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VIDEO: It is an exciting time in obesity treatment
BOSTON – For those in obesity treatment, things are looking up, said Reem Z. Sharaiha, MD, MSc, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. There are several new therapies to choose from, said Dr. Sharaiha, assistant professor of medicine at Cornell University, New York – and a variety of therapies coming down the pipeline. The key is to choose the right treatment, or right combination of treatments – surgical, endoscopic, or medical – for the right patient at the right time and to follow up. Obesity is a chronic disease that needs long-term, team treatment. With obesity treatments there is sometimes a trade-off between risk and results, but the innovations coming along may balance that risk-results equation for some patients, she said.
BOSTON – For those in obesity treatment, things are looking up, said Reem Z. Sharaiha, MD, MSc, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. There are several new therapies to choose from, said Dr. Sharaiha, assistant professor of medicine at Cornell University, New York – and a variety of therapies coming down the pipeline. The key is to choose the right treatment, or right combination of treatments – surgical, endoscopic, or medical – for the right patient at the right time and to follow up. Obesity is a chronic disease that needs long-term, team treatment. With obesity treatments there is sometimes a trade-off between risk and results, but the innovations coming along may balance that risk-results equation for some patients, she said.
BOSTON – For those in obesity treatment, things are looking up, said Reem Z. Sharaiha, MD, MSc, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. There are several new therapies to choose from, said Dr. Sharaiha, assistant professor of medicine at Cornell University, New York – and a variety of therapies coming down the pipeline. The key is to choose the right treatment, or right combination of treatments – surgical, endoscopic, or medical – for the right patient at the right time and to follow up. Obesity is a chronic disease that needs long-term, team treatment. With obesity treatments there is sometimes a trade-off between risk and results, but the innovations coming along may balance that risk-results equation for some patients, she said.
REPORTING FROM 2018 AGA TECH SUMMIT
Study links mumps outbreaks to vaccine waning
A new study links recent mumps outbreaks to the waning of the mumps vaccine – which researchers believe wears off in an average of 27 years – and not to heterologous virus genotypes.
“These observations indicate the need for either innovative clinical trial designs to measure the benefit of extending vaccine dosing schedules or new vaccines to address the problem of waning vaccine-induced protection,” the study authors wrote. The findings appeared in Science Translational Medicine.
The numbers over the past 2 years are the highest numbers by far since 2000, with the exception of 2006. The CDC attributes the 2016 and 2017 numbers to factors such as “the known effectiveness of the vaccine, waning immunity following vaccination, and the intensity of exposure to the virus in close-contact settings [such as a college campus] coupled with behaviors that increase the risk of transmission.”
This year, as of Feb. 24, the CDC stated that it has received reports of 304 cases in 32 states and Washington.
For the new study, Joseph A. Lewnard, PhD, and Yonatan H. Grad, MD, PhD, of the Harvard School of Public Health, Boston, examined six studies and estimated that mumps vaccinations provide protection for an average of 27 years (95% confidence interval, 16-51 years). They also reported finding no evidence that the effectiveness of vaccines was affected by new heterologous virus genotypes.
Their analysis also determined that outbreaks in the late 1980s and early 1990s (among teens), and from 2006 to present (in young adults), “aligned with peaks in mumps susceptibility of these age groups predicted to be due to loss of vaccine-derived protection.”
The authors suggested that third doses of vaccine or an improved mumps vaccine could provide added protection. “Although congregated U.S. military populations resemble high-risk groups based on their age distribution and close-contact environments, no outbreaks have been reported in the military since a policy of administering an MMR dose to incoming recruits, regardless of vaccination history, was adopted in 1991,” the researchers wrote, referring to a 2008 study (Vaccine 2008, 26:494-501).
For now, however, “we expect population susceptibility to mumps to continue increasing as transient vaccine-derived immunity supersedes previous infection as the main determinant of mumps susceptibility in the U.S. population,” the authors wrote.
The study was funded by awards from the National Institute of General Medical Sciences and the Doris Duke Charitable Foundation. The study authors report grant funding (Pfizer) and consulting (Pfizer, GlaxoSmithKline) for work unrelated to the study.
SOURCE: Lenward JA et al. Sci Transl Med. 2018 Mar 21. doi: 10.1126/scitranslmed.aao5945.
A new study links recent mumps outbreaks to the waning of the mumps vaccine – which researchers believe wears off in an average of 27 years – and not to heterologous virus genotypes.
“These observations indicate the need for either innovative clinical trial designs to measure the benefit of extending vaccine dosing schedules or new vaccines to address the problem of waning vaccine-induced protection,” the study authors wrote. The findings appeared in Science Translational Medicine.
The numbers over the past 2 years are the highest numbers by far since 2000, with the exception of 2006. The CDC attributes the 2016 and 2017 numbers to factors such as “the known effectiveness of the vaccine, waning immunity following vaccination, and the intensity of exposure to the virus in close-contact settings [such as a college campus] coupled with behaviors that increase the risk of transmission.”
This year, as of Feb. 24, the CDC stated that it has received reports of 304 cases in 32 states and Washington.
For the new study, Joseph A. Lewnard, PhD, and Yonatan H. Grad, MD, PhD, of the Harvard School of Public Health, Boston, examined six studies and estimated that mumps vaccinations provide protection for an average of 27 years (95% confidence interval, 16-51 years). They also reported finding no evidence that the effectiveness of vaccines was affected by new heterologous virus genotypes.
Their analysis also determined that outbreaks in the late 1980s and early 1990s (among teens), and from 2006 to present (in young adults), “aligned with peaks in mumps susceptibility of these age groups predicted to be due to loss of vaccine-derived protection.”
The authors suggested that third doses of vaccine or an improved mumps vaccine could provide added protection. “Although congregated U.S. military populations resemble high-risk groups based on their age distribution and close-contact environments, no outbreaks have been reported in the military since a policy of administering an MMR dose to incoming recruits, regardless of vaccination history, was adopted in 1991,” the researchers wrote, referring to a 2008 study (Vaccine 2008, 26:494-501).
For now, however, “we expect population susceptibility to mumps to continue increasing as transient vaccine-derived immunity supersedes previous infection as the main determinant of mumps susceptibility in the U.S. population,” the authors wrote.
The study was funded by awards from the National Institute of General Medical Sciences and the Doris Duke Charitable Foundation. The study authors report grant funding (Pfizer) and consulting (Pfizer, GlaxoSmithKline) for work unrelated to the study.
SOURCE: Lenward JA et al. Sci Transl Med. 2018 Mar 21. doi: 10.1126/scitranslmed.aao5945.
A new study links recent mumps outbreaks to the waning of the mumps vaccine – which researchers believe wears off in an average of 27 years – and not to heterologous virus genotypes.
“These observations indicate the need for either innovative clinical trial designs to measure the benefit of extending vaccine dosing schedules or new vaccines to address the problem of waning vaccine-induced protection,” the study authors wrote. The findings appeared in Science Translational Medicine.
The numbers over the past 2 years are the highest numbers by far since 2000, with the exception of 2006. The CDC attributes the 2016 and 2017 numbers to factors such as “the known effectiveness of the vaccine, waning immunity following vaccination, and the intensity of exposure to the virus in close-contact settings [such as a college campus] coupled with behaviors that increase the risk of transmission.”
This year, as of Feb. 24, the CDC stated that it has received reports of 304 cases in 32 states and Washington.
For the new study, Joseph A. Lewnard, PhD, and Yonatan H. Grad, MD, PhD, of the Harvard School of Public Health, Boston, examined six studies and estimated that mumps vaccinations provide protection for an average of 27 years (95% confidence interval, 16-51 years). They also reported finding no evidence that the effectiveness of vaccines was affected by new heterologous virus genotypes.
Their analysis also determined that outbreaks in the late 1980s and early 1990s (among teens), and from 2006 to present (in young adults), “aligned with peaks in mumps susceptibility of these age groups predicted to be due to loss of vaccine-derived protection.”
The authors suggested that third doses of vaccine or an improved mumps vaccine could provide added protection. “Although congregated U.S. military populations resemble high-risk groups based on their age distribution and close-contact environments, no outbreaks have been reported in the military since a policy of administering an MMR dose to incoming recruits, regardless of vaccination history, was adopted in 1991,” the researchers wrote, referring to a 2008 study (Vaccine 2008, 26:494-501).
For now, however, “we expect population susceptibility to mumps to continue increasing as transient vaccine-derived immunity supersedes previous infection as the main determinant of mumps susceptibility in the U.S. population,” the authors wrote.
The study was funded by awards from the National Institute of General Medical Sciences and the Doris Duke Charitable Foundation. The study authors report grant funding (Pfizer) and consulting (Pfizer, GlaxoSmithKline) for work unrelated to the study.
SOURCE: Lenward JA et al. Sci Transl Med. 2018 Mar 21. doi: 10.1126/scitranslmed.aao5945.
FROM SCIENCE TRANSLATIONAL MEDICINE
VIDEO: Organ-sparing resection techniques should be way of the future
BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.
We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.
BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.
We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.
BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.
We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.
REPORTING FROM 2018 AGA TECH SUMMIT
Late toxicities with PARP inhibitor plus RT in inflammatory breast cancer
Using the PARP inhibitor veliparib as a radiosensitizer for chest wall radiation in women with inflammatory or locally recurrent breast cancer was associated with a high rate of late grade 3 adverse events, results of a phase 1 study show.
Although the trial’s upper limit of dose-limiting toxicities during 6 weeks of treatment and 4 weeks of follow-up was not met, 46.7% of 30 patients treated with veliparib and radiation after complete surgical resection had at least one grade 3 adverse event by 3 years of follow-up, reported Reshma Jagsi, MD, of the University of Michigan, Ann Arbor.
