A special episode focuses on the issue of insulin accessibility and affordability in the United States, with four experts in the diabetes arena weighing in on the topic.

Crisis Point: Insulin Access in the United States

Connor Iapoce is an associate editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

 in the United States received 5.5 million industry payments totaling $1.1 billion from 2014 to 2019, extending prior research into how payment practices have changed since the introduction of the Open Payments Program (OPP).

The investigative team led by Vinay Kini, MD, Weill Cornell Medicine, cited an overall decline in the total value of payments, but noted the highly prevalent nature of industry payments to cardiologists, with approximately 70% of US cardiologists accepting payments for each year of study.

“We observed significant declines in the total value of payments and payment per cardiologist, but no changes in the number of cardiologists accepting payments or the total number of payments made,” investigators wrote.

Collaborations between industry and physicians often propel scientific discoveries, but indiscriminate financial relationships can lead to both bias and overutilization and patient care. The OPP was established to increase transparency on this matter, publishing data on industry-physician financial interactions.

 Using the OPP, Kini and colleagues examined contemporary trends in the proportion and characteristics of cardiologists receiving general industry payments.

Together, the investigative team performed a retrospective, population-based cohort study of cardiologists practicing in the United States from 2014 to 2019. Text-matching of physician’s full names and zip codes were used to link the OPP database that contains physicians on industry payments with the National Plan and Provider Enumeration System database that contains physician’s National Provider Identified and specialty practice.

Investigators obtained data on general industry payments between January 2014 – December 2019, excluding 2020 due to the COVID-19 pandemic. Overall, the study reported the total value and number of payments made to cardiologists, the number of cardiologists receiving payments, and the average and median aggregate value of payments per cardiologist. Values were adjusted to the weighted average of the 2019 Consumer Price index.

The investigative team calculated the annual percent change in payments over the study period and used linear regression to assess for changes in payments over time. Moreover, the Gini Index was calculated to assess payment dispersion among cardiologists. The Gini Index ranges from 0 to 1, with an index of 0 suggesting that every person in the group received an equal number of payments and an index of 1 indicating that only 1 person received all the payments.

According to the analysis, between 2014 and 2019, cardiologists in the US received 5.5 million payments totaling over $1 billion. From 2014 - 2019, investigators found the total value of payments made to cardiologists and payment per cardiologist declined significantly. The annual percent change was –4.9% (95% confidence interval [CI], –5.8% to –4.0%; 

 <.001) and –5.2% (95% CI, –6.9% to –3.2%; 

 = .002), respectively. Investigators noted no significant change in the number of cardiologists receiving payments or the number of payments made to cardiologists.

For the $1.1 billion total payments made between 2014 - 2019, speaker fees ($444.5 million, 40.8%), consulting fees ($207,7 million, 19.0%), and food and beverage ($143.2 million, 13.1%) were the largest payment groups. Speaker fees declined significantly (

 = .008) over the study period, but investigators found no significant change in consulting or food/beverage fees. Data showed the mean Gini index was 0.88 (95% CI, 0.87 - 0.89).

Investigators attributed the decline in speaker fees to an environment of increased transparency and greater scrutiny from the public and peers. 

The analysis also revealed most cardiologists (n = 28,896, 76.0%) received smaller payments of <$10,000 per year, accounting for $61.4 million (5.6% of total payments). However, a small percentage of cardiologists (n = 110, 0.3%) were indicated to have received large payments of >$1 million per year, accounting for $268.3 million (24.6% of total payments).

Kini and colleagues suggested taking further steps to address financial conflicts of interest may ultimately prove beneficial in promoting public trust in cardiology.

“In conclusion, our study suggests that although there have been some changes in industry payments to cardiologists since the inception of OPP, further targeted measures that address financial conflicts of interest may be useful in continuing to promote integrity and public trust in cardiology practice,” investigators wrote.

Zhang R, Purkayastha S, Ying X, et al. Trends in Industry Payments to Cardiologists From 2014 to 2019 [published online ahead of print, 2023 Mar 17]. 

. 2023;e009820. doi:10.1161/CIRCOUTCOMES.122.009820

Articles

Industry payments to cardiologists remained highly prevalent in each year of study, but the research showed significant declines in the total value of payments and payment per cardiologist. 

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Industry Payments to Cardiologists Totaled Over $1 Billion From 2014 to 2019

Results from an investigation on the prognostic value of Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) revealed an imaging feature that was common among patients with cardiac sarcoidosis.

