more than one biologic, the risk of cancer was similar between tocilizumab and TNF-inhibitor initiators,” Dr. Kim reported.
Roche provided funding for the study. Dr. Kim reports financial relationships with Bristol-Myers Squibb, Pfizer, and Roche.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point: Tocilizumab was not associated with a higher cancer risk in rheumatoid arthritis than TNFi treatment in a cohort study.
Major finding: Relative to TNFI, the hazard ratio for malignancy was 0.98 (95% CI, 0.80-1.19) for tocilizumab relative to TNFi.
Study details: Cohort study with propensity matching with data from 10,393 adult RA patients treated with tocilizumab and 26,357 patients treated with TNFi.
Disclosures: Roche provided funding for the study. Dr. Kim reports financial relationships with Bristol-Myers Squibb, Pfizer, and Roche.
Dermatologic complaints prolong hospital stay for hematologic cancer
and are associated with an increased mean length of hospital stay, according to a large retrospective chart review from a major cancer center.
The substantial burden imposed by dermatologic complications in patients with cancer, particularly a hematologic malignancy, highlights the importance of greater collaboration between oncology and dermatology services to mitigate the impact of these events on both quality of life and outcome, wrote Gregory S. Phillips of Memorial Sloan Kettering Cancer Center, New York, and his associates. The study was published in the Journal of the American Academy of Dermatology.
The data that produced these conclusions were drawn from a retrospective chart review of 11,533 cancer patients treated at the center during 2015. Of these, 412 (3.6%) were referred for a dermatology consultation.
Those who received a dermatology consultation were comparable for median age (60 years) and gender (roughly 50:50 male:female), compared with those who did not. However, the odds ratio (OR) for a dermatology consultation was 6.56 among those with a hematologic malignancy compared with those who had a solid tumor. In those with leukemia, the proportion receiving a dermatologic consult was nearly ninefold greater.
Whether or not undertaken in a patient with a hematologic malignancy, dermatologic consults correlated with significantly greater morbidity, as well as mortality. This included a longer median length of stay (11 vs. 5 days; P less than .0001) and a higher in-hospital rate of death (9% vs. 2%; P less than .0001), compared with patients not needing a dermatology consultation.
Of dermatologic consultations in the total study population, the most common were for inflammatory conditions (27%), infections (24%), and drug reactions (17%). Neoplasm was the dermatologic diagnosis in 10% of the total population, but in 13% of those with hematologic malignancies.
Inpatient dermatology consultations were most frequently ordered by the hematology-oncology service, accounting for 44% of the total, followed by the solid tumor oncology service (27%) and the surgery service (15%). Multiple consultations were more likely in patients with leukemia or lymphoma than other forms of cancer.
In the dermatology consult, biopsy was employed for diagnosis in only 18%. As for treatment, 42% received topical therapy alone, and 38% received a systemic therapy. Dermatologic consultations that subsequently involved consultation with another service such as allergy and immunology, were rare, occurring in only 4% of cases.
Furthermore, they suggested that the data support increased attention to dermatologic complications in cancer. Although the impact of consultations on outcome was not evaluated in this study, the authors cited another recent study in which there was a more than 2-day reduction in hospital stay when a dermatology consultation was employed in noncancer patients with an inflammatory skin disease (JAMA Dermatol. 2017 Jun 1;153[6]:523-8). Moreover, they speculated that a prompt resolution of dermatologic complaints in cancer patients has implications for better outcomes if they result in fewer delays in anti-cancer therapy.
The study was partly funded by the a grant from the National Cancer Institute’s Cancer Centers Program. Dr. Lacouture reported financial relationships with AstraZeneca, Adgero Biopharmaceuticals, Berg, Bristol-Myers Squibb, Foamix, Janssen, Legacy Healthcare, NovoCure, and Quintiles. Another author reported ties with Amgen, Roche, Eaisi, and P Value Communications.
SOURCE: Phillips GS et al. J Am Acad Dermatol. 2018 Jun;78(6):1102-9.
and are associated with an increased mean length of hospital stay, according to a large retrospective chart review from a major cancer center.
The substantial burden imposed by dermatologic complications in patients with cancer, particularly a hematologic malignancy, highlights the importance of greater collaboration between oncology and dermatology services to mitigate the impact of these events on both quality of life and outcome, wrote Gregory S. Phillips of Memorial Sloan Kettering Cancer Center, New York, and his associates. The study was published in the Journal of the American Academy of Dermatology.
The data that produced these conclusions were drawn from a retrospective chart review of 11,533 cancer patients treated at the center during 2015. Of these, 412 (3.6%) were referred for a dermatology consultation.
Those who received a dermatology consultation were comparable for median age (60 years) and gender (roughly 50:50 male:female), compared with those who did not. However, the odds ratio (OR) for a dermatology consultation was 6.56 among those with a hematologic malignancy compared with those who had a solid tumor. In those with leukemia, the proportion receiving a dermatologic consult was nearly ninefold greater.
Whether or not undertaken in a patient with a hematologic malignancy, dermatologic consults correlated with significantly greater morbidity, as well as mortality. This included a longer median length of stay (11 vs. 5 days; P less than .0001) and a higher in-hospital rate of death (9% vs. 2%; P less than .0001), compared with patients not needing a dermatology consultation.
Of dermatologic consultations in the total study population, the most common were for inflammatory conditions (27%), infections (24%), and drug reactions (17%). Neoplasm was the dermatologic diagnosis in 10% of the total population, but in 13% of those with hematologic malignancies.
Inpatient dermatology consultations were most frequently ordered by the hematology-oncology service, accounting for 44% of the total, followed by the solid tumor oncology service (27%) and the surgery service (15%). Multiple consultations were more likely in patients with leukemia or lymphoma than other forms of cancer.
