Feature

When polio paralyzed a 3-year-old girl in Lilongwe, Malawi, in November 2021, public health experts in Malawi’s Ministry of Health responded quickly. The ministry partnered with the Global Polio Eradication Initiative, the World Health Organization, and the United Nations International Children’s Emergency Fund to mobilize a surge team of personnel and resources to vaccinate all 2.9 million Malawian children aged under 5 years, WHO reported in a news release.

The first of four sequential campaigns began on March 20 and expanded on March 24 to neighboring Mozambique, Tanzania, and Zambia. The multinational, multiagency effort aims to include Zimbabwean children as well and deliver over 80 million supplemental doses of bivalent oral polio vaccines to over 23 million children in these five countries by July.

Because it takes multiple polio vaccine doses to become fully immunized, the children are expected to receive four rounds of vaccine regardless of their vaccination history.

“It is important to conduct the campaigns now to boost the immunity of our children,” Annie Chauma-Mwale, MBBS, MPH, the chief medical officer of epidemiology and surveillance in Malawi’s Ministry of Health in Lilongwe, said in an interview. “Polio is not only a medical issue. Polio is also a socioeconomic issue with long-term impacts on the child, the country, and the globe.

“In Malawi, we are using our community health and health care facility structures to ensure we do not miss any eligible child,” explained Dr. Chauma-Mwale, who is also the deputy incident manager of the poliovirus outbreak response. “We aim to play our role in the global eradication of polio by protecting the vulnerable and curtailing any potential transmission as early as possible.”

Of the three variants of wild, naturally occurring poliovirus, types 2 and 3 have been eradicated, but wild poliovirus type 1 (WPV1) remains endemic in Afghanistan and Pakistan.

As reported recently by this news organization, the girl in Malawi was infected with a WPV1 strain that had been circulating for years in Pakistan’s Sindh Province.

Malawi’s most recent clinically confirmed WPV1 case was reported in 1992, and this is the first WPV1 case detected in Africa since 2016. The continent was declared free of indigenous wild polio in 2020 and is still considered free of wild poliovirus because the child’s illness was imported from elsewhere.

The 3-year-old girl developed acute flaccid paralysis in November 2021. In February 2022, virus from her stool was sequenced by the National Institute of Communicable Disease in South Africa and the U.S. Centers for Disease Control and Prevention. On Feb. 16, Malawi was notified of the case, which was genetically linked to a sequence detected in Sindh Province around 2 years earlier.
 

‘Do not ignore polio’

Within 24 hours, the Government of Malawi declared a public health emergency and activated the national Emergency Operations Centre. Within 72 hours, the GPEI rapid response team arrived in the country. The Ministry of Health partnered with GPEI, WHO, and UNICEF to mobilize the campaign and begin vaccinating children on March 20.

‘’We rely on clinicians to support the surveillance of polio through case searches, both active and passive,” Mike Nenani Chisema, MBBS, MPH, the program manager of the expanded program on immunization and the polio response operations manager in Malawi’s Ministry of Health, said in an interview.

He noted that the young girl was diagnosed correctly and millions of children are now being protected against the disease, thanks to the acumen of one hospital clinician.

“Remember, we still have polio in some countries, and every country is at risk,” he cautioned. “Don’t forget to look for the obvious and do not ignore polio, regardless of economic status.’’

According to GPEI, all countries – especially those with weak immunization and other public health programs whose residents trade or travel to and from endemic countries – are at risk for imported polio.

Anita Gupta, DO, MPP, PharmD, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at the Johns Hopkins University, Baltimore, said that she welcomes this effort.

“Given the decades of published evidence and understanding on the vaccine’s safety and efficacy, this program in Malawi is the right step to take,” Gupta, who is not involved in the campaigns, said in an interview. “Polio is preventable, and acting now will prevent spread later.”

Dr. Chauma-Mwale and Dr. Chisema are employees of Malawi’s Ministry of Health. Dr. Gupta disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

When polio paralyzed a 3-year-old girl in Lilongwe, Malawi, in November 2021, public health experts in Malawi’s Ministry of Health responded quickly. The ministry partnered with the Global Polio Eradication Initiative, the World Health Organization, and the United Nations International Children’s Emergency Fund to mobilize a surge team of personnel and resources to vaccinate all 2.9 million Malawian children aged under 5 years, WHO reported in a news release.

The first of four sequential campaigns began on March 20 and expanded on March 24 to neighboring Mozambique, Tanzania, and Zambia. The multinational, multiagency effort aims to include Zimbabwean children as well and deliver over 80 million supplemental doses of bivalent oral polio vaccines to over 23 million children in these five countries by July.

Because it takes multiple polio vaccine doses to become fully immunized, the children are expected to receive four rounds of vaccine regardless of their vaccination history.

“It is important to conduct the campaigns now to boost the immunity of our children,” Annie Chauma-Mwale, MBBS, MPH, the chief medical officer of epidemiology and surveillance in Malawi’s Ministry of Health in Lilongwe, said in an interview. “Polio is not only a medical issue. Polio is also a socioeconomic issue with long-term impacts on the child, the country, and the globe.

“In Malawi, we are using our community health and health care facility structures to ensure we do not miss any eligible child,” explained Dr. Chauma-Mwale, who is also the deputy incident manager of the poliovirus outbreak response. “We aim to play our role in the global eradication of polio by protecting the vulnerable and curtailing any potential transmission as early as possible.”

Of the three variants of wild, naturally occurring poliovirus, types 2 and 3 have been eradicated, but wild poliovirus type 1 (WPV1) remains endemic in Afghanistan and Pakistan.

As reported recently by this news organization, the girl in Malawi was infected with a WPV1 strain that had been circulating for years in Pakistan’s Sindh Province.

Malawi’s most recent clinically confirmed WPV1 case was reported in 1992, and this is the first WPV1 case detected in Africa since 2016. The continent was declared free of indigenous wild polio in 2020 and is still considered free of wild poliovirus because the child’s illness was imported from elsewhere.

The 3-year-old girl developed acute flaccid paralysis in November 2021. In February 2022, virus from her stool was sequenced by the National Institute of Communicable Disease in South Africa and the U.S. Centers for Disease Control and Prevention. On Feb. 16, Malawi was notified of the case, which was genetically linked to a sequence detected in Sindh Province around 2 years earlier.
 

‘Do not ignore polio’

Within 24 hours, the Government of Malawi declared a public health emergency and activated the national Emergency Operations Centre. Within 72 hours, the GPEI rapid response team arrived in the country. The Ministry of Health partnered with GPEI, WHO, and UNICEF to mobilize the campaign and begin vaccinating children on March 20.

‘’We rely on clinicians to support the surveillance of polio through case searches, both active and passive,” Mike Nenani Chisema, MBBS, MPH, the program manager of the expanded program on immunization and the polio response operations manager in Malawi’s Ministry of Health, said in an interview.

He noted that the young girl was diagnosed correctly and millions of children are now being protected against the disease, thanks to the acumen of one hospital clinician.

“Remember, we still have polio in some countries, and every country is at risk,” he cautioned. “Don’t forget to look for the obvious and do not ignore polio, regardless of economic status.’’