The presence of left and right ventricular late gadolinium enhancement (LGE) on cardiac MRI scans, along with elevated fluorodeoxyglucose (FDG) uptake on PET scans, were both strong indicators of increased risk for major adverse cardiac events (MACE) in patients with cardiac sarcoidosis.

The fact that both imaging biomarkers were predictive of MACE highlights the importance of both inflammation and fibrosis in the progression of cardiac sarcoidosis, Matthew Aitken, Department of Medical Imaging, Toronto General Hospital, University Health Network, University of Toronto, and investigators emphasized in the article.

Diagnosis of cardiac sarcoidosis can be challenging, as there are no specific symptoms or diagnostic tests, according to the study. Late gadolinium enhancement at cardiac MRI and fluorodeoxyglucose uptake at PET have emerged as potential imaging biomarkers for cardiac sarcoidosis. 

MRI, PET as Predictors of MACE in Cardiac Sarcoidosis

Late gadolinium enhancement at MRI was found to be a stronger predictor than fluorodeoxyglucose uptake at PET. This may reflect differences in the underlying pathophysiology of the disease. Late gadolinium enhancement is expected to reflect fibrosis and scarring, whereas fluorodeoxyglucose uptake reflects inflammation. 

The meta-analysis showed the odds ratio (OR) for MACE was 8.0 (95% confidence interval [CI]: 4.3 to 15.0) for late gadolinium enhancement and 2.1 (95% CI: 1.4 to 3.2) for fluorodeoxyglucose uptake. However, LGE was a stronger predictor of MACE than fluorodeoxyglucose uptake. 

When the team compared MRI and PET directly, late gadolinium enhancement remained a significant predictor of MACE (OR, 10.4 [95% CI: 3.5 to 30.5]; P < .001), whereas fluorodeoxyglucose uptake was not (OR, 1.9 [95% CI: 0.82 to 4.4]; P = .13).

Investigators performed a systematic review of the literature to identify studies that evaluated the prognostic value of cardiac MRI or FDG PET in adults with cardiac sarcoidosis. The search included 6 databases from inception until January 2022 with the team identifying 37 studies that met their inclusion criteria, comprising a total of 3489 patients with a mean follow-up of 3.1 years.

The primary outcome of major adverse cardiac events was assessed as a composite including death, ventricular arrhythmia, and heart failure hospitalization.

There were few studies directly comparing MRI and PET in the same patients, which limited the ability to draw firm conclusions about the relative prognostic value of the 2 imaging modalities, investigators noted as a limitation. Additionally, they wrote that many of the included studies were at risk for bias, which could affect the reliability of the results. 

However, despite theses limitations investigators highlighted the important insight the data provided into the prognostic value of imaging biomarkers in cardiac sarcoidosis, which may help guide clinical decision-making in the management of this challenging disease.

Aitken, M., Davidson, M., Chan, M. V., Urzua Fresno, C., Vasquez, L. I., Huo, Y. R., McAllister, B. J., Broncano, J., Thavendiranathan, P., McInnes, M. D., Iwanochko, M. R., Balter, M., Moayedi, Y., Farrell, A., & Hanneman, K. (2023). Prognostic value of cardiac MRI and FDG PET in cardiac sarcoidosis: A systematic review and meta-analysis. 

Data from a meta-analysis show late gadolinium enhancement (LGE) on cardiac MRI scans and elevated fluorodeoxyglucose (FDG) uptake on PET scans are both strong predictors of major adverse cardiac events for cardiac sarcoidosis.

Rare Disease Report®

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New Biomarkers Predict Adverse Events in Cardiac Sarcoidosis

Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

The use of sex hormones in female patients with rheumatoid arthritis (RA) was independently associated with more frequent remission, especially for women who were perimenopausal, a group less likely to achieve remission compared with premenopausal, and early postmenopausal, according to a study published in 

As previous studies reported, exogenous estrogen may improve treatment outcomes in RA, although it may not reduce the risk of developing the condition.

 Further, sex hormone replacement in postmenopausal women improved disease activity, decreased inflammation, and improved bone mineral density.

“Sex is well known to influence risk, severity, and treatment outcomes of RA, although the underlying causes are uncertain,” wrote Dala N Daraghmeh, PhD, associated with Health and Biomedical Innovation, UniSA: Clinical and Health Sciences at the University of South Australia, and a team of investigators. “The aim of this research was to examine whether factors influencing female sex hormones (reproductive status and exogenous sex hormone use) are associated with the efficacy of disease-modifying antirheumatic drugs (DMARDs).”

