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Warfarin associated with higher upper GI bleeding rates, compared with DOACs
Warfarin is associated with higher rates of upper gastrointestinal bleeding but not overall or lower GI bleeding rates, compared with direct oral anticoagulants (DOACs), according to a new nationwide report from Iceland.
In addition, warfarin is associated with higher rates of major GI bleeding, compared with apixaban.
“Although there has been a myriad of studies comparing GI bleeding rates between warfarin and DOACs, very few studies have compared upper and lower GI bleeding rates specifically,” Arnar Ingason, MD, PhD, a gastroenterology resident at the University of Iceland and Landspitali University Hospital, Reykjavik, said in an interview.
“Knowing whether the risk of upper and lower GI bleeding differs between warfarin and DOACs is important, as it can help guide oral anticoagulant selection,” he said.
“Given that warfarin was associated with higher rates of upper GI bleeding compared to DOACs in our study, warfarin may not be optimal for patients with high risk of upper GI bleeding, such as patients with previous history of upper GI bleeding,” Dr. Ingason added.
The study was published online in Clinical Gastroenterology and Hepatology.
Analyzing bleed rates
Dr. Ingason and colleagues analyzed data from electronic medical records for more than 7,000 patients in Iceland who began a prescription for oral anticoagulants between 2014 and 2019. They used inverse probability weighting to yield balanced study groups and calculate the rates of overall, major, upper, and lower GI bleeding. All events of gastrointestinal bleeding were manually confirmed by chart review.
Clinically relevant GI bleeding was defined as bleeding that led to medical intervention, unscheduled physician contact, or temporary cessation of treatment. Upper GI bleeding was defined as hematemesis or a confirmed upper GI bleed site on endoscopy, whereas lower gastrointestinal bleeding was defined as hematochezia or a confirmed lower GI bleed site on endoscopy. Patients with melena and uncertain bleeding site on endoscopy were classified as having a gastrointestinal bleed of unknown location.
Major bleeding was defined as a drop in hemoglobin of at least 20 g/L, transfusion of two or more packs of red blood cells, or bleeding into a closed compartment such as the retroperitoneum.
In total, 295 gastrointestinal bleed events were identified, with 150 events (51%) classified as lower, 105 events (36%) classified as upper, and 40 events (14%) of an unknown location. About 71% required hospitalization, and 63% met the criteria for major bleeding. Five patients died, including three taking warfarin and the other two taking apixaban and rivaroxaban.
Overall, warfarin was associated with double the rate of upper GI bleeding, with 1.7 events per 100 person-years, compared with 0.8 events per 100 person-years for DOACs. The rates of lower GI bleeding were similar for the drugs.
Specifically, warfarin was associated with nearly 5.5 times higher rates of upper gastrointestinal bleeding, compared with dabigatran (Pradaxa, Boehringer Ingelheim), 2.6 times higher than apixaban (Eliquis, Bristol-Myers Squibb), and 1.7 times higher than rivaroxaban (Xarelto, Janssen). The risk for upper GI bleeding also was higher in men taking warfarin.
Warfarin was associated with higher rates of major bleeding, compared with apixaban, with 2.3 events per 100 person-years versus 1.5 events per 100 person-years. Otherwise, overall and major bleed rates were similar for users of warfarin and DOACs.
“GI bleeding among cardiac patients on anticoagulants and antiplatelets is the fastest growing group of GI bleeders,” Neena Abraham, MD, professor of medicine and a gastroenterologist at the Mayo Clinic in Scottsdale, Ariz., said in an interview.
Dr. Abraham, who wasn’t involved with this study, runs a dedicated cardiogastroenterology practice and has studied these patients’ bleeding risk for 20 years.
“This is a group that is ever increasing with aging baby boomers,” she said. “It is anticipated by 2040 that more than 40% of the U.S. adult population will have one or more cardiovascular conditions requiring the chronic prescription of anticoagulant or antiplatelet drugs.”
Considering future research
In this study, peptic ulcer disease was a proportionally less common cause of upper GI bleeding for warfarin at 18%, compared with DOACs at 39%. At the same time, the absolute propensity-weighted incidence rates of peptic ulcer–induced bleeding were similar, with 0.3 events per 100 person-years for both groups.
“As warfarin is not thought to induce peptic ulcer disease but rather promote bleeding from pre-existing lesions, one explanation may be that peptic ulcer disease almost always leads to overt bleeding in anticoagulated patients, while other lesions, such as mucosal erosions and angiodysplasias, may be more likely to lead to overt bleeding in warfarin patients due to a potentially more intense anticoagulation,” Dr. Ingason said.
Dr. Ingason and colleagues now plan to compare GI bleeding severity between warfarin and DOACs. Previous studies have suggested that GI bleeding may be more severe in patients receiving warfarin than in those receiving DOACs, he said.
In addition, large studies with manual verification of GI bleed events could better estimate the potential differences in the sources of upper and lower bleeding between warfarin and DOACs, Dr. Ingason noted.
“Some DOACs, specifically dabigatran, are known to have a mucosal effect on the luminal GI tract, as well as a systemic effect,” Dr. Abraham said. “This pharmacologic effect may contribute to an increase in lower gastrointestinal bleeding in the setting of colonic diverticulosis or mucosal injuries from inflammatory processes.”
Ongoing research should also look at different ways to reduce anticoagulant-related GI bleeding among cardiac patients, she noted.
“Our research group continues to study the risk of cardiac and bleeding adverse events in patients prescribed to DOACs compared to those patients who receive a left atrial appendage occlusion device,” Dr. Abraham said. “This device often permits patients at high risk of GI bleeding to transition off anticoagulant and antiplatelet drugs.”
The study was funded by the Icelandic Centre for Research and the Landspitali University Hospital Research Fund. The funders had no role in the design, conduct, or reporting of the study. The authors declared no competing interests. Dr. Abraham reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Warfarin is associated with higher rates of upper gastrointestinal bleeding but not overall or lower GI bleeding rates, compared with direct oral anticoagulants (DOACs), according to a new nationwide report from Iceland.
In addition, warfarin is associated with higher rates of major GI bleeding, compared with apixaban.
“Although there has been a myriad of studies comparing GI bleeding rates between warfarin and DOACs, very few studies have compared upper and lower GI bleeding rates specifically,” Arnar Ingason, MD, PhD, a gastroenterology resident at the University of Iceland and Landspitali University Hospital, Reykjavik, said in an interview.
“Knowing whether the risk of upper and lower GI bleeding differs between warfarin and DOACs is important, as it can help guide oral anticoagulant selection,” he said.
“Given that warfarin was associated with higher rates of upper GI bleeding compared to DOACs in our study, warfarin may not be optimal for patients with high risk of upper GI bleeding, such as patients with previous history of upper GI bleeding,” Dr. Ingason added.
The study was published online in Clinical Gastroenterology and Hepatology.
Analyzing bleed rates
Dr. Ingason and colleagues analyzed data from electronic medical records for more than 7,000 patients in Iceland who began a prescription for oral anticoagulants between 2014 and 2019. They used inverse probability weighting to yield balanced study groups and calculate the rates of overall, major, upper, and lower GI bleeding. All events of gastrointestinal bleeding were manually confirmed by chart review.
Clinically relevant GI bleeding was defined as bleeding that led to medical intervention, unscheduled physician contact, or temporary cessation of treatment. Upper GI bleeding was defined as hematemesis or a confirmed upper GI bleed site on endoscopy, whereas lower gastrointestinal bleeding was defined as hematochezia or a confirmed lower GI bleed site on endoscopy. Patients with melena and uncertain bleeding site on endoscopy were classified as having a gastrointestinal bleed of unknown location.
Major bleeding was defined as a drop in hemoglobin of at least 20 g/L, transfusion of two or more packs of red blood cells, or bleeding into a closed compartment such as the retroperitoneum.
In total, 295 gastrointestinal bleed events were identified, with 150 events (51%) classified as lower, 105 events (36%) classified as upper, and 40 events (14%) of an unknown location. About 71% required hospitalization, and 63% met the criteria for major bleeding. Five patients died, including three taking warfarin and the other two taking apixaban and rivaroxaban.
Overall, warfarin was associated with double the rate of upper GI bleeding, with 1.7 events per 100 person-years, compared with 0.8 events per 100 person-years for DOACs. The rates of lower GI bleeding were similar for the drugs.
Specifically, warfarin was associated with nearly 5.5 times higher rates of upper gastrointestinal bleeding, compared with dabigatran (Pradaxa, Boehringer Ingelheim), 2.6 times higher than apixaban (Eliquis, Bristol-Myers Squibb), and 1.7 times higher than rivaroxaban (Xarelto, Janssen). The risk for upper GI bleeding also was higher in men taking warfarin.
Warfarin was associated with higher rates of major bleeding, compared with apixaban, with 2.3 events per 100 person-years versus 1.5 events per 100 person-years. Otherwise, overall and major bleed rates were similar for users of warfarin and DOACs.
“GI bleeding among cardiac patients on anticoagulants and antiplatelets is the fastest growing group of GI bleeders,” Neena Abraham, MD, professor of medicine and a gastroenterologist at the Mayo Clinic in Scottsdale, Ariz., said in an interview.
Dr. Abraham, who wasn’t involved with this study, runs a dedicated cardiogastroenterology practice and has studied these patients’ bleeding risk for 20 years.
“This is a group that is ever increasing with aging baby boomers,” she said. “It is anticipated by 2040 that more than 40% of the U.S. adult population will have one or more cardiovascular conditions requiring the chronic prescription of anticoagulant or antiplatelet drugs.”
Considering future research
In this study, peptic ulcer disease was a proportionally less common cause of upper GI bleeding for warfarin at 18%, compared with DOACs at 39%. At the same time, the absolute propensity-weighted incidence rates of peptic ulcer–induced bleeding were similar, with 0.3 events per 100 person-years for both groups.
“As warfarin is not thought to induce peptic ulcer disease but rather promote bleeding from pre-existing lesions, one explanation may be that peptic ulcer disease almost always leads to overt bleeding in anticoagulated patients, while other lesions, such as mucosal erosions and angiodysplasias, may be more likely to lead to overt bleeding in warfarin patients due to a potentially more intense anticoagulation,” Dr. Ingason said.
Dr. Ingason and colleagues now plan to compare GI bleeding severity between warfarin and DOACs. Previous studies have suggested that GI bleeding may be more severe in patients receiving warfarin than in those receiving DOACs, he said.
In addition, large studies with manual verification of GI bleed events could better estimate the potential differences in the sources of upper and lower bleeding between warfarin and DOACs, Dr. Ingason noted.
“Some DOACs, specifically dabigatran, are known to have a mucosal effect on the luminal GI tract, as well as a systemic effect,” Dr. Abraham said. “This pharmacologic effect may contribute to an increase in lower gastrointestinal bleeding in the setting of colonic diverticulosis or mucosal injuries from inflammatory processes.”
Ongoing research should also look at different ways to reduce anticoagulant-related GI bleeding among cardiac patients, she noted.
“Our research group continues to study the risk of cardiac and bleeding adverse events in patients prescribed to DOACs compared to those patients who receive a left atrial appendage occlusion device,” Dr. Abraham said. “This device often permits patients at high risk of GI bleeding to transition off anticoagulant and antiplatelet drugs.”
The study was funded by the Icelandic Centre for Research and the Landspitali University Hospital Research Fund. The funders had no role in the design, conduct, or reporting of the study. The authors declared no competing interests. Dr. Abraham reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Warfarin is associated with higher rates of upper gastrointestinal bleeding but not overall or lower GI bleeding rates, compared with direct oral anticoagulants (DOACs), according to a new nationwide report from Iceland.
In addition, warfarin is associated with higher rates of major GI bleeding, compared with apixaban.
“Although there has been a myriad of studies comparing GI bleeding rates between warfarin and DOACs, very few studies have compared upper and lower GI bleeding rates specifically,” Arnar Ingason, MD, PhD, a gastroenterology resident at the University of Iceland and Landspitali University Hospital, Reykjavik, said in an interview.
“Knowing whether the risk of upper and lower GI bleeding differs between warfarin and DOACs is important, as it can help guide oral anticoagulant selection,” he said.