“In this multicenter phase 1 trial, severe acute toxicity did not exceed the prespecified target of 30%, even at the highest tested dose of veliparib (200 mg twice a day), and we observed no grade 4 or 5 events. However, given observations of grade 3 late toxicity in nearly one-half of all patients evaluated at 3 years, we recommend a phase 2 dose of 50 mg twice a day if veliparib is investigated further for radiosensitization in patients with breast cancer at high risk of locoregional recurrence and in need of treatment intensification,” they wrote in the Journal of Clinical Oncology.
In preclinical studies, PARP (poly [ADP-ribose] polymerase) inhibitors have been shown to enhance radiosensitivty of breast malignancies when given concurrently with radiation.
In a phase 1 dosing and safety study, 30 women with inflammatory or locally recurrent breast cancer of the chest wall underwent complete surgical resection and were then assigned to radiation consisting of 50 Gy to the chest wall and regional lymph nodes, plus a 10 Gy boost. The patients also received oral veliparib at a dose of either 50, 100, 150, or 200 mg taken twice daily during the 6-week course of radiotherapy.
During the 6 weeks of therapy and 4 weeks of follow-up, there were five dose-limiting toxicities, including two cases each of confluent moist desquamation greater than 100 cm2 in the 100- and 150-mg dose groups, and one case of neutropenia in a patient at the 200-mg dose level.
The respective rates of any grade 3 toxicity, treatment related or otherwise, at 1, 2, and 3 years of follow-up were 10%, 16.7%, and 46.7%.
The investigators noted that, at year 3, severe fibrosis in the treatment field was seen in 6 of the 15 surviving patients. Of the six patients, two also had grade 3 skin induration, and two had grade 3 lymphedema.
“Although some of the late adverse events we observed might have occurred even in the absence of the investigational agent and with standard therapy, severe late toxicity is relatively uncommon with standard therapy alone, so we believe that a cautious approach is prudent,” Dr. Jagsi and associates wrote.
The study was supported by the Translational Breast Cancer Research Consortium, Breast Cancer Research Foundation, University of Michigan Comprehensive Cancer Center, and Michigan Institute for Clinical and Health Research. Dr. Jagsi reported institutional research support from AbbVie, which donated the veliparib used in the study.
SOURCE: Jagsi R et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.77.2665
Using the PARP inhibitor veliparib as a radiosensitizer for chest wall radiation in women with inflammatory or locally recurrent breast cancer was associated with a high rate of late grade 3 adverse events, results of a phase 1 study show.
Although the trial’s upper limit of dose-limiting toxicities during 6 weeks of treatment and 4 weeks of follow-up was not met, 46.7% of 30 patients treated with veliparib and radiation after complete surgical resection had at least one grade 3 adverse event by 3 years of follow-up, reported Reshma Jagsi, MD, of the University of Michigan, Ann Arbor.
“In this multicenter phase 1 trial, severe acute toxicity did not exceed the prespecified target of 30%, even at the highest tested dose of veliparib (200 mg twice a day), and we observed no grade 4 or 5 events. However, given observations of grade 3 late toxicity in nearly one-half of all patients evaluated at 3 years, we recommend a phase 2 dose of 50 mg twice a day if veliparib is investigated further for radiosensitization in patients with breast cancer at high risk of locoregional recurrence and in need of treatment intensification,” they wrote in the Journal of Clinical Oncology.
In preclinical studies, PARP (poly [ADP-ribose] polymerase) inhibitors have been shown to enhance radiosensitivty of breast malignancies when given concurrently with radiation.
In a phase 1 dosing and safety study, 30 women with inflammatory or locally recurrent breast cancer of the chest wall underwent complete surgical resection and were then assigned to radiation consisting of 50 Gy to the chest wall and regional lymph nodes, plus a 10 Gy boost. The patients also received oral veliparib at a dose of either 50, 100, 150, or 200 mg taken twice daily during the 6-week course of radiotherapy.
During the 6 weeks of therapy and 4 weeks of follow-up, there were five dose-limiting toxicities, including two cases each of confluent moist desquamation greater than 100 cm2 in the 100- and 150-mg dose groups, and one case of neutropenia in a patient at the 200-mg dose level.
The respective rates of any grade 3 toxicity, treatment related or otherwise, at 1, 2, and 3 years of follow-up were 10%, 16.7%, and 46.7%.
The investigators noted that, at year 3, severe fibrosis in the treatment field was seen in 6 of the 15 surviving patients. Of the six patients, two also had grade 3 skin induration, and two had grade 3 lymphedema.
“Although some of the late adverse events we observed might have occurred even in the absence of the investigational agent and with standard therapy, severe late toxicity is relatively uncommon with standard therapy alone, so we believe that a cautious approach is prudent,” Dr. Jagsi and associates wrote.
The study was supported by the Translational Breast Cancer Research Consortium, Breast Cancer Research Foundation, University of Michigan Comprehensive Cancer Center, and Michigan Institute for Clinical and Health Research. Dr. Jagsi reported institutional research support from AbbVie, which donated the veliparib used in the study.
SOURCE: Jagsi R et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.77.2665
Using the PARP inhibitor veliparib as a radiosensitizer for chest wall radiation in women with inflammatory or locally recurrent breast cancer was associated with a high rate of late grade 3 adverse events, results of a phase 1 study show.
Although the trial’s upper limit of dose-limiting toxicities during 6 weeks of treatment and 4 weeks of follow-up was not met, 46.7% of 30 patients treated with veliparib and radiation after complete surgical resection had at least one grade 3 adverse event by 3 years of follow-up, reported Reshma Jagsi, MD, of the University of Michigan, Ann Arbor.
“In this multicenter phase 1 trial, severe acute toxicity did not exceed the prespecified target of 30%, even at the highest tested dose of veliparib (200 mg twice a day), and we observed no grade 4 or 5 events. However, given observations of grade 3 late toxicity in nearly one-half of all patients evaluated at 3 years, we recommend a phase 2 dose of 50 mg twice a day if veliparib is investigated further for radiosensitization in patients with breast cancer at high risk of locoregional recurrence and in need of treatment intensification,” they wrote in the Journal of Clinical Oncology.
In preclinical studies, PARP (poly [ADP-ribose] polymerase) inhibitors have been shown to enhance radiosensitivty of breast malignancies when given concurrently with radiation.
In a phase 1 dosing and safety study, 30 women with inflammatory or locally recurrent breast cancer of the chest wall underwent complete surgical resection and were then assigned to radiation consisting of 50 Gy to the chest wall and regional lymph nodes, plus a 10 Gy boost. The patients also received oral veliparib at a dose of either 50, 100, 150, or 200 mg taken twice daily during the 6-week course of radiotherapy.
During the 6 weeks of therapy and 4 weeks of follow-up, there were five dose-limiting toxicities, including two cases each of confluent moist desquamation greater than 100 cm2 in the 100- and 150-mg dose groups, and one case of neutropenia in a patient at the 200-mg dose level.
The respective rates of any grade 3 toxicity, treatment related or otherwise, at 1, 2, and 3 years of follow-up were 10%, 16.7%, and 46.7%.
The investigators noted that, at year 3, severe fibrosis in the treatment field was seen in 6 of the 15 surviving patients. Of the six patients, two also had grade 3 skin induration, and two had grade 3 lymphedema.
“Although some of the late adverse events we observed might have occurred even in the absence of the investigational agent and with standard therapy, severe late toxicity is relatively uncommon with standard therapy alone, so we believe that a cautious approach is prudent,” Dr. Jagsi and associates wrote.
The study was supported by the Translational Breast Cancer Research Consortium, Breast Cancer Research Foundation, University of Michigan Comprehensive Cancer Center, and Michigan Institute for Clinical and Health Research. Dr. Jagsi reported institutional research support from AbbVie, which donated the veliparib used in the study.
SOURCE: Jagsi R et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.77.2665
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: PARP inhibitors have a radiosensitizing effect when used in treatment of inflammatory breast cancer but are associated with late grade 3 adverse events.
Major finding: At 3 years, 46.7% of patients had a grade 3 adverse event of any kind.
Study details: Phase 1 dose-finding and safety study in 30 women treated with radiation and veliparib after complete surgical resection of inflammatory or recurrent breast cancer of the chest wall and regional lymph nodes.
Disclosures: The study was supported by the Translational Breast Cancer Research Consortium, Breast Cancer Research Foundation, University of Michigan Comprehensive Cancer Center, and Michigan Institute for Clinical and Health Research. Dr. Jagsi reported institutional research support from AbbVie, which donated the veliparib used in the study.
Source: Jagsi R et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.77.2665.
FDA approves nilotinib for children with CML
Nilotinib is now approved for use by children aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.
The Food and Drug Administration expanded the drug’s indication to include use as first- and second-line treatment in children.
Adverse events in the pediatric studies were similar to those observed in adults. However, children experienced hyperbilirubinemia (grade 3/4: 13%) and transaminase elevation (AST grade 3/4: 1%; ALT grade 3/4: 9%). Additionally, one previously treated pediatric patient progressed with advance phase/blast crisis after about 10 months of treatment.
Nilotinib (Tasigna) was already approved in adults with newly diagnosed Ph+ CML in the chronic phase and adults with chronic phase and accelerated phase Ph+ CML resistant or intolerant to prior therapy.
Nilotinib is now approved for use by children aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.
The Food and Drug Administration expanded the drug’s indication to include use as first- and second-line treatment in children.
Adverse events in the pediatric studies were similar to those observed in adults. However, children experienced hyperbilirubinemia (grade 3/4: 13%) and transaminase elevation (AST grade 3/4: 1%; ALT grade 3/4: 9%). Additionally, one previously treated pediatric patient progressed with advance phase/blast crisis after about 10 months of treatment.
Nilotinib (Tasigna) was already approved in adults with newly diagnosed Ph+ CML in the chronic phase and adults with chronic phase and accelerated phase Ph+ CML resistant or intolerant to prior therapy.
Nilotinib is now approved for use by children aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.
The Food and Drug Administration expanded the drug’s indication to include use as first- and second-line treatment in children.
