MDedge Rheumatology

People with psoriatic arthritis can be symptomatic for years before the condition is diagnosed, according to two recent reports.

Courtesy Dr. Alexis Ogdie-Beatty

There are no reliable diagnostic biomarkers, and sometimes patients have vague symptoms with only minimal physical findings, which makes it hard for physicians to recognize the problem and refer to rheumatology.

In the meantime, the longer it takes to diagnose psoriatic arthritis (PsA) and treat it properly, the worse off patients are when it’s finally caught. They “present with a greater rate of clinical progression and worse physical function, compared with patients with an undelayed diagnosis,” and more radiographic joint damage, according to investigators led by rheumatologist Alexis Ogdie, MD, an associate professor of medicine at the University of Pennsylvania, Philadelphia.

Dr. Ogdie’s study in BMC Rheumatology, and a second one from Arthritis Care & Research, both described the early phase of psoriatic arthritis, before formal diagnosis, to help with early recognition.
 

Delay associated with misdiagnosis

Dr. Ogdie’s team surveyed 203 adults with PsA – average age of 52 years, mostly white, and over 80% women – about their diagnosis history. The time between seeking medical attention for PsA-related symptoms and receiving a diagnosis was less than 6 months for 69 participants, 6 months to 4 years for 68, and 5 years or more for 66.

Typical symptoms, like joint pain, swollen joints, reduced range of motion, and dactylitis, were associated with quicker diagnosis. Turning early to dermatologists and rheumatologists – instead of general practitioners, orthopedics, chiropractors, and others – sped diagnosis, as well. People diagnosed within 6 months also tended to be slightly older, were less likely to be disabled or unemployed, have more education, and were more likely to make $100,000 per year or more.

Vaguer symptoms, such as stiffness, fatigue, and enthesitis-associated foot pain, delayed diagnosis. The longer PsA went unrecognized, the more likely people were to be misdiagnosed with osteoarthritis, psychosomatic disorders, and other problems.

“Increased recognition of heterogeneous symptoms associated with PsA, as well as understanding existing diagnostic barriers, may lead to prompt diagnosis and initiation of appropriate treatment that may improve outcomes,” the investigators concluded.
 

A prodromal phase

In the Arthritis Care & Research study, investigators led by Lihi Eder, MD, PhD, codirector of the cardio-rheumatology program at Women’s College Hospital, Toronto, used health records and databases to compare primary care histories of 462 Canadian PsA patients in the 5 years before they were diagnosed with 2,310 age- and sex-matched controls without PsA and treated by the same family physicians. The mean age in the study was 54 years, and just over half the subjects were women. Socioeconomic status and rurality were similar between the two groups.

Courtesy Michael Wong/Women's College Hospital

The mean time from the initial primary care visit for a musculoskeletal complaint to rheumatology referral was 513 days among PsA patients, “which was substantially longer than for other inflammatory arthritic conditions, such as rheumatoid arthritis,” Dr. Eder and associates noted.

PsA patients were more than twice as likely to visit primary care for nonspecific musculoskeletal issues in the year before their diagnosis, and more likely in the 5 years prior. The odds of visits to musculoskeletal specialists, joint injections, joint imaging, and ED visits, was also higher as early as 5 years before PsA recognition, and hinted at the impending diagnosis.

“Our study characterized a prediagnosis period in PsA and supports the notion that a prodromal PsA phase occurs in a significant proportion of patients. ... This pattern reveals some of the underlying causes of diagnosis delays of PsA and highlights the need for diagnostic strategies and novel reliable biomarkers to aid in early diagnosis of PsA,” the investigators concluded.

Dr. Ogdie and colleagues suggested that community case searches, public awareness programs, patient education, and referral guidelines for primary care providers might help. They also suggested greater use of validated screening tools, such as the Psoriasis Epidemiology Screening Tool, in primary care.

Dr. Eder had no disclosures, and her study was funded by the Canadian Rheumatology Association. Dr. Ogdie’s study was funded by Novartis, maker of secukinumab (Cosentyx), which is indicated for PsA. She is a consultant for Novartis and has received grant support from the company. One author is an employee.

aotto@mdedge.com

SOURCES: Ogdie A et al. BMC Rheumatol. 2020 Jan 10. doi: 10.1186/s41927-019-0102-7; Eder L et al. Arthritis Care Res. 2020 Jan 21. doi: 10.1002/acr.24146.

People with psoriatic arthritis can be symptomatic for years before the condition is diagnosed, according to two recent reports.

Courtesy Dr. Alexis Ogdie-Beatty

There are no reliable diagnostic biomarkers, and sometimes patients have vague symptoms with only minimal physical findings, which makes it hard for physicians to recognize the problem and refer to rheumatology.

In the meantime, the longer it takes to diagnose psoriatic arthritis (PsA) and treat it properly, the worse off patients are when it’s finally caught. They “present with a greater rate of clinical progression and worse physical function, compared with patients with an undelayed diagnosis,” and more radiographic joint damage, according to investigators led by rheumatologist Alexis Ogdie, MD, an associate professor of medicine at the University of Pennsylvania, Philadelphia.

Dr. Ogdie’s study in BMC Rheumatology, and a second one from Arthritis Care & Research, both described the early phase of psoriatic arthritis, before formal diagnosis, to help with early recognition.
 

Delay associated with misdiagnosis

Dr. Ogdie’s team surveyed 203 adults with PsA – average age of 52 years, mostly white, and over 80% women – about their diagnosis history. The time between seeking medical attention for PsA-related symptoms and receiving a diagnosis was less than 6 months for 69 participants, 6 months to 4 years for 68, and 5 years or more for 66.

Typical symptoms, like joint pain, swollen joints, reduced range of motion, and dactylitis, were associated with quicker diagnosis. Turning early to dermatologists and rheumatologists – instead of general practitioners, orthopedics, chiropractors, and others – sped diagnosis, as well. People diagnosed within 6 months also tended to be slightly older, were less likely to be disabled or unemployed, have more education, and were more likely to make $100,000 per year or more.

Vaguer symptoms, such as stiffness, fatigue, and enthesitis-associated foot pain, delayed diagnosis. The longer PsA went unrecognized, the more likely people were to be misdiagnosed with osteoarthritis, psychosomatic disorders, and other problems.

“Increased recognition of heterogeneous symptoms associated with PsA, as well as understanding existing diagnostic barriers, may lead to prompt diagnosis and initiation of appropriate treatment that may improve outcomes,” the investigators concluded.
 

A prodromal phase

In the Arthritis Care & Research study, investigators led by Lihi Eder, MD, PhD, codirector of the cardio-rheumatology program at Women’s College Hospital, Toronto, used health records and databases to compare primary care histories of 462 Canadian PsA patients in the 5 years before they were diagnosed with 2,310 age- and sex-matched controls without PsA and treated by the same family physicians. The mean age in the study was 54 years, and just over half the subjects were women. Socioeconomic status and rurality were similar between the two groups.

Courtesy Michael Wong/Women's College Hospital

The mean time from the initial primary care visit for a musculoskeletal complaint to rheumatology referral was 513 days among PsA patients, “which was substantially longer than for other inflammatory arthritic conditions, such as rheumatoid arthritis,” Dr. Eder and associates noted.

PsA patients were more than twice as likely to visit primary care for nonspecific musculoskeletal issues in the year before their diagnosis, and more likely in the 5 years prior. The odds of visits to musculoskeletal specialists, joint injections, joint imaging, and ED visits, was also higher as early as 5 years before PsA recognition, and hinted at the impending diagnosis.

“Our study characterized a prediagnosis period in PsA and supports the notion that a prodromal PsA phase occurs in a significant proportion of patients. ... This pattern reveals some of the underlying causes of diagnosis delays of PsA and highlights the need for diagnostic strategies and novel reliable biomarkers to aid in early diagnosis of PsA,” the investigators concluded.

Dr. Ogdie and colleagues suggested that community case searches, public awareness programs, patient education, and referral guidelines for primary care providers might help. They also suggested greater use of validated screening tools, such as the Psoriasis Epidemiology Screening Tool, in primary care.

Dr. Eder had no disclosures, and her study was funded by the Canadian Rheumatology Association. Dr. Ogdie’s study was funded by Novartis, maker of secukinumab (Cosentyx), which is indicated for PsA. She is a consultant for Novartis and has received grant support from the company. One author is an employee.

aotto@mdedge.com

SOURCES: Ogdie A et al. BMC Rheumatol. 2020 Jan 10. doi: 10.1186/s41927-019-0102-7; Eder L et al. Arthritis Care Res. 2020 Jan 21. doi: 10.1002/acr.24146.

People with psoriatic arthritis can be symptomatic for years before the condition is diagnosed, according to two recent reports.

Courtesy Dr. Alexis Ogdie-Beatty

There are no reliable diagnostic biomarkers, and sometimes patients have vague symptoms with only minimal physical findings, which makes it hard for physicians to recognize the problem and refer to rheumatology.

In the meantime, the longer it takes to diagnose psoriatic arthritis (PsA) and treat it properly, the worse off patients are when it’s finally caught. They “present with a greater rate of clinical progression and worse physical function, compared with patients with an undelayed diagnosis,” and more radiographic joint damage, according to investigators led by rheumatologist Alexis Ogdie, MD, an associate professor of medicine at the University of Pennsylvania, Philadelphia.

Dr. Ogdie’s study in BMC Rheumatology, and a second one from Arthritis Care & Research, both described the early phase of psoriatic arthritis, before formal diagnosis, to help with early recognition.
 

Delay associated with misdiagnosis

Dr. Ogdie’s team surveyed 203 adults with PsA – average age of 52 years, mostly white, and over 80% women – about their diagnosis history. The time between seeking medical attention for PsA-related symptoms and receiving a diagnosis was less than 6 months for 69 participants, 6 months to 4 years for 68, and 5 years or more for 66.

Typical symptoms, like joint pain, swollen joints, reduced range of motion, and dactylitis, were associated with quicker diagnosis. Turning early to dermatologists and rheumatologists – instead of general practitioners, orthopedics, chiropractors, and others – sped diagnosis, as well. People diagnosed within 6 months also tended to be slightly older, were less likely to be disabled or unemployed, have more education, and were more likely to make $100,000 per year or more.

Vaguer symptoms, such as stiffness, fatigue, and enthesitis-associated foot pain, delayed diagnosis. The longer PsA went unrecognized, the more likely people were to be misdiagnosed with osteoarthritis, psychosomatic disorders, and other problems.

“Increased recognition of heterogeneous symptoms associated with PsA, as well as understanding existing diagnostic barriers, may lead to prompt diagnosis and initiation of appropriate treatment that may improve outcomes,” the investigators concluded.
 

A prodromal phase

In the Arthritis Care & Research study, investigators led by Lihi Eder, MD, PhD, codirector of the cardio-rheumatology program at Women’s College Hospital, Toronto, used health records and databases to compare primary care histories of 462 Canadian PsA patients in the 5 years before they were diagnosed with 2,310 age- and sex-matched controls without PsA and treated by the same family physicians. The mean age in the study was 54 years, and just over half the subjects were women. Socioeconomic status and rurality were similar between the two groups.

Courtesy Michael Wong/Women's College Hospital

The mean time from the initial primary care visit for a musculoskeletal complaint to rheumatology referral was 513 days among PsA patients, “which was substantially longer than for other inflammatory arthritic conditions, such as rheumatoid arthritis,” Dr. Eder and associates noted.