“Given that warfarin was associated with higher rates of upper GI bleeding compared to DOACs in our study, warfarin may not be optimal for patients with high risk of upper GI bleeding, such as patients with previous history of upper GI bleeding,” Dr. Ingason added.
The study was published online in Clinical Gastroenterology and Hepatology.
Analyzing bleed rates
Dr. Ingason and colleagues analyzed data from electronic medical records for more than 7,000 patients in Iceland who began a prescription for oral anticoagulants between 2014 and 2019. They used inverse probability weighting to yield balanced study groups and calculate the rates of overall, major, upper, and lower GI bleeding. All events of gastrointestinal bleeding were manually confirmed by chart review.
Clinically relevant GI bleeding was defined as bleeding that led to medical intervention, unscheduled physician contact, or temporary cessation of treatment. Upper GI bleeding was defined as hematemesis or a confirmed upper GI bleed site on endoscopy, whereas lower gastrointestinal bleeding was defined as hematochezia or a confirmed lower GI bleed site on endoscopy. Patients with melena and uncertain bleeding site on endoscopy were classified as having a gastrointestinal bleed of unknown location.
Major bleeding was defined as a drop in hemoglobin of at least 20 g/L, transfusion of two or more packs of red blood cells, or bleeding into a closed compartment such as the retroperitoneum.
In total, 295 gastrointestinal bleed events were identified, with 150 events (51%) classified as lower, 105 events (36%) classified as upper, and 40 events (14%) of an unknown location. About 71% required hospitalization, and 63% met the criteria for major bleeding. Five patients died, including three taking warfarin and the other two taking apixaban and rivaroxaban.
Overall, warfarin was associated with double the rate of upper GI bleeding, with 1.7 events per 100 person-years, compared with 0.8 events per 100 person-years for DOACs. The rates of lower GI bleeding were similar for the drugs.
Specifically, warfarin was associated with nearly 5.5 times higher rates of upper gastrointestinal bleeding, compared with dabigatran (Pradaxa, Boehringer Ingelheim), 2.6 times higher than apixaban (Eliquis, Bristol-Myers Squibb), and 1.7 times higher than rivaroxaban (Xarelto, Janssen). The risk for upper GI bleeding also was higher in men taking warfarin.
Warfarin was associated with higher rates of major bleeding, compared with apixaban, with 2.3 events per 100 person-years versus 1.5 events per 100 person-years. Otherwise, overall and major bleed rates were similar for users of warfarin and DOACs.
“GI bleeding among cardiac patients on anticoagulants and antiplatelets is the fastest growing group of GI bleeders,” Neena Abraham, MD, professor of medicine and a gastroenterologist at the Mayo Clinic in Scottsdale, Ariz., said in an interview.
Dr. Abraham, who wasn’t involved with this study, runs a dedicated cardiogastroenterology practice and has studied these patients’ bleeding risk for 20 years.
“This is a group that is ever increasing with aging baby boomers,” she said. “It is anticipated by 2040 that more than 40% of the U.S. adult population will have one or more cardiovascular conditions requiring the chronic prescription of anticoagulant or antiplatelet drugs.”
Considering future research
In this study, peptic ulcer disease was a proportionally less common cause of upper GI bleeding for warfarin at 18%, compared with DOACs at 39%. At the same time, the absolute propensity-weighted incidence rates of peptic ulcer–induced bleeding were similar, with 0.3 events per 100 person-years for both groups.
“As warfarin is not thought to induce peptic ulcer disease but rather promote bleeding from pre-existing lesions, one explanation may be that peptic ulcer disease almost always leads to overt bleeding in anticoagulated patients, while other lesions, such as mucosal erosions and angiodysplasias, may be more likely to lead to overt bleeding in warfarin patients due to a potentially more intense anticoagulation,” Dr. Ingason said.
Dr. Ingason and colleagues now plan to compare GI bleeding severity between warfarin and DOACs. Previous studies have suggested that GI bleeding may be more severe in patients receiving warfarin than in those receiving DOACs, he said.
In addition, large studies with manual verification of GI bleed events could better estimate the potential differences in the sources of upper and lower bleeding between warfarin and DOACs, Dr. Ingason noted.
“Some DOACs, specifically dabigatran, are known to have a mucosal effect on the luminal GI tract, as well as a systemic effect,” Dr. Abraham said. “This pharmacologic effect may contribute to an increase in lower gastrointestinal bleeding in the setting of colonic diverticulosis or mucosal injuries from inflammatory processes.”
Ongoing research should also look at different ways to reduce anticoagulant-related GI bleeding among cardiac patients, she noted.
“Our research group continues to study the risk of cardiac and bleeding adverse events in patients prescribed to DOACs compared to those patients who receive a left atrial appendage occlusion device,” Dr. Abraham said. “This device often permits patients at high risk of GI bleeding to transition off anticoagulant and antiplatelet drugs.”
The study was funded by the Icelandic Centre for Research and the Landspitali University Hospital Research Fund. The funders had no role in the design, conduct, or reporting of the study. The authors declared no competing interests. Dr. Abraham reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Reassuring data on NSAIDs in IBD flares
A new study has found no convincing evidence to suggest a causal relationship between nonsteroidal anti-inflammatory drug (NSAID) use and inflammatory bowel disease (IBD) exacerbations.
Rather, the study suggests that observed associations between IBD exacerbation and NSAID exposure may be explained by preexisting underlying risks for IBD flares, residual confounding, and reverse causality.
“We hope these study findings will aid providers in better directing IBD patients on their risk for IBD exacerbation with NSAID use,” write Shirley Cohen-Mekelburg, MD, with University of Michigan Medicine, Ann Arbor, and colleagues.
“This may guide therapy for both IBD and non-IBD related pain management, and the comfort of patients with IBD and the clinicians who treat them when considering NSAIDs as a non-opioid treatment option,” they add.
The study was published online in the American Journal of Gastroenterology.
Taking a second look
Patients with IBD (Crohn’s disease and ulcerative colitis) are prone to both inflammatory and noninflammatory pain, and there has been long-standing concern that NSAIDs may play a role in disease flare-ups.
To see whether a true association exists, Dr. Cohen-Mekelburg and colleagues conducted a series of studies that involved roughly 35,000 patients with IBD.
First, they created a propensity-matched cohort of 15,705 patients who had received NSAIDs and 19,326 who had not taken NSAIDs. Findings from a Cox proportional hazards model suggested a higher likelihood of IBD exacerbation in the group that had taken NSAIDs (hazard ratio, 1.24; 95% confidence interval, 1.16-1.33), after adjusting for age, gender, race, Charlson comorbidity index, smoking status, IBD type, and use of immunomodulator or biologic medications.
However, those who received NSAIDs were already at increased risk of experiencing a disease flare. And the prior event rate ratio for IBD exacerbation, as determined by dividing the adjusted HR after NSAID exposure by the adjusted HR for pre-NSAID exposure, was 0.95 (95% CI, 0.89-1.01).
The researchers used a self-controlled case series to verify their findings and to adjust for other immeasurable patient-level confounders. In this analysis, which involved 3,968 patients, the risk of IBD flare did not increase in the period from 2 weeks to 6 months after exposure to an NSAID.
The incidence of IBD exacerbations was higher in the 0- to 2-week transition period after an NSAID was prescribed, but it dropped after the 2-week “risk” window. This suggests that these short-term flares may be secondary to residual confounding related to reverse causality, rather than the NSAIDs themselves, the researchers say.
While NSAIDs represent the most common first-line analgesic, their use for patients with IBD is variable, in part due to the suspected risk of IBD exacerbation “despite inconclusive evidence of harm to date,” Dr. Cohen-Mekelburg and colleagues note.
They also note that about 36% of patients with IBD in their cohort received at least one NSAID prescription, and three-quarters of these patients did not experience an IBD exacerbation during an average of 5.9 years of follow-up.
Good study, reassuring data
“This is a good study trying to understand the potential sources of bias in associations,” Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.
Overall, he said the study “provides reassurance that cautious, short-duration or low-dose use is likely well tolerated in most patients with IBD. But more work is needed to understand the impact of higher dose or more frequent use.”
Also weighing in, Adam Steinlauf, MD, with Mount Sinai Health System and Icahn School of Medicine at Mount Sinai in New York, noted that patients with IBD experience pain throughout the course of their disease, both intestinal and extraintestinal.
“Treating the underlying IBD is important, but medications used to treat joint pain and inflammation specifically are few,” said Dr. Steinlauf, who wasn’t involved in the new study.
“Sulfasalazine has been used with success, but it does not work in everyone, and many are allergic to the sulfa component, limiting its use. Narcotics are often reluctantly used for these issues as well. Medical marijuana has emerged on the scene to control both types of pain, but to date, there is inconclusive evidence that it significantly treats both pain and underlying inflammation,” Dr. Steinlauf pointed out.
NSAIDs, on the other hand, are “excellent” choices for treating joint pain and inflammation, but gastroenterologists often try to avoid these medications, given the fear of triggering flares of underlying IBD, Dr. Steinlauf told this news organization.
In his view, this new study is “important in that it quite elegantly challenges the notion that gastroenterologists should avoid NSAIDs in patients with IBD.”
Although more data are clearly needed, Dr. Steinlauf said this study “should give practitioners a bit more confidence in prescribing NSAIDs for their patients with IBD if absolutely necessary to control pain and inflammation and improve quality of life when other standard treatments fail.
“The association of NSAIDs with subsequent flares, of which we are all so well aware of and afraid of, may in fact be related more to our patients’ underlying risks for IBD and reverse causality rather than the NSAIDs themselves. Future studies should further clarify this notion,” Dr. Steinlauf said.
The study received no commercial funding. Dr. Cohen-Mekelburg, Dr. Ananthakrishnan, and Dr. Steinlauf have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study has found no convincing evidence to suggest a causal relationship between nonsteroidal anti-inflammatory drug (NSAID) use and inflammatory bowel disease (IBD) exacerbations.
Rather, the study suggests that observed associations between IBD exacerbation and NSAID exposure may be explained by preexisting underlying risks for IBD flares, residual confounding, and reverse causality.
“We hope these study findings will aid providers in better directing IBD patients on their risk for IBD exacerbation with NSAID use,” write Shirley Cohen-Mekelburg, MD, with University of Michigan Medicine, Ann Arbor, and colleagues.
“This may guide therapy for both IBD and non-IBD related pain management, and the comfort of patients with IBD and the clinicians who treat them when considering NSAIDs as a non-opioid treatment option,” they add.
The study was published online in the American Journal of Gastroenterology.
Taking a second look
Patients with IBD (Crohn’s disease and ulcerative colitis) are prone to both inflammatory and noninflammatory pain, and there has been long-standing concern that NSAIDs may play a role in disease flare-ups.
To see whether a true association exists, Dr. Cohen-Mekelburg and colleagues conducted a series of studies that involved roughly 35,000 patients with IBD.
First, they created a propensity-matched cohort of 15,705 patients who had received NSAIDs and 19,326 who had not taken NSAIDs. Findings from a Cox proportional hazards model suggested a higher likelihood of IBD exacerbation in the group that had taken NSAIDs (hazard ratio, 1.24; 95% confidence interval, 1.16-1.33), after adjusting for age, gender, race, Charlson comorbidity index, smoking status, IBD type, and use of immunomodulator or biologic medications.
However, those who received NSAIDs were already at increased risk of experiencing a disease flare. And the prior event rate ratio for IBD exacerbation, as determined by dividing the adjusted HR after NSAID exposure by the adjusted HR for pre-NSAID exposure, was 0.95 (95% CI, 0.89-1.01).
The researchers used a self-controlled case series to verify their findings and to adjust for other immeasurable patient-level confounders. In this analysis, which involved 3,968 patients, the risk of IBD flare did not increase in the period from 2 weeks to 6 months after exposure to an NSAID.
The incidence of IBD exacerbations was higher in the 0- to 2-week transition period after an NSAID was prescribed, but it dropped after the 2-week “risk” window. This suggests that these short-term flares may be secondary to residual confounding related to reverse causality, rather than the NSAIDs themselves, the researchers say.
While NSAIDs represent the most common first-line analgesic, their use for patients with IBD is variable, in part due to the suspected risk of IBD exacerbation “despite inconclusive evidence of harm to date,” Dr. Cohen-Mekelburg and colleagues note.