Adverse events in the pediatric studies were similar to those observed in adults. However, children experienced hyperbilirubinemia (grade 3/4: 13%) and transaminase elevation (AST grade 3/4: 1%; ALT grade 3/4: 9%). Additionally, one previously treated pediatric patient progressed with advance phase/blast crisis after about 10 months of treatment.
Nilotinib (Tasigna) was already approved in adults with newly diagnosed Ph+ CML in the chronic phase and adults with chronic phase and accelerated phase Ph+ CML resistant or intolerant to prior therapy.
Rheumatologists push back on feds’ association health plan proposal
A proposed rule defining association health plans has raised red flags for the American College of Rheumatology.
In particular, ACR is concerned that, if enacted, the proposed rule published by the Department of Labor on Jan. 5 could create access issues.
“There is a marked lack of current data available related to the risk profile of existing and potential associations and how those intersect with the individual and small group markets,” ACR said in a March 6 comment letter to the Department of Labor.
The college also noted that, “we especially have concerns regarding patient access to care in rural and remote areas of the United States.”
The organization suggested that the Labor department write regulations to ensure network adequacy, particularly for specialty care, and address other reforms related to prior authorization.
Significantly, ACR expressed concerns that a kind of economic discrimination could occur under AHPs.
Discrimination could come from opting not to cover prescription drugs, extreme utilization management protocols, coverage caps, increased coinsurance for patients, and discriminatory tiering and other formulary designs for high-cost medications.
ACR “strongly opposes excessive patient cost sharing that results in untenable patient financial burden, thereby creating a de facto situation in which the patient does not have access to a medically necessary treatment,” the organization wrote. “For patients with complex conditions like rheumatoid arthritis, biologic medications are very expensive and excessive cost sharing can reduce adherence and patient access to treatment, leading to risk for irreversible damage, excess morbidity, and even mortality.”
“The ACR is concerned that loosening these consumer protections will reduce our patients’ access to care, either through weaker coverage or by driving up their premiums,” ACR President David Daikh, MD, said in a statement. “Our patients require continuous access to specialized care to manage pain and avoid long-term disability. Therefore it is imperative that the administration ensure that Americans living with rheumatic diseases be afforded adequate protections under these new rules.”
The comment period for the proposed rule closed in early March. At press time, the Labor department had not published a timeline for publishing a final rule.
A proposed rule defining association health plans has raised red flags for the American College of Rheumatology.
In particular, ACR is concerned that, if enacted, the proposed rule published by the Department of Labor on Jan. 5 could create access issues.
“There is a marked lack of current data available related to the risk profile of existing and potential associations and how those intersect with the individual and small group markets,” ACR said in a March 6 comment letter to the Department of Labor.
The college also noted that, “we especially have concerns regarding patient access to care in rural and remote areas of the United States.”
The organization suggested that the Labor department write regulations to ensure network adequacy, particularly for specialty care, and address other reforms related to prior authorization.
Significantly, ACR expressed concerns that a kind of economic discrimination could occur under AHPs.
Discrimination could come from opting not to cover prescription drugs, extreme utilization management protocols, coverage caps, increased coinsurance for patients, and discriminatory tiering and other formulary designs for high-cost medications.
ACR “strongly opposes excessive patient cost sharing that results in untenable patient financial burden, thereby creating a de facto situation in which the patient does not have access to a medically necessary treatment,” the organization wrote. “For patients with complex conditions like rheumatoid arthritis, biologic medications are very expensive and excessive cost sharing can reduce adherence and patient access to treatment, leading to risk for irreversible damage, excess morbidity, and even mortality.”
“The ACR is concerned that loosening these consumer protections will reduce our patients’ access to care, either through weaker coverage or by driving up their premiums,” ACR President David Daikh, MD, said in a statement. “Our patients require continuous access to specialized care to manage pain and avoid long-term disability. Therefore it is imperative that the administration ensure that Americans living with rheumatic diseases be afforded adequate protections under these new rules.”
The comment period for the proposed rule closed in early March. At press time, the Labor department had not published a timeline for publishing a final rule.
A proposed rule defining association health plans has raised red flags for the American College of Rheumatology.
In particular, ACR is concerned that, if enacted, the proposed rule published by the Department of Labor on Jan. 5 could create access issues.
“There is a marked lack of current data available related to the risk profile of existing and potential associations and how those intersect with the individual and small group markets,” ACR said in a March 6 comment letter to the Department of Labor.
The college also noted that, “we especially have concerns regarding patient access to care in rural and remote areas of the United States.”
The organization suggested that the Labor department write regulations to ensure network adequacy, particularly for specialty care, and address other reforms related to prior authorization.
Significantly, ACR expressed concerns that a kind of economic discrimination could occur under AHPs.
Discrimination could come from opting not to cover prescription drugs, extreme utilization management protocols, coverage caps, increased coinsurance for patients, and discriminatory tiering and other formulary designs for high-cost medications.
ACR “strongly opposes excessive patient cost sharing that results in untenable patient financial burden, thereby creating a de facto situation in which the patient does not have access to a medically necessary treatment,” the organization wrote. “For patients with complex conditions like rheumatoid arthritis, biologic medications are very expensive and excessive cost sharing can reduce adherence and patient access to treatment, leading to risk for irreversible damage, excess morbidity, and even mortality.”
“The ACR is concerned that loosening these consumer protections will reduce our patients’ access to care, either through weaker coverage or by driving up their premiums,” ACR President David Daikh, MD, said in a statement. “Our patients require continuous access to specialized care to manage pain and avoid long-term disability. Therefore it is imperative that the administration ensure that Americans living with rheumatic diseases be afforded adequate protections under these new rules.”
The comment period for the proposed rule closed in early March. At press time, the Labor department had not published a timeline for publishing a final rule.
Early diagnosis of Alzheimer’s could save U.S. trillions over time
Alzheimer’s disease may cost the United States alone more than $1.3 trillion by 2050, but early diagnosis could be one way to mitigate at least some of that increase, a special report released by the Alzheimer’s Association says.
An improved clinical scenario, with 88% of patients diagnosed in the early stage of mild cognitive impairment (MCI), could save $231.4 billion in direct treatment and long-term care costs by that time, according to the report, contained in the 2018 Alzheimer’s Disease Facts and Figures. Extrapolated out to the full lifespan of everyone now alive in the United States, the 88% diagnostic scenario could reap $7 trillion in savings, the report noted. This benefit would comprise $3.3 trillion in Medicare savings, $2.3 trillion in Medicaid savings, and $1.4 trillion in other areas of spending, including out-of-pocket expenses and private insurance.
The improved clinical diagnosis picture could manifest if diagnoses were based solely on biomarkers rather than the current method, which relies largely on symptoms and performance on cognitive tests, without biomarker confirmation. The biomarker-based diagnostic algorithm has been proposed for research cohorts, but not for clinical care.
The diagnostic workup currently employed, which is most often not confirmed with biomarkers, “means that many people who are diagnosed with Alzheimer’s may in reality have MCI or dementia due to other causes,” the report noted. Studies consistently show that up to 30% of patients diagnosed with apparent Alzheimer’s actually have another source of cognitive dysfunction. The misdiagnosis gap haunts clinical trialists and makes a strong case for incorporating biomarkers, including amyloid imaging, into the diagnostic workup – something the Alzheimer’s Association is pushing for with its IDEAS study.
Diagnostic reliance on symptoms and cognitive test performance without the additional information provided by biomarkers can affect the confidence clinicians have in making a diagnosis and thereby delay a diagnosis, dementia specialist Marwan N. Sabbagh, MD, said when asked to comment on the report.
“The report by the Alzheimer’s Association underscores the fact that early diagnosis of dementia or MCI due to Alzheimer’s disease is important not only because it is good health care but because net savings can be realized. The simple fact is that physicians have been taught to approach a diagnosis of dementia as a diagnosis of exclusion and they have been told that a diagnosis can be absolutely attained only by biopsy or autopsy. The consequence of these messages is that there is a lack of confidence in the clinic diagnosis and a subsequent delay in making a diagnosis,” said Dr. Sabbagh, the Karsten Solheim Chair for Dementia, professor of neurology, and director of the Alzheimer’s and memory disorders division at the Barrow Neurological Institute, Phoenix. “The deployment of in vivo biomarkers will transform the diagnosis from one of exclusion to one of inclusion. The up front costs will be saved later in the course.”
Earlier diagnosis is also associated with greater per-person savings, the report noted. “Under the current status quo, an individual with Alzheimer’s has total projected health and long-term care costs of $424,000 (present value of future costs) from the year before MCI until death. Under the partial early diagnosis scenario, the average per-person cost for an individual with Alzheimer’s is projected to be $360,000, saving $64,000 per individual.”
The economic modeling study employed The Health Economics Medical Innovation Simulation (THEMIS), which uses data from the Health and Retirement Study (HRS), a nationally representative sample of adults aged 50 and older.
The simulated population included everyone alive in the United States in 2018 and assumed cognitive assessment beginning at age 50. The model did not assume that biomarkers would be used in the diagnostic process.
It included three scenarios:
• The current situation, in which many people never receive a diagnosis or receive it later in the disease.
• A partial early-diagnosis scenario, with 88% of Alzheimer’s patients diagnosed in the MCI stage.
• A full early diagnosis scenario, in which all Alzheimer’s patients receive an early MCI diagnosis.
The current situation of inaccurate or late diagnosis remains the most expensive scenario. The model projected a total expenditure of $47.1 trillion over the lifetime of everyone alive in the United States in 2018 ($23.1 trillion in Medicare costs, $11.8 trillion in Medicaid costs, and $12.1 trillion in other costs). The report also noted that this total doesn’t include the current expense of caring for everyone in the United States who has Alzheimer’s now.
The partial early diagnosis scenario assumes that everyone with Alzheimer’s has a 70% chance of being diagnosed with MCI every 2 years; this would yield a total diagnostic rate of 88%.