PsA patients were more than twice as likely to visit primary care for nonspecific musculoskeletal issues in the year before their diagnosis, and more likely in the 5 years prior. The odds of visits to musculoskeletal specialists, joint injections, joint imaging, and ED visits, was also higher as early as 5 years before PsA recognition, and hinted at the impending diagnosis.

“Our study characterized a prediagnosis period in PsA and supports the notion that a prodromal PsA phase occurs in a significant proportion of patients. ... This pattern reveals some of the underlying causes of diagnosis delays of PsA and highlights the need for diagnostic strategies and novel reliable biomarkers to aid in early diagnosis of PsA,” the investigators concluded.

Dr. Ogdie and colleagues suggested that community case searches, public awareness programs, patient education, and referral guidelines for primary care providers might help. They also suggested greater use of validated screening tools, such as the Psoriasis Epidemiology Screening Tool, in primary care.

Dr. Eder had no disclosures, and her study was funded by the Canadian Rheumatology Association. Dr. Ogdie’s study was funded by Novartis, maker of secukinumab (Cosentyx), which is indicated for PsA. She is a consultant for Novartis and has received grant support from the company. One author is an employee.

aotto@mdedge.com

SOURCES: Ogdie A et al. BMC Rheumatol. 2020 Jan 10. doi: 10.1186/s41927-019-0102-7; Eder L et al. Arthritis Care Res. 2020 Jan 21. doi: 10.1002/acr.24146.

Low serum levels of hydroxychloroquine (HCQ) among patients with systemic lupus erythematosus are associated with a threefold increased likelihood of physician- and patient-reported nonadherence to the medication. In addition, routine monitoring of HCQ levels are associated with improvements in adherence and disease activity.

Alexander Raths/ThinkStock

Those are two key findings from a systematic review and meta-analysis published in Arthritis Care & Research.

“HCQ is recommended for all patients with systemic lupus erythematosus (SLE, or lupus) to reduce disease activity and improve damage-free-survival,” the authors, led by Shivani Garg, MD, of the University of Wisconsin–Madison, wrote in the article. “Yet, up to 83% of lupus patients are nonadherent to HCQ commonly because of poor understanding of benefits of HCQ, lack of motivation to continue therapy, and inflated concerns regarding side effects from HCQ use.”

For their analysis, the researchers drew from 17 published observational and interventional studies that measured HCQ levels and assessed adherence or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in adults with SLE. They used forest plots to compare pooled estimates of correlations between HCQ levels and reported nonadherence, or SLEDAI scores. Patient-reported nonadherence was defined as less than 80% medication adherence reported, and physician-reported adherence was estimated based on physicians’ interpretations of the previous month’s adherence as reported by patients during clinic visits.

The study population consisted of 1,223 patients. Dr. Garg and colleagues found a threefold higher odds of reported nonadherence in patients with low HCQ levels (odds ratio, 2.95; P less than .001). The mean SLEDAI score was 3.14 points higher in a group with below-threshold HCQ levels on a priori analysis (P = .053), and 1.4 points higher in a group with HCQ levels below 500 ng/mL (P = .039). Among all patients, those with HCQ levels 750 ng/mL or greater had a 58% lower risk of active disease, and their SLEDAI score was 3.2 points lower. “Our study support levels greater than or equal to 750 ng/mL to be clinically meaningful and statistically significant to identify disease flare (change in SLEDAI greater than or equal to 3 points) and predict active disease (SLEDAI greater than or equal to 6),” the authors wrote.

In an interview, Michelle A. Petri, MD, MPH, took issue with the HCQ goal of 750 ng/mL or greater recommended by the authors. “I think that was premature,” said Dr. Petri, professor of medicine at Johns Hopkins University, Baltimore. “We presented data at last year’s ACR [which showed] that the level needs to be higher than that to prevent thrombosis. But it is important to open the discussion that HCQ blood levels are not just for nonadherence. I believe they will help us to reduce retinopathy, and also to make sure the dose remains in an efficacious range, such as what is needed to prevent thrombosis.”

Dr. Petri, who also directs the Hopkins Lupus Center, said that the study’s overall conclusions confirms the need for blood testing for HCQ to identify nonadherence. “Everyone remembers the saying of the [former] Surgeon General Dr. C. Everett Koop: ‘Drugs can’t work if patients don’t take them!’ – in particular, blood levels which represent what the patient has taken in the last month. I call blood levels the ‘lupus A_1C.’ ”

She added that HCQ blood levels have utility for nonadherence, prediction of retinopathy, and prevention of thrombosis. Such tests “are now much more widely available, including by some large national laboratories such as Quest Diagnostics, as well as by Exagen. No more excuses.” LabCorp plans to start offering HCQ blood level testing by the middle of 2020, she said.

In their manuscript, the study authors acknowledged certain limitations of their analysis, including the fact that there were only four studies that measured HCQ levels and nonadherence or SLEDAI. “Second, most of the studies that examined the correlation between reported adherence and HCQ blood levels were performed in Europe, and there was only one small U.S. study,” they wrote. “Therefore, generalizability for our findings could be limited because of differences in cultural beliefs, social issues, and insurance/medical coverage in populations from diverse countries.”

The study authors reported having no disclosures. Dr. Petri disclosed that she has conducted research on HCQ that was funded by the National Institutes of Health. She has also conducted research for Exagen.

dbrunk@mdedge.com

SOURCE: Garg S et al. Arthritis Care Res. 2020 Jan 31. doi: 10.1002/acr.24155.

Low serum levels of hydroxychloroquine (HCQ) among patients with systemic lupus erythematosus are associated with a threefold increased likelihood of physician- and patient-reported nonadherence to the medication. In addition, routine monitoring of HCQ levels are associated with improvements in adherence and disease activity.

Alexander Raths/ThinkStock

Those are two key findings from a systematic review and meta-analysis published in Arthritis Care & Research.

“HCQ is recommended for all patients with systemic lupus erythematosus (SLE, or lupus) to reduce disease activity and improve damage-free-survival,” the authors, led by Shivani Garg, MD, of the University of Wisconsin–Madison, wrote in the article. “Yet, up to 83% of lupus patients are nonadherent to HCQ commonly because of poor understanding of benefits of HCQ, lack of motivation to continue therapy, and inflated concerns regarding side effects from HCQ use.”

For their analysis, the researchers drew from 17 published observational and interventional studies that measured HCQ levels and assessed adherence or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in adults with SLE. They used forest plots to compare pooled estimates of correlations between HCQ levels and reported nonadherence, or SLEDAI scores. Patient-reported nonadherence was defined as less than 80% medication adherence reported, and physician-reported adherence was estimated based on physicians’ interpretations of the previous month’s adherence as reported by patients during clinic visits.

The study population consisted of 1,223 patients. Dr. Garg and colleagues found a threefold higher odds of reported nonadherence in patients with low HCQ levels (odds ratio, 2.95; P less than .001). The mean SLEDAI score was 3.14 points higher in a group with below-threshold HCQ levels on a priori analysis (P = .053), and 1.4 points higher in a group with HCQ levels below 500 ng/mL (P = .039). Among all patients, those with HCQ levels 750 ng/mL or greater had a 58% lower risk of active disease, and their SLEDAI score was 3.2 points lower. “Our study support levels greater than or equal to 750 ng/mL to be clinically meaningful and statistically significant to identify disease flare (change in SLEDAI greater than or equal to 3 points) and predict active disease (SLEDAI greater than or equal to 6),” the authors wrote.

In an interview, Michelle A. Petri, MD, MPH, took issue with the HCQ goal of 750 ng/mL or greater recommended by the authors. “I think that was premature,” said Dr. Petri, professor of medicine at Johns Hopkins University, Baltimore. “We presented data at last year’s ACR [which showed] that the level needs to be higher than that to prevent thrombosis. But it is important to open the discussion that HCQ blood levels are not just for nonadherence. I believe they will help us to reduce retinopathy, and also to make sure the dose remains in an efficacious range, such as what is needed to prevent thrombosis.”

Dr. Petri, who also directs the Hopkins Lupus Center, said that the study’s overall conclusions confirms the need for blood testing for HCQ to identify nonadherence. “Everyone remembers the saying of the [former] Surgeon General Dr. C. Everett Koop: ‘Drugs can’t work if patients don’t take them!’ – in particular, blood levels which represent what the patient has taken in the last month. I call blood levels the ‘lupus A_1C.’ ”

She added that HCQ blood levels have utility for nonadherence, prediction of retinopathy, and prevention of thrombosis. Such tests “are now much more widely available, including by some large national laboratories such as Quest Diagnostics, as well as by Exagen. No more excuses.” LabCorp plans to start offering HCQ blood level testing by the middle of 2020, she said.

In their manuscript, the study authors acknowledged certain limitations of their analysis, including the fact that there were only four studies that measured HCQ levels and nonadherence or SLEDAI. “Second, most of the studies that examined the correlation between reported adherence and HCQ blood levels were performed in Europe, and there was only one small U.S. study,” they wrote. “Therefore, generalizability for our findings could be limited because of differences in cultural beliefs, social issues, and insurance/medical coverage in populations from diverse countries.”

The study authors reported having no disclosures. Dr. Petri disclosed that she has conducted research on HCQ that was funded by the National Institutes of Health. She has also conducted research for Exagen.

dbrunk@mdedge.com

SOURCE: Garg S et al. Arthritis Care Res. 2020 Jan 31. doi: 10.1002/acr.24155.

Low serum levels of hydroxychloroquine (HCQ) among patients with systemic lupus erythematosus are associated with a threefold increased likelihood of physician- and patient-reported nonadherence to the medication. In addition, routine monitoring of HCQ levels are associated with improvements in adherence and disease activity.

Alexander Raths/ThinkStock

Those are two key findings from a systematic review and meta-analysis published in Arthritis Care & Research.

“HCQ is recommended for all patients with systemic lupus erythematosus (SLE, or lupus) to reduce disease activity and improve damage-free-survival,” the authors, led by Shivani Garg, MD, of the University of Wisconsin–Madison, wrote in the article. “Yet, up to 83% of lupus patients are nonadherent to HCQ commonly because of poor understanding of benefits of HCQ, lack of motivation to continue therapy, and inflated concerns regarding side effects from HCQ use.”

For their analysis, the researchers drew from 17 published observational and interventional studies that measured HCQ levels and assessed adherence or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in adults with SLE. They used forest plots to compare pooled estimates of correlations between HCQ levels and reported nonadherence, or SLEDAI scores. Patient-reported nonadherence was defined as less than 80% medication adherence reported, and physician-reported adherence was estimated based on physicians’ interpretations of the previous month’s adherence as reported by patients during clinic visits.

The study population consisted of 1,223 patients. Dr. Garg and colleagues found a threefold higher odds of reported nonadherence in patients with low HCQ levels (odds ratio, 2.95; P less than .001). The mean SLEDAI score was 3.14 points higher in a group with below-threshold HCQ levels on a priori analysis (P = .053), and 1.4 points higher in a group with HCQ levels below 500 ng/mL (P = .039). Among all patients, those with HCQ levels 750 ng/mL or greater had a 58% lower risk of active disease, and their SLEDAI score was 3.2 points lower. “Our study support levels greater than or equal to 750 ng/mL to be clinically meaningful and statistically significant to identify disease flare (change in SLEDAI greater than or equal to 3 points) and predict active disease (SLEDAI greater than or equal to 6),” the authors wrote.