They also note that about 36% of patients with IBD in their cohort received at least one NSAID prescription, and three-quarters of these patients did not experience an IBD exacerbation during an average of 5.9 years of follow-up.
Good study, reassuring data
“This is a good study trying to understand the potential sources of bias in associations,” Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.
Overall, he said the study “provides reassurance that cautious, short-duration or low-dose use is likely well tolerated in most patients with IBD. But more work is needed to understand the impact of higher dose or more frequent use.”
Also weighing in, Adam Steinlauf, MD, with Mount Sinai Health System and Icahn School of Medicine at Mount Sinai in New York, noted that patients with IBD experience pain throughout the course of their disease, both intestinal and extraintestinal.
“Treating the underlying IBD is important, but medications used to treat joint pain and inflammation specifically are few,” said Dr. Steinlauf, who wasn’t involved in the new study.
“Sulfasalazine has been used with success, but it does not work in everyone, and many are allergic to the sulfa component, limiting its use. Narcotics are often reluctantly used for these issues as well. Medical marijuana has emerged on the scene to control both types of pain, but to date, there is inconclusive evidence that it significantly treats both pain and underlying inflammation,” Dr. Steinlauf pointed out.
NSAIDs, on the other hand, are “excellent” choices for treating joint pain and inflammation, but gastroenterologists often try to avoid these medications, given the fear of triggering flares of underlying IBD, Dr. Steinlauf told this news organization.
In his view, this new study is “important in that it quite elegantly challenges the notion that gastroenterologists should avoid NSAIDs in patients with IBD.”
Although more data are clearly needed, Dr. Steinlauf said this study “should give practitioners a bit more confidence in prescribing NSAIDs for their patients with IBD if absolutely necessary to control pain and inflammation and improve quality of life when other standard treatments fail.
“The association of NSAIDs with subsequent flares, of which we are all so well aware of and afraid of, may in fact be related more to our patients’ underlying risks for IBD and reverse causality rather than the NSAIDs themselves. Future studies should further clarify this notion,” Dr. Steinlauf said.
The study received no commercial funding. Dr. Cohen-Mekelburg, Dr. Ananthakrishnan, and Dr. Steinlauf have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study has found no convincing evidence to suggest a causal relationship between nonsteroidal anti-inflammatory drug (NSAID) use and inflammatory bowel disease (IBD) exacerbations.
Rather, the study suggests that observed associations between IBD exacerbation and NSAID exposure may be explained by preexisting underlying risks for IBD flares, residual confounding, and reverse causality.
“We hope these study findings will aid providers in better directing IBD patients on their risk for IBD exacerbation with NSAID use,” write Shirley Cohen-Mekelburg, MD, with University of Michigan Medicine, Ann Arbor, and colleagues.
“This may guide therapy for both IBD and non-IBD related pain management, and the comfort of patients with IBD and the clinicians who treat them when considering NSAIDs as a non-opioid treatment option,” they add.
The study was published online in the American Journal of Gastroenterology.
Taking a second look
Patients with IBD (Crohn’s disease and ulcerative colitis) are prone to both inflammatory and noninflammatory pain, and there has been long-standing concern that NSAIDs may play a role in disease flare-ups.
To see whether a true association exists, Dr. Cohen-Mekelburg and colleagues conducted a series of studies that involved roughly 35,000 patients with IBD.
First, they created a propensity-matched cohort of 15,705 patients who had received NSAIDs and 19,326 who had not taken NSAIDs. Findings from a Cox proportional hazards model suggested a higher likelihood of IBD exacerbation in the group that had taken NSAIDs (hazard ratio, 1.24; 95% confidence interval, 1.16-1.33), after adjusting for age, gender, race, Charlson comorbidity index, smoking status, IBD type, and use of immunomodulator or biologic medications.
However, those who received NSAIDs were already at increased risk of experiencing a disease flare. And the prior event rate ratio for IBD exacerbation, as determined by dividing the adjusted HR after NSAID exposure by the adjusted HR for pre-NSAID exposure, was 0.95 (95% CI, 0.89-1.01).
The researchers used a self-controlled case series to verify their findings and to adjust for other immeasurable patient-level confounders. In this analysis, which involved 3,968 patients, the risk of IBD flare did not increase in the period from 2 weeks to 6 months after exposure to an NSAID.
The incidence of IBD exacerbations was higher in the 0- to 2-week transition period after an NSAID was prescribed, but it dropped after the 2-week “risk” window. This suggests that these short-term flares may be secondary to residual confounding related to reverse causality, rather than the NSAIDs themselves, the researchers say.
While NSAIDs represent the most common first-line analgesic, their use for patients with IBD is variable, in part due to the suspected risk of IBD exacerbation “despite inconclusive evidence of harm to date,” Dr. Cohen-Mekelburg and colleagues note.
They also note that about 36% of patients with IBD in their cohort received at least one NSAID prescription, and three-quarters of these patients did not experience an IBD exacerbation during an average of 5.9 years of follow-up.
Good study, reassuring data
“This is a good study trying to understand the potential sources of bias in associations,” Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.
Overall, he said the study “provides reassurance that cautious, short-duration or low-dose use is likely well tolerated in most patients with IBD. But more work is needed to understand the impact of higher dose or more frequent use.”
Also weighing in, Adam Steinlauf, MD, with Mount Sinai Health System and Icahn School of Medicine at Mount Sinai in New York, noted that patients with IBD experience pain throughout the course of their disease, both intestinal and extraintestinal.
“Treating the underlying IBD is important, but medications used to treat joint pain and inflammation specifically are few,” said Dr. Steinlauf, who wasn’t involved in the new study.
“Sulfasalazine has been used with success, but it does not work in everyone, and many are allergic to the sulfa component, limiting its use. Narcotics are often reluctantly used for these issues as well. Medical marijuana has emerged on the scene to control both types of pain, but to date, there is inconclusive evidence that it significantly treats both pain and underlying inflammation,” Dr. Steinlauf pointed out.
NSAIDs, on the other hand, are “excellent” choices for treating joint pain and inflammation, but gastroenterologists often try to avoid these medications, given the fear of triggering flares of underlying IBD, Dr. Steinlauf told this news organization.
In his view, this new study is “important in that it quite elegantly challenges the notion that gastroenterologists should avoid NSAIDs in patients with IBD.”
Although more data are clearly needed, Dr. Steinlauf said this study “should give practitioners a bit more confidence in prescribing NSAIDs for their patients with IBD if absolutely necessary to control pain and inflammation and improve quality of life when other standard treatments fail.
“The association of NSAIDs with subsequent flares, of which we are all so well aware of and afraid of, may in fact be related more to our patients’ underlying risks for IBD and reverse causality rather than the NSAIDs themselves. Future studies should further clarify this notion,” Dr. Steinlauf said.
The study received no commercial funding. Dr. Cohen-Mekelburg, Dr. Ananthakrishnan, and Dr. Steinlauf have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AMERICAN JOURNAL OF GASTROENTEROLOGY
Influenza vaccine may offer much more than flu prevention
in new findings that suggest the vaccine itself, and not just avoidance of the virus, may be beneficial.
“We postulate that influenza vaccination may have a protective effect against stroke that may be partly independent of influenza prevention,” study investigator Francisco J. de Abajo, MD, PhD, MPH, of the University of Alcalá, Madrid, said in an interview.
“Although the study is observational and this finding can also be explained by unmeasured confounding factors, we feel that a direct biological effect of vaccine cannot be ruled out and this finding opens new avenues for investigation.”
The study was published online in Neurology.
‘Not a spurious association’
While there is a well-established link between seasonal influenza and increased ischemic stroke risk, the role of flu vaccination in stroke prevention is unclear.
In the nested case-control study, researchers evaluated data from primary care practices in Spain between 2001 and 2015. They identified 14,322 patients with first-time ischemic stroke. Of these, 9,542 had noncardioembolic stroke and 4,780 had cardioembolic stroke.
Each case was matched with five controls from the population of age- and sex-matched controls without stroke (n = 71,610).
Those in the stroke group had a slightly higher rate of flu vaccination than controls, at 41.4% versus 40.5% (odds ratio, 1.05).
Adjusted analysis revealed those who received flu vaccination were less likely to experience ischemic stroke within 15-30 days of vaccination (OR, 0.79) and, to a lesser degree, over up to 150 days (OR, 0.92).
The reduced risk associated with the flu vaccine was observed with both types of ischemic stroke and appeared to offer stroke protection outside of flu season.
The reduced risk was also found in subgroup comparisons in men, women, those aged over and under 65 years, and those with intermediate and high vascular risk.
Importantly, a separate analysis of pneumococcal vaccination did not show a similar reduction in stroke risk (adjusted OR, 1.08).
“The lack of protection found with the pneumococcal vaccine actually reinforces the hypothesis that the protection of influenza vaccine is not a spurious association, as both vaccines might share the same biases and confounding factors,” Dr. de Abajo said.
Anti-inflammatory effect?
Influenza infection is known to induce a systemic inflammatory response that “can precipitate atheroma plaque rupture mediated by elevated concentrations of reactive proteins and cytokines,” the investigators noted, and so, avoiding infection could prevent those effects.
The results are consistent with other studies that have shown similar findings, including recent data from the INTERSTROKE trial. However, the reduced risk observed in the current study even in years without a flu epidemic expands on previous findings.
“This finding suggests that other mechanisms different from the prevention of influenza infection – e.g., a direct biological effect – could account for the risk reduction found,” the investigators wrote.
In terms of the nature of that effect, Dr. de Abajo noted that, “at this stage, we can only speculate.
“Having said that, there are some pieces of evidence that suggest influenza vaccination may release anti-inflammatory mediators that can stabilize the atheroma plaque. This is an interesting hypothesis that should be addressed in the near future,” he added.
‘More than just flu prevention’
In an accompanying editorial, Dixon Yang, MD, and Mitchell S.V. Elkind, MD, agree that the findings point to intriguing potential unexpected benefits of the vaccine.
“This case-control study ... importantly suggests the influenza vaccine is more than just about preventing the flu,” they wrote.
Dr. Elkind said in an interview that the mechanism could indeed involve an anti-inflammatory effect.
“There is some evidence that antibiotics also have anti-inflammatory properties that might reduce risk of stroke or the brain damage from a stroke,” he noted. “So, it is plausible that some of the effect of the vaccine on reducing risk of stroke may be through a reduction in inflammation.”
Dr. Elkind noted that the magnitude of the reduction observed with the vaccine, though not substantial, is important. “The magnitude of effect for any one individual may be modest, but it is in the ballpark of the effect of other commonly used approaches to stroke prevention, such as taking an aspirin a day, which reduces risk of stroke by about 20%. But because influenza is so common, the impact of even a small effect for an individual can have a large impact at the population level. So, the results are of public health significance.”
The study received support from the Biomedical Research Foundation of the Prince of Asturias University Hospital and the Institute of Health Carlos III in Madrid. Dr. Elkind has reported receiving ancillary funding but no personal compensation from Roche for a federally funded trial of stroke prevention.
A version of this article first appeared on Medscape.com.
in new findings that suggest the vaccine itself, and not just avoidance of the virus, may be beneficial.
“We postulate that influenza vaccination may have a protective effect against stroke that may be partly independent of influenza prevention,” study investigator Francisco J. de Abajo, MD, PhD, MPH, of the University of Alcalá, Madrid, said in an interview.
“Although the study is observational and this finding can also be explained by unmeasured confounding factors, we feel that a direct biological effect of vaccine cannot be ruled out and this finding opens new avenues for investigation.”
The study was published online in Neurology.
‘Not a spurious association’
While there is a well-established link between seasonal influenza and increased ischemic stroke risk, the role of flu vaccination in stroke prevention is unclear.
In the nested case-control study, researchers evaluated data from primary care practices in Spain between 2001 and 2015. They identified 14,322 patients with first-time ischemic stroke. Of these, 9,542 had noncardioembolic stroke and 4,780 had cardioembolic stroke.
Each case was matched with five controls from the population of age- and sex-matched controls without stroke (n = 71,610).
Those in the stroke group had a slightly higher rate of flu vaccination than controls, at 41.4% versus 40.5% (odds ratio, 1.05).
Adjusted analysis revealed those who received flu vaccination were less likely to experience ischemic stroke within 15-30 days of vaccination (OR, 0.79) and, to a lesser degree, over up to 150 days (OR, 0.92).