According to GPEI, all countries – especially those with weak immunization and other public health programs whose residents trade or travel to and from endemic countries – are at risk for imported polio.

Anita Gupta, DO, MPP, PharmD, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at the Johns Hopkins University, Baltimore, said that she welcomes this effort.

“Given the decades of published evidence and understanding on the vaccine’s safety and efficacy, this program in Malawi is the right step to take,” Gupta, who is not involved in the campaigns, said in an interview. “Polio is preventable, and acting now will prevent spread later.”

Dr. Chauma-Mwale and Dr. Chisema are employees of Malawi’s Ministry of Health. Dr. Gupta disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

When polio paralyzed a 3-year-old girl in Lilongwe, Malawi, in November 2021, public health experts in Malawi’s Ministry of Health responded quickly. The ministry partnered with the Global Polio Eradication Initiative, the World Health Organization, and the United Nations International Children’s Emergency Fund to mobilize a surge team of personnel and resources to vaccinate all 2.9 million Malawian children aged under 5 years, WHO reported in a news release.

The first of four sequential campaigns began on March 20 and expanded on March 24 to neighboring Mozambique, Tanzania, and Zambia. The multinational, multiagency effort aims to include Zimbabwean children as well and deliver over 80 million supplemental doses of bivalent oral polio vaccines to over 23 million children in these five countries by July.

Because it takes multiple polio vaccine doses to become fully immunized, the children are expected to receive four rounds of vaccine regardless of their vaccination history.

“It is important to conduct the campaigns now to boost the immunity of our children,” Annie Chauma-Mwale, MBBS, MPH, the chief medical officer of epidemiology and surveillance in Malawi’s Ministry of Health in Lilongwe, said in an interview. “Polio is not only a medical issue. Polio is also a socioeconomic issue with long-term impacts on the child, the country, and the globe.

“In Malawi, we are using our community health and health care facility structures to ensure we do not miss any eligible child,” explained Dr. Chauma-Mwale, who is also the deputy incident manager of the poliovirus outbreak response. “We aim to play our role in the global eradication of polio by protecting the vulnerable and curtailing any potential transmission as early as possible.”

Of the three variants of wild, naturally occurring poliovirus, types 2 and 3 have been eradicated, but wild poliovirus type 1 (WPV1) remains endemic in Afghanistan and Pakistan.

As reported recently by this news organization, the girl in Malawi was infected with a WPV1 strain that had been circulating for years in Pakistan’s Sindh Province.

Malawi’s most recent clinically confirmed WPV1 case was reported in 1992, and this is the first WPV1 case detected in Africa since 2016. The continent was declared free of indigenous wild polio in 2020 and is still considered free of wild poliovirus because the child’s illness was imported from elsewhere.

The 3-year-old girl developed acute flaccid paralysis in November 2021. In February 2022, virus from her stool was sequenced by the National Institute of Communicable Disease in South Africa and the U.S. Centers for Disease Control and Prevention. On Feb. 16, Malawi was notified of the case, which was genetically linked to a sequence detected in Sindh Province around 2 years earlier.
 

‘Do not ignore polio’

Within 24 hours, the Government of Malawi declared a public health emergency and activated the national Emergency Operations Centre. Within 72 hours, the GPEI rapid response team arrived in the country. The Ministry of Health partnered with GPEI, WHO, and UNICEF to mobilize the campaign and begin vaccinating children on March 20.

‘’We rely on clinicians to support the surveillance of polio through case searches, both active and passive,” Mike Nenani Chisema, MBBS, MPH, the program manager of the expanded program on immunization and the polio response operations manager in Malawi’s Ministry of Health, said in an interview.

He noted that the young girl was diagnosed correctly and millions of children are now being protected against the disease, thanks to the acumen of one hospital clinician.

“Remember, we still have polio in some countries, and every country is at risk,” he cautioned. “Don’t forget to look for the obvious and do not ignore polio, regardless of economic status.’’

According to GPEI, all countries – especially those with weak immunization and other public health programs whose residents trade or travel to and from endemic countries – are at risk for imported polio.

Anita Gupta, DO, MPP, PharmD, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at the Johns Hopkins University, Baltimore, said that she welcomes this effort.

“Given the decades of published evidence and understanding on the vaccine’s safety and efficacy, this program in Malawi is the right step to take,” Gupta, who is not involved in the campaigns, said in an interview. “Polio is preventable, and acting now will prevent spread later.”

Dr. Chauma-Mwale and Dr. Chisema are employees of Malawi’s Ministry of Health. Dr. Gupta disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Regardless of the pandemic’s sometimes mercurial behavior, the cardiology community appears set to reclaim valued traditions perhaps taken for granted in the pre-COVID era.

They include the bustling scientific congress and its myriad educational and networking prospects, along with pleiotropic effects like unplanned reunions with colleagues and catching up face-to-face with old friends.

That seems evident in the growing number of registrants for live attendance at at the annual scientific sessions of the American College of Cardiology, set for this Saturday through Monday in Washington as well as virtually, for a global reach that was unattainable in the pre-COVID era.

Registrations had hit the 11,000 mark and were picking up speed in recent weeks, ACC 2022 cochair Pamela B. Morris, MD, Medical University of South Carolina, Charleston, said at a mid-March presentation to the media.

They had reached about 12,880 and were still climbing a week before the conference, the ACC confirmed to this news organization. By then the professional registration had surpassed 9,900, of whom more than two-thirds reported plans to attend in person.

Dr. Morris said there had been 117 international submissions for what turned out to be 39 coveted spots on the meeting’s Late-Breaking Clinical Trial (LBCT) and Featured Clinical Research agenda spread across eight separate sessions.

On-site participants at the Walter E. Washington Convention Center should head for the Main Tent in Hall D for all LBCT presentations; venues for the Featured Clinical Research sessions are as noted below. Their real-time virtual equivalents will reside on the online platform’s Hot Topics channel. All noted session times are Eastern Daylight Time.
 

Saturday, April 2, 9:30 a.m.–10:30 a.m. Joint American College of Cardiology/Journal of the American College of Cardiology LBCT (I)

Leading off the conference’s first LBCT session, the randomized VALOR-HCM trial explored whether 16 weeks of mavacamten (MyoKardia) could help patients with severe obstructive hypertrophic cardiomyopathy (HCM) avoid septal reduction therapy, either surgical or by alcohol ablation.

The 22-center VALOR-HCM trial with an estimated enrollment of 100 follows EXPLORER-HCM, which in 2020 suggested the novel myosin-inhibiting agent could improve symptoms, exercise capacity, cardiac remodeling, and quality of life in such patients.

Simply advising people with heart failure (HF) to consume less salt is one thing, but it’s another to show them clinical trial evidence that it might help keep them out of the hospital. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure) study, conducted at 27 sites in six countries, sought to provide that evidence.

The trial randomly assigned 1,000 patients with NYHA class 2-3 HF to consume no more than 1,500 mg/day in sodium or to receive standard advice to limit sodium intake, and followed them for a year for the endpoint of death from any cause, cardiovascular (CV) hospitalization, or CV emergency department visit.