In an interview, Michelle A. Petri, MD, MPH, took issue with the HCQ goal of 750 ng/mL or greater recommended by the authors. “I think that was premature,” said Dr. Petri, professor of medicine at Johns Hopkins University, Baltimore. “We presented data at last year’s ACR [which showed] that the level needs to be higher than that to prevent thrombosis. But it is important to open the discussion that HCQ blood levels are not just for nonadherence. I believe they will help us to reduce retinopathy, and also to make sure the dose remains in an efficacious range, such as what is needed to prevent thrombosis.”

Dr. Petri, who also directs the Hopkins Lupus Center, said that the study’s overall conclusions confirms the need for blood testing for HCQ to identify nonadherence. “Everyone remembers the saying of the [former] Surgeon General Dr. C. Everett Koop: ‘Drugs can’t work if patients don’t take them!’ – in particular, blood levels which represent what the patient has taken in the last month. I call blood levels the ‘lupus A_1C.’ ”

She added that HCQ blood levels have utility for nonadherence, prediction of retinopathy, and prevention of thrombosis. Such tests “are now much more widely available, including by some large national laboratories such as Quest Diagnostics, as well as by Exagen. No more excuses.” LabCorp plans to start offering HCQ blood level testing by the middle of 2020, she said.

In their manuscript, the study authors acknowledged certain limitations of their analysis, including the fact that there were only four studies that measured HCQ levels and nonadherence or SLEDAI. “Second, most of the studies that examined the correlation between reported adherence and HCQ blood levels were performed in Europe, and there was only one small U.S. study,” they wrote. “Therefore, generalizability for our findings could be limited because of differences in cultural beliefs, social issues, and insurance/medical coverage in populations from diverse countries.”

The study authors reported having no disclosures. Dr. Petri disclosed that she has conducted research on HCQ that was funded by the National Institutes of Health. She has also conducted research for Exagen.

dbrunk@mdedge.com

SOURCE: Garg S et al. Arthritis Care Res. 2020 Jan 31. doi: 10.1002/acr.24155.

SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?

Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.

“A personalized approach to pain, on the other hand, considers each patient’s individual journey: their sensitivities, experiences, and failures,” he said. “It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”

Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.

“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”

The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”

Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”

He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”

Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).

Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”

A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”

In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.

Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m² or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.

The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.

According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.

He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.

Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.

dbrunk@mdedge.com

SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?

Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.

“A personalized approach to pain, on the other hand, considers each patient’s individual journey: their sensitivities, experiences, and failures,” he said. “It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”

Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.

“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”

The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”

Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”

He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”

Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).

Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”

A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”

In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.

Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m² or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.

The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.

According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.

He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.

Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.

dbrunk@mdedge.com

SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?

Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.

“A personalized approach to pain, on the other hand, considers each patient’s individual journey: their sensitivities, experiences, and failures,” he said. “It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”

Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.

“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”

The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”

Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”

He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”

Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).

Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”

A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”

In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.

Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m² or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.

The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.

According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.

He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.

Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.

dbrunk@mdedge.com

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

In October 2012, Pamela Wible, MD, attended a memorial service in her town for a physician who had died by suicide. Sitting in the third row, she began to count all the colleagues she had lost to suicide, and the result shocked her: 3 in her small town alone, 10 if she expanded her scope to all the doctors she’d ever known.

And so she set out on a mission to document as many physician suicides as she could, in an attempt to understand why her fellow doctors were taking their lives. “I viewed this as a personal quest,” she said in an interview. “I wanted to find out why my friends were dying.” Over the course of 7 years, she documented more than 1,300 physician suicides in the United States with the help of individuals who have lost colleagues and loved ones. She maintains a suicide prevention hotline for medical students and doctors.

On her website, Dr. Wible calls high physician suicide rates a “public health crisis.” She states many conclusions from the stories she’s collected, among them that anesthesiologists are at highest risk for suicide among physicians.

The claim that doctors have a high suicide rate is a common one beyond Dr. Wible’s documentation project. Frequently cited papers contend that 300 physicians commit suicide per year, and that physicians’ suicide rate is higher than the general population. Researchers presenting at the American Psychiatric Association meeting in 2018 said physicians have the highest suicide rate of any profession – double that of the general population, with one completed suicide every day – and Medscape’s coverage of the talk has been widely referenced as supporting evidence.

A closer look at the data behind these claims, however, reveals the difficulty of establishing reliable statistics. Dr. Wible acknowledges that her data are limited. “We do not have accurate numbers. These [statistics] have come to me organically,” she said. Incorrectly coded death certificates are one reason it’s hard to get solid information. “When we’re trying to figure out how many doctors do die by suicide, it’s very hard to know.”

Similar claims have been made at various times about dentists, construction workers, and farmers, perhaps in an effort to call attention to difficult working conditions and inadequate mental health care. Overall, the claims about physician suicide are “widely quoted as fact without any clear evidence,” said Katherine J. Gold, MD, MSW, MS, an associate professor at the University of Michigan, Ann Arbor, who researches physician wellness, mental health, and suicide. It’s critical to know the accurate numbers, she said, “so we can know if we’re making progress.”

Scrutinizing a statistic

The idea for the research presented at the APA meeting in 2018 came up a year earlier “when there were quite a number of physician deaths by suicide,” lead author Omotola T’Sarumi, MD, psychiatrist and chief resident at Columbia University’s Harlem Hospital in New York at the time of the presentation, said in an interview. The poster describes the methodology as a systematic review of research articles published in the last 10 years. Dr. T’Sarumi and colleagues concluded that the rate was 28-40 suicides per 100,000 doctors, compared with a rate of 12.3 per 100,000 for the general population. “That just stunned me,” she said. “We should be doing better.” A peer-reviewed article on the work has not been published.

The references on the poster show limited data to support the headline conclusion that physicians have the highest suicide rate of any profession: four papers and a book chapter. The poster itself does not describe the methodology used to arrive at the numbers stated, and Dr. T’Sarumi said that she was unable to gain access to her previous research since moving to a new institution. Dr. Gold, the first author on one of the papers the poster cites, said there are “huge issues” with the work. “In my paper that they’re citing, I was not looking at rates of suicide,” she said. “This is just picking a couple of studies and highlighting them.”

Dr. Gold’s paper uses data from the Centers for Disease Control and Prevention’s National Violent Death Reporting System (NVDRS) to identify differences in risk factors and suicide methods between physicians and others who died by suicide in 17 states. The researchers did not attempt to quantify a difference in overall rates, but found that physicians who end their own lives are more likely to have a known mental health disorder with lower rates of medication treatment than nonphysicians. “Inadequate treatment and increased problems related to job stress may be potentially modifiable risk factors to reduce suicidal death among physicians,” the authors conclude.

The second study referenced in the 2018 poster, “A History of Physician Suicide in America” by Rupinder Legha, MD, offers a narrative history of physician suicide, including a reference to an 1897 editorial in the Philadelphia Medical and Surgical Reporter that says: “Our profession is more prone to suicide than any other.” The study does not, however, attempt to quantify that risk.

The third study referenced does offer a quantitative analysis based on death and census data in 26 states, and concludes that the suicide rate for white female physicians was about two times higher than the general population. For white male physicians and dentists, however, the study found that the overall rate of suicide was lower than in the general population, but higher in male physicians and dentists older than 55 years.

In search of reliable data

With all of the popular but poorly substantiated claims about physician suicide, Dr. Gold argues that getting accurate numbers is critical. Without them, there is no way to know if rates are increasing or decreasing over time, or if attempts to help physicians in crisis are effective.

The CDC just released its own updated analysis of NVDRS data by major occupational groups across 32 states in 2016. It shows that males and females in the construction and extraction industries had the highest suicide rates: 49.4 per 100,000 and 25.5 per 100,000 respectively. Males in the “health care practitioners and technical” occupation group had a lower than average rate, while females in the same group had a higher than average rate.

The most reliable data that exist, according to Dr. Gold, are found in the CDC’s National Occupational Mortality Surveillance catalog, though it does not contain information from all states and is missing several years of records. Based on its data, the CDC provides a proportionate mortality ratio (PMR) that indicates whether the proportion of deaths tied to a given cause for a given occupation appears high or low, compared with all other occupations. But occupation data are often missing from the CDC’s records, which could make the PMRs unreliable. “You’re talking about relatively small numbers,” said Dr. Gold. “Even if we’re talking about 400 a year, the difference in one or two or five people being physicians could make a huge difference in the rate.”

The PMR for physicians who have died by intentional self-harm suggests that they are 2.5 times as likely as other populations to die by suicide. Filtering the data by race and gender, it appears black female physicians are at highest risk, more than five times as likely to die by suicide as other populations, while white males are twice as likely. Overall, the professionals with highest suicide risk in the database are hunters and trappers, followed by podiatrists, dentists, veterans, and nuclear engineers. Physicians follow with the fifth-highest rate.

The only way to get a true sense of physician suicide rates would be to collect all of the vital records data that states report to the federal government, according to Dr. Gold. “That would require 50 separate institutional review boards, so I doubt anyone is going to go to the effort to do that study,” she said.

Even without a reliable, exact number, it’s clear there are more physician suicides than there should be, Dr. Gold said. “This is a population that really should not be having a relatively high number of suicide deaths, whether it’s highest or not.”

As Dr. Legha wrote in his “History of Physician Suicide,” cited in the 2018 APA poster: “The problem of physician suicide is not solely a matter of whether or not it takes place at a rate higher than the general public. That a professional caregiver can fall ill and not receive adequate care and support, despite being surrounded by other caregivers, begs for a thoughtful assessment to determine why it happens at all.”

If you or someone you know is in need of support, the National Suicide Prevention Lifeline’s toll-free number is 1-800-273-TALK (8255). A version of this article first appeared on Medscape.com.

In October 2012, Pamela Wible, MD, attended a memorial service in her town for a physician who had died by suicide. Sitting in the third row, she began to count all the colleagues she had lost to suicide, and the result shocked her: 3 in her small town alone, 10 if she expanded her scope to all the doctors she’d ever known.

And so she set out on a mission to document as many physician suicides as she could, in an attempt to understand why her fellow doctors were taking their lives. “I viewed this as a personal quest,” she said in an interview. “I wanted to find out why my friends were dying.” Over the course of 7 years, she documented more than 1,300 physician suicides in the United States with the help of individuals who have lost colleagues and loved ones. She maintains a suicide prevention hotline for medical students and doctors.

On her website, Dr. Wible calls high physician suicide rates a “public health crisis.” She states many conclusions from the stories she’s collected, among them that anesthesiologists are at highest risk for suicide among physicians.

The claim that doctors have a high suicide rate is a common one beyond Dr. Wible’s documentation project. Frequently cited papers contend that 300 physicians commit suicide per year, and that physicians’ suicide rate is higher than the general population. Researchers presenting at the American Psychiatric Association meeting in 2018 said physicians have the highest suicide rate of any profession – double that of the general population, with one completed suicide every day – and Medscape’s coverage of the talk has been widely referenced as supporting evidence.

A closer look at the data behind these claims, however, reveals the difficulty of establishing reliable statistics. Dr. Wible acknowledges that her data are limited. “We do not have accurate numbers. These [statistics] have come to me organically,” she said. Incorrectly coded death certificates are one reason it’s hard to get solid information. “When we’re trying to figure out how many doctors do die by suicide, it’s very hard to know.”