In the dermatology consult, biopsy was employed for diagnosis in only 18%. As for treatment, 42% received topical therapy alone, and 38% received a systemic therapy. Dermatologic consultations that subsequently involved consultation with another service such as allergy and immunology, were rare, occurring in only 4% of cases.
Furthermore, they suggested that the data support increased attention to dermatologic complications in cancer. Although the impact of consultations on outcome was not evaluated in this study, the authors cited another recent study in which there was a more than 2-day reduction in hospital stay when a dermatology consultation was employed in noncancer patients with an inflammatory skin disease (JAMA Dermatol. 2017 Jun 1;153[6]:523-8). Moreover, they speculated that a prompt resolution of dermatologic complaints in cancer patients has implications for better outcomes if they result in fewer delays in anti-cancer therapy.
The study was partly funded by the a grant from the National Cancer Institute’s Cancer Centers Program. Dr. Lacouture reported financial relationships with AstraZeneca, Adgero Biopharmaceuticals, Berg, Bristol-Myers Squibb, Foamix, Janssen, Legacy Healthcare, NovoCure, and Quintiles. Another author reported ties with Amgen, Roche, Eaisi, and P Value Communications.
SOURCE: Phillips GS et al. J Am Acad Dermatol. 2018 Jun;78(6):1102-9.
and are associated with an increased mean length of hospital stay, according to a large retrospective chart review from a major cancer center.
The substantial burden imposed by dermatologic complications in patients with cancer, particularly a hematologic malignancy, highlights the importance of greater collaboration between oncology and dermatology services to mitigate the impact of these events on both quality of life and outcome, wrote Gregory S. Phillips of Memorial Sloan Kettering Cancer Center, New York, and his associates. The study was published in the Journal of the American Academy of Dermatology.
The data that produced these conclusions were drawn from a retrospective chart review of 11,533 cancer patients treated at the center during 2015. Of these, 412 (3.6%) were referred for a dermatology consultation.
Those who received a dermatology consultation were comparable for median age (60 years) and gender (roughly 50:50 male:female), compared with those who did not. However, the odds ratio (OR) for a dermatology consultation was 6.56 among those with a hematologic malignancy compared with those who had a solid tumor. In those with leukemia, the proportion receiving a dermatologic consult was nearly ninefold greater.
Whether or not undertaken in a patient with a hematologic malignancy, dermatologic consults correlated with significantly greater morbidity, as well as mortality. This included a longer median length of stay (11 vs. 5 days; P less than .0001) and a higher in-hospital rate of death (9% vs. 2%; P less than .0001), compared with patients not needing a dermatology consultation.
Of dermatologic consultations in the total study population, the most common were for inflammatory conditions (27%), infections (24%), and drug reactions (17%). Neoplasm was the dermatologic diagnosis in 10% of the total population, but in 13% of those with hematologic malignancies.
Inpatient dermatology consultations were most frequently ordered by the hematology-oncology service, accounting for 44% of the total, followed by the solid tumor oncology service (27%) and the surgery service (15%). Multiple consultations were more likely in patients with leukemia or lymphoma than other forms of cancer.
In the dermatology consult, biopsy was employed for diagnosis in only 18%. As for treatment, 42% received topical therapy alone, and 38% received a systemic therapy. Dermatologic consultations that subsequently involved consultation with another service such as allergy and immunology, were rare, occurring in only 4% of cases.
Furthermore, they suggested that the data support increased attention to dermatologic complications in cancer. Although the impact of consultations on outcome was not evaluated in this study, the authors cited another recent study in which there was a more than 2-day reduction in hospital stay when a dermatology consultation was employed in noncancer patients with an inflammatory skin disease (JAMA Dermatol. 2017 Jun 1;153[6]:523-8). Moreover, they speculated that a prompt resolution of dermatologic complaints in cancer patients has implications for better outcomes if they result in fewer delays in anti-cancer therapy.
The study was partly funded by the a grant from the National Cancer Institute’s Cancer Centers Program. Dr. Lacouture reported financial relationships with AstraZeneca, Adgero Biopharmaceuticals, Berg, Bristol-Myers Squibb, Foamix, Janssen, Legacy Healthcare, NovoCure, and Quintiles. Another author reported ties with Amgen, Roche, Eaisi, and P Value Communications.
SOURCE: Phillips GS et al. J Am Acad Dermatol. 2018 Jun;78(6):1102-9.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Key clinical point: Dermatologic complications are more common in hematologic than solid tumor cancers and correlate with adverse outcomes.
Major finding: In cancer patients, dermatologic consults are associated with longer hospital stay (11 vs. 5 days) and death (9% vs. 2%).
Study details: Retrospective chart review of inpatient dermatology consultations during 2015.
Disclosures: The study was partly funded by the a grant from the National Cancer Institute’s Cancer Centers Program. Dr. Lacouture reported financial relationships with AstraZeneca, Adgero Biopharmaceuticals, Berg, Bristol-Myers Squibb, Foamix, Janssen, Legacy Healthcare, NovoCure, and Quintiles. Another author reported ties with Amgen, Roche, Eaisi, and P Value Communications.
Source: Phillips et al. J Am Acad Dermatol. 2018;78:1102-9.
Opioids still overprescribed for postop pain management
Most patients use far less opioids than they are prescribed after hernia and other abdominal surgery, resulting in substantial waste and potential diversion, a prospective cohort study has found.
In an evaluation of 176 narcotic-naive patients who underwent surgery in a over the 14-day postdischarge study period was 30 morphine milligram equivalents (MME) but the median prescription was 150 MME, reported Wen Hui Tan, MD, and her research team at Washington University, St. Louis. The report was published in the Journal of the American College of Surgeons.
Overall, 76.7% of patients reported being satisfied or very satisfied with their postoperative pain management. Some patients (n = 31, 17.6%) reported not filling their prescription or not taking any of their prescribed opioid pain medications at all.