SODIUM-HF “may provide a rigorous evidence base for sodium restriction in patients with heart failure and may truly change our practice and how we recommend dietary modification,” ACC 2022 vice chair Douglas E. Drachman, MD, Massachusetts General Hospital, Boston, said at the media presentation.

In the same session, the CHAP (Chronic Hypertension and Pregnancy) study explored whether blood pressure (BP) control in pregnant women with new or untreated chronic hypertension could help avert preeclampsia, poor fetal outcomes, and other adverse events.

CHAP assigned about 2,400 women to receive either stepwise antihypertensive therapy to a BP goal of 140/90 mm Hg or lower or no such meds unless their BP reached or exceeded 160/105 mm Hg. Stepwise therapy featured either labetalol or extended-release nifedipine to start, the other agent added as necessary.

The LBCT block also includes the POISE-3 (Perioperative Ischemic Evaluation-3) comparison of the hemostatic agent tranexamic acid vs. placebo in nearly 10,000 patients undergoing noncardiac surgery. A separate randomization of the same cohort, to be reported at a Monday LBCT session, compared pre- and perioperative BP-control strategies.
 

Saturday, April 2, 12:00 p.m.–1:15 p.m. Featured Clinical Research I. Room 143A

This session features a subgroup analysis by age from the REVERSE-IT trial, which had previously showcased the monoclonal antibody bentracimab (PhaseBio Pharmaceuticals) for its ability to reverse the antiplatelet effects of ticagrelor.

REVERSE-IT is accompanied on the schedule by several secondary-endpoint presentations from trials whose primary outcomes have already been presented at meetings or in the journals.

They include the SCORED trial of sotagliflozin in patients with diabetes and chronic kidney disease (CKD); COMPLETE, which explored complete revascularization of multivessel coronary disease at primary stenting; and the FAME-3 comparison of coronary bypass surgery (CABG) vs. percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) readings.

The session is to conclude with EDIT-CMD, which was a small, randomized assessment of diltiazem for improving microvascular dysfunction in patients with chronic angina despite nonobstructive coronary disease.
 

Sunday, April 3, 8:00 a.m.–9:15 a.m. Joint American College of Cardiology/Journal of the American Medical Association LBCT (II)

The SuperWIN (Supermarket Web Intervention) study tested an innovative strategy for community-based promotion of healthy lifestyle choices: point-of-purchase dietary education for grocery shoppers with an online instructional component, and follow-up to determine whether it influenced future food choices.

“Dietary interventions are notoriously difficult for us to implement, let alone to study scientifically,” Dr. Drachman observed. “So we think that there may be opportunity for dietary interventions to be best implemented at grocery stores where people are doing their shopping for food.”

SuperWIN compared supermarket shoppers with at least one CV risk factor who participated in the education intervention to a nonintervention control group for any changes in their DASH scores. The scores reflected consistency with the venerable DASH diet based on participants’ food purchases over 3 months.

In the same session, the MITIGATE trial explored whether daily administration of icosapent ethyl (Vascepa) might cut the risk of upper respiratory infection (especially from SARS-CoV-2 or seasonal influenza virus) in persons 50 or older with a history of clinical coronary, neurovascular, or peripheral vascular disease or revascularization. The trial has an estimated enrollment of 39,600.

Accompanying SuperWIN and MITIGATE are studies of several dyslipidemia drugs, including the discontinued antisense agent vupanorsen (Pfizer), as tested in TRANSLATE-TIMI 70;  the PCSK9 inhibitor alirocumab (Praluent), explored for its effects on coronary plaque volume and composition in the PACMAN-AMI trial; and the APOLLO trial, a phase 1 evaluation of SLN360 (Silence Therapeutics), a short interfering ribonucleic acid (siRNA) that suppresses the molecular machinery in the liver that produces lipoprotein(a), or Lp(a).

The 32-patient APOLLO trial’s recently released top-line results suggested that SLN360 at varying dosages reduced Lp(a) levels by about one-half to more than 90%. Although elevated Lp(a) is known to track with CV risk, it remains to be shown whether dropping Lp(a) levels pharmacologically is protective.
 

Sunday, April 3, 9:45 a.m.–11:00 a.m. Joint American College of Cardiology/New England Journal of Medicine LBCT (III)

The meeting’s all-HF late-breaker session includes the METEORIC-HF trial, which compared the myotropic agent omecamtiv mecarbil (Cytokinetics) against placebo for effects on exercise performance over 20 weeks. The trial entered 276 patients with HF with reduced ejection fraction (HFrEF) and reduced peak VO₂.

The GALACTIC-HF trial had previously suggested that the drug improved the risk of HF-related events or CV death in more than 8000 patients with HFrEF, those with the lowest ejection fractions benefiting the most.

This block of trials also features DIAMOND, the latest trial with a gemologic name to look at the potassium sequestrant patiromer (Veltassa) for any protection against hyperkalemia, a familiar side effect of renin-angiotensin-aldosterone inhibitors. DIAMOND tested patiromer in 878 patients with HFrEF who were on beta-blockers and other HF-appropriate medications and had a history of drug-associated hyperkalemia.

Previously, the AMBER trial of patients with CKD or refractory hypertension on spironolactone had suggested the drug might be protective enough against hyperkalemia to allow higher and more consistent dosing of BP-lowering agents.

Also in the session: the randomized IVVE (Influenza Vaccine to Prevent Adverse Vascular Events) trial, with an estimated 5,000 patients with HF in Africa, Asia, and the Middle East; PROMPT-HF, with a projected 1,310 HF patients and billed as a cluster-randomized pragmatic trial of a strategy for improving guideline-directed outpatient medical therapy; and MAVA-LTE, the long-term extension study of an estimated 310 patients who were in the MAVERICK-HCM and EXPLORER-HCM mavacamten trials.
 

Sunday, April 3, 12:15–1:30 p.m. Featured Clinical Research II. Main Tent, Hall D

The arrhythmia-centric session includes PARTITA, with its estimated 590 patients with primary- or secondary-prevention implantable cardioverter-defibrillators (ICDs). The trial followed them initially for burden of untreated nonsustained ventricular tachycardia (VT) or events treated with anti-tachycardia pacing. Then it randomly assigned those who experienced a first appropriate ICD shock to either immediate VT ablation or standard care. The latter included ablation on next occurrence of arrhythmic storm.

Investigational oral factor XIa inhibitors, viewed by many as potentially safer as anticoagulants than contemporary oral inhibitors of factor Xa, are now on the scene and include milvexian (Bristol-Myers Squibb/Janssen) and, lately, asundexian (BAY 2433334; Bayer). The latter agent was compared to the factor Xa inhibitor apixaban (Eliquis) in 753 patients with AF in the phase 2 PACIFIC-AF trial, which looked at the newer drug’s safety and optimal dosing.

Also on the bill: a long-term follow-up of the mAFA-2 (Mobile AF Application 2) extension study, which explored the value of a smartphone-based atrial fibrillation (AF) screening app for improving risk of AF-related events; a presentation billed as “Residual Leaks Post Left Atrial Appendage Occlusion”; and one that declares “low rates of guideline-directed care” to be “associated with higher mortality” in patients with pacemakers or ICDs.
 