Under this scenario, the model projected a total care cost of $40.1 trillion – a $7 trillion benefit composed of $3.3 trillion in Medicare savings, $2.3 trillion in Medicaid savings, and $1.4 trillion in other savings.
“Thus, nearly all of the potential savings of early diagnosis can be realized under the partial early diagnosis scenario,” the report noted.
These savings would be realized over a long period, but there could be massive shorter-term benefits as well, the report said. Savings under the partial early-diagnosis scenario could be $31.8 billion in 2025 and $231.4 billion in 2050.
That would be good financial news, especially in light of the report’s current cost analysis. In 2018, the cost of caring for Alzheimer’s patients and those with other dementias is on track to exceed $277 billion, which is $18 billion more than the United States paid out last year. If the current diagnostic scenario and incidence rates continue unabated, the report projected an annual expense of $1.35 trillion for care in 2050.
Alzheimer’s disease may cost the United States alone more than $1.3 trillion by 2050, but early diagnosis could be one way to mitigate at least some of that increase, a special report released by the Alzheimer’s Association says.
An improved clinical scenario, with 88% of patients diagnosed in the early stage of mild cognitive impairment (MCI), could save $231.4 billion in direct treatment and long-term care costs by that time, according to the report, contained in the 2018 Alzheimer’s Disease Facts and Figures. Extrapolated out to the full lifespan of everyone now alive in the United States, the 88% diagnostic scenario could reap $7 trillion in savings, the report noted. This benefit would comprise $3.3 trillion in Medicare savings, $2.3 trillion in Medicaid savings, and $1.4 trillion in other areas of spending, including out-of-pocket expenses and private insurance.
The improved clinical diagnosis picture could manifest if diagnoses were based solely on biomarkers rather than the current method, which relies largely on symptoms and performance on cognitive tests, without biomarker confirmation. The biomarker-based diagnostic algorithm has been proposed for research cohorts, but not for clinical care.
The diagnostic workup currently employed, which is most often not confirmed with biomarkers, “means that many people who are diagnosed with Alzheimer’s may in reality have MCI or dementia due to other causes,” the report noted. Studies consistently show that up to 30% of patients diagnosed with apparent Alzheimer’s actually have another source of cognitive dysfunction. The misdiagnosis gap haunts clinical trialists and makes a strong case for incorporating biomarkers, including amyloid imaging, into the diagnostic workup – something the Alzheimer’s Association is pushing for with its IDEAS study.
Diagnostic reliance on symptoms and cognitive test performance without the additional information provided by biomarkers can affect the confidence clinicians have in making a diagnosis and thereby delay a diagnosis, dementia specialist Marwan N. Sabbagh, MD, said when asked to comment on the report.
“The report by the Alzheimer’s Association underscores the fact that early diagnosis of dementia or MCI due to Alzheimer’s disease is important not only because it is good health care but because net savings can be realized. The simple fact is that physicians have been taught to approach a diagnosis of dementia as a diagnosis of exclusion and they have been told that a diagnosis can be absolutely attained only by biopsy or autopsy. The consequence of these messages is that there is a lack of confidence in the clinic diagnosis and a subsequent delay in making a diagnosis,” said Dr. Sabbagh, the Karsten Solheim Chair for Dementia, professor of neurology, and director of the Alzheimer’s and memory disorders division at the Barrow Neurological Institute, Phoenix. “The deployment of in vivo biomarkers will transform the diagnosis from one of exclusion to one of inclusion. The up front costs will be saved later in the course.”
Earlier diagnosis is also associated with greater per-person savings, the report noted. “Under the current status quo, an individual with Alzheimer’s has total projected health and long-term care costs of $424,000 (present value of future costs) from the year before MCI until death. Under the partial early diagnosis scenario, the average per-person cost for an individual with Alzheimer’s is projected to be $360,000, saving $64,000 per individual.”
The economic modeling study employed The Health Economics Medical Innovation Simulation (THEMIS), which uses data from the Health and Retirement Study (HRS), a nationally representative sample of adults aged 50 and older.
The simulated population included everyone alive in the United States in 2018 and assumed cognitive assessment beginning at age 50. The model did not assume that biomarkers would be used in the diagnostic process.
It included three scenarios:
• The current situation, in which many people never receive a diagnosis or receive it later in the disease.
• A partial early-diagnosis scenario, with 88% of Alzheimer’s patients diagnosed in the MCI stage.
• A full early diagnosis scenario, in which all Alzheimer’s patients receive an early MCI diagnosis.
The current situation of inaccurate or late diagnosis remains the most expensive scenario. The model projected a total expenditure of $47.1 trillion over the lifetime of everyone alive in the United States in 2018 ($23.1 trillion in Medicare costs, $11.8 trillion in Medicaid costs, and $12.1 trillion in other costs). The report also noted that this total doesn’t include the current expense of caring for everyone in the United States who has Alzheimer’s now.
The partial early diagnosis scenario assumes that everyone with Alzheimer’s has a 70% chance of being diagnosed with MCI every 2 years; this would yield a total diagnostic rate of 88%.
Under this scenario, the model projected a total care cost of $40.1 trillion – a $7 trillion benefit composed of $3.3 trillion in Medicare savings, $2.3 trillion in Medicaid savings, and $1.4 trillion in other savings.
“Thus, nearly all of the potential savings of early diagnosis can be realized under the partial early diagnosis scenario,” the report noted.
These savings would be realized over a long period, but there could be massive shorter-term benefits as well, the report said. Savings under the partial early-diagnosis scenario could be $31.8 billion in 2025 and $231.4 billion in 2050.
That would be good financial news, especially in light of the report’s current cost analysis. In 2018, the cost of caring for Alzheimer’s patients and those with other dementias is on track to exceed $277 billion, which is $18 billion more than the United States paid out last year. If the current diagnostic scenario and incidence rates continue unabated, the report projected an annual expense of $1.35 trillion for care in 2050.
Alzheimer’s disease may cost the United States alone more than $1.3 trillion by 2050, but early diagnosis could be one way to mitigate at least some of that increase, a special report released by the Alzheimer’s Association says.
An improved clinical scenario, with 88% of patients diagnosed in the early stage of mild cognitive impairment (MCI), could save $231.4 billion in direct treatment and long-term care costs by that time, according to the report, contained in the 2018 Alzheimer’s Disease Facts and Figures. Extrapolated out to the full lifespan of everyone now alive in the United States, the 88% diagnostic scenario could reap $7 trillion in savings, the report noted. This benefit would comprise $3.3 trillion in Medicare savings, $2.3 trillion in Medicaid savings, and $1.4 trillion in other areas of spending, including out-of-pocket expenses and private insurance.
The improved clinical diagnosis picture could manifest if diagnoses were based solely on biomarkers rather than the current method, which relies largely on symptoms and performance on cognitive tests, without biomarker confirmation. The biomarker-based diagnostic algorithm has been proposed for research cohorts, but not for clinical care.
The diagnostic workup currently employed, which is most often not confirmed with biomarkers, “means that many people who are diagnosed with Alzheimer’s may in reality have MCI or dementia due to other causes,” the report noted. Studies consistently show that up to 30% of patients diagnosed with apparent Alzheimer’s actually have another source of cognitive dysfunction. The misdiagnosis gap haunts clinical trialists and makes a strong case for incorporating biomarkers, including amyloid imaging, into the diagnostic workup – something the Alzheimer’s Association is pushing for with its IDEAS study.
Diagnostic reliance on symptoms and cognitive test performance without the additional information provided by biomarkers can affect the confidence clinicians have in making a diagnosis and thereby delay a diagnosis, dementia specialist Marwan N. Sabbagh, MD, said when asked to comment on the report.
“The report by the Alzheimer’s Association underscores the fact that early diagnosis of dementia or MCI due to Alzheimer’s disease is important not only because it is good health care but because net savings can be realized. The simple fact is that physicians have been taught to approach a diagnosis of dementia as a diagnosis of exclusion and they have been told that a diagnosis can be absolutely attained only by biopsy or autopsy. The consequence of these messages is that there is a lack of confidence in the clinic diagnosis and a subsequent delay in making a diagnosis,” said Dr. Sabbagh, the Karsten Solheim Chair for Dementia, professor of neurology, and director of the Alzheimer’s and memory disorders division at the Barrow Neurological Institute, Phoenix. “The deployment of in vivo biomarkers will transform the diagnosis from one of exclusion to one of inclusion. The up front costs will be saved later in the course.”
Earlier diagnosis is also associated with greater per-person savings, the report noted. “Under the current status quo, an individual with Alzheimer’s has total projected health and long-term care costs of $424,000 (present value of future costs) from the year before MCI until death. Under the partial early diagnosis scenario, the average per-person cost for an individual with Alzheimer’s is projected to be $360,000, saving $64,000 per individual.”
The economic modeling study employed The Health Economics Medical Innovation Simulation (THEMIS), which uses data from the Health and Retirement Study (HRS), a nationally representative sample of adults aged 50 and older.
The simulated population included everyone alive in the United States in 2018 and assumed cognitive assessment beginning at age 50. The model did not assume that biomarkers would be used in the diagnostic process.
It included three scenarios:
• The current situation, in which many people never receive a diagnosis or receive it later in the disease.
• A partial early-diagnosis scenario, with 88% of Alzheimer’s patients diagnosed in the MCI stage.
• A full early diagnosis scenario, in which all Alzheimer’s patients receive an early MCI diagnosis.
The current situation of inaccurate or late diagnosis remains the most expensive scenario. The model projected a total expenditure of $47.1 trillion over the lifetime of everyone alive in the United States in 2018 ($23.1 trillion in Medicare costs, $11.8 trillion in Medicaid costs, and $12.1 trillion in other costs). The report also noted that this total doesn’t include the current expense of caring for everyone in the United States who has Alzheimer’s now.