Similar claims have been made at various times about dentists, construction workers, and farmers, perhaps in an effort to call attention to difficult working conditions and inadequate mental health care. Overall, the claims about physician suicide are “widely quoted as fact without any clear evidence,” said Katherine J. Gold, MD, MSW, MS, an associate professor at the University of Michigan, Ann Arbor, who researches physician wellness, mental health, and suicide. It’s critical to know the accurate numbers, she said, “so we can know if we’re making progress.”

Scrutinizing a statistic

The idea for the research presented at the APA meeting in 2018 came up a year earlier “when there were quite a number of physician deaths by suicide,” lead author Omotola T’Sarumi, MD, psychiatrist and chief resident at Columbia University’s Harlem Hospital in New York at the time of the presentation, said in an interview. The poster describes the methodology as a systematic review of research articles published in the last 10 years. Dr. T’Sarumi and colleagues concluded that the rate was 28-40 suicides per 100,000 doctors, compared with a rate of 12.3 per 100,000 for the general population. “That just stunned me,” she said. “We should be doing better.” A peer-reviewed article on the work has not been published.

The references on the poster show limited data to support the headline conclusion that physicians have the highest suicide rate of any profession: four papers and a book chapter. The poster itself does not describe the methodology used to arrive at the numbers stated, and Dr. T’Sarumi said that she was unable to gain access to her previous research since moving to a new institution. Dr. Gold, the first author on one of the papers the poster cites, said there are “huge issues” with the work. “In my paper that they’re citing, I was not looking at rates of suicide,” she said. “This is just picking a couple of studies and highlighting them.”

Dr. Gold’s paper uses data from the Centers for Disease Control and Prevention’s National Violent Death Reporting System (NVDRS) to identify differences in risk factors and suicide methods between physicians and others who died by suicide in 17 states. The researchers did not attempt to quantify a difference in overall rates, but found that physicians who end their own lives are more likely to have a known mental health disorder with lower rates of medication treatment than nonphysicians. “Inadequate treatment and increased problems related to job stress may be potentially modifiable risk factors to reduce suicidal death among physicians,” the authors conclude.

The second study referenced in the 2018 poster, “A History of Physician Suicide in America” by Rupinder Legha, MD, offers a narrative history of physician suicide, including a reference to an 1897 editorial in the Philadelphia Medical and Surgical Reporter that says: “Our profession is more prone to suicide than any other.” The study does not, however, attempt to quantify that risk.

The third study referenced does offer a quantitative analysis based on death and census data in 26 states, and concludes that the suicide rate for white female physicians was about two times higher than the general population. For white male physicians and dentists, however, the study found that the overall rate of suicide was lower than in the general population, but higher in male physicians and dentists older than 55 years.

In search of reliable data

With all of the popular but poorly substantiated claims about physician suicide, Dr. Gold argues that getting accurate numbers is critical. Without them, there is no way to know if rates are increasing or decreasing over time, or if attempts to help physicians in crisis are effective.

The CDC just released its own updated analysis of NVDRS data by major occupational groups across 32 states in 2016. It shows that males and females in the construction and extraction industries had the highest suicide rates: 49.4 per 100,000 and 25.5 per 100,000 respectively. Males in the “health care practitioners and technical” occupation group had a lower than average rate, while females in the same group had a higher than average rate.

The most reliable data that exist, according to Dr. Gold, are found in the CDC’s National Occupational Mortality Surveillance catalog, though it does not contain information from all states and is missing several years of records. Based on its data, the CDC provides a proportionate mortality ratio (PMR) that indicates whether the proportion of deaths tied to a given cause for a given occupation appears high or low, compared with all other occupations. But occupation data are often missing from the CDC’s records, which could make the PMRs unreliable. “You’re talking about relatively small numbers,” said Dr. Gold. “Even if we’re talking about 400 a year, the difference in one or two or five people being physicians could make a huge difference in the rate.”

The PMR for physicians who have died by intentional self-harm suggests that they are 2.5 times as likely as other populations to die by suicide. Filtering the data by race and gender, it appears black female physicians are at highest risk, more than five times as likely to die by suicide as other populations, while white males are twice as likely. Overall, the professionals with highest suicide risk in the database are hunters and trappers, followed by podiatrists, dentists, veterans, and nuclear engineers. Physicians follow with the fifth-highest rate.

The only way to get a true sense of physician suicide rates would be to collect all of the vital records data that states report to the federal government, according to Dr. Gold. “That would require 50 separate institutional review boards, so I doubt anyone is going to go to the effort to do that study,” she said.

Even without a reliable, exact number, it’s clear there are more physician suicides than there should be, Dr. Gold said. “This is a population that really should not be having a relatively high number of suicide deaths, whether it’s highest or not.”

As Dr. Legha wrote in his “History of Physician Suicide,” cited in the 2018 APA poster: “The problem of physician suicide is not solely a matter of whether or not it takes place at a rate higher than the general public. That a professional caregiver can fall ill and not receive adequate care and support, despite being surrounded by other caregivers, begs for a thoughtful assessment to determine why it happens at all.”

If you or someone you know is in need of support, the National Suicide Prevention Lifeline’s toll-free number is 1-800-273-TALK (8255). A version of this article first appeared on Medscape.com.

In October 2012, Pamela Wible, MD, attended a memorial service in her town for a physician who had died by suicide. Sitting in the third row, she began to count all the colleagues she had lost to suicide, and the result shocked her: 3 in her small town alone, 10 if she expanded her scope to all the doctors she’d ever known.

And so she set out on a mission to document as many physician suicides as she could, in an attempt to understand why her fellow doctors were taking their lives. “I viewed this as a personal quest,” she said in an interview. “I wanted to find out why my friends were dying.” Over the course of 7 years, she documented more than 1,300 physician suicides in the United States with the help of individuals who have lost colleagues and loved ones. She maintains a suicide prevention hotline for medical students and doctors.

On her website, Dr. Wible calls high physician suicide rates a “public health crisis.” She states many conclusions from the stories she’s collected, among them that anesthesiologists are at highest risk for suicide among physicians.

The claim that doctors have a high suicide rate is a common one beyond Dr. Wible’s documentation project. Frequently cited papers contend that 300 physicians commit suicide per year, and that physicians’ suicide rate is higher than the general population. Researchers presenting at the American Psychiatric Association meeting in 2018 said physicians have the highest suicide rate of any profession – double that of the general population, with one completed suicide every day – and Medscape’s coverage of the talk has been widely referenced as supporting evidence.

A closer look at the data behind these claims, however, reveals the difficulty of establishing reliable statistics. Dr. Wible acknowledges that her data are limited. “We do not have accurate numbers. These [statistics] have come to me organically,” she said. Incorrectly coded death certificates are one reason it’s hard to get solid information. “When we’re trying to figure out how many doctors do die by suicide, it’s very hard to know.”

Similar claims have been made at various times about dentists, construction workers, and farmers, perhaps in an effort to call attention to difficult working conditions and inadequate mental health care. Overall, the claims about physician suicide are “widely quoted as fact without any clear evidence,” said Katherine J. Gold, MD, MSW, MS, an associate professor at the University of Michigan, Ann Arbor, who researches physician wellness, mental health, and suicide. It’s critical to know the accurate numbers, she said, “so we can know if we’re making progress.”

Scrutinizing a statistic

The idea for the research presented at the APA meeting in 2018 came up a year earlier “when there were quite a number of physician deaths by suicide,” lead author Omotola T’Sarumi, MD, psychiatrist and chief resident at Columbia University’s Harlem Hospital in New York at the time of the presentation, said in an interview. The poster describes the methodology as a systematic review of research articles published in the last 10 years. Dr. T’Sarumi and colleagues concluded that the rate was 28-40 suicides per 100,000 doctors, compared with a rate of 12.3 per 100,000 for the general population. “That just stunned me,” she said. “We should be doing better.” A peer-reviewed article on the work has not been published.

The references on the poster show limited data to support the headline conclusion that physicians have the highest suicide rate of any profession: four papers and a book chapter. The poster itself does not describe the methodology used to arrive at the numbers stated, and Dr. T’Sarumi said that she was unable to gain access to her previous research since moving to a new institution. Dr. Gold, the first author on one of the papers the poster cites, said there are “huge issues” with the work. “In my paper that they’re citing, I was not looking at rates of suicide,” she said. “This is just picking a couple of studies and highlighting them.”

Dr. Gold’s paper uses data from the Centers for Disease Control and Prevention’s National Violent Death Reporting System (NVDRS) to identify differences in risk factors and suicide methods between physicians and others who died by suicide in 17 states. The researchers did not attempt to quantify a difference in overall rates, but found that physicians who end their own lives are more likely to have a known mental health disorder with lower rates of medication treatment than nonphysicians. “Inadequate treatment and increased problems related to job stress may be potentially modifiable risk factors to reduce suicidal death among physicians,” the authors conclude.

The second study referenced in the 2018 poster, “A History of Physician Suicide in America” by Rupinder Legha, MD, offers a narrative history of physician suicide, including a reference to an 1897 editorial in the Philadelphia Medical and Surgical Reporter that says: “Our profession is more prone to suicide than any other.” The study does not, however, attempt to quantify that risk.

The third study referenced does offer a quantitative analysis based on death and census data in 26 states, and concludes that the suicide rate for white female physicians was about two times higher than the general population. For white male physicians and dentists, however, the study found that the overall rate of suicide was lower than in the general population, but higher in male physicians and dentists older than 55 years.

In search of reliable data

With all of the popular but poorly substantiated claims about physician suicide, Dr. Gold argues that getting accurate numbers is critical. Without them, there is no way to know if rates are increasing or decreasing over time, or if attempts to help physicians in crisis are effective.

The CDC just released its own updated analysis of NVDRS data by major occupational groups across 32 states in 2016. It shows that males and females in the construction and extraction industries had the highest suicide rates: 49.4 per 100,000 and 25.5 per 100,000 respectively. Males in the “health care practitioners and technical” occupation group had a lower than average rate, while females in the same group had a higher than average rate.

The most reliable data that exist, according to Dr. Gold, are found in the CDC’s National Occupational Mortality Surveillance catalog, though it does not contain information from all states and is missing several years of records. Based on its data, the CDC provides a proportionate mortality ratio (PMR) that indicates whether the proportion of deaths tied to a given cause for a given occupation appears high or low, compared with all other occupations. But occupation data are often missing from the CDC’s records, which could make the PMRs unreliable. “You’re talking about relatively small numbers,” said Dr. Gold. “Even if we’re talking about 400 a year, the difference in one or two or five people being physicians could make a huge difference in the rate.”

The PMR for physicians who have died by intentional self-harm suggests that they are 2.5 times as likely as other populations to die by suicide. Filtering the data by race and gender, it appears black female physicians are at highest risk, more than five times as likely to die by suicide as other populations, while white males are twice as likely. Overall, the professionals with highest suicide risk in the database are hunters and trappers, followed by podiatrists, dentists, veterans, and nuclear engineers. Physicians follow with the fifth-highest rate.

The only way to get a true sense of physician suicide rates would be to collect all of the vital records data that states report to the federal government, according to Dr. Gold. “That would require 50 separate institutional review boards, so I doubt anyone is going to go to the effort to do that study,” she said.

Even without a reliable, exact number, it’s clear there are more physician suicides than there should be, Dr. Gold said. “This is a population that really should not be having a relatively high number of suicide deaths, whether it’s highest or not.”

As Dr. Legha wrote in his “History of Physician Suicide,” cited in the 2018 APA poster: “The problem of physician suicide is not solely a matter of whether or not it takes place at a rate higher than the general public. That a professional caregiver can fall ill and not receive adequate care and support, despite being surrounded by other caregivers, begs for a thoughtful assessment to determine why it happens at all.”