Monday, April 4, 8:30 a.m.–9:45 a.m. LBCT IV

This session is to open with the PROTECT trial, which sought to determine whether perioperative “aggressive warming” may be cardioprotective in patients with CV risk factors undergoing noncardiac surgery. Its estimated 5,100 patients were randomly assigned to a procedure that achieves normothermia, that is 37° C (98.6° F), vs. standard care in which patients’ core temperature may decline to no further than 35.5° C (95.9° F).

Next on the list are a second POISE-3 comparison of BP-control strategies comparing hypotension avoidance vs. hypertension avoidance in patients undergoing noncardiac surgery; the pivotal CLASP 2 TR trial of patients with symptomatic tricuspid regurgitation on optimal medical therapy with vs. without treatment with the Edwards PASCAL Transcatheter Repair System; and one said to provide “insights from the Corevalve US Pivotal and SURTAVI trials” on 5-year incidence, timing, and predictors of hemodynamic valve deterioration transcatheter and surgical aortic bioprostheses.”

Rounding out the block of presentations: the ADAPT-TAVR comparison of the factor Xa inhibitor edoxaban (Lixiana) to dual-antiplatelet therapy for prevention of leaflet thrombosis after successful transcatheter aortic valve replacement (TAVR). The 235-patient trial was conducted at five centers in South Korea, Hong Kong, and Taiwan.
 

Monday, April 4, 11:00–12:15 p.m. LBCT V

This session includes the FLAVOUR randomized comparison of PCI guided by either FFR or intravascular ultrasound (IVUS) in 1,700 patients with 40%-70% stenoses. The patients from centers in China and South Korea were followed for death from any cause, MI, or any repeat revascularization at 24 months.

Also scheduled: the 2-year report on 4,000 patients with ST-segment elevation MI (STEMI) in the ACC-sponsored quality improvement program GHATI (Global Heart Attack Treatment Initiative); the GIPS-4 myocardial protection study of an estimated 380 patients with STEMI assigned to receive pre- and post-PCI infusions of sodium thiosulfate or placebo, with infarct size at 4 months as the primary endpoint; and a randomized test of an arrhythmia-monitoring implant for influence on clinical outcomes in 802 patients with a history of MI but no pacemaker or ICD indication, called BIO-GUARD-MI,

Last in the session: the Chocolate Touch Study of peripheral-artery angioplasty using a drug-coated balloon (DCB) with a confectionery name that treats lesions not with theobromine, but the antiproliferative mainstay paclitaxel.

The randomized comparison of the Chocolate Touch DCB (TriReme Medical) and the more established Lutonix DCB (Bard) assigned a projected 585 patients with symptomatic peripheral vascular disease to treatment of superficial femoral or popliteal artery lesions with one of the two paclitaxel-coated balloon catheters.
 

Monday, April 4, 12:45–2 p.m. Featured Clinical Research III. Room 143A 

The final session features five subgroup analyses or other updates from trials that have already reported their primary outcomes. Among them is the SPYRAL HTN-ON MED trial, which helped to revitalize hopes for renal denervation therapy as a catheter-based treatment for drug-resistant hypertension by showing significant effects on both systolic and diastolic blood pressure. The new data follow the trial’s more than 400 patients out to 3 years.

There is also a symptom and quality-of-life analysis from the 530-patient EMPULSE trial of 530 patients with stabilized acute HF assigned in-hospital to start on empagliflozin (Jardiance) or placebo. The trial made a splash last year when it reported a significant improvement in risk for death or HF rehospitalization for its patients put on the SGLT2 inhibitor.

A secondary analysis from CANTOS is also featured; the trial had randomly assigned more than 10,000 patients with recent acute MI and elevated C-reactive protein (CRP) levels to receive or not receive the anti-inflammatory canakinumab (Ilaris). Those assigned to active therapy showed benefits for a range of outcomes, including CV mortality and stroke, but no decreases in cholesterol levels. Billing for the new CANTOS analysis promises insights on the “differential impact of residual inflammatory risk and residual cholesterol risk among atherosclerosis patients with and without chronic kidney disease.”

The session also features “trends and final results” from the NACMI (North American COVID-19 Myocardial Infarction) registry, which had shown excellent primary-PCI results without compromise of door-to-balloon times in patients with confirmed SARS-CoV-2 infection; and a FIDELITY analysis of cardiorenal endpoints by history of CV disease in the study’s more than 13,000 patients with diabetes and CKD assigned to placebo or finerenone (Kerendia), a mineralocorticoid receptor antagonist.

A version of this article first appeared on Medscape.com.

Regardless of the pandemic’s sometimes mercurial behavior, the cardiology community appears set to reclaim valued traditions perhaps taken for granted in the pre-COVID era.

They include the bustling scientific congress and its myriad educational and networking prospects, along with pleiotropic effects like unplanned reunions with colleagues and catching up face-to-face with old friends.

That seems evident in the growing number of registrants for live attendance at at the annual scientific sessions of the American College of Cardiology, set for this Saturday through Monday in Washington as well as virtually, for a global reach that was unattainable in the pre-COVID era.

Registrations had hit the 11,000 mark and were picking up speed in recent weeks, ACC 2022 cochair Pamela B. Morris, MD, Medical University of South Carolina, Charleston, said at a mid-March presentation to the media.

They had reached about 12,880 and were still climbing a week before the conference, the ACC confirmed to this news organization. By then the professional registration had surpassed 9,900, of whom more than two-thirds reported plans to attend in person.

Dr. Morris said there had been 117 international submissions for what turned out to be 39 coveted spots on the meeting’s Late-Breaking Clinical Trial (LBCT) and Featured Clinical Research agenda spread across eight separate sessions.

On-site participants at the Walter E. Washington Convention Center should head for the Main Tent in Hall D for all LBCT presentations; venues for the Featured Clinical Research sessions are as noted below. Their real-time virtual equivalents will reside on the online platform’s Hot Topics channel. All noted session times are Eastern Daylight Time.
 

Saturday, April 2, 9:30 a.m.–10:30 a.m. Joint American College of Cardiology/Journal of the American College of Cardiology LBCT (I)

Leading off the conference’s first LBCT session, the randomized VALOR-HCM trial explored whether 16 weeks of mavacamten (MyoKardia) could help patients with severe obstructive hypertrophic cardiomyopathy (HCM) avoid septal reduction therapy, either surgical or by alcohol ablation.

The 22-center VALOR-HCM trial with an estimated enrollment of 100 follows EXPLORER-HCM, which in 2020 suggested the novel myosin-inhibiting agent could improve symptoms, exercise capacity, cardiac remodeling, and quality of life in such patients.

Simply advising people with heart failure (HF) to consume less salt is one thing, but it’s another to show them clinical trial evidence that it might help keep them out of the hospital. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure) study, conducted at 27 sites in six countries, sought to provide that evidence.

The trial randomly assigned 1,000 patients with NYHA class 2-3 HF to consume no more than 1,500 mg/day in sodium or to receive standard advice to limit sodium intake, and followed them for a year for the endpoint of death from any cause, cardiovascular (CV) hospitalization, or CV emergency department visit.