The reduced risk associated with the flu vaccine was observed with both types of ischemic stroke and appeared to offer stroke protection outside of flu season.
The reduced risk was also found in subgroup comparisons in men, women, those aged over and under 65 years, and those with intermediate and high vascular risk.
Importantly, a separate analysis of pneumococcal vaccination did not show a similar reduction in stroke risk (adjusted OR, 1.08).
“The lack of protection found with the pneumococcal vaccine actually reinforces the hypothesis that the protection of influenza vaccine is not a spurious association, as both vaccines might share the same biases and confounding factors,” Dr. de Abajo said.
Anti-inflammatory effect?
Influenza infection is known to induce a systemic inflammatory response that “can precipitate atheroma plaque rupture mediated by elevated concentrations of reactive proteins and cytokines,” the investigators noted, and so, avoiding infection could prevent those effects.
The results are consistent with other studies that have shown similar findings, including recent data from the INTERSTROKE trial. However, the reduced risk observed in the current study even in years without a flu epidemic expands on previous findings.
“This finding suggests that other mechanisms different from the prevention of influenza infection – e.g., a direct biological effect – could account for the risk reduction found,” the investigators wrote.
In terms of the nature of that effect, Dr. de Abajo noted that, “at this stage, we can only speculate.
“Having said that, there are some pieces of evidence that suggest influenza vaccination may release anti-inflammatory mediators that can stabilize the atheroma plaque. This is an interesting hypothesis that should be addressed in the near future,” he added.
‘More than just flu prevention’
In an accompanying editorial, Dixon Yang, MD, and Mitchell S.V. Elkind, MD, agree that the findings point to intriguing potential unexpected benefits of the vaccine.
“This case-control study ... importantly suggests the influenza vaccine is more than just about preventing the flu,” they wrote.
Dr. Elkind said in an interview that the mechanism could indeed involve an anti-inflammatory effect.
“There is some evidence that antibiotics also have anti-inflammatory properties that might reduce risk of stroke or the brain damage from a stroke,” he noted. “So, it is plausible that some of the effect of the vaccine on reducing risk of stroke may be through a reduction in inflammation.”
Dr. Elkind noted that the magnitude of the reduction observed with the vaccine, though not substantial, is important. “The magnitude of effect for any one individual may be modest, but it is in the ballpark of the effect of other commonly used approaches to stroke prevention, such as taking an aspirin a day, which reduces risk of stroke by about 20%. But because influenza is so common, the impact of even a small effect for an individual can have a large impact at the population level. So, the results are of public health significance.”
The study received support from the Biomedical Research Foundation of the Prince of Asturias University Hospital and the Institute of Health Carlos III in Madrid. Dr. Elkind has reported receiving ancillary funding but no personal compensation from Roche for a federally funded trial of stroke prevention.
A version of this article first appeared on Medscape.com.
in new findings that suggest the vaccine itself, and not just avoidance of the virus, may be beneficial.
“We postulate that influenza vaccination may have a protective effect against stroke that may be partly independent of influenza prevention,” study investigator Francisco J. de Abajo, MD, PhD, MPH, of the University of Alcalá, Madrid, said in an interview.
“Although the study is observational and this finding can also be explained by unmeasured confounding factors, we feel that a direct biological effect of vaccine cannot be ruled out and this finding opens new avenues for investigation.”
The study was published online in Neurology.
‘Not a spurious association’
While there is a well-established link between seasonal influenza and increased ischemic stroke risk, the role of flu vaccination in stroke prevention is unclear.
In the nested case-control study, researchers evaluated data from primary care practices in Spain between 2001 and 2015. They identified 14,322 patients with first-time ischemic stroke. Of these, 9,542 had noncardioembolic stroke and 4,780 had cardioembolic stroke.
Each case was matched with five controls from the population of age- and sex-matched controls without stroke (n = 71,610).
Those in the stroke group had a slightly higher rate of flu vaccination than controls, at 41.4% versus 40.5% (odds ratio, 1.05).
Adjusted analysis revealed those who received flu vaccination were less likely to experience ischemic stroke within 15-30 days of vaccination (OR, 0.79) and, to a lesser degree, over up to 150 days (OR, 0.92).
The reduced risk associated with the flu vaccine was observed with both types of ischemic stroke and appeared to offer stroke protection outside of flu season.
The reduced risk was also found in subgroup comparisons in men, women, those aged over and under 65 years, and those with intermediate and high vascular risk.
Importantly, a separate analysis of pneumococcal vaccination did not show a similar reduction in stroke risk (adjusted OR, 1.08).
“The lack of protection found with the pneumococcal vaccine actually reinforces the hypothesis that the protection of influenza vaccine is not a spurious association, as both vaccines might share the same biases and confounding factors,” Dr. de Abajo said.
Anti-inflammatory effect?
Influenza infection is known to induce a systemic inflammatory response that “can precipitate atheroma plaque rupture mediated by elevated concentrations of reactive proteins and cytokines,” the investigators noted, and so, avoiding infection could prevent those effects.
The results are consistent with other studies that have shown similar findings, including recent data from the INTERSTROKE trial. However, the reduced risk observed in the current study even in years without a flu epidemic expands on previous findings.
“This finding suggests that other mechanisms different from the prevention of influenza infection – e.g., a direct biological effect – could account for the risk reduction found,” the investigators wrote.
In terms of the nature of that effect, Dr. de Abajo noted that, “at this stage, we can only speculate.
“Having said that, there are some pieces of evidence that suggest influenza vaccination may release anti-inflammatory mediators that can stabilize the atheroma plaque. This is an interesting hypothesis that should be addressed in the near future,” he added.
‘More than just flu prevention’
In an accompanying editorial, Dixon Yang, MD, and Mitchell S.V. Elkind, MD, agree that the findings point to intriguing potential unexpected benefits of the vaccine.
“This case-control study ... importantly suggests the influenza vaccine is more than just about preventing the flu,” they wrote.
Dr. Elkind said in an interview that the mechanism could indeed involve an anti-inflammatory effect.
“There is some evidence that antibiotics also have anti-inflammatory properties that might reduce risk of stroke or the brain damage from a stroke,” he noted. “So, it is plausible that some of the effect of the vaccine on reducing risk of stroke may be through a reduction in inflammation.”
Dr. Elkind noted that the magnitude of the reduction observed with the vaccine, though not substantial, is important. “The magnitude of effect for any one individual may be modest, but it is in the ballpark of the effect of other commonly used approaches to stroke prevention, such as taking an aspirin a day, which reduces risk of stroke by about 20%. But because influenza is so common, the impact of even a small effect for an individual can have a large impact at the population level. So, the results are of public health significance.”
The study received support from the Biomedical Research Foundation of the Prince of Asturias University Hospital and the Institute of Health Carlos III in Madrid. Dr. Elkind has reported receiving ancillary funding but no personal compensation from Roche for a federally funded trial of stroke prevention.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
CDC says 44% of people hospitalized with COVID had third dose or booster
Centers for Disease Control and Prevention says.
, theUnvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
Centers for Disease Control and Prevention says.
, theUnvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
Centers for Disease Control and Prevention says.
, theUnvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
FROM MMWR
Unvaccinated 10 times more likely to be hospitalized for Omicron
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
FROM JAMA INTERNAL MEDICINE
One fish, two fish, are good fish for you ... fish
Good news for pregnant women; bad news for fish
As soon as women find out they’re pregnant, doctors recommend they give up smoking, drinking, and eating certain types of fish. That last item may need to be reconsidered, since a recent study supports the idea that it doesn’t matter what type of fish pregnant women are eating, as long as they’re eating it.
Researchers collected data from two different studies that reviewed the mercury levels of mothers from Bristol, England, and the Seychelles, a island chain off East Africa where “fish consumption is high and prenatal mercury levels are 10 times higher than in the [United States],” they said in NeuroToxicology.
Those data showed that the mercury levels had no adverse effects on child development as long as the mother ate fish. The nutrients and vitamins in the fish – vitamin D, long-chain fatty acids, selenium, and iodine – provide protection against mercury. There’s also the already-known benefits to eyesight and intellectual abilities that have been associated with fish consumption.
This analysis goes starkly against the grain of what is commonly recommended to expectant mothers, which is to cut out fish altogether. The researchers suggested that governments should review and change those recommendations to focus on the benefits instead.
As long as women follow the researchers’ recommendation to eat “at least two portions of fish a week, one of which should be oily,” they may not have to lay off on the sushi after all.
We’ll show our gut worms the world
Never let it be said that mankind is not a generous species. Sure, we could maybe be kinder to our fellow human beings, maybe declare a little less war on each other, but for the past 50,000 years, we’ve been giving a free ride to millions upon millions to one of mankind’s closest companions: the whipworm.
This revelation into human kindness comes from Denmark, where researchers from Copenhagen conducted a genetic analysis of ancient preserved whipworm eggs found in old Viking and Norse settlements, some of which date back over 2,000 years. In normal conditions genetic material wouldn’t last very long, but these were Viking whipworms eggs with tiny little horned helmets, so the DNA within has remained unchanged. Or it may be the tough chitinous exterior of the eggs protecting the DNA from degrading, combined with their preservation in moist soil.
Once they had their Viking whipworm DNA, the researchers compared it with whipworm DNA from all over the world, tracing its history as it followed mankind from Africa. And it’s been a while: We brought whipworms with us during our initial migration into Asia and Europe over 50,000 years ago. When the Bering land bridge opened up and humanity moved into the Americas, the worms came as well.
This is all possible because the whipworm goes about its parasitic business quietly and cleverly. It mostly sits harmlessly in our digestive systems, producing thousands of eggs a day that get expelled through poop and picked up by another host (human or otherwise); whipworms only cause disease in those with compromised immune systems.
The researchers noted that their study, the first complete genetic analysis of the whipworm, could help combat the parasite, which to this day infects hundred of millions who don’t have access to modern medicine or sanitary conditions. Hopefully, though, the days of free rides will soon be over for the whipworm. After all, if we have to pay hundreds or thousands of dollars to visit other countries, it’s only fair that our parasites do as well.
From zero to vasectomy in 6.7 seconds
There’s an old saying that you’ve probably heard: When life gives you lemons, make lemonade. It’s meant to encourage optimism in the face of adversity. Then there’s the new saying we just made up: When life gives you a power outage, plug your surgical instruments into an electric pickup.
That’s what Dr. Christopher Yang did, and now we’re making the urologist from Austin, Tex., famous by sharing his surgical/electrical adventure with all 17 of LOTME’s regular readers. That’s some serious lemonade.
Dr. Yang’s tale begins when the electricity went out at his clinic, seemingly forcing him to cancel or reschedule several surgical procedures. Not so fast. Dr. Yang happens to own a Rivian R1T, an electric pickup truck that has four power outlets. A staff member suggested plugging the surgical instruments into the truck and, surprisingly, one of the day’s patients agreed to go ahead with his vasectomy.
“We were fortunate that my normal parking spot is close enough to a patient room to run an extension cord,” Dr. Yang said on TheDrive.com. That extension cord was attached to an electrocautery device, with a handheld device available as backup, and “after we were done, I told his family. We all had a good laugh together too,” Dr. Yang told radio station WGLT in Normal, Ill.
To us, anyway, this opens up all sorts of alternative energy possibilities. Can a windmill power a liposuction? Is a gerbil running in a wheel enough to do a colonoscopy? How many potatoes do you need to keep an EHR going?
Learning through random acts of not-exactly noisiness
First things first. Transcranial random noise stimulation (tRNS) is not really noise in the auditory sense of the word. For some people with learning disabilities, though, it can actually be very helpful. The technology, which uses electrodes attached to the head so a weak current can pass through specific parts of the brain, may help those with learning disabilities, perhaps even those with brain injuries and visual deficits, learn, said Dr. Onno van der Groen of Edith Cowan University in Perth, Australia.
“When you add this type of stimulation during learning, you get better performance, faster learning and better attention afterwards as well,” he said in a statement from the university.
The researchers say that tRNS can allow the brain to form new connections and pathways, which in turn help a person learn more effectively. “If you do 10 sessions of a visual perception task with the tRNS and then come back and do it again without it, you’ll find you perform better than the control group who hasn’t used it,” Dr. van der Groen noted.