Patients with moderate-to-severe active RA treated with tocilizumab (4 or 8 mg/kg once every 4 weeks) and/or conventional synthetic DMARDs (csDMARDs), mainly methotrexate, were pooled from 5 phase 3 clinical trials. The primary outcome was the time to first remission based on the Simplified Disease Activity Index (SDAI) criteria. Patients with an inadequate response to at least 1 DMARD were included in 4 out of the 5 studies. A Cox proportional analysis examined the relationship between menopausal status or the use of exogenous sex hormones and first remission.

Data of interest included baseline menopausal status, defined as premenopausal, perimenopausal, early postmenopausal, and postmenopausal, as well as sex, age, body mass index (BMI), race, baseline disease activity, and the number of previous DMARDs.

Of the 4474 patients, 62.9% (n=2817) were postmenopausal, 22.8% (n=1021) were premenopausal, 9.2% (n=414) were perimenopausal, and 4.5% (n=202) were early postmenopausal. Among these groups, 7.8% (n=221), 25% (n=225), 11.4% (n=47), and 6.4% (n=13), respectively, were being treated with exogenous sex hormones. Most (75%, n=3347) were treated with tocilizumab ± csDMARDs.

According to the pooled analysis, perimenopause was linked to reduced remission when compared with patients with premenopausal status (adjusted hazard ratio [HR] 0.78 [95% confidence interval (CI) 0.61, 0.99]). Reproductive status was not associated with SDAI remission, although it was significantly associated using the Clinical Disease Activity Index (CDAI) and the Disease Activity Score-28 for Rheumatoid Arthritis with ESR (DAS28-ESR).

Sex hormone use was linked to significantly higher remission (adjusted HR 1.20 [95% CI 1.01, 1.43]). An exploratory analysis of the perimenopausal subgroup indicated that patients receiving exogenous sex hormones more frequently achieved SDAI- and CDAI-defined remission (SDAI: HR 2.18 [95% CI 1.27, 3.72], 

 = 0.004; CDAI: HR 1.86 [95% CI 1.09, 3.15], 

The 5 clinical trials studied were not designed to evaluate the association between sex hormone use, reproductive status, and remission. Therefore, information regarding sex hormone use, menopausal classification criteria, and age at the initiation of menopause could not be analyzed. Further, the number of patients using exogenous sex hormones was comparatively low, particularly after categorizing patients into 4 reproductive subgroups.

However, the large number of patients included in the study allowed for high-powered analysis and adjustment for confounders. Using SDAI, CDAI, and DAS28-ESR to evaluate the consistency of results increased robustness and strengthened the analysis. Future research is necessary to better understand and confirm these findings.

Daraghmeh DN, Hopkins AM, King C, et al. Female reproductive status and exogenous sex hormone use in rheumatoid arthritis patients treated with tocilizumab and csDMARDs. 

. 2023;62(2):583-595. doi:10.1093/rheumatology/keac357

Qi S, Xin R, Guo W, Liu Y. Meta-analysis of oral contraceptives and rheumatoid arthritis risk in women. Ther Clin Risk Manag 2014;10:915–23.

An analysis of perimenopausal women with rheumatoid arthritis indicated that patients receiving exogenous sex hormones more frequently achieved SDAI- and CDAI-defined remission. 

Rheumatoid Arthritis

The HCPLive rheumatoid arthritis page is a comprehensive resource for clinical news and insights on arthritis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for RA, and more.

Sex Hormone Therapy May be Linked to Remission in Female Patients With RA

Approximately one-third of adults in the United States indicated the 

, with nearly 28 million people considering weight loss methods they had not considered before the onset of the pandemic, according to new research.

The public opinion survey conducted by the American Society for Metabolic and Bariatric Surgery revealed around 6.4 million Americans considered having weight-loss surgery or using anti-obesity prescription drugs during the pandemic. The investigative team noted the findings as particularly interesting, as only around 1% of eligible patients undergo bariatric surgery and only 1 - 3% of patients take prescription drugs for obesity each year.

“We’ve definitely seen a significant rise in interest in weight-loss surgery and other underutilized treatments since obesity was linked to worse outcomes from COVID-19,” said Shanu N. Kothari, MD, co-author of the study and past president of the ASMBS.