SODIUM-HF “may provide a rigorous evidence base for sodium restriction in patients with heart failure and may truly change our practice and how we recommend dietary modification,” ACC 2022 vice chair Douglas E. Drachman, MD, Massachusetts General Hospital, Boston, said at the media presentation.

In the same session, the CHAP (Chronic Hypertension and Pregnancy) study explored whether blood pressure (BP) control in pregnant women with new or untreated chronic hypertension could help avert preeclampsia, poor fetal outcomes, and other adverse events.

CHAP assigned about 2,400 women to receive either stepwise antihypertensive therapy to a BP goal of 140/90 mm Hg or lower or no such meds unless their BP reached or exceeded 160/105 mm Hg. Stepwise therapy featured either labetalol or extended-release nifedipine to start, the other agent added as necessary.

The LBCT block also includes the POISE-3 (Perioperative Ischemic Evaluation-3) comparison of the hemostatic agent tranexamic acid vs. placebo in nearly 10,000 patients undergoing noncardiac surgery. A separate randomization of the same cohort, to be reported at a Monday LBCT session, compared pre- and perioperative BP-control strategies.
 

Saturday, April 2, 12:00 p.m.–1:15 p.m. Featured Clinical Research I. Room 143A

This session features a subgroup analysis by age from the REVERSE-IT trial, which had previously showcased the monoclonal antibody bentracimab (PhaseBio Pharmaceuticals) for its ability to reverse the antiplatelet effects of ticagrelor.

REVERSE-IT is accompanied on the schedule by several secondary-endpoint presentations from trials whose primary outcomes have already been presented at meetings or in the journals.

They include the SCORED trial of sotagliflozin in patients with diabetes and chronic kidney disease (CKD); COMPLETE, which explored complete revascularization of multivessel coronary disease at primary stenting; and the FAME-3 comparison of coronary bypass surgery (CABG) vs. percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) readings.

The session is to conclude with EDIT-CMD, which was a small, randomized assessment of diltiazem for improving microvascular dysfunction in patients with chronic angina despite nonobstructive coronary disease.
 

Sunday, April 3, 8:00 a.m.–9:15 a.m. Joint American College of Cardiology/Journal of the American Medical Association LBCT (II)

The SuperWIN (Supermarket Web Intervention) study tested an innovative strategy for community-based promotion of healthy lifestyle choices: point-of-purchase dietary education for grocery shoppers with an online instructional component, and follow-up to determine whether it influenced future food choices.

“Dietary interventions are notoriously difficult for us to implement, let alone to study scientifically,” Dr. Drachman observed. “So we think that there may be opportunity for dietary interventions to be best implemented at grocery stores where people are doing their shopping for food.”

SuperWIN compared supermarket shoppers with at least one CV risk factor who participated in the education intervention to a nonintervention control group for any changes in their DASH scores. The scores reflected consistency with the venerable DASH diet based on participants’ food purchases over 3 months.

In the same session, the MITIGATE trial explored whether daily administration of icosapent ethyl (Vascepa) might cut the risk of upper respiratory infection (especially from SARS-CoV-2 or seasonal influenza virus) in persons 50 or older with a history of clinical coronary, neurovascular, or peripheral vascular disease or revascularization. The trial has an estimated enrollment of 39,600.

Accompanying SuperWIN and MITIGATE are studies of several dyslipidemia drugs, including the discontinued antisense agent vupanorsen (Pfizer), as tested in TRANSLATE-TIMI 70;  the PCSK9 inhibitor alirocumab (Praluent), explored for its effects on coronary plaque volume and composition in the PACMAN-AMI trial; and the APOLLO trial, a phase 1 evaluation of SLN360 (Silence Therapeutics), a short interfering ribonucleic acid (siRNA) that suppresses the molecular machinery in the liver that produces lipoprotein(a), or Lp(a).

The 32-patient APOLLO trial’s recently released top-line results suggested that SLN360 at varying dosages reduced Lp(a) levels by about one-half to more than 90%. Although elevated Lp(a) is known to track with CV risk, it remains to be shown whether dropping Lp(a) levels pharmacologically is protective.
 

Sunday, April 3, 9:45 a.m.–11:00 a.m. Joint American College of Cardiology/New England Journal of Medicine LBCT (III)

The meeting’s all-HF late-breaker session includes the METEORIC-HF trial, which compared the myotropic agent omecamtiv mecarbil (Cytokinetics) against placebo for effects on exercise performance over 20 weeks. The trial entered 276 patients with HF with reduced ejection fraction (HFrEF) and reduced peak VO₂.

The GALACTIC-HF trial had previously suggested that the drug improved the risk of HF-related events or CV death in more than 8000 patients with HFrEF, those with the lowest ejection fractions benefiting the most.

This block of trials also features DIAMOND, the latest trial with a gemologic name to look at the potassium sequestrant patiromer (Veltassa) for any protection against hyperkalemia, a familiar side effect of renin-angiotensin-aldosterone inhibitors. DIAMOND tested patiromer in 878 patients with HFrEF who were on beta-blockers and other HF-appropriate medications and had a history of drug-associated hyperkalemia.

Previously, the AMBER trial of patients with CKD or refractory hypertension on spironolactone had suggested the drug might be protective enough against hyperkalemia to allow higher and more consistent dosing of BP-lowering agents.

Also in the session: the randomized IVVE (Influenza Vaccine to Prevent Adverse Vascular Events) trial, with an estimated 5,000 patients with HF in Africa, Asia, and the Middle East; PROMPT-HF, with a projected 1,310 HF patients and billed as a cluster-randomized pragmatic trial of a strategy for improving guideline-directed outpatient medical therapy; and MAVA-LTE, the long-term extension study of an estimated 310 patients who were in the MAVERICK-HCM and EXPLORER-HCM mavacamten trials.
 

Sunday, April 3, 12:15–1:30 p.m. Featured Clinical Research II. Main Tent, Hall D

The arrhythmia-centric session includes PARTITA, with its estimated 590 patients with primary- or secondary-prevention implantable cardioverter-defibrillators (ICDs). The trial followed them initially for burden of untreated nonsustained ventricular tachycardia (VT) or events treated with anti-tachycardia pacing. Then it randomly assigned those who experienced a first appropriate ICD shock to either immediate VT ablation or standard care. The latter included ablation on next occurrence of arrhythmic storm.

Investigational oral factor XIa inhibitors, viewed by many as potentially safer as anticoagulants than contemporary oral inhibitors of factor Xa, are now on the scene and include milvexian (Bristol-Myers Squibb/Janssen) and, lately, asundexian (BAY 2433334; Bayer). The latter agent was compared to the factor Xa inhibitor apixaban (Eliquis) in 753 patients with AF in the phase 2 PACIFIC-AF trial, which looked at the newer drug’s safety and optimal dosing.