The partial early diagnosis scenario assumes that everyone with Alzheimer’s has a 70% chance of being diagnosed with MCI every 2 years; this would yield a total diagnostic rate of 88%.
Under this scenario, the model projected a total care cost of $40.1 trillion – a $7 trillion benefit composed of $3.3 trillion in Medicare savings, $2.3 trillion in Medicaid savings, and $1.4 trillion in other savings.
“Thus, nearly all of the potential savings of early diagnosis can be realized under the partial early diagnosis scenario,” the report noted.
These savings would be realized over a long period, but there could be massive shorter-term benefits as well, the report said. Savings under the partial early-diagnosis scenario could be $31.8 billion in 2025 and $231.4 billion in 2050.
That would be good financial news, especially in light of the report’s current cost analysis. In 2018, the cost of caring for Alzheimer’s patients and those with other dementias is on track to exceed $277 billion, which is $18 billion more than the United States paid out last year. If the current diagnostic scenario and incidence rates continue unabated, the report projected an annual expense of $1.35 trillion for care in 2050.
How policy illustrates the value of SHM membership
Federal programs can be enormously complicated, and the Medicare value-based payment programs, such as the Physician Quality Reporting System, the physician value-based payment modifier, and the new Merit-Based Incentive Payment System, are no exception.
It can be a challenge to navigate the rules, to identify how and which measures to report, and to determine how to integrate those requirements into your practice. Furthermore, the feedback from these programs to providers can be difficult to read and interpret.
Part of the value of being a member of the Society of Hospital Medicine (SHM) is having another set of eyes – particularly those that spend a significant amount of time immersed in federal regulations – to parse the policy-practice nexus. SHM hears from members all over the country, many in different practice types and with different policy needs. This knowledge can be shared, both with other members and with policymakers. A recent example highlights the power of this relationship.
Your membership contributes directly to the advocacy efforts of SHM, and the engagement of members with SHM staff on policy issues is a force multiplier for the effect SHM can have on policy decisions. There is a lot of value for belonging to SHM, and sometimes, we can put an exact number on it.
A solo-practicing hospitalist called seeking perspective on why he received a letter indicating he would be receiving a penalty in 2018 for failing the requirements of Physician Quality Reporting System reporting. This hospitalist had successfully reported on as many measures as he possibly could, so he could not understand why he would be receiving a penalty.
All told, a different read of the feedback reports, and some strategic questions from SHM staff, helped this hospitalist understand why he was being penalized and how, in this case, he could ask Centers for Medicare & Medicaid Services for reconsideration. Upon second review by CMS, the penalties were overturned, and this provider should save nearly $30,000 in Medicare payments in 2018.
SHM helped the provider by being a sounding board and by sharing information learned from experiences other members had had with these programs. In turn, the knowledge gained from this interaction will be used to fine-tune SHM’s educational materials and outreach efforts about these programs. It has also already contributed to advocacy efforts with CMS policymakers regarding how they can improve the programs to be more transparent and equitable. The learning is shared in both directions.
Want to learn more about SHM’s advocacy efforts and how policy affects hospitalists? Stop by sessions at Hospital Medicine 2018 in Orlando; there will be one on pay-for-performance programs on Monday, April 9, at 3:15 p.m. and others on health policy throughout the day on Wednesday, April 11. Learn more at www.shmannualconference.org.
Mr. Lapps is the government relations manager at the Society of Hospital Medicine.
Federal programs can be enormously complicated, and the Medicare value-based payment programs, such as the Physician Quality Reporting System, the physician value-based payment modifier, and the new Merit-Based Incentive Payment System, are no exception.
It can be a challenge to navigate the rules, to identify how and which measures to report, and to determine how to integrate those requirements into your practice. Furthermore, the feedback from these programs to providers can be difficult to read and interpret.
Part of the value of being a member of the Society of Hospital Medicine (SHM) is having another set of eyes – particularly those that spend a significant amount of time immersed in federal regulations – to parse the policy-practice nexus. SHM hears from members all over the country, many in different practice types and with different policy needs. This knowledge can be shared, both with other members and with policymakers. A recent example highlights the power of this relationship.
Your membership contributes directly to the advocacy efforts of SHM, and the engagement of members with SHM staff on policy issues is a force multiplier for the effect SHM can have on policy decisions. There is a lot of value for belonging to SHM, and sometimes, we can put an exact number on it.
A solo-practicing hospitalist called seeking perspective on why he received a letter indicating he would be receiving a penalty in 2018 for failing the requirements of Physician Quality Reporting System reporting. This hospitalist had successfully reported on as many measures as he possibly could, so he could not understand why he would be receiving a penalty.
All told, a different read of the feedback reports, and some strategic questions from SHM staff, helped this hospitalist understand why he was being penalized and how, in this case, he could ask Centers for Medicare & Medicaid Services for reconsideration. Upon second review by CMS, the penalties were overturned, and this provider should save nearly $30,000 in Medicare payments in 2018.
SHM helped the provider by being a sounding board and by sharing information learned from experiences other members had had with these programs. In turn, the knowledge gained from this interaction will be used to fine-tune SHM’s educational materials and outreach efforts about these programs. It has also already contributed to advocacy efforts with CMS policymakers regarding how they can improve the programs to be more transparent and equitable. The learning is shared in both directions.
Want to learn more about SHM’s advocacy efforts and how policy affects hospitalists? Stop by sessions at Hospital Medicine 2018 in Orlando; there will be one on pay-for-performance programs on Monday, April 9, at 3:15 p.m. and others on health policy throughout the day on Wednesday, April 11. Learn more at www.shmannualconference.org.
Mr. Lapps is the government relations manager at the Society of Hospital Medicine.
Federal programs can be enormously complicated, and the Medicare value-based payment programs, such as the Physician Quality Reporting System, the physician value-based payment modifier, and the new Merit-Based Incentive Payment System, are no exception.
It can be a challenge to navigate the rules, to identify how and which measures to report, and to determine how to integrate those requirements into your practice. Furthermore, the feedback from these programs to providers can be difficult to read and interpret.
Part of the value of being a member of the Society of Hospital Medicine (SHM) is having another set of eyes – particularly those that spend a significant amount of time immersed in federal regulations – to parse the policy-practice nexus. SHM hears from members all over the country, many in different practice types and with different policy needs. This knowledge can be shared, both with other members and with policymakers. A recent example highlights the power of this relationship.
Your membership contributes directly to the advocacy efforts of SHM, and the engagement of members with SHM staff on policy issues is a force multiplier for the effect SHM can have on policy decisions. There is a lot of value for belonging to SHM, and sometimes, we can put an exact number on it.
A solo-practicing hospitalist called seeking perspective on why he received a letter indicating he would be receiving a penalty in 2018 for failing the requirements of Physician Quality Reporting System reporting. This hospitalist had successfully reported on as many measures as he possibly could, so he could not understand why he would be receiving a penalty.
All told, a different read of the feedback reports, and some strategic questions from SHM staff, helped this hospitalist understand why he was being penalized and how, in this case, he could ask Centers for Medicare & Medicaid Services for reconsideration. Upon second review by CMS, the penalties were overturned, and this provider should save nearly $30,000 in Medicare payments in 2018.
SHM helped the provider by being a sounding board and by sharing information learned from experiences other members had had with these programs. In turn, the knowledge gained from this interaction will be used to fine-tune SHM’s educational materials and outreach efforts about these programs. It has also already contributed to advocacy efforts with CMS policymakers regarding how they can improve the programs to be more transparent and equitable. The learning is shared in both directions.
Want to learn more about SHM’s advocacy efforts and how policy affects hospitalists? Stop by sessions at Hospital Medicine 2018 in Orlando; there will be one on pay-for-performance programs on Monday, April 9, at 3:15 p.m. and others on health policy throughout the day on Wednesday, April 11. Learn more at www.shmannualconference.org.
Mr. Lapps is the government relations manager at the Society of Hospital Medicine.
VIDEO: PFO closure device 100% effective against future strokes
ORLANDO – Closing a patent foramen ovale reduced the incidence of stroke and other adverse events in patients at increased risk the DEFENSE-PRO trial.
“The potential association between patent foramen ovale [PFO] and cryptogenic stroke has been a controversial issue for decades,” Jae Kwan Song, MD, of Asan Medical Center in Seoul, South Korea, said in an interview at the annual meeting of the American College of Cardiology.
In this study, 60 patients with high-risk PFOs (at least 2 mm) were randomized to receive anticoagulant or antiplatelet medications alone, and 60 were randomized to medication plus implantation of the Amplatzer PFO closure device.
The device implantation was successful for all patients in the device group. The primary endpoint was a combination of stroke, vascular death, and major bleeding within 2 years of follow-up after the procedure.
After an average follow-up of 2.8 years, none of the patients in the device group and six (10%) of patients in the medication-only group experienced a primary endpoint event. The events in the medication-only group included five cases of ischemic stroke, two cases of TIMI-defined major bleeding, one cerebral hemorrhage, and one transient ischemic attack.
Nonfatal procedural complications included two cases of atrial fibrillation, one case of pericardial effusion, and one pseudoaneurysm.
The average age of the patients was 54 years in the medication-only group and 49 years in the device group, and roughly one-third of the patients in each group were male. The baseline clinical characteristics, including the presence of hypertension, diabetes, smoking, and high cholesterol, were similar between the groups.
“We should consider two things before clinical decision of device closure,” Dr. Song said. First, exclude other causes of cryptogenic stroke; and second, conduct a comprehensive evaluation of the PFO to determine which patients are at highest risk and would be most likely to benefit from the procedure, he said.
To better determine which patients would benefit from the device implantation, Dr. Song and his colleagues used imaging to review data on the size and features of the PFO; patients with evidence of an atrial septal aneurysm or hypermobility (defined as a septal excursion 10 mm or larger) were deemed at especially high risk.
Dr. Song said that the next steps for research on management of PFOs include determining which medications are most effective in patients treated with medication alone, as well as clarifying the process of patient selection for device use based on PFO morphology.