 “COVID-19 lit the match for many people to get healthier and protect themselves from severe disease, whether that be COVID-19, diabetes, or heart disease. Treating obesity, the source of so many of these diseases, is the best way.”

With obesity affecting around 42% of Americans, research has suggested obesity was tied to severe COVID-19 infection, characterized by increased need for mechanical ventilation and increased mortality. Among nearly 150,000 adults who received a COVID-19 diagnosis at 238 hospitals between March – December 2020, more than half (50.8%) had obesity.

Prior to the pandemic, the investigative team conducted a study that revealed 81% of Americans viewed obesity as an extremely or very serious health problem, but few knew the best methods to combat the disease. Kothari and colleagues repeated some questions posed in the original survey to explore if views on the risks of obesity and its treatment have changed after more than 2 years of the COVID-19 pandemic in America. A survey of 1,714 adults was conducted between December 10 – 28 2021 and data were collected using AmeriSpeak®, a probability-based panel designed to be representative of the US household population.

Upon analysis, the investigative team found 8 in 10 adults (82%) consider obesity the biggest health threat facing the country, even more significant than heart disease (77%), diabetes (76%), and COVID-19 (68%). Black adults considered COVID-19 a bigger health threat than obesity (87% vs. 81%) but were more worried about the dangers of obesity than the general population (45% vs. 29%). The data showed nearly 4 in 10 of all Americans view obesity as a greater risk to their health now than prior to the pandemic.

Investigators additionally suggested COVID-19 was a motivating factor for 39% of Americans who had attempted weight loss in the past year, with 20% considering weight loss-methods that they had not tried before the pandemic, including diet and exercise (65%). Nearly-two thirds of Americans reported paying closer attention to their overall health due to COVID-19. However, weight loss has remained a struggle for the majority of Americans, according to Kothari and colleagues.

The research indicates most people do not go beyond traditional diet and exercise alone or involve doctors in their attempt to lose weight and could potentially overestimate the effectiveness of some treatments. Survey data show 73% of people considered diet and exercise on their own to be the most effective method for long-term weight loss, even more effective than involving a doctor (65%) or weight-loss surgery (56%). Meanwhile, only 23% reported taking prescription medication as effective, followed by dietary supplements (18%).

Regarding safety, more Americans correctly believed someone would have a greater change of mortality from complications of obesity (47%) or COVID-19 (39%) than weight-loss surgery (19%), according to investigators. However, investigators cited a disconnect between the public and the medical community on obesity.

Survey results showed only 41% of patients reported having spoken to their doctor about their weight, with patients more likely to initiate the discussion (60% vs. 39%). Moreover, nearly 1 in 5 people (18%) said concerns surrounding COVID-19 increased the chance they would bring up the issue of their weight to their providers.

The survey revealed most Americans view it as a risk factor for other diseases rather than a disease itself and 73% of those who have tried to lose weight believe obesity is caused by a lack of willpower. Investigators noted these percentages have not changed much since the 2016 ASMBC-NORC Obesity in America Survey, despite obesity being classified as a disease caused by a combination of biological, genetic, social, and environmental factors.

“Our hope is that people turn the fear of obesity and the consideration of new weight-loss strategies into action,” said Teresa LaMasters, MD, president of the ASMBS.

 “With greater eligibility for weight-loss surgery and the emergence of effective new anti-obesity medications, Americans have more and better options than ever before, and they should take advantage of them when appropriate.”

1. Kissin, R., Khoury, L., Wallenborn, G., & Kothari, S. N. (2023). When the COVID-19 pandemic collides with the obesity epidemic in America – A national survey. 

. https://doi.org/10.1016/j.soard.2023.02.020

New survey finds covid-19 pandemic changed public's view of obesity

. EurekAlert! (2023, March 22). Retrieved March 23, 2023, from https://www.eurekalert.org/news-releases/983013

A new survey found the COVID-19 pandemic changed many Americans view of obesity and caused others to consider new weight-loss methods due to their concerns. 

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COVID-19 Amplified Obesity Concerns in the United States

Dupilumab (Dupixent) has potential to become the first biologic to treat 

chronic obstructive pulmonary disease (COPD)

 following promising results where the drug demonstrated clinically meaningful and statistically significant reduction in exacerbations when compared with placebo.

 is characterized by reduced lung function, shortness of breath, and frequent exacerbations. It’s the third leading cause of death worldwide, and new treatments for the condition have been lacking.

“COPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no novel treatments approved in more than a decade,” George Yancopoulus, MD, PhD, President, Chief Scientific Officer, Regeneron, 

. “In this landmark Phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic.”

According to the data shared by developing companies Regeneron and Sanofi, dupilumab demonstrated a clinically meaningful and statistically significant reduction of 30% in exacerbations compared with placebo, making it the first and only biologic to show such results. 

Among the study population of patients with moderate to severe COPD, those who received the intervention experienced rapid and significant improvement in lung function, with a 160 mL increase in forced expiratory volume in one second (FEV1) compared with a 77 mL increase in the placebo group.

Significant improvements in quality of life and respiratory symptoms in patients with evidence of type 2 inflammation (as indicated by blood eosinophils levels of at least 300 cells/μL) who were treated with dupilumab were also observed. COPD is the seventh disease in which dupilumab has exhibited positive pivotal results, confirming the key role of interleukin-4 (IL-4) and interleukin-13 (IL-13) in these type 2 inflammatory diseases.

“These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community’s understanding of the underlying biology of this disease,” Yancopoulus stated. “We look forward to discussing these exciting results with regulatory authorities.”

Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial. News release. Regeneron. Published March 23, 2023. Accessed March 23, 2023. 

https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-demonstrates-potential-become-first-biologic

Data also show significant improvements in quality of life and respiratory symptoms in patients with evidence of type 2 inflammation who were treated with dupilumab.

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Dupilumab Shows Potential as First Biologic for COPD Treatment

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

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Siperstein highlighted some more major takeaways from her conference presentation, including facts about how to determine which patients are good candidates for microneedling.


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Robyn D. Siperstein, MD: Radiofrequency Microneedling for Hypertrophic Scars, Hyperpigmentation

. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with 

. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

The results from the INSPIRE trial show risankizumab met all primary and secondary endpoints in treating adult patients with moderately to severely active ulcerative colitis. 

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Topline, Phase 3 Data Supports the Use of Risankizumab for Ulcerative Colitis

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

New research from the Family Heart Foundation indicates high-risk patients who fail to achieve LDL-C targets had a 49% greater rate of cardiovascular events than their counterparts who met LDL-C targets.

Dyslipidemia

Failure to Reach LDL-C Target Increases Event Risk Nearly 50% in High-Risk Individuals

In this interview, Siperstein explained some of the biggest takeaways from her conference presentation on advances in microneedling techniques, including radiofrequency specifically.


Robyn D. Siperstein, MD: Microneedling Techniques for Skin of Color

There was very little evidence of an effect growth or increased risk of psychiatric or neurological adverse events in the methylphenidate group compared with the no-methylphenidate group.

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Long-Term Methylphenidate Use Safe for Pediatric ADHD Patients

A 14-day randomized clinical trial assessing effects of caffeinated coffee consumption in a population of 100 adult patients, CRAVE offers what could be the most definitive insight yet into the effects of coffee consumption on overall health.

CRAVE Trials Offers Most Comprehensive Overview Yet of Impact of Coffee, Caffeine Intake

Statistical analysis showed no differences between each pairwise comparison of the bevacizumab biosimilars, MB02-SP and MB02-DM, and the reference drug. 

Biosimilars

Biosimilar MB02-DM Demonstrates Bioequivalence to Bevacizumab

Proposed biosimilar AVT04 shows comparable efficacy to ustekinumab.

Bioequivalence and Immunogenicity of AVT04 Compared with Ustekinumab

New phase 2b findings support the oral JAK1 inhibitor's capability to improve  repigmentation versus placebo.

Vitiligo

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Oral Povorcitinib Significantly Improves Total, Facial Vitiligo in 24 Week Trial

An analysis of NHANES from 2013 - March 2020 suggest individuals with an indication for statin therapy for primary prevention based on 10-year risk saw low overall use across risk categories and race and ethnicity strata. 



Latest News

Industry Payments to Cardiologists Totaled Over $1 Billion From 2014 to 2019

New Biomarkers Predict Adverse Events in Cardiac Sarcoidosis

Sex Hormone Therapy May be Linked to Remission in Female Patients With RA

COVID-19 Amplified Obesity Concerns in the United States

Dupilumab Shows Potential as First Biologic for COPD Treatment