Sixty-nine percent of the surgeries were laparoscopic. A variety of abdominal procedures were represented, including hiatal hernia repair, inguinal hernia repair, and cholecystectomy. The median age was 60 years. Of postoperative pain prescriptions, 67% were for hydrocodone-acetaminophen and most of the remainder were for oxycodone-acetaminophen or oxycodone alone. The median prescription was for the equivalent of 20 5-mg oxycodone pills, while the median consumption in the first 7 postoperative days was 3.7 pills. Only 4.5% of patients received a refill.
The findings are consistent with numerous studies of different types of operations showing that patients often don’t use all of the opioid medications they are prescribed for pain control after surgery.
“Now that opioid pain medications can no longer be refilled with a pharmacy via telephone, overprescription may also be partially driven by a desire to prevent future inconvenience and workload of office staff from patients requesting refills. However, the rising numbers of opioid-related unintentional deaths over the last decade point to the fact that overprescription has serious potential consequences,” the researchers wrote.
They reported having no potential conflicts of interest.
SOURCE: Tan et al. J Am Coll Surg 2018 May 7. doi: 10.1016/j.jamcollsurg.2018.04.032.
Most patients use far less opioids than they are prescribed after hernia and other abdominal surgery, resulting in substantial waste and potential diversion, a prospective cohort study has found.
In an evaluation of 176 narcotic-naive patients who underwent surgery in a over the 14-day postdischarge study period was 30 morphine milligram equivalents (MME) but the median prescription was 150 MME, reported Wen Hui Tan, MD, and her research team at Washington University, St. Louis. The report was published in the Journal of the American College of Surgeons.
Overall, 76.7% of patients reported being satisfied or very satisfied with their postoperative pain management. Some patients (n = 31, 17.6%) reported not filling their prescription or not taking any of their prescribed opioid pain medications at all.
Sixty-nine percent of the surgeries were laparoscopic. A variety of abdominal procedures were represented, including hiatal hernia repair, inguinal hernia repair, and cholecystectomy. The median age was 60 years. Of postoperative pain prescriptions, 67% were for hydrocodone-acetaminophen and most of the remainder were for oxycodone-acetaminophen or oxycodone alone. The median prescription was for the equivalent of 20 5-mg oxycodone pills, while the median consumption in the first 7 postoperative days was 3.7 pills. Only 4.5% of patients received a refill.
The findings are consistent with numerous studies of different types of operations showing that patients often don’t use all of the opioid medications they are prescribed for pain control after surgery.
“Now that opioid pain medications can no longer be refilled with a pharmacy via telephone, overprescription may also be partially driven by a desire to prevent future inconvenience and workload of office staff from patients requesting refills. However, the rising numbers of opioid-related unintentional deaths over the last decade point to the fact that overprescription has serious potential consequences,” the researchers wrote.
They reported having no potential conflicts of interest.
SOURCE: Tan et al. J Am Coll Surg 2018 May 7. doi: 10.1016/j.jamcollsurg.2018.04.032.
Most patients use far less opioids than they are prescribed after hernia and other abdominal surgery, resulting in substantial waste and potential diversion, a prospective cohort study has found.
In an evaluation of 176 narcotic-naive patients who underwent surgery in a over the 14-day postdischarge study period was 30 morphine milligram equivalents (MME) but the median prescription was 150 MME, reported Wen Hui Tan, MD, and her research team at Washington University, St. Louis. The report was published in the Journal of the American College of Surgeons.
Overall, 76.7% of patients reported being satisfied or very satisfied with their postoperative pain management. Some patients (n = 31, 17.6%) reported not filling their prescription or not taking any of their prescribed opioid pain medications at all.
Sixty-nine percent of the surgeries were laparoscopic. A variety of abdominal procedures were represented, including hiatal hernia repair, inguinal hernia repair, and cholecystectomy. The median age was 60 years. Of postoperative pain prescriptions, 67% were for hydrocodone-acetaminophen and most of the remainder were for oxycodone-acetaminophen or oxycodone alone. The median prescription was for the equivalent of 20 5-mg oxycodone pills, while the median consumption in the first 7 postoperative days was 3.7 pills. Only 4.5% of patients received a refill.
The findings are consistent with numerous studies of different types of operations showing that patients often don’t use all of the opioid medications they are prescribed for pain control after surgery.
“Now that opioid pain medications can no longer be refilled with a pharmacy via telephone, overprescription may also be partially driven by a desire to prevent future inconvenience and workload of office staff from patients requesting refills. However, the rising numbers of opioid-related unintentional deaths over the last decade point to the fact that overprescription has serious potential consequences,” the researchers wrote.
They reported having no potential conflicts of interest.
SOURCE: Tan et al. J Am Coll Surg 2018 May 7. doi: 10.1016/j.jamcollsurg.2018.04.032.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Key clinical point: For postoperative recovery, a survey showed that far more opioids are prescribed than are consumed.
Major finding: On average, surgical patients went home with opioid prescriptions of 150 MME but took a median of 30 MME.
Study details: Prospective cohort study.
Disclosures: The authors report no potential conflicts of interest.
Source: Tan et al. J Am Coll Surg 2018 May 7. doi: 10.1016/j.jamcollsurg.2018.04.032.
TAVR safe in low-risk aortic stenosis, early data indicate
WASHINGTON – , according to results of the first U.S. study to evaluate mortality in a low-risk population.
Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.
At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.
Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.
“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.
In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.
Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.
The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.
In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.
Full results from all 200 patients are expected in the fall of 2018.
Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.
Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”
Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.
WASHINGTON – , according to results of the first U.S. study to evaluate mortality in a low-risk population.
Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.
At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.
Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.
“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.
In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.
Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.
The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.
In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.
Full results from all 200 patients are expected in the fall of 2018.
Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.
Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”
Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.
WASHINGTON – , according to results of the first U.S. study to evaluate mortality in a low-risk population.
Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.
At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.
Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.
“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.
In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.
Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.
The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.
In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.