The study was terminated early because of several factors, including low patient recruitment and the decision not to deny patients the closure treatment because of its demonstrated effectiveness, Dr. Song noted.
The study was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose. The findings were published simultaneously in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2018.02.046).
SOURCE: Song J. ACC 2018.
ORLANDO – Closing a patent foramen ovale reduced the incidence of stroke and other adverse events in patients at increased risk the DEFENSE-PRO trial.
“The potential association between patent foramen ovale [PFO] and cryptogenic stroke has been a controversial issue for decades,” Jae Kwan Song, MD, of Asan Medical Center in Seoul, South Korea, said in an interview at the annual meeting of the American College of Cardiology.
In this study, 60 patients with high-risk PFOs (at least 2 mm) were randomized to receive anticoagulant or antiplatelet medications alone, and 60 were randomized to medication plus implantation of the Amplatzer PFO closure device.
The device implantation was successful for all patients in the device group. The primary endpoint was a combination of stroke, vascular death, and major bleeding within 2 years of follow-up after the procedure.
After an average follow-up of 2.8 years, none of the patients in the device group and six (10%) of patients in the medication-only group experienced a primary endpoint event. The events in the medication-only group included five cases of ischemic stroke, two cases of TIMI-defined major bleeding, one cerebral hemorrhage, and one transient ischemic attack.
Nonfatal procedural complications included two cases of atrial fibrillation, one case of pericardial effusion, and one pseudoaneurysm.
The average age of the patients was 54 years in the medication-only group and 49 years in the device group, and roughly one-third of the patients in each group were male. The baseline clinical characteristics, including the presence of hypertension, diabetes, smoking, and high cholesterol, were similar between the groups.
“We should consider two things before clinical decision of device closure,” Dr. Song said. First, exclude other causes of cryptogenic stroke; and second, conduct a comprehensive evaluation of the PFO to determine which patients are at highest risk and would be most likely to benefit from the procedure, he said.
To better determine which patients would benefit from the device implantation, Dr. Song and his colleagues used imaging to review data on the size and features of the PFO; patients with evidence of an atrial septal aneurysm or hypermobility (defined as a septal excursion 10 mm or larger) were deemed at especially high risk.
Dr. Song said that the next steps for research on management of PFOs include determining which medications are most effective in patients treated with medication alone, as well as clarifying the process of patient selection for device use based on PFO morphology.
The study was terminated early because of several factors, including low patient recruitment and the decision not to deny patients the closure treatment because of its demonstrated effectiveness, Dr. Song noted.
The study was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose. The findings were published simultaneously in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2018.02.046).
SOURCE: Song J. ACC 2018.
ORLANDO – Closing a patent foramen ovale reduced the incidence of stroke and other adverse events in patients at increased risk the DEFENSE-PRO trial.
“The potential association between patent foramen ovale [PFO] and cryptogenic stroke has been a controversial issue for decades,” Jae Kwan Song, MD, of Asan Medical Center in Seoul, South Korea, said in an interview at the annual meeting of the American College of Cardiology.
In this study, 60 patients with high-risk PFOs (at least 2 mm) were randomized to receive anticoagulant or antiplatelet medications alone, and 60 were randomized to medication plus implantation of the Amplatzer PFO closure device.
The device implantation was successful for all patients in the device group. The primary endpoint was a combination of stroke, vascular death, and major bleeding within 2 years of follow-up after the procedure.
After an average follow-up of 2.8 years, none of the patients in the device group and six (10%) of patients in the medication-only group experienced a primary endpoint event. The events in the medication-only group included five cases of ischemic stroke, two cases of TIMI-defined major bleeding, one cerebral hemorrhage, and one transient ischemic attack.
Nonfatal procedural complications included two cases of atrial fibrillation, one case of pericardial effusion, and one pseudoaneurysm.
The average age of the patients was 54 years in the medication-only group and 49 years in the device group, and roughly one-third of the patients in each group were male. The baseline clinical characteristics, including the presence of hypertension, diabetes, smoking, and high cholesterol, were similar between the groups.
“We should consider two things before clinical decision of device closure,” Dr. Song said. First, exclude other causes of cryptogenic stroke; and second, conduct a comprehensive evaluation of the PFO to determine which patients are at highest risk and would be most likely to benefit from the procedure, he said.
To better determine which patients would benefit from the device implantation, Dr. Song and his colleagues used imaging to review data on the size and features of the PFO; patients with evidence of an atrial septal aneurysm or hypermobility (defined as a septal excursion 10 mm or larger) were deemed at especially high risk.
Dr. Song said that the next steps for research on management of PFOs include determining which medications are most effective in patients treated with medication alone, as well as clarifying the process of patient selection for device use based on PFO morphology.
The study was terminated early because of several factors, including low patient recruitment and the decision not to deny patients the closure treatment because of its demonstrated effectiveness, Dr. Song noted.
The study was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose. The findings were published simultaneously in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2018.02.046).
SOURCE: Song J. ACC 2018.
REPORTING FROM ACC 18
Key clinical point: Closure of patent foramen ovale resulted in no adverse events or recurrent strokes during 2 years’ follow-up.
Major finding: No adverse event or strokes occurred in the device-plus-medication group, compared with six events in the medication-only group.
Study details: The data come from DEFENSE-PFO, a randomized trial of 120 adults with a history of cryptogenic stroke and high-risk PFO.
Disclosures: DEFENSE-PFO was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose.
Source: Song J. ACC 2018.
Is kratom the answer to the opioid crisis?
As the opioid epidemic continues to ravage the United States, patients and physicians are looking for less-addictive alternatives for pain control.
For a growing number of U.S. patients, top among the contenders is kratom, a plant-based product that shows a dose-dependent opioidlike effect. For physicians, toxicologists – and federal regulators, however – the absence of evidence-based studies on the herb’s effectiveness and safety is raising concerns.
“
Petros Levounis, MD, an addiction psychiatrist who has treated kratom users, said an inherent challenge is countering patients’ perceptions about the substance.
“Somehow, in the popular culture, kratom has a reputation as being a mild opioid. And we’re not sure about that,” said Dr. Levounis, a member of the American Academy of Addiction Psychiatry. “But the fact that people think it’s more natural and therefore it must be safer is very problematic.”
The uncertainty around kratom raises the stakes when it comes to treating patients. “From a medical perspective, one of the trickiest issues is we’re not sure that naloxone reverses the opioid effects,” said Dr. Levounis, also chair of psychiatry at Robert Wood Johnson Medical School, New Brunswick. “We do use naloxone, but it is not clear that it works as an antidote. This is probably the most problematic area about kratom.”
Origins, demographics
A member of the coffee family, kratom (Mitragyna speciosa) grows in Thailand, Malaysia, Indonesia, and Papua New Guinea, and has been used throughout southeast Asia for many years to manage pain and bolster energy, according to the National Center for Complementary and Integrative Health.
Dr. Grundmann conducted an anonymous survey last year about kratom and found that most users are white, married or partnered, and employed for wages. Dr. Grundmann’s survey of 8,049 kratom users also found that a majority of users reported having some college. However, the survey found an inverse relationship between years of education and the tendency to use kratom (Drug Alcohol Depend. 2017 Jul 1;176:63-70).
“The more education somebody has, the less likely they are to use kratom for prescription medicine dependency or for an emotional or mental condition,” Dr. Grundmann said.
Anecdotal evidence
One study conducted by David Galbis-Reig, MD, president-elect of the Wisconsin Society of Addiction Medicine, followed a 37-year-old woman who experienced kratom addiction.
“The mitragynine and 7-Hydroxymitragynine very clearly have partial opioid agonist activity with kappa antagonist activity, which is very similar to buprenorphine,” said Dr. Galbis-Reig, who is also with American Society of Addiction Medicine.
A major concern that Dr. Galbis-Reig’s case brings up is the use of liquid kratom extract.
“My biggest concern is we just don’t know what the stimulant properties of the drug are,” Dr. Galbis-Reig said. “If it turns out the properties are more in line with an amphetamine, I’m not sure that’s a great drug to use in a clinical setting for many conditions.”
But Murray A. Holcomb, MD, an acute care surgeon at Seton Healthcare Family Center, Round Rock, Tex., offered a different take. He said he and his family were first highly skeptical when they first heard about kratom. But after years of trying to help his son overcome his depression and substance abuse, Dr. Holcomb said he was ready to try anything.
After researching and consulting with his colleagues, Dr. Holcomb helped his son acquire the plant. What was expected to be another substance that overpromised and underdelivered turned out to be the real thing.
“Out of desperation, [my son] tried kratom, and within a few short days, he began to experience remission of his symptoms – which was immediately noticeable to all of us who knew him,” said Dr. Holcomb. “It is important to note that kratom does not make him high, loopy, or anything but normal. He lives independently, works full time, maintains healthy relationships, is pleasant and responsible, reestablished contact with his sister and brother, and is largely a happy normal person.”
Not only was his son able to return to his normal life, but the costs for his dose of kratom were within his budget while making minimum wage, similar to a majority of users – who make $35,000-$50,000 per year, Dr. Grundmann’s survey results suggest.
For people with substance use disorder, the issue of addiction always is present, Dr. Holcomb believes, and if that is the case, it’s better to be using kratom than another drug,
“If people steer themselves to kratom rather than something else, that’s probably a good thing, because if someone wants to abuse something, you can’t stop them; you can’t regulate intent,“ Dr. Holcomb said. “Kratom is a partial agonist. It doesn’t make you euphorically high, it doesn’t make you quit breathing, and you don’t really have any withdrawal symptoms, and no one is going to overdose on a natural plant – because it will make them sick to their stomach.”
In a systematic review of studies related to kratom use, investigators found that the product “may be useful for analgesia, mood elevation, anxiety reduction, and may aid opioid withdrawal management. Negative themes also emerged, including unfavorable side effects, especially stomach upset and vomiting,” wrote Marc T. Swogger, PhD, and his colleagues (J Psychoactive Drugs. 2015 Nov-Dec;47[5]:360-7).