Can this also work for the average person? It’s possible, but tRNS didn’t seem to improve the math skills of a top-level mathematician who underwent the process, according to a case study that Dr. van der Groen mentioned.
This line of work is still pretty new, though, so researchers don’t have all the answers yet. As always, we’re rooting for you, science!
Good news for pregnant women; bad news for fish
As soon as women find out they’re pregnant, doctors recommend they give up smoking, drinking, and eating certain types of fish. That last item may need to be reconsidered, since a recent study supports the idea that it doesn’t matter what type of fish pregnant women are eating, as long as they’re eating it.
Researchers collected data from two different studies that reviewed the mercury levels of mothers from Bristol, England, and the Seychelles, a island chain off East Africa where “fish consumption is high and prenatal mercury levels are 10 times higher than in the [United States],” they said in NeuroToxicology.
Those data showed that the mercury levels had no adverse effects on child development as long as the mother ate fish. The nutrients and vitamins in the fish – vitamin D, long-chain fatty acids, selenium, and iodine – provide protection against mercury. There’s also the already-known benefits to eyesight and intellectual abilities that have been associated with fish consumption.
This analysis goes starkly against the grain of what is commonly recommended to expectant mothers, which is to cut out fish altogether. The researchers suggested that governments should review and change those recommendations to focus on the benefits instead.
As long as women follow the researchers’ recommendation to eat “at least two portions of fish a week, one of which should be oily,” they may not have to lay off on the sushi after all.
We’ll show our gut worms the world
Never let it be said that mankind is not a generous species. Sure, we could maybe be kinder to our fellow human beings, maybe declare a little less war on each other, but for the past 50,000 years, we’ve been giving a free ride to millions upon millions to one of mankind’s closest companions: the whipworm.
This revelation into human kindness comes from Denmark, where researchers from Copenhagen conducted a genetic analysis of ancient preserved whipworm eggs found in old Viking and Norse settlements, some of which date back over 2,000 years. In normal conditions genetic material wouldn’t last very long, but these were Viking whipworms eggs with tiny little horned helmets, so the DNA within has remained unchanged. Or it may be the tough chitinous exterior of the eggs protecting the DNA from degrading, combined with their preservation in moist soil.
Once they had their Viking whipworm DNA, the researchers compared it with whipworm DNA from all over the world, tracing its history as it followed mankind from Africa. And it’s been a while: We brought whipworms with us during our initial migration into Asia and Europe over 50,000 years ago. When the Bering land bridge opened up and humanity moved into the Americas, the worms came as well.
This is all possible because the whipworm goes about its parasitic business quietly and cleverly. It mostly sits harmlessly in our digestive systems, producing thousands of eggs a day that get expelled through poop and picked up by another host (human or otherwise); whipworms only cause disease in those with compromised immune systems.
The researchers noted that their study, the first complete genetic analysis of the whipworm, could help combat the parasite, which to this day infects hundred of millions who don’t have access to modern medicine or sanitary conditions. Hopefully, though, the days of free rides will soon be over for the whipworm. After all, if we have to pay hundreds or thousands of dollars to visit other countries, it’s only fair that our parasites do as well.
From zero to vasectomy in 6.7 seconds
There’s an old saying that you’ve probably heard: When life gives you lemons, make lemonade. It’s meant to encourage optimism in the face of adversity. Then there’s the new saying we just made up: When life gives you a power outage, plug your surgical instruments into an electric pickup.
That’s what Dr. Christopher Yang did, and now we’re making the urologist from Austin, Tex., famous by sharing his surgical/electrical adventure with all 17 of LOTME’s regular readers. That’s some serious lemonade.
Dr. Yang’s tale begins when the electricity went out at his clinic, seemingly forcing him to cancel or reschedule several surgical procedures. Not so fast. Dr. Yang happens to own a Rivian R1T, an electric pickup truck that has four power outlets. A staff member suggested plugging the surgical instruments into the truck and, surprisingly, one of the day’s patients agreed to go ahead with his vasectomy.
“We were fortunate that my normal parking spot is close enough to a patient room to run an extension cord,” Dr. Yang said on TheDrive.com. That extension cord was attached to an electrocautery device, with a handheld device available as backup, and “after we were done, I told his family. We all had a good laugh together too,” Dr. Yang told radio station WGLT in Normal, Ill.
To us, anyway, this opens up all sorts of alternative energy possibilities. Can a windmill power a liposuction? Is a gerbil running in a wheel enough to do a colonoscopy? How many potatoes do you need to keep an EHR going?
Learning through random acts of not-exactly noisiness
First things first. Transcranial random noise stimulation (tRNS) is not really noise in the auditory sense of the word. For some people with learning disabilities, though, it can actually be very helpful. The technology, which uses electrodes attached to the head so a weak current can pass through specific parts of the brain, may help those with learning disabilities, perhaps even those with brain injuries and visual deficits, learn, said Dr. Onno van der Groen of Edith Cowan University in Perth, Australia.
“When you add this type of stimulation during learning, you get better performance, faster learning and better attention afterwards as well,” he said in a statement from the university.
The researchers say that tRNS can allow the brain to form new connections and pathways, which in turn help a person learn more effectively. “If you do 10 sessions of a visual perception task with the tRNS and then come back and do it again without it, you’ll find you perform better than the control group who hasn’t used it,” Dr. van der Groen noted.
Can this also work for the average person? It’s possible, but tRNS didn’t seem to improve the math skills of a top-level mathematician who underwent the process, according to a case study that Dr. van der Groen mentioned.
This line of work is still pretty new, though, so researchers don’t have all the answers yet. As always, we’re rooting for you, science!
Good news for pregnant women; bad news for fish
As soon as women find out they’re pregnant, doctors recommend they give up smoking, drinking, and eating certain types of fish. That last item may need to be reconsidered, since a recent study supports the idea that it doesn’t matter what type of fish pregnant women are eating, as long as they’re eating it.
Researchers collected data from two different studies that reviewed the mercury levels of mothers from Bristol, England, and the Seychelles, a island chain off East Africa where “fish consumption is high and prenatal mercury levels are 10 times higher than in the [United States],” they said in NeuroToxicology.
Those data showed that the mercury levels had no adverse effects on child development as long as the mother ate fish. The nutrients and vitamins in the fish – vitamin D, long-chain fatty acids, selenium, and iodine – provide protection against mercury. There’s also the already-known benefits to eyesight and intellectual abilities that have been associated with fish consumption.
This analysis goes starkly against the grain of what is commonly recommended to expectant mothers, which is to cut out fish altogether. The researchers suggested that governments should review and change those recommendations to focus on the benefits instead.
As long as women follow the researchers’ recommendation to eat “at least two portions of fish a week, one of which should be oily,” they may not have to lay off on the sushi after all.
We’ll show our gut worms the world
Never let it be said that mankind is not a generous species. Sure, we could maybe be kinder to our fellow human beings, maybe declare a little less war on each other, but for the past 50,000 years, we’ve been giving a free ride to millions upon millions to one of mankind’s closest companions: the whipworm.
This revelation into human kindness comes from Denmark, where researchers from Copenhagen conducted a genetic analysis of ancient preserved whipworm eggs found in old Viking and Norse settlements, some of which date back over 2,000 years. In normal conditions genetic material wouldn’t last very long, but these were Viking whipworms eggs with tiny little horned helmets, so the DNA within has remained unchanged. Or it may be the tough chitinous exterior of the eggs protecting the DNA from degrading, combined with their preservation in moist soil.
Once they had their Viking whipworm DNA, the researchers compared it with whipworm DNA from all over the world, tracing its history as it followed mankind from Africa. And it’s been a while: We brought whipworms with us during our initial migration into Asia and Europe over 50,000 years ago. When the Bering land bridge opened up and humanity moved into the Americas, the worms came as well.
This is all possible because the whipworm goes about its parasitic business quietly and cleverly. It mostly sits harmlessly in our digestive systems, producing thousands of eggs a day that get expelled through poop and picked up by another host (human or otherwise); whipworms only cause disease in those with compromised immune systems.
The researchers noted that their study, the first complete genetic analysis of the whipworm, could help combat the parasite, which to this day infects hundred of millions who don’t have access to modern medicine or sanitary conditions. Hopefully, though, the days of free rides will soon be over for the whipworm. After all, if we have to pay hundreds or thousands of dollars to visit other countries, it’s only fair that our parasites do as well.
From zero to vasectomy in 6.7 seconds
There’s an old saying that you’ve probably heard: When life gives you lemons, make lemonade. It’s meant to encourage optimism in the face of adversity. Then there’s the new saying we just made up: When life gives you a power outage, plug your surgical instruments into an electric pickup.
That’s what Dr. Christopher Yang did, and now we’re making the urologist from Austin, Tex., famous by sharing his surgical/electrical adventure with all 17 of LOTME’s regular readers. That’s some serious lemonade.
Dr. Yang’s tale begins when the electricity went out at his clinic, seemingly forcing him to cancel or reschedule several surgical procedures. Not so fast. Dr. Yang happens to own a Rivian R1T, an electric pickup truck that has four power outlets. A staff member suggested plugging the surgical instruments into the truck and, surprisingly, one of the day’s patients agreed to go ahead with his vasectomy.
“We were fortunate that my normal parking spot is close enough to a patient room to run an extension cord,” Dr. Yang said on TheDrive.com. That extension cord was attached to an electrocautery device, with a handheld device available as backup, and “after we were done, I told his family. We all had a good laugh together too,” Dr. Yang told radio station WGLT in Normal, Ill.
To us, anyway, this opens up all sorts of alternative energy possibilities. Can a windmill power a liposuction? Is a gerbil running in a wheel enough to do a colonoscopy? How many potatoes do you need to keep an EHR going?
Learning through random acts of not-exactly noisiness
First things first. Transcranial random noise stimulation (tRNS) is not really noise in the auditory sense of the word. For some people with learning disabilities, though, it can actually be very helpful. The technology, which uses electrodes attached to the head so a weak current can pass through specific parts of the brain, may help those with learning disabilities, perhaps even those with brain injuries and visual deficits, learn, said Dr. Onno van der Groen of Edith Cowan University in Perth, Australia.
“When you add this type of stimulation during learning, you get better performance, faster learning and better attention afterwards as well,” he said in a statement from the university.
The researchers say that tRNS can allow the brain to form new connections and pathways, which in turn help a person learn more effectively. “If you do 10 sessions of a visual perception task with the tRNS and then come back and do it again without it, you’ll find you perform better than the control group who hasn’t used it,” Dr. van der Groen noted.
Can this also work for the average person? It’s possible, but tRNS didn’t seem to improve the math skills of a top-level mathematician who underwent the process, according to a case study that Dr. van der Groen mentioned.
This line of work is still pretty new, though, so researchers don’t have all the answers yet. As always, we’re rooting for you, science!
RETHINC takes air out of COPD-like therapy for smokers
Current or former smokers who have clinically significant respiratory symptoms but no spirometric evidence of airway obstruction are often treated with dual bronchodilators commonly prescribed for patients with chronic obstructive pulmonary disease (COPD).
But as results of the randomized RETHINC (Redefining Therapy In Early COPD for the Pulmonary Trials Cooperative) trial showed, bronchodilator therapy was no better than placebo at reducing respiratory symptoms in smokers, reported MeiLan K. Han, MD, from the University of Michigan, Ann Arbor, on behalf of colleagues in the RETHINC study group.
“Many tobacco-exposed symptomatic individuals are currently being treated. We don’t know if this is because physicians just aren’t doing spirometry and assuming COPD or they strongly believe that there’s a benefit, but the bottom line is that we really need to do spirometry to understand who benefits from bronchodilators, and we need further research to understand how to treat this specific group of patients because there truly is pathogenesis and disease burden,” Dr. Han said in an oral abstract presentation at the annual congress of the European Respiratory Society.
The study results were also published online in the New England Journal of Medicine to coincide with the presentation.
In an editorial accompanying the study, Don D. Sin, MD, MPH, from the University of British Columbia, Vancouver, commented that these medications should most likely be reserved for patients with COPD who have clinically significant airflow limitation,” and that “respiratory symptoms in tobacco-exposed persons are common but are highly variable over time.”
Dave Singh, MD, from the University of Manchester (England), the invited discussant, called it “a very important negative study.”