If you or someone you know is in need of support, the National Suicide Prevention Lifeline’s toll-free number is 1-800-273-TALK (8255). A version of this article first appeared on Medscape.com.

The time has come for good men and women to unite and rise up against a common foe. For too long nurses and doctors have labored under the tyranny of a dictator who claimed to help them provide high-quality care for their patients while at the same time cutting their paperwork to nil. But like most autocrats he failed to engage his subjects in a meaningful dialogue as each new version of his promised improvements rolled off the drawing board. When the caregivers were slow to adopt these new nonsystems he offered them financial incentives and issued threats to their survival. Although they were warned that there might be uncomfortable adjustment periods, the caregivers were promised that the steep learning curves would level out and their professional lives would again be valued and productive.

Of course, the dictator is not a single person but a motley and disorganized conglomerate of user- and patient-unfriendly electronic health record nonsystems. Ask almost any nurse or physician for her feelings about computer-based medical record systems, and you will hear tales of long hours, disengagement, and frustration. Caregivers are unhappy at all levels, and patients have grown tired of their nurses and physicians spending most of their time looking at computer screens.

You certainly have heard this all before. But you are hearing it in hospital hallways and grocery store checkout lines as a low rumble of discontent emerging from separate individuals, not as a well-articulated and widely distributed voice of physicians as a group. To some extent this relative silence is because there is no such group, at least not in same mold as a labor union. The term “labor union” may make you uncomfortable. But given the current climate in medicine, unionizing may be the best and only way to effect change.

But organizing to effect change in the workplace isn’t part of the physician genome. In the 1960s, a group of house officers in Boston engaged in a heal-in to successfully improve their salaries and working conditions. But over the ensuing half century physicians have remained tragically silent in the face of a changing workplace landscape in which they have gone from being independent owner operators in control of their destinies to becoming employees feeling powerless to improve their working conditions. This perceived impotence has escalated in the face of the challenge posed by the introduction of dysfunctional EHRs.

Ironically, a solution is at almost every physician’s elbow. In a recent New York Times opinion piece Theresa Brown and Stephen Bergman acknowledge that physicians don’t seem prepared to mount a meaningful response to the challenge to the failed promise of EHRs (“Doctors, Nurses and the Paperwork Crisis That Could Unite Them,” Dec. 31, 2019). They point out that, over the last half century, physicians have remained isolated on the sidelines, finding just enough voice to grumble. Nurses have in a variety of situations organized to effect change in their working conditions – in some cases by forming labor unions.

The authors of this op-ed piece, a physician and a nurse, make a strong argument that the time has come for nurses and doctors shake off the shackles of their stereotypic roles and join in creating a loud, forceful, and effective voice to demand a working environment in which the computer functions as an asset and no longer as the terrible burden it has become. Neither group has the power to do it alone, but together they may be able to turn the tide. For physicians it will probably mean venturing several steps outside of their comfort zone. But working shoulder to shoulder with nurses may provide the courage to speak out.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

The time has come for good men and women to unite and rise up against a common foe. For too long nurses and doctors have labored under the tyranny of a dictator who claimed to help them provide high-quality care for their patients while at the same time cutting their paperwork to nil. But like most autocrats he failed to engage his subjects in a meaningful dialogue as each new version of his promised improvements rolled off the drawing board. When the caregivers were slow to adopt these new nonsystems he offered them financial incentives and issued threats to their survival. Although they were warned that there might be uncomfortable adjustment periods, the caregivers were promised that the steep learning curves would level out and their professional lives would again be valued and productive.

Of course, the dictator is not a single person but a motley and disorganized conglomerate of user- and patient-unfriendly electronic health record nonsystems. Ask almost any nurse or physician for her feelings about computer-based medical record systems, and you will hear tales of long hours, disengagement, and frustration. Caregivers are unhappy at all levels, and patients have grown tired of their nurses and physicians spending most of their time looking at computer screens.

You certainly have heard this all before. But you are hearing it in hospital hallways and grocery store checkout lines as a low rumble of discontent emerging from separate individuals, not as a well-articulated and widely distributed voice of physicians as a group. To some extent this relative silence is because there is no such group, at least not in same mold as a labor union. The term “labor union” may make you uncomfortable. But given the current climate in medicine, unionizing may be the best and only way to effect change.

But organizing to effect change in the workplace isn’t part of the physician genome. In the 1960s, a group of house officers in Boston engaged in a heal-in to successfully improve their salaries and working conditions. But over the ensuing half century physicians have remained tragically silent in the face of a changing workplace landscape in which they have gone from being independent owner operators in control of their destinies to becoming employees feeling powerless to improve their working conditions. This perceived impotence has escalated in the face of the challenge posed by the introduction of dysfunctional EHRs.

Ironically, a solution is at almost every physician’s elbow. In a recent New York Times opinion piece Theresa Brown and Stephen Bergman acknowledge that physicians don’t seem prepared to mount a meaningful response to the challenge to the failed promise of EHRs (“Doctors, Nurses and the Paperwork Crisis That Could Unite Them,” Dec. 31, 2019). They point out that, over the last half century, physicians have remained isolated on the sidelines, finding just enough voice to grumble. Nurses have in a variety of situations organized to effect change in their working conditions – in some cases by forming labor unions.

The authors of this op-ed piece, a physician and a nurse, make a strong argument that the time has come for nurses and doctors shake off the shackles of their stereotypic roles and join in creating a loud, forceful, and effective voice to demand a working environment in which the computer functions as an asset and no longer as the terrible burden it has become. Neither group has the power to do it alone, but together they may be able to turn the tide. For physicians it will probably mean venturing several steps outside of their comfort zone. But working shoulder to shoulder with nurses may provide the courage to speak out.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

The time has come for good men and women to unite and rise up against a common foe. For too long nurses and doctors have labored under the tyranny of a dictator who claimed to help them provide high-quality care for their patients while at the same time cutting their paperwork to nil. But like most autocrats he failed to engage his subjects in a meaningful dialogue as each new version of his promised improvements rolled off the drawing board. When the caregivers were slow to adopt these new nonsystems he offered them financial incentives and issued threats to their survival. Although they were warned that there might be uncomfortable adjustment periods, the caregivers were promised that the steep learning curves would level out and their professional lives would again be valued and productive.

Of course, the dictator is not a single person but a motley and disorganized conglomerate of user- and patient-unfriendly electronic health record nonsystems. Ask almost any nurse or physician for her feelings about computer-based medical record systems, and you will hear tales of long hours, disengagement, and frustration. Caregivers are unhappy at all levels, and patients have grown tired of their nurses and physicians spending most of their time looking at computer screens.

You certainly have heard this all before. But you are hearing it in hospital hallways and grocery store checkout lines as a low rumble of discontent emerging from separate individuals, not as a well-articulated and widely distributed voice of physicians as a group. To some extent this relative silence is because there is no such group, at least not in same mold as a labor union. The term “labor union” may make you uncomfortable. But given the current climate in medicine, unionizing may be the best and only way to effect change.

But organizing to effect change in the workplace isn’t part of the physician genome. In the 1960s, a group of house officers in Boston engaged in a heal-in to successfully improve their salaries and working conditions. But over the ensuing half century physicians have remained tragically silent in the face of a changing workplace landscape in which they have gone from being independent owner operators in control of their destinies to becoming employees feeling powerless to improve their working conditions. This perceived impotence has escalated in the face of the challenge posed by the introduction of dysfunctional EHRs.

Ironically, a solution is at almost every physician’s elbow. In a recent New York Times opinion piece Theresa Brown and Stephen Bergman acknowledge that physicians don’t seem prepared to mount a meaningful response to the challenge to the failed promise of EHRs (“Doctors, Nurses and the Paperwork Crisis That Could Unite Them,” Dec. 31, 2019). They point out that, over the last half century, physicians have remained isolated on the sidelines, finding just enough voice to grumble. Nurses have in a variety of situations organized to effect change in their working conditions – in some cases by forming labor unions.

The authors of this op-ed piece, a physician and a nurse, make a strong argument that the time has come for nurses and doctors shake off the shackles of their stereotypic roles and join in creating a loud, forceful, and effective voice to demand a working environment in which the computer functions as an asset and no longer as the terrible burden it has become. Neither group has the power to do it alone, but together they may be able to turn the tide. For physicians it will probably mean venturing several steps outside of their comfort zone. But working shoulder to shoulder with nurses may provide the courage to speak out.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

SNOWMASS, COLO. – Physical activity is potent medicine, and it doesn’t take all that much of it to derive the maximum cardiovascular benefit: namely, the equivalent of a brisk hour-long walk 5 days/week or jogging at a 10-minute-per-mile pace for half an hour twice weekly, Robert A. Vogel, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

“I’m not telling you to run marathons. A message for your patients is, ‘You don’t have to do a lot, but you have to do something,’ ” said Dr. Vogel, a cardiologist at the University of Colorado at Denver, Aurora, with a longstanding interest in preventive cardiology.

He presented selected highlights from the massive evidence base underlying the recommendations put forth in the current comprehensive U.S. Department of Health & Human Services Physical Activity Guidelines for Americans.

One particularly compelling chunk of evidence comes from a Taiwanese government–funded prospective cohort study of more than 416,000 individuals followed for an average of 8 years. A key finding: 15 minutes of moderate-intensity physical activity daily was associated with a 14% reduction in the relative risk of all-cause mortality and a 19% reduction in death caused by cardiovascular disease, compared with that of inactive individuals. Moreover, each additional 15 minutes of daily moderate exercise further reduced mortality by 4%. These benefits extended across the full age spectrum of both sexes and applied to patients with cardiovascular disease (Lancet. 2011 Oct 1;378[9798]:1244-53).

“That’s a very impressive result for modest physical activity,” the cardiologist commented.

Data on more than 50,000 adult participants in the Aerobics Center Longitudinal Study based at the Cooper Clinic in Dallas show that vigorous exercise in the form of running at 6 mph for half an hour twice weekly, or a total of 10 metabolic equivalent of task hours (MET-HR) per week, was associated with a roughly 40% reduction in cardiovascular disease mortality. Importantly, 20, 40, or 50 MET-HR/week of vigorous exercise conferred no further survival benefit (J Am Coll Cardiol. 2014 Aug 5;64[5]:472-81). The same group showed that the sweet spot for moderate physical activity in terms of reduced cardiovascular mortality was brisk walking for an hour daily 5 days/week, for a total of 20 MET-HR, which was also associated with roughly a 40% risk reduction compared to inactivity. At that point the benefit plateaued, with no further mortality reduction noted with additional MET-HR of moderate exercise.

“For more than that, we have no evidence of additional cardiovascular benefit. It’s not going to get you to the Tokyo Olympics, but that’s what we need to be doing,” Dr. Vogel observed.

In another report from the Aerobics Center Longitudinal Study, investigators found that moderate-level cardiorespiratory fitness as defined by METs was associated with a 44% reduction in the risk of sudden cardiac death in men and women after adjustment for potential confounders, while high-level cardiorespiratory fitness was associated with a closely similar 48% reduction in risk. This applied to individuals who were hypertensive, overweight, and/or had poor health status, as well as to others (Mayo Clin Proc. 2016 Jul;91[7]:849-57).