Full results from all 200 patients are expected in the fall of 2018.
Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.
Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”
Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.
REPORTING FROM CRT 2018
Key clinical point: In an interim analysis, transcatheter aortic valve replacement was found safe in low-risk patients with symptomatic aortic stenosis.
Major finding: Through 30 days of follow-up, the mortality rate was 0% or lower than observed in studies conducted in higher-risk populations.
Study details: Interim analysis of 125 patients in a prospective registry study.
Disclosures: Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.
Sapien M3 mitral valve replacement data reported for first 10 patients
WASHINGTON – A novel transcatheter mitral valve replacement with a transseptally introduced docking mechanism that secures the valve with native mitral valve leaflets was found feasible and effective in an initial series of 10 patients, according to a first-in-man report at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“All patients remained hemodynamically stable throughout the procedure, and the valve was successfully implanted in all patients,” reported John G. Webb, MD, McLeod Professor of Heart Valve Intervention at the University of British Columbia, Vancouver.
The docking system “is retrievable up until the point of the final release,” Dr. Webb explained. A knitted polyethylene terephthalate skirt is employed to aid in creating a seal between the leaflets and the dock. Once the docking system is in place, the procedure “then becomes a relatively standard transcatheter transseptal valve-in-valve–type procedure” that is a “fairly easy part of the procedure at centers with transcatheter valve implantation experience.”
The very first case was performed in a 75-year-old woman with severe mitral valve insufficiency. Frail with multiple comorbidities and a left ventricular ejection fraction of 30%, the patient was not a candidate for surgery. Although Dr. Webb acknowledged that the first case “was a learning process,” he reported that the patient was discharged after a 1-night hospital stay with reassuring valve placement and function based on imaging studies.
Data was available from 10 patients from five participating centers in Canada and the United States. The mean age was 74 years, and all were New York Heart Association class III or higher. The mean left ventricular ejection fraction was 37.5%. Although the average Society of Thoracic Surgery risk score was only 4.9%, Dr. Webb noted that this underestimated the vulnerability of a population in which most had compromised renal function. Half of the 10 had severe mitral valve regurgitation prior to valve replacement, and the remainder had moderate to severe regurgitation.
“At the end of 30 days, all had mild or less insufficiency,” Dr. Webb reported. Although one patient did develop significant mitral insufficiency after discharge because of a small tear attributed to probing, it was repaired with a plug. The one technical failure occurred in a patient who required a plug during the course of valve replacement; again, the plug proved effective for preventing significant valve insufficiency.
In this series of patients, one stroke occurred 2 days after the procedure, but there were no deaths in the initial 30-day follow-up, according to Dr. Webb. Although he noted that the procedure time in the first case was 4 hours, the procedure times became shorter with experience and the second-to-last and last cases took 2.5 and 1.3 hours, respectively.
Howard C. Herrmann, MD, director of the interventional cardiology program at the University of Pennsylvania, Philadelphia, and a panelist on the symposium where these data were presented, called the results “exciting.” However, he also noted that “this is the first time that any us have had a look at this device,” so more data will be needed to understand its clinical potential.
Edwards Lifesciences sponsored this study. Dr. Webb reported financial relationships with Abbott Vascular, Edwards Lifesciences, Essential Medical, and Vivitro.
WASHINGTON – A novel transcatheter mitral valve replacement with a transseptally introduced docking mechanism that secures the valve with native mitral valve leaflets was found feasible and effective in an initial series of 10 patients, according to a first-in-man report at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“All patients remained hemodynamically stable throughout the procedure, and the valve was successfully implanted in all patients,” reported John G. Webb, MD, McLeod Professor of Heart Valve Intervention at the University of British Columbia, Vancouver.
The docking system “is retrievable up until the point of the final release,” Dr. Webb explained. A knitted polyethylene terephthalate skirt is employed to aid in creating a seal between the leaflets and the dock. Once the docking system is in place, the procedure “then becomes a relatively standard transcatheter transseptal valve-in-valve–type procedure” that is a “fairly easy part of the procedure at centers with transcatheter valve implantation experience.”
The very first case was performed in a 75-year-old woman with severe mitral valve insufficiency. Frail with multiple comorbidities and a left ventricular ejection fraction of 30%, the patient was not a candidate for surgery. Although Dr. Webb acknowledged that the first case “was a learning process,” he reported that the patient was discharged after a 1-night hospital stay with reassuring valve placement and function based on imaging studies.
Data was available from 10 patients from five participating centers in Canada and the United States. The mean age was 74 years, and all were New York Heart Association class III or higher. The mean left ventricular ejection fraction was 37.5%. Although the average Society of Thoracic Surgery risk score was only 4.9%, Dr. Webb noted that this underestimated the vulnerability of a population in which most had compromised renal function. Half of the 10 had severe mitral valve regurgitation prior to valve replacement, and the remainder had moderate to severe regurgitation.
“At the end of 30 days, all had mild or less insufficiency,” Dr. Webb reported. Although one patient did develop significant mitral insufficiency after discharge because of a small tear attributed to probing, it was repaired with a plug. The one technical failure occurred in a patient who required a plug during the course of valve replacement; again, the plug proved effective for preventing significant valve insufficiency.
In this series of patients, one stroke occurred 2 days after the procedure, but there were no deaths in the initial 30-day follow-up, according to Dr. Webb. Although he noted that the procedure time in the first case was 4 hours, the procedure times became shorter with experience and the second-to-last and last cases took 2.5 and 1.3 hours, respectively.
Howard C. Herrmann, MD, director of the interventional cardiology program at the University of Pennsylvania, Philadelphia, and a panelist on the symposium where these data were presented, called the results “exciting.” However, he also noted that “this is the first time that any us have had a look at this device,” so more data will be needed to understand its clinical potential.
Edwards Lifesciences sponsored this study. Dr. Webb reported financial relationships with Abbott Vascular, Edwards Lifesciences, Essential Medical, and Vivitro.