Not up to GOLD standard
Current or former smokers who are symptomatic, with COPD Assessment Test (CAT) scores of at least 10 despite having preserved function on spirometry, have been shown to have higher prospective rates of respiratory disease exacerbations and increased sputum total mucin concentrations. Approximately 43% of such patients are treated with bronchodilators, and 23% are treated with inhaled corticosteroids (ICS), Dr. Han noted.
Her group hypothesized that ever-smokers with spirometric values that fall within the normal range – that is, a postbronchodilator FEV1/FVC ratio of 70 or greater – would still derive benefit from long-acting bronchodilator therapy, even though these patients are currently excluded from Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations.
To test this, they conducted a 12-week, multicenter, randomized, parallel-group study in which patients were assigned to receive either indacaterol (27.5 mcg) and glycopyrrolate (15.6 mcg) inhaled twice daily or placebo.
They enrolled adults aged 40-80 years with a minimum of 10 pack-years of smoking history, postbronchodilator FEV1/FVC ratio of 70 or greater, and CAT scores of 10 or greater. Patients with known concomitant lung disease, a primary diagnosis of asthma, or body mass index lower than 15 or higher than 40 and those being concomitantly treated with long-acting beta2-agonists or muscarinic antagonists or a short-acting combination were excluded, although patients were allowed to be on a short-acting beta-agonist.
A total of 535 participants were randomized, but COVID-19 pandemic–imposed obstacles resulted in a modified intention-to-treat population of 277 patients assigned to receive the active treatment and 244 assigned to receive placebo.
There was no difference between the groups for the primary outcome of an at least 4-point decrease in St. George’s Respiratory Questionnaire scores in patients who did not experience treatment failure, defined as an increase in respiratory symptoms requiring treatment with active long-acting bronchodilators or ICS.
The primary endpoint was seen in 56.4% of patients in the bronchodilator group, and 59% of controls.
Although there was greater improvement in pulmonary function from baseline in the treatment group, compared with the placebo group, the improvements did not correlate with similar improvements in symptoms, Dr. Han said.
There were 4 serious adverse events in the bronchodilator group and 11 in the placebo group, but none of the events were deemed to be related to the assigned treatments.
Dr. Han acknowledged limitations of the study, which may have included symptoms driven by other factors such as cardiac disease, suggesting that if such patients had been identified and excluded, a stronger effect might have been seen for the active treatment.
In addition, the study was underpowered to look at the subgroup of participants with chronic bronchitis, and the 12 weeks of the study may have been too short to see improvements in symptoms.
In his editorial, Dr. Sin noted that the study showed that cough and sputum production rather than exertion dyspnea are the primary symptoms among ever-smokers.
“Although bronchodilators are effective in ameliorating breathlessness and improving exercise tolerance, they are generally ineffective for cough,” he wrote. “Existing drugs for the treatment of COPD, such as inhaled glucocorticoids or phosphodiesterase-4 inhibitors, or new therapeutics such as P2X3 receptor antagonists may be more effective for the treatment of cough and sputum production related to smoking and could be considered for future evaluations in this patient population.”
The study was supported by the National Heart, Lung, and Blood Institute, the National Center for Advancing Translational Sciences, and Sunovion Pharmaceuticals. Novartis Pharmaceuticals donated the trial medication and placebo. Dr. Han disclosed grant/research support and honoraria or consulting fees from various companies. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Sin reported having no conflicts of interest to disclose.
A version of this article first appeared on Medscape.com.
Current or former smokers who have clinically significant respiratory symptoms but no spirometric evidence of airway obstruction are often treated with dual bronchodilators commonly prescribed for patients with chronic obstructive pulmonary disease (COPD).
But as results of the randomized RETHINC (Redefining Therapy In Early COPD for the Pulmonary Trials Cooperative) trial showed, bronchodilator therapy was no better than placebo at reducing respiratory symptoms in smokers, reported MeiLan K. Han, MD, from the University of Michigan, Ann Arbor, on behalf of colleagues in the RETHINC study group.
“Many tobacco-exposed symptomatic individuals are currently being treated. We don’t know if this is because physicians just aren’t doing spirometry and assuming COPD or they strongly believe that there’s a benefit, but the bottom line is that we really need to do spirometry to understand who benefits from bronchodilators, and we need further research to understand how to treat this specific group of patients because there truly is pathogenesis and disease burden,” Dr. Han said in an oral abstract presentation at the annual congress of the European Respiratory Society.
The study results were also published online in the New England Journal of Medicine to coincide with the presentation.
In an editorial accompanying the study, Don D. Sin, MD, MPH, from the University of British Columbia, Vancouver, commented that these medications should most likely be reserved for patients with COPD who have clinically significant airflow limitation,” and that “respiratory symptoms in tobacco-exposed persons are common but are highly variable over time.”
Dave Singh, MD, from the University of Manchester (England), the invited discussant, called it “a very important negative study.”
Not up to GOLD standard
Current or former smokers who are symptomatic, with COPD Assessment Test (CAT) scores of at least 10 despite having preserved function on spirometry, have been shown to have higher prospective rates of respiratory disease exacerbations and increased sputum total mucin concentrations. Approximately 43% of such patients are treated with bronchodilators, and 23% are treated with inhaled corticosteroids (ICS), Dr. Han noted.
Her group hypothesized that ever-smokers with spirometric values that fall within the normal range – that is, a postbronchodilator FEV1/FVC ratio of 70 or greater – would still derive benefit from long-acting bronchodilator therapy, even though these patients are currently excluded from Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations.
To test this, they conducted a 12-week, multicenter, randomized, parallel-group study in which patients were assigned to receive either indacaterol (27.5 mcg) and glycopyrrolate (15.6 mcg) inhaled twice daily or placebo.
They enrolled adults aged 40-80 years with a minimum of 10 pack-years of smoking history, postbronchodilator FEV1/FVC ratio of 70 or greater, and CAT scores of 10 or greater. Patients with known concomitant lung disease, a primary diagnosis of asthma, or body mass index lower than 15 or higher than 40 and those being concomitantly treated with long-acting beta2-agonists or muscarinic antagonists or a short-acting combination were excluded, although patients were allowed to be on a short-acting beta-agonist.
A total of 535 participants were randomized, but COVID-19 pandemic–imposed obstacles resulted in a modified intention-to-treat population of 277 patients assigned to receive the active treatment and 244 assigned to receive placebo.
There was no difference between the groups for the primary outcome of an at least 4-point decrease in St. George’s Respiratory Questionnaire scores in patients who did not experience treatment failure, defined as an increase in respiratory symptoms requiring treatment with active long-acting bronchodilators or ICS.
The primary endpoint was seen in 56.4% of patients in the bronchodilator group, and 59% of controls.
Although there was greater improvement in pulmonary function from baseline in the treatment group, compared with the placebo group, the improvements did not correlate with similar improvements in symptoms, Dr. Han said.
There were 4 serious adverse events in the bronchodilator group and 11 in the placebo group, but none of the events were deemed to be related to the assigned treatments.
Dr. Han acknowledged limitations of the study, which may have included symptoms driven by other factors such as cardiac disease, suggesting that if such patients had been identified and excluded, a stronger effect might have been seen for the active treatment.
In addition, the study was underpowered to look at the subgroup of participants with chronic bronchitis, and the 12 weeks of the study may have been too short to see improvements in symptoms.
In his editorial, Dr. Sin noted that the study showed that cough and sputum production rather than exertion dyspnea are the primary symptoms among ever-smokers.
“Although bronchodilators are effective in ameliorating breathlessness and improving exercise tolerance, they are generally ineffective for cough,” he wrote. “Existing drugs for the treatment of COPD, such as inhaled glucocorticoids or phosphodiesterase-4 inhibitors, or new therapeutics such as P2X3 receptor antagonists may be more effective for the treatment of cough and sputum production related to smoking and could be considered for future evaluations in this patient population.”
The study was supported by the National Heart, Lung, and Blood Institute, the National Center for Advancing Translational Sciences, and Sunovion Pharmaceuticals. Novartis Pharmaceuticals donated the trial medication and placebo. Dr. Han disclosed grant/research support and honoraria or consulting fees from various companies. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Sin reported having no conflicts of interest to disclose.
A version of this article first appeared on Medscape.com.
Current or former smokers who have clinically significant respiratory symptoms but no spirometric evidence of airway obstruction are often treated with dual bronchodilators commonly prescribed for patients with chronic obstructive pulmonary disease (COPD).
But as results of the randomized RETHINC (Redefining Therapy In Early COPD for the Pulmonary Trials Cooperative) trial showed, bronchodilator therapy was no better than placebo at reducing respiratory symptoms in smokers, reported MeiLan K. Han, MD, from the University of Michigan, Ann Arbor, on behalf of colleagues in the RETHINC study group.
“Many tobacco-exposed symptomatic individuals are currently being treated. We don’t know if this is because physicians just aren’t doing spirometry and assuming COPD or they strongly believe that there’s a benefit, but the bottom line is that we really need to do spirometry to understand who benefits from bronchodilators, and we need further research to understand how to treat this specific group of patients because there truly is pathogenesis and disease burden,” Dr. Han said in an oral abstract presentation at the annual congress of the European Respiratory Society.
The study results were also published online in the New England Journal of Medicine to coincide with the presentation.
In an editorial accompanying the study, Don D. Sin, MD, MPH, from the University of British Columbia, Vancouver, commented that these medications should most likely be reserved for patients with COPD who have clinically significant airflow limitation,” and that “respiratory symptoms in tobacco-exposed persons are common but are highly variable over time.”
Dave Singh, MD, from the University of Manchester (England), the invited discussant, called it “a very important negative study.”
Not up to GOLD standard
Current or former smokers who are symptomatic, with COPD Assessment Test (CAT) scores of at least 10 despite having preserved function on spirometry, have been shown to have higher prospective rates of respiratory disease exacerbations and increased sputum total mucin concentrations. Approximately 43% of such patients are treated with bronchodilators, and 23% are treated with inhaled corticosteroids (ICS), Dr. Han noted.
Her group hypothesized that ever-smokers with spirometric values that fall within the normal range – that is, a postbronchodilator FEV1/FVC ratio of 70 or greater – would still derive benefit from long-acting bronchodilator therapy, even though these patients are currently excluded from Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations.
To test this, they conducted a 12-week, multicenter, randomized, parallel-group study in which patients were assigned to receive either indacaterol (27.5 mcg) and glycopyrrolate (15.6 mcg) inhaled twice daily or placebo.
They enrolled adults aged 40-80 years with a minimum of 10 pack-years of smoking history, postbronchodilator FEV1/FVC ratio of 70 or greater, and CAT scores of 10 or greater. Patients with known concomitant lung disease, a primary diagnosis of asthma, or body mass index lower than 15 or higher than 40 and those being concomitantly treated with long-acting beta2-agonists or muscarinic antagonists or a short-acting combination were excluded, although patients were allowed to be on a short-acting beta-agonist.
A total of 535 participants were randomized, but COVID-19 pandemic–imposed obstacles resulted in a modified intention-to-treat population of 277 patients assigned to receive the active treatment and 244 assigned to receive placebo.
There was no difference between the groups for the primary outcome of an at least 4-point decrease in St. George’s Respiratory Questionnaire scores in patients who did not experience treatment failure, defined as an increase in respiratory symptoms requiring treatment with active long-acting bronchodilators or ICS.
The primary endpoint was seen in 56.4% of patients in the bronchodilator group, and 59% of controls.
Although there was greater improvement in pulmonary function from baseline in the treatment group, compared with the placebo group, the improvements did not correlate with similar improvements in symptoms, Dr. Han said.
There were 4 serious adverse events in the bronchodilator group and 11 in the placebo group, but none of the events were deemed to be related to the assigned treatments.
Dr. Han acknowledged limitations of the study, which may have included symptoms driven by other factors such as cardiac disease, suggesting that if such patients had been identified and excluded, a stronger effect might have been seen for the active treatment.
In addition, the study was underpowered to look at the subgroup of participants with chronic bronchitis, and the 12 weeks of the study may have been too short to see improvements in symptoms.
In his editorial, Dr. Sin noted that the study showed that cough and sputum production rather than exertion dyspnea are the primary symptoms among ever-smokers.