 

All activity counts

Exercise physiologists speak of NEPA – nonexercise physical activity – such as taking out the garbage. Swedish investigators followed more than 4,200 individuals for an average of 12.5 years and found that high NEPA activity was independently associated with a 30% reduction in all-cause mortality and a 27% lower risk of a first cardiovascular disease event, compared with low NEPA. High NEPA in regular exercisers was associated with a lower rate of metabolic syndrome than in low-NEPA regular exercisers (Br J Sports Med. 2014 Feb;48[3]:233-8).

Don’t just sit there – stand!

The current federal physical activity guidelines place a new emphasis on the detrimental effects of sitting. A report on more than 221,000 participants in the Australian 45 and Up Study, with close to 1 million person-years of follow-up, demonstrated a linear inverse relationship between standing time per day and all-cause mortality. In a multivariate analysis adjusted for potential confounders, individuals who stood for 2-5 hours per day had a 10% lower risk of all-cause mortality than did those who stood for less than 2 hours. Standing for 5-8 hours was associated with a 15% relative risk reduction. And standing for more than 8 hours daily was linked to a 24% reduction in risk (Prev Med. 2014 Dec;69:187-91).

And it’s not just total daily sitting time that’s a risk factor. Prolonged, uninterrupted sedentary time was also associated with a dose-dependent increase in all-cause mortality in a prospective cohort study of nearly 8,000 U.S. adults (Ann Intern Med. 2017 Oct 3;167[7]:465-75).

“If you can’t walk around, talk to your patients standing up. That activity of getting out of your chair is lifesaving,” the cardiologist advised.
 

Get strong

Muscle-strengthening activity on at least 2 days/week is recommended in the federal guidelines because it’s independently associated with decreased all-cause mortality, even in individuals getting sufficient aerobic exercise, as shown in a large national study with 15-years’ follow-up (Prev Med. 2016 Jun;87:121-127).

“As we get older, we tend to forget about muscle. I work with the National Football League. These folks are pretty strong, but we never see diabetes in these very big players, who are often well over 300 lb. They’ve got a lot of muscle. If you want to prevent diabetes, be strong. It’s a very important factor,” Dr. Vogel said.
 

For the time constrained

Jogging is more time-efficient than brisk walking as a way to attain the maximum cardiovascular benefit of exercise. And the so-called “Weekend Warrior” study of nearly 64,000 U.K. adults showed that it’s okay to cram the full week’s worth of exercise into one or two sessions and be done with it. Compared with the inactive study participants, the weekend warriors had a 40% reduction in cardiovascular disease mortality, while individuals who split their physical activity up into three or more sessions per week had a nearly identical 41% relative risk reduction (JAMA Intern Med. 2017 Mar 1;177[3]:335-42).

Interval training is a standard way for athletes in training to improve their endurance by alternating short, intense exercise with brief recovery periods. It’s also a time saver: In one classic bicycling study, physically active men were randomized to standardized 2-week programs of sprint interval training or high-volume endurance training on the bike. The training time required to pass a rigorous cycling time trial test was 90% lower in the interval training group (J Physiol. 2006 Sep 15;575(Pt 3):901-11).

The same principle is applicable to the nonathlete interested in physical activity for heart health.

“When I run a couple of miles, I walk for 5 minutes, then maybe run for three-quarters of a mile, then walk again, then run. In interval training you get your heart rate up, and you drop it down. It’s a very good form of exercise. As a vascular biologist I know that if you put endothelial cells in a Petri dish and spin them real fast continuously, you will not get as good an improvement in endothelial function as if you spin the dish, stop it, spin it, stop it,” Dr. Vogel said.
 

High-volume exercise is safe, even with high coronary calcium

A clinically significant coronary artery calcification score of 100 Agatston units or more is no reason not to exercise. A Cooper Clinic report on nearly 22,000 middle-aged men without baseline cardiovascular disease who were followed for a mean of 10.4 years concluded that those in the highest-volume exercise group, many of whom were marathon runners and engaged in the equivalent of running for at least 5-6 hours/week at a pace of 10 minutes per mile, were 11% more likely to have an elevated baseline coronary artery calcification score than those who exercised less. But these highest-volume exercisers with elevated coronary calcium – their mean level was 807 Agatston units – had risks of all-cause and cardiovascular mortality that weren’t significantly different from those of men with elevated coronary calcium who exercised more moderately (JAMA Cardiol. 2019 Feb 1;4[2]:174-81).

Cardiac rehab

Dr. Vogel had harsh words for his physician colleagues with respect to the widespread underprescribing of cardiac rehabilitation programs.

“You guys are doing a crappy job with exercise in our most vulnerable patients: those who’ve had cardiovascular events,” he charged. “Cardiac rehabilitation is a Class I recommendation in our guidelines. And yet utilization in the United States is just 10%-20%. No other Class I recommendation is in that ballpark.”

A meta-analysis of 34 randomized trials totaling more than 6,000 post-MI patients concluded that those randomized to exercise-based cardiac rehabilitation had a 47% reduction in the risk of reinfarction, 36% lower cardiac mortality, and a 26% reduction in all-cause mortality (Am Heart J. 2011 Oct;162[4]:571-584.e2).

“The data show that cardiac rehabilitation is as effective as anything else we do in cardiovascular medicine. I understand that patients live far away, they don’t like to exercise – I’ve heard every excuse. But I am charging you with the responsibility of meeting a Class I recommendation that gets patients to live longer,” he declared.

Medicare now covers an enhanced, 72-session program called Intensive Cardiac Rehabilitation that teaches comprehensive lifestyle change and provides reasonable reimbursement. “It’s a good thing for our patients,” Dr. Vogel commented.
 

Yoga

For patients who are reluctant to pound the pavement, yoga may provide an alternative form of physical activity with tangible cardiovascular benefits. Dr. Vogel pointed to the Yoga-CaRe trial presented at the 2018 scientific sessions of the American Heart Association. Yoga-CaRe randomized 3,959 post-MI patients at 29 centers in India to a program of 13 supervised in-hospital yoga classes followed by yoga at home, or to a control group with three educational sessions. The rate of major adverse cardiovascular events over 42 months of follow-up was cut in half, compared with controls, in the 27% of participants who attended at least 10 of the 13 yoga classes. Their quality of life scores were higher, too.

Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center. He is on the speaker’s bureau for Sanofi and Regeneron.

bjancin@mdedge.com

SNOWMASS, COLO. – Physical activity is potent medicine, and it doesn’t take all that much of it to derive the maximum cardiovascular benefit: namely, the equivalent of a brisk hour-long walk 5 days/week or jogging at a 10-minute-per-mile pace for half an hour twice weekly, Robert A. Vogel, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

“I’m not telling you to run marathons. A message for your patients is, ‘You don’t have to do a lot, but you have to do something,’ ” said Dr. Vogel, a cardiologist at the University of Colorado at Denver, Aurora, with a longstanding interest in preventive cardiology.

He presented selected highlights from the massive evidence base underlying the recommendations put forth in the current comprehensive U.S. Department of Health & Human Services Physical Activity Guidelines for Americans.

One particularly compelling chunk of evidence comes from a Taiwanese government–funded prospective cohort study of more than 416,000 individuals followed for an average of 8 years. A key finding: 15 minutes of moderate-intensity physical activity daily was associated with a 14% reduction in the relative risk of all-cause mortality and a 19% reduction in death caused by cardiovascular disease, compared with that of inactive individuals. Moreover, each additional 15 minutes of daily moderate exercise further reduced mortality by 4%. These benefits extended across the full age spectrum of both sexes and applied to patients with cardiovascular disease (Lancet. 2011 Oct 1;378[9798]:1244-53).

“That’s a very impressive result for modest physical activity,” the cardiologist commented.

Data on more than 50,000 adult participants in the Aerobics Center Longitudinal Study based at the Cooper Clinic in Dallas show that vigorous exercise in the form of running at 6 mph for half an hour twice weekly, or a total of 10 metabolic equivalent of task hours (MET-HR) per week, was associated with a roughly 40% reduction in cardiovascular disease mortality. Importantly, 20, 40, or 50 MET-HR/week of vigorous exercise conferred no further survival benefit (J Am Coll Cardiol. 2014 Aug 5;64[5]:472-81). The same group showed that the sweet spot for moderate physical activity in terms of reduced cardiovascular mortality was brisk walking for an hour daily 5 days/week, for a total of 20 MET-HR, which was also associated with roughly a 40% risk reduction compared to inactivity. At that point the benefit plateaued, with no further mortality reduction noted with additional MET-HR of moderate exercise.

“For more than that, we have no evidence of additional cardiovascular benefit. It’s not going to get you to the Tokyo Olympics, but that’s what we need to be doing,” Dr. Vogel observed.

In another report from the Aerobics Center Longitudinal Study, investigators found that moderate-level cardiorespiratory fitness as defined by METs was associated with a 44% reduction in the risk of sudden cardiac death in men and women after adjustment for potential confounders, while high-level cardiorespiratory fitness was associated with a closely similar 48% reduction in risk. This applied to individuals who were hypertensive, overweight, and/or had poor health status, as well as to others (Mayo Clin Proc. 2016 Jul;91[7]:849-57).


 

All activity counts

Exercise physiologists speak of NEPA – nonexercise physical activity – such as taking out the garbage. Swedish investigators followed more than 4,200 individuals for an average of 12.5 years and found that high NEPA activity was independently associated with a 30% reduction in all-cause mortality and a 27% lower risk of a first cardiovascular disease event, compared with low NEPA. High NEPA in regular exercisers was associated with a lower rate of metabolic syndrome than in low-NEPA regular exercisers (Br J Sports Med. 2014 Feb;48[3]:233-8).

Don’t just sit there – stand!

The current federal physical activity guidelines place a new emphasis on the detrimental effects of sitting. A report on more than 221,000 participants in the Australian 45 and Up Study, with close to 1 million person-years of follow-up, demonstrated a linear inverse relationship between standing time per day and all-cause mortality. In a multivariate analysis adjusted for potential confounders, individuals who stood for 2-5 hours per day had a 10% lower risk of all-cause mortality than did those who stood for less than 2 hours. Standing for 5-8 hours was associated with a 15% relative risk reduction. And standing for more than 8 hours daily was linked to a 24% reduction in risk (Prev Med. 2014 Dec;69:187-91).

And it’s not just total daily sitting time that’s a risk factor. Prolonged, uninterrupted sedentary time was also associated with a dose-dependent increase in all-cause mortality in a prospective cohort study of nearly 8,000 U.S. adults (Ann Intern Med. 2017 Oct 3;167[7]:465-75).

“If you can’t walk around, talk to your patients standing up. That activity of getting out of your chair is lifesaving,” the cardiologist advised.
 

Get strong

Muscle-strengthening activity on at least 2 days/week is recommended in the federal guidelines because it’s independently associated with decreased all-cause mortality, even in individuals getting sufficient aerobic exercise, as shown in a large national study with 15-years’ follow-up (Prev Med. 2016 Jun;87:121-127).

“As we get older, we tend to forget about muscle. I work with the National Football League. These folks are pretty strong, but we never see diabetes in these very big players, who are often well over 300 lb. They’ve got a lot of muscle. If you want to prevent diabetes, be strong. It’s a very important factor,” Dr. Vogel said.
 