WASHINGTON – A novel transcatheter mitral valve replacement with a transseptally introduced docking mechanism that secures the valve with native mitral valve leaflets was found feasible and effective in an initial series of 10 patients, according to a first-in-man report at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“All patients remained hemodynamically stable throughout the procedure, and the valve was successfully implanted in all patients,” reported John G. Webb, MD, McLeod Professor of Heart Valve Intervention at the University of British Columbia, Vancouver.
The docking system “is retrievable up until the point of the final release,” Dr. Webb explained. A knitted polyethylene terephthalate skirt is employed to aid in creating a seal between the leaflets and the dock. Once the docking system is in place, the procedure “then becomes a relatively standard transcatheter transseptal valve-in-valve–type procedure” that is a “fairly easy part of the procedure at centers with transcatheter valve implantation experience.”
The very first case was performed in a 75-year-old woman with severe mitral valve insufficiency. Frail with multiple comorbidities and a left ventricular ejection fraction of 30%, the patient was not a candidate for surgery. Although Dr. Webb acknowledged that the first case “was a learning process,” he reported that the patient was discharged after a 1-night hospital stay with reassuring valve placement and function based on imaging studies.
Data was available from 10 patients from five participating centers in Canada and the United States. The mean age was 74 years, and all were New York Heart Association class III or higher. The mean left ventricular ejection fraction was 37.5%. Although the average Society of Thoracic Surgery risk score was only 4.9%, Dr. Webb noted that this underestimated the vulnerability of a population in which most had compromised renal function. Half of the 10 had severe mitral valve regurgitation prior to valve replacement, and the remainder had moderate to severe regurgitation.
“At the end of 30 days, all had mild or less insufficiency,” Dr. Webb reported. Although one patient did develop significant mitral insufficiency after discharge because of a small tear attributed to probing, it was repaired with a plug. The one technical failure occurred in a patient who required a plug during the course of valve replacement; again, the plug proved effective for preventing significant valve insufficiency.
In this series of patients, one stroke occurred 2 days after the procedure, but there were no deaths in the initial 30-day follow-up, according to Dr. Webb. Although he noted that the procedure time in the first case was 4 hours, the procedure times became shorter with experience and the second-to-last and last cases took 2.5 and 1.3 hours, respectively.
Howard C. Herrmann, MD, director of the interventional cardiology program at the University of Pennsylvania, Philadelphia, and a panelist on the symposium where these data were presented, called the results “exciting.” However, he also noted that “this is the first time that any us have had a look at this device,” so more data will be needed to understand its clinical potential.
Edwards Lifesciences sponsored this study. Dr. Webb reported financial relationships with Abbott Vascular, Edwards Lifesciences, Essential Medical, and Vivitro.
REPORTING FROM CRT 2018
Key clinical point: Initial experience with a transcatheter transseptal mitral valve replacement is encouraging.
Major finding: In the first 10 patients, technical success was achieved in 9.
Study details: A summary of first clinical experience at multiple centers.
Disclosures: Edwards Lifesciences sponsored this study. Dr. Webb reported financial relationships with Abbott Vascular, Edwards Lifesciences, Essential Medical, and Vivitro.
Cultural sensitivity key to delivering effective psychiatric care
NEW YORK – A mental health clinic started for an urban Hispanic community in Connecticut in 1972 continues to generate lessons on how to apply cultural sensitivity to improve care, according to a critical assessment of the program presented at the annual meeting of the American Psychiatric Association.
“Reviews of the literature show that there is a difference when clinicians are culturally responsive and sensitive to the populations they serve,” reported Esperanza Díaz, MD, of the department of psychiatry at Yale University and medical director, Latino Behavioral Health System (LBHS), both in New Haven, Conn.
“How can I talk about depression treatment to a patient who does not have a place to live?” Dr. Díaz asked. Citing a variety of evidence that links mental health to social issues, Dr. Díaz explained, “We learned to partner with everyone in the community to achieve treatment goals.”
By “everyone,” Dr. Díaz was referring to primary care clinicians, family members, church community groups, social support groups, and even local politicians. She also credited success to peer counselors, which are prior patients trained to provide supportive care. Not least important, family members are recruited to help.
“In the Latino community, family is central to identity,” Dr. Díaz explained. One of treatment goals is to help patients reestablish ties with family and other community members who were lost during a mental health crisis. For this task, peer counselors have proven particularly effective for mitigating stigma and providing guidance.
All of these strategies are relevant to cultural competence, a concept for delivering effective mental health services that received particular attention in the DSM-5. Of strategies and tools relevant to this topic in the DSM-5, Dr. Díaz indicated that the Cultural Formulation Interview (CFI) should be considered particularly important for aiding clinicians in understanding mental health issues in a cultural context.
“For us as psychiatrists, the interview is our tool. ” Dr. Díaz asked. She led a recent study demonstrating that the CFI can help clinicians identify unique needs and preferences in a Hispanic population (Psychiatr Serv. 2017 Feb 1;68[2]:112-4). She said the principles of the CFI are relevant to any cultural group.
For evaluating and demonstrating efficacy of mental health services developed for a target cultural group, Dr. Díaz recommended identifying goals and then performance measures to track success. At her own center, quarterly reports track effectiveness and communicate value to the community and those providing funding its activities.
In the period during 2008-2017, 950 adult patients received mental health or substance use services from LBHS, Dr. Díaz reported. In addition to the full-time staff, LBHS has provided training to social workers and psychologists. In addition, 11 psychiatric residents in their third or fourth year of training have worked in LBHS during this period. Many of the peer counselors trained at LBHS have been hired away because of the skills they acquired.
Of the many elements that Dr. Díaz believes are important to the success of the LBHS, “confianza” has provided a key to patient willingness to stay with care through recovery. This word, Spanish for trust, recognizes that patients must have confidence in the ability of clinicians to understand and resolve their problems.