Also on the bill: a long-term follow-up of the mAFA-2 (Mobile AF Application 2) extension study, which explored the value of a smartphone-based atrial fibrillation (AF) screening app for improving risk of AF-related events; a presentation billed as “Residual Leaks Post Left Atrial Appendage Occlusion”; and one that declares “low rates of guideline-directed care” to be “associated with higher mortality” in patients with pacemakers or ICDs.
 

Monday, April 4, 8:30 a.m.–9:45 a.m. LBCT IV

This session is to open with the PROTECT trial, which sought to determine whether perioperative “aggressive warming” may be cardioprotective in patients with CV risk factors undergoing noncardiac surgery. Its estimated 5,100 patients were randomly assigned to a procedure that achieves normothermia, that is 37° C (98.6° F), vs. standard care in which patients’ core temperature may decline to no further than 35.5° C (95.9° F).

Next on the list are a second POISE-3 comparison of BP-control strategies comparing hypotension avoidance vs. hypertension avoidance in patients undergoing noncardiac surgery; the pivotal CLASP 2 TR trial of patients with symptomatic tricuspid regurgitation on optimal medical therapy with vs. without treatment with the Edwards PASCAL Transcatheter Repair System; and one said to provide “insights from the Corevalve US Pivotal and SURTAVI trials” on 5-year incidence, timing, and predictors of hemodynamic valve deterioration transcatheter and surgical aortic bioprostheses.”

Rounding out the block of presentations: the ADAPT-TAVR comparison of the factor Xa inhibitor edoxaban (Lixiana) to dual-antiplatelet therapy for prevention of leaflet thrombosis after successful transcatheter aortic valve replacement (TAVR). The 235-patient trial was conducted at five centers in South Korea, Hong Kong, and Taiwan.
 

Monday, April 4, 11:00–12:15 p.m. LBCT V

This session includes the FLAVOUR randomized comparison of PCI guided by either FFR or intravascular ultrasound (IVUS) in 1,700 patients with 40%-70% stenoses. The patients from centers in China and South Korea were followed for death from any cause, MI, or any repeat revascularization at 24 months.

Also scheduled: the 2-year report on 4,000 patients with ST-segment elevation MI (STEMI) in the ACC-sponsored quality improvement program GHATI (Global Heart Attack Treatment Initiative); the GIPS-4 myocardial protection study of an estimated 380 patients with STEMI assigned to receive pre- and post-PCI infusions of sodium thiosulfate or placebo, with infarct size at 4 months as the primary endpoint; and a randomized test of an arrhythmia-monitoring implant for influence on clinical outcomes in 802 patients with a history of MI but no pacemaker or ICD indication, called BIO-GUARD-MI,

Last in the session: the Chocolate Touch Study of peripheral-artery angioplasty using a drug-coated balloon (DCB) with a confectionery name that treats lesions not with theobromine, but the antiproliferative mainstay paclitaxel.

The randomized comparison of the Chocolate Touch DCB (TriReme Medical) and the more established Lutonix DCB (Bard) assigned a projected 585 patients with symptomatic peripheral vascular disease to treatment of superficial femoral or popliteal artery lesions with one of the two paclitaxel-coated balloon catheters.
 

Monday, April 4, 12:45–2 p.m. Featured Clinical Research III. Room 143A 

The final session features five subgroup analyses or other updates from trials that have already reported their primary outcomes. Among them is the SPYRAL HTN-ON MED trial, which helped to revitalize hopes for renal denervation therapy as a catheter-based treatment for drug-resistant hypertension by showing significant effects on both systolic and diastolic blood pressure. The new data follow the trial’s more than 400 patients out to 3 years.

There is also a symptom and quality-of-life analysis from the 530-patient EMPULSE trial of 530 patients with stabilized acute HF assigned in-hospital to start on empagliflozin (Jardiance) or placebo. The trial made a splash last year when it reported a significant improvement in risk for death or HF rehospitalization for its patients put on the SGLT2 inhibitor.

A secondary analysis from CANTOS is also featured; the trial had randomly assigned more than 10,000 patients with recent acute MI and elevated C-reactive protein (CRP) levels to receive or not receive the anti-inflammatory canakinumab (Ilaris). Those assigned to active therapy showed benefits for a range of outcomes, including CV mortality and stroke, but no decreases in cholesterol levels. Billing for the new CANTOS analysis promises insights on the “differential impact of residual inflammatory risk and residual cholesterol risk among atherosclerosis patients with and without chronic kidney disease.”

The session also features “trends and final results” from the NACMI (North American COVID-19 Myocardial Infarction) registry, which had shown excellent primary-PCI results without compromise of door-to-balloon times in patients with confirmed SARS-CoV-2 infection; and a FIDELITY analysis of cardiorenal endpoints by history of CV disease in the study’s more than 13,000 patients with diabetes and CKD assigned to placebo or finerenone (Kerendia), a mineralocorticoid receptor antagonist.

A version of this article first appeared on Medscape.com.

Regardless of the pandemic’s sometimes mercurial behavior, the cardiology community appears set to reclaim valued traditions perhaps taken for granted in the pre-COVID era.

They include the bustling scientific congress and its myriad educational and networking prospects, along with pleiotropic effects like unplanned reunions with colleagues and catching up face-to-face with old friends.

That seems evident in the growing number of registrants for live attendance at at the annual scientific sessions of the American College of Cardiology, set for this Saturday through Monday in Washington as well as virtually, for a global reach that was unattainable in the pre-COVID era.

Registrations had hit the 11,000 mark and were picking up speed in recent weeks, ACC 2022 cochair Pamela B. Morris, MD, Medical University of South Carolina, Charleston, said at a mid-March presentation to the media.

They had reached about 12,880 and were still climbing a week before the conference, the ACC confirmed to this news organization. By then the professional registration had surpassed 9,900, of whom more than two-thirds reported plans to attend in person.

Dr. Morris said there had been 117 international submissions for what turned out to be 39 coveted spots on the meeting’s Late-Breaking Clinical Trial (LBCT) and Featured Clinical Research agenda spread across eight separate sessions.

On-site participants at the Walter E. Washington Convention Center should head for the Main Tent in Hall D for all LBCT presentations; venues for the Featured Clinical Research sessions are as noted below. Their real-time virtual equivalents will reside on the online platform’s Hot Topics channel. All noted session times are Eastern Daylight Time.
 

Saturday, April 2, 9:30 a.m.–10:30 a.m. Joint American College of Cardiology/Journal of the American College of Cardiology LBCT (I)

Leading off the conference’s first LBCT session, the randomized VALOR-HCM trial explored whether 16 weeks of mavacamten (MyoKardia) could help patients with severe obstructive hypertrophic cardiomyopathy (HCM) avoid septal reduction therapy, either surgical or by alcohol ablation.

The 22-center VALOR-HCM trial with an estimated enrollment of 100 follows EXPLORER-HCM, which in 2020 suggested the novel myosin-inhibiting agent could improve symptoms, exercise capacity, cardiac remodeling, and quality of life in such patients.

Simply advising people with heart failure (HF) to consume less salt is one thing, but it’s another to show them clinical trial evidence that it might help keep them out of the hospital. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure) study, conducted at 27 sites in six countries, sought to provide that evidence.