For the time constrained

Jogging is more time-efficient than brisk walking as a way to attain the maximum cardiovascular benefit of exercise. And the so-called “Weekend Warrior” study of nearly 64,000 U.K. adults showed that it’s okay to cram the full week’s worth of exercise into one or two sessions and be done with it. Compared with the inactive study participants, the weekend warriors had a 40% reduction in cardiovascular disease mortality, while individuals who split their physical activity up into three or more sessions per week had a nearly identical 41% relative risk reduction (JAMA Intern Med. 2017 Mar 1;177[3]:335-42).

Interval training is a standard way for athletes in training to improve their endurance by alternating short, intense exercise with brief recovery periods. It’s also a time saver: In one classic bicycling study, physically active men were randomized to standardized 2-week programs of sprint interval training or high-volume endurance training on the bike. The training time required to pass a rigorous cycling time trial test was 90% lower in the interval training group (J Physiol. 2006 Sep 15;575(Pt 3):901-11).

The same principle is applicable to the nonathlete interested in physical activity for heart health.

“When I run a couple of miles, I walk for 5 minutes, then maybe run for three-quarters of a mile, then walk again, then run. In interval training you get your heart rate up, and you drop it down. It’s a very good form of exercise. As a vascular biologist I know that if you put endothelial cells in a Petri dish and spin them real fast continuously, you will not get as good an improvement in endothelial function as if you spin the dish, stop it, spin it, stop it,” Dr. Vogel said.
 

High-volume exercise is safe, even with high coronary calcium

A clinically significant coronary artery calcification score of 100 Agatston units or more is no reason not to exercise. A Cooper Clinic report on nearly 22,000 middle-aged men without baseline cardiovascular disease who were followed for a mean of 10.4 years concluded that those in the highest-volume exercise group, many of whom were marathon runners and engaged in the equivalent of running for at least 5-6 hours/week at a pace of 10 minutes per mile, were 11% more likely to have an elevated baseline coronary artery calcification score than those who exercised less. But these highest-volume exercisers with elevated coronary calcium – their mean level was 807 Agatston units – had risks of all-cause and cardiovascular mortality that weren’t significantly different from those of men with elevated coronary calcium who exercised more moderately (JAMA Cardiol. 2019 Feb 1;4[2]:174-81).

Cardiac rehab

Dr. Vogel had harsh words for his physician colleagues with respect to the widespread underprescribing of cardiac rehabilitation programs.

“You guys are doing a crappy job with exercise in our most vulnerable patients: those who’ve had cardiovascular events,” he charged. “Cardiac rehabilitation is a Class I recommendation in our guidelines. And yet utilization in the United States is just 10%-20%. No other Class I recommendation is in that ballpark.”

A meta-analysis of 34 randomized trials totaling more than 6,000 post-MI patients concluded that those randomized to exercise-based cardiac rehabilitation had a 47% reduction in the risk of reinfarction, 36% lower cardiac mortality, and a 26% reduction in all-cause mortality (Am Heart J. 2011 Oct;162[4]:571-584.e2).

“The data show that cardiac rehabilitation is as effective as anything else we do in cardiovascular medicine. I understand that patients live far away, they don’t like to exercise – I’ve heard every excuse. But I am charging you with the responsibility of meeting a Class I recommendation that gets patients to live longer,” he declared.

Medicare now covers an enhanced, 72-session program called Intensive Cardiac Rehabilitation that teaches comprehensive lifestyle change and provides reasonable reimbursement. “It’s a good thing for our patients,” Dr. Vogel commented.
 

Yoga

For patients who are reluctant to pound the pavement, yoga may provide an alternative form of physical activity with tangible cardiovascular benefits. Dr. Vogel pointed to the Yoga-CaRe trial presented at the 2018 scientific sessions of the American Heart Association. Yoga-CaRe randomized 3,959 post-MI patients at 29 centers in India to a program of 13 supervised in-hospital yoga classes followed by yoga at home, or to a control group with three educational sessions. The rate of major adverse cardiovascular events over 42 months of follow-up was cut in half, compared with controls, in the 27% of participants who attended at least 10 of the 13 yoga classes. Their quality of life scores were higher, too.

Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center. He is on the speaker’s bureau for Sanofi and Regeneron.

bjancin@mdedge.com

SNOWMASS, COLO. – Physical activity is potent medicine, and it doesn’t take all that much of it to derive the maximum cardiovascular benefit: namely, the equivalent of a brisk hour-long walk 5 days/week or jogging at a 10-minute-per-mile pace for half an hour twice weekly, Robert A. Vogel, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

“I’m not telling you to run marathons. A message for your patients is, ‘You don’t have to do a lot, but you have to do something,’ ” said Dr. Vogel, a cardiologist at the University of Colorado at Denver, Aurora, with a longstanding interest in preventive cardiology.

He presented selected highlights from the massive evidence base underlying the recommendations put forth in the current comprehensive U.S. Department of Health & Human Services Physical Activity Guidelines for Americans.

One particularly compelling chunk of evidence comes from a Taiwanese government–funded prospective cohort study of more than 416,000 individuals followed for an average of 8 years. A key finding: 15 minutes of moderate-intensity physical activity daily was associated with a 14% reduction in the relative risk of all-cause mortality and a 19% reduction in death caused by cardiovascular disease, compared with that of inactive individuals. Moreover, each additional 15 minutes of daily moderate exercise further reduced mortality by 4%. These benefits extended across the full age spectrum of both sexes and applied to patients with cardiovascular disease (Lancet. 2011 Oct 1;378[9798]:1244-53).

“That’s a very impressive result for modest physical activity,” the cardiologist commented.

Data on more than 50,000 adult participants in the Aerobics Center Longitudinal Study based at the Cooper Clinic in Dallas show that vigorous exercise in the form of running at 6 mph for half an hour twice weekly, or a total of 10 metabolic equivalent of task hours (MET-HR) per week, was associated with a roughly 40% reduction in cardiovascular disease mortality. Importantly, 20, 40, or 50 MET-HR/week of vigorous exercise conferred no further survival benefit (J Am Coll Cardiol. 2014 Aug 5;64[5]:472-81). The same group showed that the sweet spot for moderate physical activity in terms of reduced cardiovascular mortality was brisk walking for an hour daily 5 days/week, for a total of 20 MET-HR, which was also associated with roughly a 40% risk reduction compared to inactivity. At that point the benefit plateaued, with no further mortality reduction noted with additional MET-HR of moderate exercise.

“For more than that, we have no evidence of additional cardiovascular benefit. It’s not going to get you to the Tokyo Olympics, but that’s what we need to be doing,” Dr. Vogel observed.

In another report from the Aerobics Center Longitudinal Study, investigators found that moderate-level cardiorespiratory fitness as defined by METs was associated with a 44% reduction in the risk of sudden cardiac death in men and women after adjustment for potential confounders, while high-level cardiorespiratory fitness was associated with a closely similar 48% reduction in risk. This applied to individuals who were hypertensive, overweight, and/or had poor health status, as well as to others (Mayo Clin Proc. 2016 Jul;91[7]:849-57).


 

All activity counts

Exercise physiologists speak of NEPA – nonexercise physical activity – such as taking out the garbage. Swedish investigators followed more than 4,200 individuals for an average of 12.5 years and found that high NEPA activity was independently associated with a 30% reduction in all-cause mortality and a 27% lower risk of a first cardiovascular disease event, compared with low NEPA. High NEPA in regular exercisers was associated with a lower rate of metabolic syndrome than in low-NEPA regular exercisers (Br J Sports Med. 2014 Feb;48[3]:233-8).

Don’t just sit there – stand!

The current federal physical activity guidelines place a new emphasis on the detrimental effects of sitting. A report on more than 221,000 participants in the Australian 45 and Up Study, with close to 1 million person-years of follow-up, demonstrated a linear inverse relationship between standing time per day and all-cause mortality. In a multivariate analysis adjusted for potential confounders, individuals who stood for 2-5 hours per day had a 10% lower risk of all-cause mortality than did those who stood for less than 2 hours. Standing for 5-8 hours was associated with a 15% relative risk reduction. And standing for more than 8 hours daily was linked to a 24% reduction in risk (Prev Med. 2014 Dec;69:187-91).

And it’s not just total daily sitting time that’s a risk factor. Prolonged, uninterrupted sedentary time was also associated with a dose-dependent increase in all-cause mortality in a prospective cohort study of nearly 8,000 U.S. adults (Ann Intern Med. 2017 Oct 3;167[7]:465-75).

“If you can’t walk around, talk to your patients standing up. That activity of getting out of your chair is lifesaving,” the cardiologist advised.
 

Get strong

Muscle-strengthening activity on at least 2 days/week is recommended in the federal guidelines because it’s independently associated with decreased all-cause mortality, even in individuals getting sufficient aerobic exercise, as shown in a large national study with 15-years’ follow-up (Prev Med. 2016 Jun;87:121-127).

“As we get older, we tend to forget about muscle. I work with the National Football League. These folks are pretty strong, but we never see diabetes in these very big players, who are often well over 300 lb. They’ve got a lot of muscle. If you want to prevent diabetes, be strong. It’s a very important factor,” Dr. Vogel said.
 

For the time constrained

Jogging is more time-efficient than brisk walking as a way to attain the maximum cardiovascular benefit of exercise. And the so-called “Weekend Warrior” study of nearly 64,000 U.K. adults showed that it’s okay to cram the full week’s worth of exercise into one or two sessions and be done with it. Compared with the inactive study participants, the weekend warriors had a 40% reduction in cardiovascular disease mortality, while individuals who split their physical activity up into three or more sessions per week had a nearly identical 41% relative risk reduction (JAMA Intern Med. 2017 Mar 1;177[3]:335-42).

Interval training is a standard way for athletes in training to improve their endurance by alternating short, intense exercise with brief recovery periods. It’s also a time saver: In one classic bicycling study, physically active men were randomized to standardized 2-week programs of sprint interval training or high-volume endurance training on the bike. The training time required to pass a rigorous cycling time trial test was 90% lower in the interval training group (J Physiol. 2006 Sep 15;575(Pt 3):901-11).

The same principle is applicable to the nonathlete interested in physical activity for heart health.

“When I run a couple of miles, I walk for 5 minutes, then maybe run for three-quarters of a mile, then walk again, then run. In interval training you get your heart rate up, and you drop it down. It’s a very good form of exercise. As a vascular biologist I know that if you put endothelial cells in a Petri dish and spin them real fast continuously, you will not get as good an improvement in endothelial function as if you spin the dish, stop it, spin it, stop it,” Dr. Vogel said.
 

High-volume exercise is safe, even with high coronary calcium

A clinically significant coronary artery calcification score of 100 Agatston units or more is no reason not to exercise. A Cooper Clinic report on nearly 22,000 middle-aged men without baseline cardiovascular disease who were followed for a mean of 10.4 years concluded that those in the highest-volume exercise group, many of whom were marathon runners and engaged in the equivalent of running for at least 5-6 hours/week at a pace of 10 minutes per mile, were 11% more likely to have an elevated baseline coronary artery calcification score than those who exercised less. But these highest-volume exercisers with elevated coronary calcium – their mean level was 807 Agatston units – had risks of all-cause and cardiovascular mortality that weren’t significantly different from those of men with elevated coronary calcium who exercised more moderately (JAMA Cardiol. 2019 Feb 1;4[2]:174-81).

Cardiac rehab

Dr. Vogel had harsh words for his physician colleagues with respect to the widespread underprescribing of cardiac rehabilitation programs.

“You guys are doing a crappy job with exercise in our most vulnerable patients: those who’ve had cardiovascular events,” he charged. “Cardiac rehabilitation is a Class I recommendation in our guidelines. And yet utilization in the United States is just 10%-20%. No other Class I recommendation is in that ballpark.”