Recognizing the importance of collaborating with the community to design effective therapy, Dr. Díaz also emphasized the importance of humility to the success of LBHS.
“Humility to accept recommendations from people who are not supposedly experts, like family members,” Dr. Díaz said. “We learned that we need to know how to partner.”
NEW YORK – A mental health clinic started for an urban Hispanic community in Connecticut in 1972 continues to generate lessons on how to apply cultural sensitivity to improve care, according to a critical assessment of the program presented at the annual meeting of the American Psychiatric Association.
“Reviews of the literature show that there is a difference when clinicians are culturally responsive and sensitive to the populations they serve,” reported Esperanza Díaz, MD, of the department of psychiatry at Yale University and medical director, Latino Behavioral Health System (LBHS), both in New Haven, Conn.
“How can I talk about depression treatment to a patient who does not have a place to live?” Dr. Díaz asked. Citing a variety of evidence that links mental health to social issues, Dr. Díaz explained, “We learned to partner with everyone in the community to achieve treatment goals.”
By “everyone,” Dr. Díaz was referring to primary care clinicians, family members, church community groups, social support groups, and even local politicians. She also credited success to peer counselors, which are prior patients trained to provide supportive care. Not least important, family members are recruited to help.
“In the Latino community, family is central to identity,” Dr. Díaz explained. One of treatment goals is to help patients reestablish ties with family and other community members who were lost during a mental health crisis. For this task, peer counselors have proven particularly effective for mitigating stigma and providing guidance.
All of these strategies are relevant to cultural competence, a concept for delivering effective mental health services that received particular attention in the DSM-5. Of strategies and tools relevant to this topic in the DSM-5, Dr. Díaz indicated that the Cultural Formulation Interview (CFI) should be considered particularly important for aiding clinicians in understanding mental health issues in a cultural context.
“For us as psychiatrists, the interview is our tool. ” Dr. Díaz asked. She led a recent study demonstrating that the CFI can help clinicians identify unique needs and preferences in a Hispanic population (Psychiatr Serv. 2017 Feb 1;68[2]:112-4). She said the principles of the CFI are relevant to any cultural group.
For evaluating and demonstrating efficacy of mental health services developed for a target cultural group, Dr. Díaz recommended identifying goals and then performance measures to track success. At her own center, quarterly reports track effectiveness and communicate value to the community and those providing funding its activities.
In the period during 2008-2017, 950 adult patients received mental health or substance use services from LBHS, Dr. Díaz reported. In addition to the full-time staff, LBHS has provided training to social workers and psychologists. In addition, 11 psychiatric residents in their third or fourth year of training have worked in LBHS during this period. Many of the peer counselors trained at LBHS have been hired away because of the skills they acquired.
Of the many elements that Dr. Díaz believes are important to the success of the LBHS, “confianza” has provided a key to patient willingness to stay with care through recovery. This word, Spanish for trust, recognizes that patients must have confidence in the ability of clinicians to understand and resolve their problems.
Recognizing the importance of collaborating with the community to design effective therapy, Dr. Díaz also emphasized the importance of humility to the success of LBHS.
“Humility to accept recommendations from people who are not supposedly experts, like family members,” Dr. Díaz said. “We learned that we need to know how to partner.”
NEW YORK – A mental health clinic started for an urban Hispanic community in Connecticut in 1972 continues to generate lessons on how to apply cultural sensitivity to improve care, according to a critical assessment of the program presented at the annual meeting of the American Psychiatric Association.
“Reviews of the literature show that there is a difference when clinicians are culturally responsive and sensitive to the populations they serve,” reported Esperanza Díaz, MD, of the department of psychiatry at Yale University and medical director, Latino Behavioral Health System (LBHS), both in New Haven, Conn.
“How can I talk about depression treatment to a patient who does not have a place to live?” Dr. Díaz asked. Citing a variety of evidence that links mental health to social issues, Dr. Díaz explained, “We learned to partner with everyone in the community to achieve treatment goals.”
By “everyone,” Dr. Díaz was referring to primary care clinicians, family members, church community groups, social support groups, and even local politicians. She also credited success to peer counselors, which are prior patients trained to provide supportive care. Not least important, family members are recruited to help.
“In the Latino community, family is central to identity,” Dr. Díaz explained. One of treatment goals is to help patients reestablish ties with family and other community members who were lost during a mental health crisis. For this task, peer counselors have proven particularly effective for mitigating stigma and providing guidance.
All of these strategies are relevant to cultural competence, a concept for delivering effective mental health services that received particular attention in the DSM-5. Of strategies and tools relevant to this topic in the DSM-5, Dr. Díaz indicated that the Cultural Formulation Interview (CFI) should be considered particularly important for aiding clinicians in understanding mental health issues in a cultural context.
“For us as psychiatrists, the interview is our tool. ” Dr. Díaz asked. She led a recent study demonstrating that the CFI can help clinicians identify unique needs and preferences in a Hispanic population (Psychiatr Serv. 2017 Feb 1;68[2]:112-4). She said the principles of the CFI are relevant to any cultural group.
For evaluating and demonstrating efficacy of mental health services developed for a target cultural group, Dr. Díaz recommended identifying goals and then performance measures to track success. At her own center, quarterly reports track effectiveness and communicate value to the community and those providing funding its activities.
In the period during 2008-2017, 950 adult patients received mental health or substance use services from LBHS, Dr. Díaz reported. In addition to the full-time staff, LBHS has provided training to social workers and psychologists. In addition, 11 psychiatric residents in their third or fourth year of training have worked in LBHS during this period. Many of the peer counselors trained at LBHS have been hired away because of the skills they acquired.
Of the many elements that Dr. Díaz believes are important to the success of the LBHS, “confianza” has provided a key to patient willingness to stay with care through recovery. This word, Spanish for trust, recognizes that patients must have confidence in the ability of clinicians to understand and resolve their problems.