“As an opioid substitute, it seems to be used in good effect to decrease opioid withdrawal symptoms, including cravings for more opioids,” said Dr. Swogger, clinical psychologist at the University of Rochester (N.Y.). “People are able to use kratom as a way to get through systemic hoops to get the medicine they need.”
The regulatory fight
In 2016, the Drug Enforcement Administration announced its intentions to classify mitragynine and 7-Hydroxymitragynine, the active ingredients in kratom, as a schedule I drug in order to “avoid an imminent hazard to public safety” after two cases of kratom exposure were reported to the American Association for Poison Control Centers, according to a statement released by the DEA.
In November 2017, Scott Gottlieb, MD, commissioner of the Food and Drug Administration, issued a public health advisory reporting that kratom-related calls to U.S. poison control centers soared 10-fold during 2010-2015. It also said that 36 people have died after using products containing kratom. In light of those developments and with the absence of evidence showing that the substance is safe, the agency is taking action, he wrote.
“To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S.,” Dr. Gottlieb wrote. “Kratom is already a controlled substance in 16 countries, including 2 of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden, and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin, and several others have pending legislation to ban it.”
In December 2017, a group comprising 17 members of Congress responded wrote a letter to Dr. Gottlieb imploring the Trump administration to recognize the merits of the substance and to drop its intention to make it more difficult to procure.
“Given that numerous stakeholders, former opioid addicts, and scientific researchers vouch for kratom’s safety and support its use, and responsible manufacturers of kratom products ensure that their products are properly labeled for adult-only consumption, we respectfully request that the FDA reconsider its stance and take a closer look at the facts and recent science regarding this plant,” the members wrote in the letter. After the letter was received by the FDA, the DEA decided to hold off on its scheduling.
But controversy surrounding the botanical product continues. Earlier this year, the FDA ordered the recall and destruction of kratom-containing dietary supplements made by a company in Grain Valley, Mo., the agency said in a statement. The FDA also is investigating a possible association between kratom intake and an outbreak of salmonella in North Dakota and Utah, in which 17 of 24 patients reported taking products thought to contain kratom before becoming sick, the agency wrote. Meanwhile, in late March, the FDA reported that it was investigating a multistate outbreak of salmonella infections tied to products that were reported to contain kratom. For example, the agency said, it is "reporting four additional products tested by Oregon Health Authority identified as positive for salmonella in four additional product samples collected from the retailer Torched Illusions." As of March 15, the FDA said, the Centers for Disease Control and Prevention reported that 87 people had been infected with outbreak strains of salmonella reported from 35 states.*
Dr. Gottlieb had issued a statement a few weeks earlier, in February, saying that the agency was able to confirm that kratom contains opioids. “The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” Dr. Gottlieb wrote. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use, and take aggressive enforcement action against kratom-containing products.”
For physicians like Dr. Levounis, who treat kratom users in emergency departments, patients should heed those warnings. “People erroneously feel that herbal products are milder than other products,” he said. “Nature can manufacture incredibly strong stuff – for good and for bad.”
*This story was updated 3/23/2018.
Dr. Goldberger, Dr. Levounis, Dr. Grundmann, and Dr. Holcomb had no disclosures. Dr. Galbis-Reig disclosed in his study that he is the owner of stock in GW Pharmaceuticals and Cortex Pharmaceuticals, Pfizer bonds, and has spousal ownership of stock in AbbVie, Abbott Pharma, and Hospira. Dr. Swogger and other authors of the systematic review reported serving as consultants for the American Kratom Association, as well as sponsors of other kratom products.
As the opioid epidemic continues to ravage the United States, patients and physicians are looking for less-addictive alternatives for pain control.
For a growing number of U.S. patients, top among the contenders is kratom, a plant-based product that shows a dose-dependent opioidlike effect. For physicians, toxicologists – and federal regulators, however – the absence of evidence-based studies on the herb’s effectiveness and safety is raising concerns.
“
Petros Levounis, MD, an addiction psychiatrist who has treated kratom users, said an inherent challenge is countering patients’ perceptions about the substance.
“Somehow, in the popular culture, kratom has a reputation as being a mild opioid. And we’re not sure about that,” said Dr. Levounis, a member of the American Academy of Addiction Psychiatry. “But the fact that people think it’s more natural and therefore it must be safer is very problematic.”
The uncertainty around kratom raises the stakes when it comes to treating patients. “From a medical perspective, one of the trickiest issues is we’re not sure that naloxone reverses the opioid effects,” said Dr. Levounis, also chair of psychiatry at Robert Wood Johnson Medical School, New Brunswick. “We do use naloxone, but it is not clear that it works as an antidote. This is probably the most problematic area about kratom.”
Origins, demographics
A member of the coffee family, kratom (Mitragyna speciosa) grows in Thailand, Malaysia, Indonesia, and Papua New Guinea, and has been used throughout southeast Asia for many years to manage pain and bolster energy, according to the National Center for Complementary and Integrative Health.
Dr. Grundmann conducted an anonymous survey last year about kratom and found that most users are white, married or partnered, and employed for wages. Dr. Grundmann’s survey of 8,049 kratom users also found that a majority of users reported having some college. However, the survey found an inverse relationship between years of education and the tendency to use kratom (Drug Alcohol Depend. 2017 Jul 1;176:63-70).
“The more education somebody has, the less likely they are to use kratom for prescription medicine dependency or for an emotional or mental condition,” Dr. Grundmann said.
Anecdotal evidence
One study conducted by David Galbis-Reig, MD, president-elect of the Wisconsin Society of Addiction Medicine, followed a 37-year-old woman who experienced kratom addiction.
“The mitragynine and 7-Hydroxymitragynine very clearly have partial opioid agonist activity with kappa antagonist activity, which is very similar to buprenorphine,” said Dr. Galbis-Reig, who is also with American Society of Addiction Medicine.
A major concern that Dr. Galbis-Reig’s case brings up is the use of liquid kratom extract.
“My biggest concern is we just don’t know what the stimulant properties of the drug are,” Dr. Galbis-Reig said. “If it turns out the properties are more in line with an amphetamine, I’m not sure that’s a great drug to use in a clinical setting for many conditions.”
But Murray A. Holcomb, MD, an acute care surgeon at Seton Healthcare Family Center, Round Rock, Tex., offered a different take. He said he and his family were first highly skeptical when they first heard about kratom. But after years of trying to help his son overcome his depression and substance abuse, Dr. Holcomb said he was ready to try anything.
After researching and consulting with his colleagues, Dr. Holcomb helped his son acquire the plant. What was expected to be another substance that overpromised and underdelivered turned out to be the real thing.
“Out of desperation, [my son] tried kratom, and within a few short days, he began to experience remission of his symptoms – which was immediately noticeable to all of us who knew him,” said Dr. Holcomb. “It is important to note that kratom does not make him high, loopy, or anything but normal. He lives independently, works full time, maintains healthy relationships, is pleasant and responsible, reestablished contact with his sister and brother, and is largely a happy normal person.”
Not only was his son able to return to his normal life, but the costs for his dose of kratom were within his budget while making minimum wage, similar to a majority of users – who make $35,000-$50,000 per year, Dr. Grundmann’s survey results suggest.
For people with substance use disorder, the issue of addiction always is present, Dr. Holcomb believes, and if that is the case, it’s better to be using kratom than another drug,
“If people steer themselves to kratom rather than something else, that’s probably a good thing, because if someone wants to abuse something, you can’t stop them; you can’t regulate intent,“ Dr. Holcomb said. “Kratom is a partial agonist. It doesn’t make you euphorically high, it doesn’t make you quit breathing, and you don’t really have any withdrawal symptoms, and no one is going to overdose on a natural plant – because it will make them sick to their stomach.”
In a systematic review of studies related to kratom use, investigators found that the product “may be useful for analgesia, mood elevation, anxiety reduction, and may aid opioid withdrawal management. Negative themes also emerged, including unfavorable side effects, especially stomach upset and vomiting,” wrote Marc T. Swogger, PhD, and his colleagues (J Psychoactive Drugs. 2015 Nov-Dec;47[5]:360-7).
“As an opioid substitute, it seems to be used in good effect to decrease opioid withdrawal symptoms, including cravings for more opioids,” said Dr. Swogger, clinical psychologist at the University of Rochester (N.Y.). “People are able to use kratom as a way to get through systemic hoops to get the medicine they need.”
The regulatory fight
In 2016, the Drug Enforcement Administration announced its intentions to classify mitragynine and 7-Hydroxymitragynine, the active ingredients in kratom, as a schedule I drug in order to “avoid an imminent hazard to public safety” after two cases of kratom exposure were reported to the American Association for Poison Control Centers, according to a statement released by the DEA.
In November 2017, Scott Gottlieb, MD, commissioner of the Food and Drug Administration, issued a public health advisory reporting that kratom-related calls to U.S. poison control centers soared 10-fold during 2010-2015. It also said that 36 people have died after using products containing kratom. In light of those developments and with the absence of evidence showing that the substance is safe, the agency is taking action, he wrote.
“To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S.,” Dr. Gottlieb wrote. “Kratom is already a controlled substance in 16 countries, including 2 of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden, and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin, and several others have pending legislation to ban it.”
In December 2017, a group comprising 17 members of Congress responded wrote a letter to Dr. Gottlieb imploring the Trump administration to recognize the merits of the substance and to drop its intention to make it more difficult to procure.
“Given that numerous stakeholders, former opioid addicts, and scientific researchers vouch for kratom’s safety and support its use, and responsible manufacturers of kratom products ensure that their products are properly labeled for adult-only consumption, we respectfully request that the FDA reconsider its stance and take a closer look at the facts and recent science regarding this plant,” the members wrote in the letter. After the letter was received by the FDA, the DEA decided to hold off on its scheduling.