The trial randomly assigned 1,000 patients with NYHA class 2-3 HF to consume no more than 1,500 mg/day in sodium or to receive standard advice to limit sodium intake, and followed them for a year for the endpoint of death from any cause, cardiovascular (CV) hospitalization, or CV emergency department visit.

SODIUM-HF “may provide a rigorous evidence base for sodium restriction in patients with heart failure and may truly change our practice and how we recommend dietary modification,” ACC 2022 vice chair Douglas E. Drachman, MD, Massachusetts General Hospital, Boston, said at the media presentation.

In the same session, the CHAP (Chronic Hypertension and Pregnancy) study explored whether blood pressure (BP) control in pregnant women with new or untreated chronic hypertension could help avert preeclampsia, poor fetal outcomes, and other adverse events.

CHAP assigned about 2,400 women to receive either stepwise antihypertensive therapy to a BP goal of 140/90 mm Hg or lower or no such meds unless their BP reached or exceeded 160/105 mm Hg. Stepwise therapy featured either labetalol or extended-release nifedipine to start, the other agent added as necessary.

The LBCT block also includes the POISE-3 (Perioperative Ischemic Evaluation-3) comparison of the hemostatic agent tranexamic acid vs. placebo in nearly 10,000 patients undergoing noncardiac surgery. A separate randomization of the same cohort, to be reported at a Monday LBCT session, compared pre- and perioperative BP-control strategies.
 

Saturday, April 2, 12:00 p.m.–1:15 p.m. Featured Clinical Research I. Room 143A

This session features a subgroup analysis by age from the REVERSE-IT trial, which had previously showcased the monoclonal antibody bentracimab (PhaseBio Pharmaceuticals) for its ability to reverse the antiplatelet effects of ticagrelor.

REVERSE-IT is accompanied on the schedule by several secondary-endpoint presentations from trials whose primary outcomes have already been presented at meetings or in the journals.

They include the SCORED trial of sotagliflozin in patients with diabetes and chronic kidney disease (CKD); COMPLETE, which explored complete revascularization of multivessel coronary disease at primary stenting; and the FAME-3 comparison of coronary bypass surgery (CABG) vs. percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) readings.

The session is to conclude with EDIT-CMD, which was a small, randomized assessment of diltiazem for improving microvascular dysfunction in patients with chronic angina despite nonobstructive coronary disease.
 

Sunday, April 3, 8:00 a.m.–9:15 a.m. Joint American College of Cardiology/Journal of the American Medical Association LBCT (II)

The SuperWIN (Supermarket Web Intervention) study tested an innovative strategy for community-based promotion of healthy lifestyle choices: point-of-purchase dietary education for grocery shoppers with an online instructional component, and follow-up to determine whether it influenced future food choices.

“Dietary interventions are notoriously difficult for us to implement, let alone to study scientifically,” Dr. Drachman observed. “So we think that there may be opportunity for dietary interventions to be best implemented at grocery stores where people are doing their shopping for food.”

SuperWIN compared supermarket shoppers with at least one CV risk factor who participated in the education intervention to a nonintervention control group for any changes in their DASH scores. The scores reflected consistency with the venerable DASH diet based on participants’ food purchases over 3 months.

In the same session, the MITIGATE trial explored whether daily administration of icosapent ethyl (Vascepa) might cut the risk of upper respiratory infection (especially from SARS-CoV-2 or seasonal influenza virus) in persons 50 or older with a history of clinical coronary, neurovascular, or peripheral vascular disease or revascularization. The trial has an estimated enrollment of 39,600.

Accompanying SuperWIN and MITIGATE are studies of several dyslipidemia drugs, including the discontinued antisense agent vupanorsen (Pfizer), as tested in TRANSLATE-TIMI 70;  the PCSK9 inhibitor alirocumab (Praluent), explored for its effects on coronary plaque volume and composition in the PACMAN-AMI trial; and the APOLLO trial, a phase 1 evaluation of SLN360 (Silence Therapeutics), a short interfering ribonucleic acid (siRNA) that suppresses the molecular machinery in the liver that produces lipoprotein(a), or Lp(a).

The 32-patient APOLLO trial’s recently released top-line results suggested that SLN360 at varying dosages reduced Lp(a) levels by about one-half to more than 90%. Although elevated Lp(a) is known to track with CV risk, it remains to be shown whether dropping Lp(a) levels pharmacologically is protective.
 

Sunday, April 3, 9:45 a.m.–11:00 a.m. Joint American College of Cardiology/New England Journal of Medicine LBCT (III)

The meeting’s all-HF late-breaker session includes the METEORIC-HF trial, which compared the myotropic agent omecamtiv mecarbil (Cytokinetics) against placebo for effects on exercise performance over 20 weeks. The trial entered 276 patients with HF with reduced ejection fraction (HFrEF) and reduced peak VO₂.

The GALACTIC-HF trial had previously suggested that the drug improved the risk of HF-related events or CV death in more than 8000 patients with HFrEF, those with the lowest ejection fractions benefiting the most.

This block of trials also features DIAMOND, the latest trial with a gemologic name to look at the potassium sequestrant patiromer (Veltassa) for any protection against hyperkalemia, a familiar side effect of renin-angiotensin-aldosterone inhibitors. DIAMOND tested patiromer in 878 patients with HFrEF who were on beta-blockers and other HF-appropriate medications and had a history of drug-associated hyperkalemia.

Previously, the AMBER trial of patients with CKD or refractory hypertension on spironolactone had suggested the drug might be protective enough against hyperkalemia to allow higher and more consistent dosing of BP-lowering agents.

Also in the session: the randomized IVVE (Influenza Vaccine to Prevent Adverse Vascular Events) trial, with an estimated 5,000 patients with HF in Africa, Asia, and the Middle East; PROMPT-HF, with a projected 1,310 HF patients and billed as a cluster-randomized pragmatic trial of a strategy for improving guideline-directed outpatient medical therapy; and MAVA-LTE, the long-term extension study of an estimated 310 patients who were in the MAVERICK-HCM and EXPLORER-HCM mavacamten trials.
 

Sunday, April 3, 12:15–1:30 p.m. Featured Clinical Research II. Main Tent, Hall D

The arrhythmia-centric session includes PARTITA, with its estimated 590 patients with primary- or secondary-prevention implantable cardioverter-defibrillators (ICDs). The trial followed them initially for burden of untreated nonsustained ventricular tachycardia (VT) or events treated with anti-tachycardia pacing. Then it randomly assigned those who experienced a first appropriate ICD shock to either immediate VT ablation or standard care. The latter included ablation on next occurrence of arrhythmic storm.

Investigational oral factor XIa inhibitors, viewed by many as potentially safer as anticoagulants than contemporary oral inhibitors of factor Xa, are now on the scene and include milvexian (Bristol-Myers Squibb/Janssen) and, lately, asundexian (BAY 2433334; Bayer). The latter agent was compared to the factor Xa inhibitor apixaban (Eliquis) in 753 patients with AF in the phase 2 PACIFIC-AF trial, which looked at the newer drug’s safety and optimal dosing.