A meta-analysis of 34 randomized trials totaling more than 6,000 post-MI patients concluded that those randomized to exercise-based cardiac rehabilitation had a 47% reduction in the risk of reinfarction, 36% lower cardiac mortality, and a 26% reduction in all-cause mortality (Am Heart J. 2011 Oct;162[4]:571-584.e2).

“The data show that cardiac rehabilitation is as effective as anything else we do in cardiovascular medicine. I understand that patients live far away, they don’t like to exercise – I’ve heard every excuse. But I am charging you with the responsibility of meeting a Class I recommendation that gets patients to live longer,” he declared.

Medicare now covers an enhanced, 72-session program called Intensive Cardiac Rehabilitation that teaches comprehensive lifestyle change and provides reasonable reimbursement. “It’s a good thing for our patients,” Dr. Vogel commented.
 

Yoga

For patients who are reluctant to pound the pavement, yoga may provide an alternative form of physical activity with tangible cardiovascular benefits. Dr. Vogel pointed to the Yoga-CaRe trial presented at the 2018 scientific sessions of the American Heart Association. Yoga-CaRe randomized 3,959 post-MI patients at 29 centers in India to a program of 13 supervised in-hospital yoga classes followed by yoga at home, or to a control group with three educational sessions. The rate of major adverse cardiovascular events over 42 months of follow-up was cut in half, compared with controls, in the 27% of participants who attended at least 10 of the 13 yoga classes. Their quality of life scores were higher, too.

Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center. He is on the speaker’s bureau for Sanofi and Regeneron.

bjancin@mdedge.com

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

When people learn they have enough cardiovascular disease risk to start treatment with a statin or antihypertensive drug, the impact on their healthy-lifestyle choices seems to often be a wash, based on findings from more than 40,000 Finland residents followed for at least 4 years after starting their primary-prevention regimen.

American Heart Association

“Patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” wrote Maarit J. Korhonen, PhD, and associates in a report published in the Journal of the American Heart Association.

“Initiation of antihypertensive or statin therapy appears to be associated with lifestyle changes, some positive and others negative,” wrote Dr. Korhonen, a pharmacoepidemiologist at the University of Turku (Finland), and associates. This was the first reported study to assess a large-scale and prospectively followed cohort to look for associations between the use of medicines that prevent cardiovascular disease (CVD) and lifestyle changes. Most previous studies of these associations “have been cross sectional and provide no information on potential lifestyle changes during the time window around the initiation of medication use,” they added.

The new study specifically found that, on average, people who began treatment with at least one CVD-prevention medication for the first time were more likely to gain weight and more likely to become less active during the years following their treatment onset. But at the same time, these patients were also more likely to either quit or cut down on their smoking and alcohol consumption, the researchers found.

Their analysis used data from 41,225 people enrolled in the Finnish Public Sector Study, which prospectively began collecting data on a large number of Finland residents in the 1990s. They specifically focused on 81,772 completed questionnaires – collected at 4-year intervals – from people who completed at least two consecutive rounds of the survey during 2000-2013, and who were also at least 40 years old and free of prevalent CVD at the time of their first survey. The participants averaged nearly 53 years of age at their first survey, and 84% were women.

The researchers subdivided the survey responses into 8,837 (11%) people who began a statin, antihypertensive drug, or both during their participation; 26,914 (33%) already on a statin or antihypertensive drug when they completed their first questionnaire; and 46,021 response sets (56%) from people who never began treatment with either drug class. People who initiated a relevant drug began a median of 1.7 years following completion of their first survey, and a median of 2.4 years before their next survey. During follow-up, about 2% of all participants became newly diagnosed with some form of CVD.

The results showed that, after full adjustment for possible confounders, the mean increase in body mass index was larger among those who initiated a CVD-prevention drug, compared with those who did not. Among participants who were obese at entry, those who started a CVD drug had a statistically significant 37% increased rate of remaining obese, compared with those not starting these drugs. Among those who were not obese at baseline, those who began a CVD prevention drug had a statistically significant 82%% higher rate of becoming obese, compared with those not on a CVD-prevention drug. In addition, average daily energy expenditure, a measure of physical activity, showed a statistically significant decline among those who started a CVD drug, compared with those who did not. In contrast, CVD drug initiators had an average 1.85 gram/week decline in alcohol intake, compared with noninitiators, and those who were current smokers at the first survey and then started a CVD drug had a 26% relative drop in their smoking prevalence, compared with those who did not start a CVD drug, both statistically significant differences.

The findings suggest that “patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” the authors concluded. “This means that expansion of pharmacologic interventions toward populations at low CVD risk may not necessarily lead to expected benefits at the population level.”

The study received no commercial funding. Dr. Korhonen had no disclosures.

mzoler@mdedge.com

SOURCE: Korhonen MJ et al. J Am Heart Assoc. 2020 Feb 5. doi: 10.1161/JAHA.119.014.168.

When people learn they have enough cardiovascular disease risk to start treatment with a statin or antihypertensive drug, the impact on their healthy-lifestyle choices seems to often be a wash, based on findings from more than 40,000 Finland residents followed for at least 4 years after starting their primary-prevention regimen.

American Heart Association

“Patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” wrote Maarit J. Korhonen, PhD, and associates in a report published in the Journal of the American Heart Association.

“Initiation of antihypertensive or statin therapy appears to be associated with lifestyle changes, some positive and others negative,” wrote Dr. Korhonen, a pharmacoepidemiologist at the University of Turku (Finland), and associates. This was the first reported study to assess a large-scale and prospectively followed cohort to look for associations between the use of medicines that prevent cardiovascular disease (CVD) and lifestyle changes. Most previous studies of these associations “have been cross sectional and provide no information on potential lifestyle changes during the time window around the initiation of medication use,” they added.

The new study specifically found that, on average, people who began treatment with at least one CVD-prevention medication for the first time were more likely to gain weight and more likely to become less active during the years following their treatment onset. But at the same time, these patients were also more likely to either quit or cut down on their smoking and alcohol consumption, the researchers found.

Their analysis used data from 41,225 people enrolled in the Finnish Public Sector Study, which prospectively began collecting data on a large number of Finland residents in the 1990s. They specifically focused on 81,772 completed questionnaires – collected at 4-year intervals – from people who completed at least two consecutive rounds of the survey during 2000-2013, and who were also at least 40 years old and free of prevalent CVD at the time of their first survey. The participants averaged nearly 53 years of age at their first survey, and 84% were women.

The researchers subdivided the survey responses into 8,837 (11%) people who began a statin, antihypertensive drug, or both during their participation; 26,914 (33%) already on a statin or antihypertensive drug when they completed their first questionnaire; and 46,021 response sets (56%) from people who never began treatment with either drug class. People who initiated a relevant drug began a median of 1.7 years following completion of their first survey, and a median of 2.4 years before their next survey. During follow-up, about 2% of all participants became newly diagnosed with some form of CVD.

The results showed that, after full adjustment for possible confounders, the mean increase in body mass index was larger among those who initiated a CVD-prevention drug, compared with those who did not. Among participants who were obese at entry, those who started a CVD drug had a statistically significant 37% increased rate of remaining obese, compared with those not starting these drugs. Among those who were not obese at baseline, those who began a CVD prevention drug had a statistically significant 82%% higher rate of becoming obese, compared with those not on a CVD-prevention drug. In addition, average daily energy expenditure, a measure of physical activity, showed a statistically significant decline among those who started a CVD drug, compared with those who did not. In contrast, CVD drug initiators had an average 1.85 gram/week decline in alcohol intake, compared with noninitiators, and those who were current smokers at the first survey and then started a CVD drug had a 26% relative drop in their smoking prevalence, compared with those who did not start a CVD drug, both statistically significant differences.

The findings suggest that “patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” the authors concluded. “This means that expansion of pharmacologic interventions toward populations at low CVD risk may not necessarily lead to expected benefits at the population level.”

The study received no commercial funding. Dr. Korhonen had no disclosures.

mzoler@mdedge.com

SOURCE: Korhonen MJ et al. J Am Heart Assoc. 2020 Feb 5. doi: 10.1161/JAHA.119.014.168.

When people learn they have enough cardiovascular disease risk to start treatment with a statin or antihypertensive drug, the impact on their healthy-lifestyle choices seems to often be a wash, based on findings from more than 40,000 Finland residents followed for at least 4 years after starting their primary-prevention regimen.

American Heart Association

“Patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” wrote Maarit J. Korhonen, PhD, and associates in a report published in the Journal of the American Heart Association.

“Initiation of antihypertensive or statin therapy appears to be associated with lifestyle changes, some positive and others negative,” wrote Dr. Korhonen, a pharmacoepidemiologist at the University of Turku (Finland), and associates. This was the first reported study to assess a large-scale and prospectively followed cohort to look for associations between the use of medicines that prevent cardiovascular disease (CVD) and lifestyle changes. Most previous studies of these associations “have been cross sectional and provide no information on potential lifestyle changes during the time window around the initiation of medication use,” they added.

The new study specifically found that, on average, people who began treatment with at least one CVD-prevention medication for the first time were more likely to gain weight and more likely to become less active during the years following their treatment onset. But at the same time, these patients were also more likely to either quit or cut down on their smoking and alcohol consumption, the researchers found.

Their analysis used data from 41,225 people enrolled in the Finnish Public Sector Study, which prospectively began collecting data on a large number of Finland residents in the 1990s. They specifically focused on 81,772 completed questionnaires – collected at 4-year intervals – from people who completed at least two consecutive rounds of the survey during 2000-2013, and who were also at least 40 years old and free of prevalent CVD at the time of their first survey. The participants averaged nearly 53 years of age at their first survey, and 84% were women.

The researchers subdivided the survey responses into 8,837 (11%) people who began a statin, antihypertensive drug, or both during their participation; 26,914 (33%) already on a statin or antihypertensive drug when they completed their first questionnaire; and 46,021 response sets (56%) from people who never began treatment with either drug class. People who initiated a relevant drug began a median of 1.7 years following completion of their first survey, and a median of 2.4 years before their next survey. During follow-up, about 2% of all participants became newly diagnosed with some form of CVD.

The results showed that, after full adjustment for possible confounders, the mean increase in body mass index was larger among those who initiated a CVD-prevention drug, compared with those who did not. Among participants who were obese at entry, those who started a CVD drug had a statistically significant 37% increased rate of remaining obese, compared with those not starting these drugs. Among those who were not obese at baseline, those who began a CVD prevention drug had a statistically significant 82%% higher rate of becoming obese, compared with those not on a CVD-prevention drug. In addition, average daily energy expenditure, a measure of physical activity, showed a statistically significant decline among those who started a CVD drug, compared with those who did not. In contrast, CVD drug initiators had an average 1.85 gram/week decline in alcohol intake, compared with noninitiators, and those who were current smokers at the first survey and then started a CVD drug had a 26% relative drop in their smoking prevalence, compared with those who did not start a CVD drug, both statistically significant differences.

The findings suggest that “patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” the authors concluded. “This means that expansion of pharmacologic interventions toward populations at low CVD risk may not necessarily lead to expected benefits at the population level.”

The study received no commercial funding. Dr. Korhonen had no disclosures.

mzoler@mdedge.com

SOURCE: Korhonen MJ et al. J Am Heart Assoc. 2020 Feb 5. doi: 10.1161/JAHA.119.014.168.