Recognizing the importance of collaborating with the community to design effective therapy, Dr. Díaz also emphasized the importance of humility to the success of LBHS.
“Humility to accept recommendations from people who are not supposedly experts, like family members,” Dr. Díaz said. “We learned that we need to know how to partner.”
REPORTING FROM APA
Legalization of marijuana debate moving away from medical need
NEW YORK – The risk curve of societal harm from marijuana when graphed from a policy of complete prohibition to one of unregulated access is U shaped, according to a panel of experts who participated in a workshop on the harms and benefits of cannabis at the annual meeting of the American Psychiatric Association.
Based on more than 80 years of experience, it is clear that prohibition supports criminal activity but does not eliminate use, said Jason Hershberger, MD, chair of the department of psychiatry at Brookdale University Hospital Medical Center, New York. With progressive degrees of decriminalization, the harms to society associated with criminal distribution and the criminalization of use decreases, but they are replaced with increasing societal risks imposed by the availability of an intoxicating substance.
Theoretically, one argument is that the inflection point occurs where cannabis has been decriminalized for medical indications but prohibited for recreational use. But this is a tenuous position. Clinicians, including psychiatrists, might support the use of cannabis to reduce stress, but it is well known that the pleasant intoxication provided by cannabis is relaxing – whether or not this is characterized as stress relief.
reported Stephan M. Carlson, MD, who also is affiliated with Brookdale University Hospital Medical Center. Based on his belief that marijuana, after alcohol and tobacco, may soon be the third legal drug where it isn’t already, “physicians have just a temporary role” in mediating the debate about medical legalization from a legal or political standpoint. Why? Because this part of the debate is growing irrelevant.
This does not mean medical indications or medical harms are not valid topics of discussion, Dr. Hershberger and Dr. Carlson said. The problem is that recreational use is supplanting medical use as the central issue in making this drug available.
The road toward U.S. legalization started in 1996, when California voters approved the use of marijuana for medical indications. Other states followed. Then, in 2012, Colorado and Washington became the first states to approve the drug for recreational use. In total, 29 states now permit some form of legal use of marijuana. In addition, marijuana possession has been decriminalized in several states where it remains illegal.
“From the federal perspective, marijuana is still a Schedule I drug. This means that it is easier to conduct research on cocaine, which is a Schedule II drug, than it is on marijuana,” Dr. Hershberger said. While the current presidential administration has adopted a tougher stance on distribution and use of marijuana than the previous, more than 60% of Americans in surveys support decriminalization of marijuana, according to Dr. Hershberger. He suggested that the current acceptability of marijuana is the reason that a recent survey indicated that more U.S. high school seniors than ever before have tried marijuana.
In light of the perceptions that the marijuana ban was ineffective, that marijuana is acceptable, and that profits from marijuana sales and distributions have been going to criminals, depriving government of tax dollars, continued decriminalization appears to be inevitable, Dr. Hershberger said. However, he believes that complete deregulation poses important risk, including an inevitable increase in accidents produced by motor impairment. It is also reasonable to anticipate more substance use in vulnerable populations. The risk to the development of children and adolescents who are likely to gain easier access to cannabis is unknown.
For psychiatrists and other medical specialists who wish to participate in the debate about the degree to which marijuana is decriminalized, both Dr. Hershberger and Dr. Carlson argued that a clear and realistic view of the landscape is essential.
“One of the reasons we are in this state we are in is that many people have declared the war on drugs a failure,” Dr. Hershberger said. Although he acknowledged that recognizing the limited efficacy of a marijuana ban is a reasonable starting point for discussion, he also expressed concern about large corporations being permitted to market cannabis in a way that obscures its risks or encourages use by those at greatest risk of harm, such as minors.
“We have to ask ourselves, is America ready for a cannabis commercial during the Super Bowl?” Dr. Hershberger said. He believes that an important trade-off exists for risks regardless of the degree to which marijuana is legalized.
“We have to approach this in the context of our current reality,” Dr. Carlson agreed. He, like Dr. Hershberger, cautioned that there are no simple answers.
Dr. Hershberger and Dr. Carlson reported no potential conflicts of interest.
NEW YORK – The risk curve of societal harm from marijuana when graphed from a policy of complete prohibition to one of unregulated access is U shaped, according to a panel of experts who participated in a workshop on the harms and benefits of cannabis at the annual meeting of the American Psychiatric Association.
Based on more than 80 years of experience, it is clear that prohibition supports criminal activity but does not eliminate use, said Jason Hershberger, MD, chair of the department of psychiatry at Brookdale University Hospital Medical Center, New York. With progressive degrees of decriminalization, the harms to society associated with criminal distribution and the criminalization of use decreases, but they are replaced with increasing societal risks imposed by the availability of an intoxicating substance.
Theoretically, one argument is that the inflection point occurs where cannabis has been decriminalized for medical indications but prohibited for recreational use. But this is a tenuous position. Clinicians, including psychiatrists, might support the use of cannabis to reduce stress, but it is well known that the pleasant intoxication provided by cannabis is relaxing – whether or not this is characterized as stress relief.
reported Stephan M. Carlson, MD, who also is affiliated with Brookdale University Hospital Medical Center. Based on his belief that marijuana, after alcohol and tobacco, may soon be the third legal drug where it isn’t already, “physicians have just a temporary role” in mediating the debate about medical legalization from a legal or political standpoint. Why? Because this part of the debate is growing irrelevant.
This does not mean medical indications or medical harms are not valid topics of discussion, Dr. Hershberger and Dr. Carlson said. The problem is that recreational use is supplanting medical use as the central issue in making this drug available.
The road toward U.S. legalization started in 1996, when California voters approved the use of marijuana for medical indications. Other states followed. Then, in 2012, Colorado and Washington became the first states to approve the drug for recreational use. In total, 29 states now permit some form of legal use of marijuana. In addition, marijuana possession has been decriminalized in several states where it remains illegal.