“Although bronchodilators are effective in ameliorating breathlessness and improving exercise tolerance, they are generally ineffective for cough,” he wrote. “Existing drugs for the treatment of COPD, such as inhaled glucocorticoids or phosphodiesterase-4 inhibitors, or new therapeutics such as P2X3 receptor antagonists may be more effective for the treatment of cough and sputum production related to smoking and could be considered for future evaluations in this patient population.”
The study was supported by the National Heart, Lung, and Blood Institute, the National Center for Advancing Translational Sciences, and Sunovion Pharmaceuticals. Novartis Pharmaceuticals donated the trial medication and placebo. Dr. Han disclosed grant/research support and honoraria or consulting fees from various companies. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Sin reported having no conflicts of interest to disclose.
A version of this article first appeared on Medscape.com.
FROM ERS 2022
Children and COVID: Weekly cases close out August with a second straight increase
New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.
Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.
Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.
Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.
Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.
New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.
Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.
Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.
Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.
Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.
New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.
Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.
Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.
Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.
Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.
How to identify and treat patients with substance use disorders
When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.
Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.
It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022,
According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.
Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
A courageous conversation
Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.
Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.
In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.
Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.
Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.
Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”
“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
Patients don’t often ask for help
In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.
“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.
Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.
Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.
“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”
“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.
“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
Check the prescription drugs they’re taking
Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.
“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.
He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.
It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
Other barriers physicians face
Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.
In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.
Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
The issue of reimbursement
Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.
For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.
Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.
At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.
Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.
“There needs to be time to talk about it.”
A version of this article first appeared on Medscape.com.
When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.
Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.
It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022,
According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.
Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
A courageous conversation
Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.
Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.
In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.
Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.
Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.
Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”
“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
Patients don’t often ask for help
In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.
“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.
Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.
Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.
“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”
“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.
“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
Check the prescription drugs they’re taking
Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.
“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.
He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.
It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
Other barriers physicians face
Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.
In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.
Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
The issue of reimbursement
Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.
For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.
Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.
At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.
Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.
“There needs to be time to talk about it.”
A version of this article first appeared on Medscape.com.
When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.
Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.
It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022,
According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.
Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
A courageous conversation
Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.
Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.
In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.
Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.
Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.
Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”
“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
Patients don’t often ask for help
In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.
“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.
Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.
Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.
“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”
“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.
“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
Check the prescription drugs they’re taking
Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.
“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.
He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.
It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
Other barriers physicians face
Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.
In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.
Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
The issue of reimbursement
Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.
For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.
Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.
At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.
Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.
“There needs to be time to talk about it.”
A version of this article first appeared on Medscape.com.
In the rush to curtail abortion, states adopt a jumbled stew of definitions for human life
As life-preserving medical technology advanced in the second half of the 20th century, doctors and families were faced with a thorny decision, one with weighty legal and moral implications: How should we define when life ends? Cardiopulmonary bypass machines could keep the blood pumping and ventilators could maintain breathing long after a patient’s natural ability to perform those vital functions had ceased.
After decades of deliberations involving physicians, bioethicists, attorneys, and theologians, a U.S. presidential commission in 1981 settled on a scientifically derived dividing line between life and death that has endured, more or less, ever since: A person was considered dead when the entire brain – including the brain stem, its most primitive portion – was no longer functioning, even if other vital functions could be maintained indefinitely through artificial life support.
In the decades since, the committee’s criteria have served as a foundation for laws in most states adopting brain death as a standard for legal death.
Now, with the overturning of Roe v. Wade and dozens of states rushing to impose abortion restrictions, At conception, the hint of a heartbeat, a first breath, the ability to survive outside the womb with the help of the latest technology?
That we’ve been able to devise and apply uniform clinical standards for when life ends, but not when it begins, is due largely to the legal and political maelstrom around abortion. And in the 2 months since the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, eliminating a longstanding federal right to abortion, state legislators are eagerly bounding into that void, looking to codify into law assorted definitions of life that carry profound repercussions for abortion rights, birth control, and assisted reproduction, as well as civil and criminal law.
“The court said that when life begins is up to whoever is running your state – whether they are wrong or not, or you agree with them or not,” said Mary Ziegler, a law professor at the University of California, Davis, who has written several books on the history of abortion.
Unlike the debate over death, which delved into exquisite medical and scientific detail, the legislative scramble to determine when life’s building blocks reach a threshold that warrants government protection as human life has generally ignored the input of mainstream medical professionals.
Instead, red states across much of the South and portions of the Midwest are adopting language drafted by elected officials that is informed by conservative Christian doctrine, often with little scientific underpinning.
A handful of Republican-led states, including Arkansas, Kentucky, Missouri, and Oklahoma, have passed laws declaring that life begins at fertilization, a contention that opens the door to a host of pregnancy-related litigation. This includes wrongful death lawsuits brought on behalf of the estate of an embryo by disgruntled ex-partners against physicians and women who end a pregnancy or even miscarry. (One such lawsuit is underway in Arizona. Another reached the Alabama Supreme Court.)
In Kentucky, the law outlawing abortion uses morally explosive terms to define pregnancy as “the human female reproductive condition of having a living unborn human being within her body throughout the entire embryonic and fetal stages of the unborn child from fertilization to full gestation and childbirth.”
Several other states, including Georgia, have adopted measures equating life with the point at which an embryo’s nascent cardiac activity can be detected by an ultrasound, at around 6 weeks of gestation. Many such laws mischaracterize the flickering electrical impulses detectable at that stage as a heartbeat, including in Georgia, whose Department of Revenue recently announced that “any unborn child with a detectable human heartbeat” can be claimed as a dependent.
The Supreme Court’s 1973 decision in Roe v. Wade that established a constitutional right to abortion did not define a moment when life begins. The opinion, written by Justice Harry Blackmun, observed that the Constitution does not provide a definition of “person,” though it extends protections to those born or naturalized in the United States. The court majority made note of the many disparate views among religions and scientists on when life begins, and concluded it was not up to the states to adopt one theory of life.
Instead, Roe created a framework intended to balance a pregnant woman’s right to make decisions about her body with a public interest in protecting potential human life. That decision and a key ruling that followed generally recognized a woman’s right to abortion up to the point medical professionals judge a fetus viable to survive outside the uterus, at about 24 weeks of gestation.
In decisively overturning Roe in June, the Supreme Court’s conservative majority drew on legal arguments that have shaped another contentious end-of-life issue. The legal standard employed in Dobbs – that there is no right to abortion in the federal Constitution and that states can decide on their own – is the same rationale used in 1997 when the Supreme Court said terminally ill people did not have a constitutional right to medically assisted death. That decision, Washington v. Glucksberg, is mentioned 15 times in the majority opinion for Dobbs and a concurrence by Justice Clarence Thomas.
Often, the same groups that have led the fight to outlaw abortion have also challenged medical aid-in-dying laws. Even after Dobbs, so-called right-to-die laws remain far less common than those codifying state abortion rights. Ten states allow physicians to prescribe lethal doses of medicine for terminally ill patients. Doctors are still prohibited from administering the drugs.
James Bopp, general counsel for the National Right to Life Committee who has been central to the efforts to outlaw abortion, said that both abortion and medically assisted death, which he refers to as physician-assisted suicide, endanger society.
“Every individual human life has inherent value and is sacred,” said Mr. Bopp. “The government has the duty to protect that life.”
Both issues raise profound societal questions: Can the government keep a patient on life support against his wishes, or force a woman to give birth? Can states bar their own residents from going to other states to end a pregnancy, or prohibit out-of-state patients from coming in to seek medically assisted death? And who gets to decide, particularly if the answer imposes a singular religious viewpoint?
Just as there are legal implications that flow from determining a person’s death, from organ donation to inheritance, the implied rights held by a legally recognized zygote are potentially vast. Will death certificates be issued for every lost pregnancy? Will miscarriages be investigated? When will Social Security numbers be issued? How will census counts be tallied and congressional districts drawn?
Medical professionals and bioethicists caution that both the beginning and end of life are complicated biological processes that are not defined by a single identifiable moment – and are ill suited to the political arena.
“Unfortunately, biological occurrences are not events, they are processes,” said David Magnus, PhD, director of the Stanford (Calif.) Center for Biomedical Ethics.
Moreover, asking doctors “What is life?” or “What is death?” may miss the point, said Dr. Magnus: “Medicine can answer the question ‘When does a biological organism cease to exist?’ But they can’t answer the question ‘When does a person begin or end?’ because those are metaphysical issues.”
Ben Sarbey, a doctoral candidate in the department of philosophy at Duke University, Durham, N.C., who studies medical ethics, echoed that perspective, recounting the Paradox of the Heap, a thought experiment that involves placing grains of sand one on top of the next. The philosophical quandary is this: At what point do those grains of sand become something more – a heap?
“We’re going to have a rough time placing a dividing line that this counts as a person and this does not count as a person,” he said. “Many things count as life – a sperm counts as life, a person in a persistent vegetative state counts as life – but does that constitute a person that we should be protecting?”
Even as debate over the court’s abortion decision percolates, the 1981 federal statute that grew out of the presidential committee’s findings, the Uniform Determination of Death Act, is also under review. In 2022, the Uniform Law Commission, a nonpartisan group of legal experts that drafts laws intended for adoption in multiple states, has taken up the work to revisit the definition of death.
The group will consider sharpening the medical standards for brain death in light of advances in the understanding of brain function. And they will look to address lingering questions raised in recent years as families and religious groups have waged heated legal battles over terminating artificial life support for patients with no brain wave activity.
Mr. Bopp, with the National Right to Life Committee, is among those serving on advisory panels for the effort, along with an array of doctors, philosophers, and medical ethicists. The concept of “personhood” that infuses the antiabortion movement’s broader push for fetal rights is expected to be an underlying topic, albeit in mirror image: When does a life form cease being a person?
Dr. Magnus, who is also serving on an advisory panel, has no doubt the commission will reach a consensus, a sober resolution rooted in science. What’s less clear, he said, is whether in today’s political environment that updated definition will hold the same sway, an enduring legal standard embraced across states.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
As life-preserving medical technology advanced in the second half of the 20th century, doctors and families were faced with a thorny decision, one with weighty legal and moral implications: How should we define when life ends? Cardiopulmonary bypass machines could keep the blood pumping and ventilators could maintain breathing long after a patient’s natural ability to perform those vital functions had ceased.
After decades of deliberations involving physicians, bioethicists, attorneys, and theologians, a U.S. presidential commission in 1981 settled on a scientifically derived dividing line between life and death that has endured, more or less, ever since: A person was considered dead when the entire brain – including the brain stem, its most primitive portion – was no longer functioning, even if other vital functions could be maintained indefinitely through artificial life support.
In the decades since, the committee’s criteria have served as a foundation for laws in most states adopting brain death as a standard for legal death.
Now, with the overturning of Roe v. Wade and dozens of states rushing to impose abortion restrictions, At conception, the hint of a heartbeat, a first breath, the ability to survive outside the womb with the help of the latest technology?
That we’ve been able to devise and apply uniform clinical standards for when life ends, but not when it begins, is due largely to the legal and political maelstrom around abortion. And in the 2 months since the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, eliminating a longstanding federal right to abortion, state legislators are eagerly bounding into that void, looking to codify into law assorted definitions of life that carry profound repercussions for abortion rights, birth control, and assisted reproduction, as well as civil and criminal law.
“The court said that when life begins is up to whoever is running your state – whether they are wrong or not, or you agree with them or not,” said Mary Ziegler, a law professor at the University of California, Davis, who has written several books on the history of abortion.
Unlike the debate over death, which delved into exquisite medical and scientific detail, the legislative scramble to determine when life’s building blocks reach a threshold that warrants government protection as human life has generally ignored the input of mainstream medical professionals.
Instead, red states across much of the South and portions of the Midwest are adopting language drafted by elected officials that is informed by conservative Christian doctrine, often with little scientific underpinning.
A handful of Republican-led states, including Arkansas, Kentucky, Missouri, and Oklahoma, have passed laws declaring that life begins at fertilization, a contention that opens the door to a host of pregnancy-related litigation. This includes wrongful death lawsuits brought on behalf of the estate of an embryo by disgruntled ex-partners against physicians and women who end a pregnancy or even miscarry. (One such lawsuit is underway in Arizona. Another reached the Alabama Supreme Court.)
In Kentucky, the law outlawing abortion uses morally explosive terms to define pregnancy as “the human female reproductive condition of having a living unborn human being within her body throughout the entire embryonic and fetal stages of the unborn child from fertilization to full gestation and childbirth.”