But controversy surrounding the botanical product continues. Earlier this year, the FDA ordered the recall and destruction of kratom-containing dietary supplements made by a company in Grain Valley, Mo., the agency said in a statement. The FDA also is investigating a possible association between kratom intake and an outbreak of salmonella in North Dakota and Utah, in which 17 of 24 patients reported taking products thought to contain kratom before becoming sick, the agency wrote. Meanwhile, in late March, the FDA reported that it was investigating a multistate outbreak of salmonella infections tied to products that were reported to contain kratom. For example, the agency said, it is "reporting four additional products tested by Oregon Health Authority identified as positive for salmonella in four additional product samples collected from the retailer Torched Illusions." As of March 15, the FDA said, the Centers for Disease Control and Prevention reported that 87 people had been infected with outbreak strains of salmonella reported from 35 states.*
Dr. Gottlieb had issued a statement a few weeks earlier, in February, saying that the agency was able to confirm that kratom contains opioids. “The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” Dr. Gottlieb wrote. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use, and take aggressive enforcement action against kratom-containing products.”
For physicians like Dr. Levounis, who treat kratom users in emergency departments, patients should heed those warnings. “People erroneously feel that herbal products are milder than other products,” he said. “Nature can manufacture incredibly strong stuff – for good and for bad.”
*This story was updated 3/23/2018.
Dr. Goldberger, Dr. Levounis, Dr. Grundmann, and Dr. Holcomb had no disclosures. Dr. Galbis-Reig disclosed in his study that he is the owner of stock in GW Pharmaceuticals and Cortex Pharmaceuticals, Pfizer bonds, and has spousal ownership of stock in AbbVie, Abbott Pharma, and Hospira. Dr. Swogger and other authors of the systematic review reported serving as consultants for the American Kratom Association, as well as sponsors of other kratom products.
As the opioid epidemic continues to ravage the United States, patients and physicians are looking for less-addictive alternatives for pain control.
For a growing number of U.S. patients, top among the contenders is kratom, a plant-based product that shows a dose-dependent opioidlike effect. For physicians, toxicologists – and federal regulators, however – the absence of evidence-based studies on the herb’s effectiveness and safety is raising concerns.
“
Petros Levounis, MD, an addiction psychiatrist who has treated kratom users, said an inherent challenge is countering patients’ perceptions about the substance.
“Somehow, in the popular culture, kratom has a reputation as being a mild opioid. And we’re not sure about that,” said Dr. Levounis, a member of the American Academy of Addiction Psychiatry. “But the fact that people think it’s more natural and therefore it must be safer is very problematic.”
The uncertainty around kratom raises the stakes when it comes to treating patients. “From a medical perspective, one of the trickiest issues is we’re not sure that naloxone reverses the opioid effects,” said Dr. Levounis, also chair of psychiatry at Robert Wood Johnson Medical School, New Brunswick. “We do use naloxone, but it is not clear that it works as an antidote. This is probably the most problematic area about kratom.”
Origins, demographics
A member of the coffee family, kratom (Mitragyna speciosa) grows in Thailand, Malaysia, Indonesia, and Papua New Guinea, and has been used throughout southeast Asia for many years to manage pain and bolster energy, according to the National Center for Complementary and Integrative Health.
Dr. Grundmann conducted an anonymous survey last year about kratom and found that most users are white, married or partnered, and employed for wages. Dr. Grundmann’s survey of 8,049 kratom users also found that a majority of users reported having some college. However, the survey found an inverse relationship between years of education and the tendency to use kratom (Drug Alcohol Depend. 2017 Jul 1;176:63-70).
“The more education somebody has, the less likely they are to use kratom for prescription medicine dependency or for an emotional or mental condition,” Dr. Grundmann said.
Anecdotal evidence
One study conducted by David Galbis-Reig, MD, president-elect of the Wisconsin Society of Addiction Medicine, followed a 37-year-old woman who experienced kratom addiction.
“The mitragynine and 7-Hydroxymitragynine very clearly have partial opioid agonist activity with kappa antagonist activity, which is very similar to buprenorphine,” said Dr. Galbis-Reig, who is also with American Society of Addiction Medicine.
A major concern that Dr. Galbis-Reig’s case brings up is the use of liquid kratom extract.
“My biggest concern is we just don’t know what the stimulant properties of the drug are,” Dr. Galbis-Reig said. “If it turns out the properties are more in line with an amphetamine, I’m not sure that’s a great drug to use in a clinical setting for many conditions.”
But Murray A. Holcomb, MD, an acute care surgeon at Seton Healthcare Family Center, Round Rock, Tex., offered a different take. He said he and his family were first highly skeptical when they first heard about kratom. But after years of trying to help his son overcome his depression and substance abuse, Dr. Holcomb said he was ready to try anything.
After researching and consulting with his colleagues, Dr. Holcomb helped his son acquire the plant. What was expected to be another substance that overpromised and underdelivered turned out to be the real thing.
“Out of desperation, [my son] tried kratom, and within a few short days, he began to experience remission of his symptoms – which was immediately noticeable to all of us who knew him,” said Dr. Holcomb. “It is important to note that kratom does not make him high, loopy, or anything but normal. He lives independently, works full time, maintains healthy relationships, is pleasant and responsible, reestablished contact with his sister and brother, and is largely a happy normal person.”
Not only was his son able to return to his normal life, but the costs for his dose of kratom were within his budget while making minimum wage, similar to a majority of users – who make $35,000-$50,000 per year, Dr. Grundmann’s survey results suggest.
For people with substance use disorder, the issue of addiction always is present, Dr. Holcomb believes, and if that is the case, it’s better to be using kratom than another drug,
“If people steer themselves to kratom rather than something else, that’s probably a good thing, because if someone wants to abuse something, you can’t stop them; you can’t regulate intent,“ Dr. Holcomb said. “Kratom is a partial agonist. It doesn’t make you euphorically high, it doesn’t make you quit breathing, and you don’t really have any withdrawal symptoms, and no one is going to overdose on a natural plant – because it will make them sick to their stomach.”
In a systematic review of studies related to kratom use, investigators found that the product “may be useful for analgesia, mood elevation, anxiety reduction, and may aid opioid withdrawal management. Negative themes also emerged, including unfavorable side effects, especially stomach upset and vomiting,” wrote Marc T. Swogger, PhD, and his colleagues (J Psychoactive Drugs. 2015 Nov-Dec;47[5]:360-7).
“As an opioid substitute, it seems to be used in good effect to decrease opioid withdrawal symptoms, including cravings for more opioids,” said Dr. Swogger, clinical psychologist at the University of Rochester (N.Y.). “People are able to use kratom as a way to get through systemic hoops to get the medicine they need.”
The regulatory fight
In 2016, the Drug Enforcement Administration announced its intentions to classify mitragynine and 7-Hydroxymitragynine, the active ingredients in kratom, as a schedule I drug in order to “avoid an imminent hazard to public safety” after two cases of kratom exposure were reported to the American Association for Poison Control Centers, according to a statement released by the DEA.
In November 2017, Scott Gottlieb, MD, commissioner of the Food and Drug Administration, issued a public health advisory reporting that kratom-related calls to U.S. poison control centers soared 10-fold during 2010-2015. It also said that 36 people have died after using products containing kratom. In light of those developments and with the absence of evidence showing that the substance is safe, the agency is taking action, he wrote.
“To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S.,” Dr. Gottlieb wrote. “Kratom is already a controlled substance in 16 countries, including 2 of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden, and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin, and several others have pending legislation to ban it.”
In December 2017, a group comprising 17 members of Congress responded wrote a letter to Dr. Gottlieb imploring the Trump administration to recognize the merits of the substance and to drop its intention to make it more difficult to procure.
“Given that numerous stakeholders, former opioid addicts, and scientific researchers vouch for kratom’s safety and support its use, and responsible manufacturers of kratom products ensure that their products are properly labeled for adult-only consumption, we respectfully request that the FDA reconsider its stance and take a closer look at the facts and recent science regarding this plant,” the members wrote in the letter. After the letter was received by the FDA, the DEA decided to hold off on its scheduling.
But controversy surrounding the botanical product continues. Earlier this year, the FDA ordered the recall and destruction of kratom-containing dietary supplements made by a company in Grain Valley, Mo., the agency said in a statement. The FDA also is investigating a possible association between kratom intake and an outbreak of salmonella in North Dakota and Utah, in which 17 of 24 patients reported taking products thought to contain kratom before becoming sick, the agency wrote. Meanwhile, in late March, the FDA reported that it was investigating a multistate outbreak of salmonella infections tied to products that were reported to contain kratom. For example, the agency said, it is "reporting four additional products tested by Oregon Health Authority identified as positive for salmonella in four additional product samples collected from the retailer Torched Illusions." As of March 15, the FDA said, the Centers for Disease Control and Prevention reported that 87 people had been infected with outbreak strains of salmonella reported from 35 states.*
Dr. Gottlieb had issued a statement a few weeks earlier, in February, saying that the agency was able to confirm that kratom contains opioids. “The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” Dr. Gottlieb wrote. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use, and take aggressive enforcement action against kratom-containing products.”
For physicians like Dr. Levounis, who treat kratom users in emergency departments, patients should heed those warnings. “People erroneously feel that herbal products are milder than other products,” he said. “Nature can manufacture incredibly strong stuff – for good and for bad.”
*This story was updated 3/23/2018.
Dr. Goldberger, Dr. Levounis, Dr. Grundmann, and Dr. Holcomb had no disclosures. Dr. Galbis-Reig disclosed in his study that he is the owner of stock in GW Pharmaceuticals and Cortex Pharmaceuticals, Pfizer bonds, and has spousal ownership of stock in AbbVie, Abbott Pharma, and Hospira. Dr. Swogger and other authors of the systematic review reported serving as consultants for the American Kratom Association, as well as sponsors of other kratom products.