“From the federal perspective, marijuana is still a Schedule I drug. This means that it is easier to conduct research on cocaine, which is a Schedule II drug, than it is on marijuana,” Dr. Hershberger said. While the current presidential administration has adopted a tougher stance on distribution and use of marijuana than the previous, more than 60% of Americans in surveys support decriminalization of marijuana, according to Dr. Hershberger. He suggested that the current acceptability of marijuana is the reason that a recent survey indicated that more U.S. high school seniors than ever before have tried marijuana.
In light of the perceptions that the marijuana ban was ineffective, that marijuana is acceptable, and that profits from marijuana sales and distributions have been going to criminals, depriving government of tax dollars, continued decriminalization appears to be inevitable, Dr. Hershberger said. However, he believes that complete deregulation poses important risk, including an inevitable increase in accidents produced by motor impairment. It is also reasonable to anticipate more substance use in vulnerable populations. The risk to the development of children and adolescents who are likely to gain easier access to cannabis is unknown.
For psychiatrists and other medical specialists who wish to participate in the debate about the degree to which marijuana is decriminalized, both Dr. Hershberger and Dr. Carlson argued that a clear and realistic view of the landscape is essential.
“One of the reasons we are in this state we are in is that many people have declared the war on drugs a failure,” Dr. Hershberger said. Although he acknowledged that recognizing the limited efficacy of a marijuana ban is a reasonable starting point for discussion, he also expressed concern about large corporations being permitted to market cannabis in a way that obscures its risks or encourages use by those at greatest risk of harm, such as minors.
“We have to ask ourselves, is America ready for a cannabis commercial during the Super Bowl?” Dr. Hershberger said. He believes that an important trade-off exists for risks regardless of the degree to which marijuana is legalized.
“We have to approach this in the context of our current reality,” Dr. Carlson agreed. He, like Dr. Hershberger, cautioned that there are no simple answers.
Dr. Hershberger and Dr. Carlson reported no potential conflicts of interest.
NEW YORK – The risk curve of societal harm from marijuana when graphed from a policy of complete prohibition to one of unregulated access is U shaped, according to a panel of experts who participated in a workshop on the harms and benefits of cannabis at the annual meeting of the American Psychiatric Association.
Based on more than 80 years of experience, it is clear that prohibition supports criminal activity but does not eliminate use, said Jason Hershberger, MD, chair of the department of psychiatry at Brookdale University Hospital Medical Center, New York. With progressive degrees of decriminalization, the harms to society associated with criminal distribution and the criminalization of use decreases, but they are replaced with increasing societal risks imposed by the availability of an intoxicating substance.
Theoretically, one argument is that the inflection point occurs where cannabis has been decriminalized for medical indications but prohibited for recreational use. But this is a tenuous position. Clinicians, including psychiatrists, might support the use of cannabis to reduce stress, but it is well known that the pleasant intoxication provided by cannabis is relaxing – whether or not this is characterized as stress relief.
reported Stephan M. Carlson, MD, who also is affiliated with Brookdale University Hospital Medical Center. Based on his belief that marijuana, after alcohol and tobacco, may soon be the third legal drug where it isn’t already, “physicians have just a temporary role” in mediating the debate about medical legalization from a legal or political standpoint. Why? Because this part of the debate is growing irrelevant.
This does not mean medical indications or medical harms are not valid topics of discussion, Dr. Hershberger and Dr. Carlson said. The problem is that recreational use is supplanting medical use as the central issue in making this drug available.
The road toward U.S. legalization started in 1996, when California voters approved the use of marijuana for medical indications. Other states followed. Then, in 2012, Colorado and Washington became the first states to approve the drug for recreational use. In total, 29 states now permit some form of legal use of marijuana. In addition, marijuana possession has been decriminalized in several states where it remains illegal.
“From the federal perspective, marijuana is still a Schedule I drug. This means that it is easier to conduct research on cocaine, which is a Schedule II drug, than it is on marijuana,” Dr. Hershberger said. While the current presidential administration has adopted a tougher stance on distribution and use of marijuana than the previous, more than 60% of Americans in surveys support decriminalization of marijuana, according to Dr. Hershberger. He suggested that the current acceptability of marijuana is the reason that a recent survey indicated that more U.S. high school seniors than ever before have tried marijuana.
In light of the perceptions that the marijuana ban was ineffective, that marijuana is acceptable, and that profits from marijuana sales and distributions have been going to criminals, depriving government of tax dollars, continued decriminalization appears to be inevitable, Dr. Hershberger said. However, he believes that complete deregulation poses important risk, including an inevitable increase in accidents produced by motor impairment. It is also reasonable to anticipate more substance use in vulnerable populations. The risk to the development of children and adolescents who are likely to gain easier access to cannabis is unknown.
For psychiatrists and other medical specialists who wish to participate in the debate about the degree to which marijuana is decriminalized, both Dr. Hershberger and Dr. Carlson argued that a clear and realistic view of the landscape is essential.
“One of the reasons we are in this state we are in is that many people have declared the war on drugs a failure,” Dr. Hershberger said. Although he acknowledged that recognizing the limited efficacy of a marijuana ban is a reasonable starting point for discussion, he also expressed concern about large corporations being permitted to market cannabis in a way that obscures its risks or encourages use by those at greatest risk of harm, such as minors.
“We have to ask ourselves, is America ready for a cannabis commercial during the Super Bowl?” Dr. Hershberger said. He believes that an important trade-off exists for risks regardless of the degree to which marijuana is legalized.
“We have to approach this in the context of our current reality,” Dr. Carlson agreed. He, like Dr. Hershberger, cautioned that there are no simple answers.
Dr. Hershberger and Dr. Carlson reported no potential conflicts of interest.
EXPERT ANALYSIS FROM APA