Several other states, including Georgia, have adopted measures equating life with the point at which an embryo’s nascent cardiac activity can be detected by an ultrasound, at around 6 weeks of gestation. Many such laws mischaracterize the flickering electrical impulses detectable at that stage as a heartbeat, including in Georgia, whose Department of Revenue recently announced that “any unborn child with a detectable human heartbeat” can be claimed as a dependent.
The Supreme Court’s 1973 decision in Roe v. Wade that established a constitutional right to abortion did not define a moment when life begins. The opinion, written by Justice Harry Blackmun, observed that the Constitution does not provide a definition of “person,” though it extends protections to those born or naturalized in the United States. The court majority made note of the many disparate views among religions and scientists on when life begins, and concluded it was not up to the states to adopt one theory of life.
Instead, Roe created a framework intended to balance a pregnant woman’s right to make decisions about her body with a public interest in protecting potential human life. That decision and a key ruling that followed generally recognized a woman’s right to abortion up to the point medical professionals judge a fetus viable to survive outside the uterus, at about 24 weeks of gestation.
In decisively overturning Roe in June, the Supreme Court’s conservative majority drew on legal arguments that have shaped another contentious end-of-life issue. The legal standard employed in Dobbs – that there is no right to abortion in the federal Constitution and that states can decide on their own – is the same rationale used in 1997 when the Supreme Court said terminally ill people did not have a constitutional right to medically assisted death. That decision, Washington v. Glucksberg, is mentioned 15 times in the majority opinion for Dobbs and a concurrence by Justice Clarence Thomas.
Often, the same groups that have led the fight to outlaw abortion have also challenged medical aid-in-dying laws. Even after Dobbs, so-called right-to-die laws remain far less common than those codifying state abortion rights. Ten states allow physicians to prescribe lethal doses of medicine for terminally ill patients. Doctors are still prohibited from administering the drugs.
James Bopp, general counsel for the National Right to Life Committee who has been central to the efforts to outlaw abortion, said that both abortion and medically assisted death, which he refers to as physician-assisted suicide, endanger society.
“Every individual human life has inherent value and is sacred,” said Mr. Bopp. “The government has the duty to protect that life.”
Both issues raise profound societal questions: Can the government keep a patient on life support against his wishes, or force a woman to give birth? Can states bar their own residents from going to other states to end a pregnancy, or prohibit out-of-state patients from coming in to seek medically assisted death? And who gets to decide, particularly if the answer imposes a singular religious viewpoint?
Just as there are legal implications that flow from determining a person’s death, from organ donation to inheritance, the implied rights held by a legally recognized zygote are potentially vast. Will death certificates be issued for every lost pregnancy? Will miscarriages be investigated? When will Social Security numbers be issued? How will census counts be tallied and congressional districts drawn?
Medical professionals and bioethicists caution that both the beginning and end of life are complicated biological processes that are not defined by a single identifiable moment – and are ill suited to the political arena.
“Unfortunately, biological occurrences are not events, they are processes,” said David Magnus, PhD, director of the Stanford (Calif.) Center for Biomedical Ethics.
Moreover, asking doctors “What is life?” or “What is death?” may miss the point, said Dr. Magnus: “Medicine can answer the question ‘When does a biological organism cease to exist?’ But they can’t answer the question ‘When does a person begin or end?’ because those are metaphysical issues.”
Ben Sarbey, a doctoral candidate in the department of philosophy at Duke University, Durham, N.C., who studies medical ethics, echoed that perspective, recounting the Paradox of the Heap, a thought experiment that involves placing grains of sand one on top of the next. The philosophical quandary is this: At what point do those grains of sand become something more – a heap?
“We’re going to have a rough time placing a dividing line that this counts as a person and this does not count as a person,” he said. “Many things count as life – a sperm counts as life, a person in a persistent vegetative state counts as life – but does that constitute a person that we should be protecting?”
Even as debate over the court’s abortion decision percolates, the 1981 federal statute that grew out of the presidential committee’s findings, the Uniform Determination of Death Act, is also under review. In 2022, the Uniform Law Commission, a nonpartisan group of legal experts that drafts laws intended for adoption in multiple states, has taken up the work to revisit the definition of death.
The group will consider sharpening the medical standards for brain death in light of advances in the understanding of brain function. And they will look to address lingering questions raised in recent years as families and religious groups have waged heated legal battles over terminating artificial life support for patients with no brain wave activity.
Mr. Bopp, with the National Right to Life Committee, is among those serving on advisory panels for the effort, along with an array of doctors, philosophers, and medical ethicists. The concept of “personhood” that infuses the antiabortion movement’s broader push for fetal rights is expected to be an underlying topic, albeit in mirror image: When does a life form cease being a person?
Dr. Magnus, who is also serving on an advisory panel, has no doubt the commission will reach a consensus, a sober resolution rooted in science. What’s less clear, he said, is whether in today’s political environment that updated definition will hold the same sway, an enduring legal standard embraced across states.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
As life-preserving medical technology advanced in the second half of the 20th century, doctors and families were faced with a thorny decision, one with weighty legal and moral implications: How should we define when life ends? Cardiopulmonary bypass machines could keep the blood pumping and ventilators could maintain breathing long after a patient’s natural ability to perform those vital functions had ceased.
After decades of deliberations involving physicians, bioethicists, attorneys, and theologians, a U.S. presidential commission in 1981 settled on a scientifically derived dividing line between life and death that has endured, more or less, ever since: A person was considered dead when the entire brain – including the brain stem, its most primitive portion – was no longer functioning, even if other vital functions could be maintained indefinitely through artificial life support.
In the decades since, the committee’s criteria have served as a foundation for laws in most states adopting brain death as a standard for legal death.
Now, with the overturning of Roe v. Wade and dozens of states rushing to impose abortion restrictions, At conception, the hint of a heartbeat, a first breath, the ability to survive outside the womb with the help of the latest technology?
That we’ve been able to devise and apply uniform clinical standards for when life ends, but not when it begins, is due largely to the legal and political maelstrom around abortion. And in the 2 months since the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, eliminating a longstanding federal right to abortion, state legislators are eagerly bounding into that void, looking to codify into law assorted definitions of life that carry profound repercussions for abortion rights, birth control, and assisted reproduction, as well as civil and criminal law.
“The court said that when life begins is up to whoever is running your state – whether they are wrong or not, or you agree with them or not,” said Mary Ziegler, a law professor at the University of California, Davis, who has written several books on the history of abortion.
Unlike the debate over death, which delved into exquisite medical and scientific detail, the legislative scramble to determine when life’s building blocks reach a threshold that warrants government protection as human life has generally ignored the input of mainstream medical professionals.
Instead, red states across much of the South and portions of the Midwest are adopting language drafted by elected officials that is informed by conservative Christian doctrine, often with little scientific underpinning.
A handful of Republican-led states, including Arkansas, Kentucky, Missouri, and Oklahoma, have passed laws declaring that life begins at fertilization, a contention that opens the door to a host of pregnancy-related litigation. This includes wrongful death lawsuits brought on behalf of the estate of an embryo by disgruntled ex-partners against physicians and women who end a pregnancy or even miscarry. (One such lawsuit is underway in Arizona. Another reached the Alabama Supreme Court.)
In Kentucky, the law outlawing abortion uses morally explosive terms to define pregnancy as “the human female reproductive condition of having a living unborn human being within her body throughout the entire embryonic and fetal stages of the unborn child from fertilization to full gestation and childbirth.”
Several other states, including Georgia, have adopted measures equating life with the point at which an embryo’s nascent cardiac activity can be detected by an ultrasound, at around 6 weeks of gestation. Many such laws mischaracterize the flickering electrical impulses detectable at that stage as a heartbeat, including in Georgia, whose Department of Revenue recently announced that “any unborn child with a detectable human heartbeat” can be claimed as a dependent.
The Supreme Court’s 1973 decision in Roe v. Wade that established a constitutional right to abortion did not define a moment when life begins. The opinion, written by Justice Harry Blackmun, observed that the Constitution does not provide a definition of “person,” though it extends protections to those born or naturalized in the United States. The court majority made note of the many disparate views among religions and scientists on when life begins, and concluded it was not up to the states to adopt one theory of life.
Instead, Roe created a framework intended to balance a pregnant woman’s right to make decisions about her body with a public interest in protecting potential human life. That decision and a key ruling that followed generally recognized a woman’s right to abortion up to the point medical professionals judge a fetus viable to survive outside the uterus, at about 24 weeks of gestation.
In decisively overturning Roe in June, the Supreme Court’s conservative majority drew on legal arguments that have shaped another contentious end-of-life issue. The legal standard employed in Dobbs – that there is no right to abortion in the federal Constitution and that states can decide on their own – is the same rationale used in 1997 when the Supreme Court said terminally ill people did not have a constitutional right to medically assisted death. That decision, Washington v. Glucksberg, is mentioned 15 times in the majority opinion for Dobbs and a concurrence by Justice Clarence Thomas.
Often, the same groups that have led the fight to outlaw abortion have also challenged medical aid-in-dying laws. Even after Dobbs, so-called right-to-die laws remain far less common than those codifying state abortion rights. Ten states allow physicians to prescribe lethal doses of medicine for terminally ill patients. Doctors are still prohibited from administering the drugs.
James Bopp, general counsel for the National Right to Life Committee who has been central to the efforts to outlaw abortion, said that both abortion and medically assisted death, which he refers to as physician-assisted suicide, endanger society.
“Every individual human life has inherent value and is sacred,” said Mr. Bopp. “The government has the duty to protect that life.”
Both issues raise profound societal questions: Can the government keep a patient on life support against his wishes, or force a woman to give birth? Can states bar their own residents from going to other states to end a pregnancy, or prohibit out-of-state patients from coming in to seek medically assisted death? And who gets to decide, particularly if the answer imposes a singular religious viewpoint?
Just as there are legal implications that flow from determining a person’s death, from organ donation to inheritance, the implied rights held by a legally recognized zygote are potentially vast. Will death certificates be issued for every lost pregnancy? Will miscarriages be investigated? When will Social Security numbers be issued? How will census counts be tallied and congressional districts drawn?
Medical professionals and bioethicists caution that both the beginning and end of life are complicated biological processes that are not defined by a single identifiable moment – and are ill suited to the political arena.
“Unfortunately, biological occurrences are not events, they are processes,” said David Magnus, PhD, director of the Stanford (Calif.) Center for Biomedical Ethics.
Moreover, asking doctors “What is life?” or “What is death?” may miss the point, said Dr. Magnus: “Medicine can answer the question ‘When does a biological organism cease to exist?’ But they can’t answer the question ‘When does a person begin or end?’ because those are metaphysical issues.”
Ben Sarbey, a doctoral candidate in the department of philosophy at Duke University, Durham, N.C., who studies medical ethics, echoed that perspective, recounting the Paradox of the Heap, a thought experiment that involves placing grains of sand one on top of the next. The philosophical quandary is this: At what point do those grains of sand become something more – a heap?
“We’re going to have a rough time placing a dividing line that this counts as a person and this does not count as a person,” he said. “Many things count as life – a sperm counts as life, a person in a persistent vegetative state counts as life – but does that constitute a person that we should be protecting?”
Even as debate over the court’s abortion decision percolates, the 1981 federal statute that grew out of the presidential committee’s findings, the Uniform Determination of Death Act, is also under review. In 2022, the Uniform Law Commission, a nonpartisan group of legal experts that drafts laws intended for adoption in multiple states, has taken up the work to revisit the definition of death.
The group will consider sharpening the medical standards for brain death in light of advances in the understanding of brain function. And they will look to address lingering questions raised in recent years as families and religious groups have waged heated legal battles over terminating artificial life support for patients with no brain wave activity.
Mr. Bopp, with the National Right to Life Committee, is among those serving on advisory panels for the effort, along with an array of doctors, philosophers, and medical ethicists. The concept of “personhood” that infuses the antiabortion movement’s broader push for fetal rights is expected to be an underlying topic, albeit in mirror image: When does a life form cease being a person?
Dr. Magnus, who is also serving on an advisory panel, has no doubt the commission will reach a consensus, a sober resolution rooted in science. What’s less clear, he said, is whether in today’s political environment that updated definition will hold the same sway, an enduring legal standard embraced across states.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.