Also on the bill: a long-term follow-up of the mAFA-2 (Mobile AF Application 2) extension study, which explored the value of a smartphone-based atrial fibrillation (AF) screening app for improving risk of AF-related events; a presentation billed as “Residual Leaks Post Left Atrial Appendage Occlusion”; and one that declares “low rates of guideline-directed care” to be “associated with higher mortality” in patients with pacemakers or ICDs.
 

Monday, April 4, 8:30 a.m.–9:45 a.m. LBCT IV

This session is to open with the PROTECT trial, which sought to determine whether perioperative “aggressive warming” may be cardioprotective in patients with CV risk factors undergoing noncardiac surgery. Its estimated 5,100 patients were randomly assigned to a procedure that achieves normothermia, that is 37° C (98.6° F), vs. standard care in which patients’ core temperature may decline to no further than 35.5° C (95.9° F).

Next on the list are a second POISE-3 comparison of BP-control strategies comparing hypotension avoidance vs. hypertension avoidance in patients undergoing noncardiac surgery; the pivotal CLASP 2 TR trial of patients with symptomatic tricuspid regurgitation on optimal medical therapy with vs. without treatment with the Edwards PASCAL Transcatheter Repair System; and one said to provide “insights from the Corevalve US Pivotal and SURTAVI trials” on 5-year incidence, timing, and predictors of hemodynamic valve deterioration transcatheter and surgical aortic bioprostheses.”

Rounding out the block of presentations: the ADAPT-TAVR comparison of the factor Xa inhibitor edoxaban (Lixiana) to dual-antiplatelet therapy for prevention of leaflet thrombosis after successful transcatheter aortic valve replacement (TAVR). The 235-patient trial was conducted at five centers in South Korea, Hong Kong, and Taiwan.
 

Monday, April 4, 11:00–12:15 p.m. LBCT V

This session includes the FLAVOUR randomized comparison of PCI guided by either FFR or intravascular ultrasound (IVUS) in 1,700 patients with 40%-70% stenoses. The patients from centers in China and South Korea were followed for death from any cause, MI, or any repeat revascularization at 24 months.

Also scheduled: the 2-year report on 4,000 patients with ST-segment elevation MI (STEMI) in the ACC-sponsored quality improvement program GHATI (Global Heart Attack Treatment Initiative); the GIPS-4 myocardial protection study of an estimated 380 patients with STEMI assigned to receive pre- and post-PCI infusions of sodium thiosulfate or placebo, with infarct size at 4 months as the primary endpoint; and a randomized test of an arrhythmia-monitoring implant for influence on clinical outcomes in 802 patients with a history of MI but no pacemaker or ICD indication, called BIO-GUARD-MI,

Last in the session: the Chocolate Touch Study of peripheral-artery angioplasty using a drug-coated balloon (DCB) with a confectionery name that treats lesions not with theobromine, but the antiproliferative mainstay paclitaxel.

The randomized comparison of the Chocolate Touch DCB (TriReme Medical) and the more established Lutonix DCB (Bard) assigned a projected 585 patients with symptomatic peripheral vascular disease to treatment of superficial femoral or popliteal artery lesions with one of the two paclitaxel-coated balloon catheters.
 

Monday, April 4, 12:45–2 p.m. Featured Clinical Research III. Room 143A 

The final session features five subgroup analyses or other updates from trials that have already reported their primary outcomes. Among them is the SPYRAL HTN-ON MED trial, which helped to revitalize hopes for renal denervation therapy as a catheter-based treatment for drug-resistant hypertension by showing significant effects on both systolic and diastolic blood pressure. The new data follow the trial’s more than 400 patients out to 3 years.

There is also a symptom and quality-of-life analysis from the 530-patient EMPULSE trial of 530 patients with stabilized acute HF assigned in-hospital to start on empagliflozin (Jardiance) or placebo. The trial made a splash last year when it reported a significant improvement in risk for death or HF rehospitalization for its patients put on the SGLT2 inhibitor.

A secondary analysis from CANTOS is also featured; the trial had randomly assigned more than 10,000 patients with recent acute MI and elevated C-reactive protein (CRP) levels to receive or not receive the anti-inflammatory canakinumab (Ilaris). Those assigned to active therapy showed benefits for a range of outcomes, including CV mortality and stroke, but no decreases in cholesterol levels. Billing for the new CANTOS analysis promises insights on the “differential impact of residual inflammatory risk and residual cholesterol risk among atherosclerosis patients with and without chronic kidney disease.”

The session also features “trends and final results” from the NACMI (North American COVID-19 Myocardial Infarction) registry, which had shown excellent primary-PCI results without compromise of door-to-balloon times in patients with confirmed SARS-CoV-2 infection; and a FIDELITY analysis of cardiorenal endpoints by history of CV disease in the study’s more than 13,000 patients with diabetes and CKD assigned to placebo or finerenone (Kerendia), a mineralocorticoid receptor antagonist.

A version of this article first appeared on Medscape.com.

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

A version of this article first appeared on Medscape.com.

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

A version of this article first appeared on Medscape.com.

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

A version of this article first appeared on Medscape.com.

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

A version of this article first appeared on Medscape.com.

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

A version of this article first appeared on Medscape.com.

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

A version of this article first appeared on Medscape.com.

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

A version of this article first appeared on Medscape.com.

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

A version of this article first appeared on Medscape.com.

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

A version of this article first appeared on Medscape.com.

Morton J, MD, a 68-year-old cardiologist based in the Midwest, saw things become dramatically worse when his nine-physician practice was taken over by a large health system.

“Everything changed. My partners and I lost a lot of autonomy. We had a say – but not the final say-so in who we hired as medical assistants or receptionists. We had to change how long we spent with patients and justify procedures or tests – not just to the insurance companies, which is an old story, but to our new employer,” said Dr. J, who asked to remain anonymous.

Worst of all, “I had to report to a kid – a doctor in his 30s, someone young enough to be my son, someone with a fraction of the clinical training and experience I had but who now got to tell me what to do and how to run my practice.”

The “final straw” for Dr. J came when the practice had to change to a new electronic health record (EHR) system. “Learning this new system was like pulling teeth,” he said. His youthful supervisor was “obviously impatient and irritated – his whole attitude and demeanor reflected a sense that he was saddled with a dinosaur.”

After much anguishing and soul-searching, Dr. J decided to retire. “I was already close to retirement age, and I thought it would be nice to spend more time with my grandchildren. Feeling so disrespected was simply the catalyst that brought the decision to a head a couple of years sooner than I had planned.”
 

Getting through a delicate discussion

This unfortunate situation could have been avoided had the younger supervisor shown more sensitivity, says otolaryngologist Mark Wallace, DO.

Dr. Wallace is speaking from personal experience. Early in his career, he was a younger physician who was forced to discuss a practice management issue with an older physician.

Dr. Wallace was a member of a committee that was responsible for “maximizing the efficiency of good care, while still being aware of cost issues.” When the committee “wanted one of the physicians in the group to change their behavior to improve cost savings, it was my job to discuss that with them.”

Dr. Wallace, who today is a locum tenens physician and a medical practice consultant to Physicians Thrive – an advisory group that helps physicians with financial and practice management problems – recalls feeling uncomfortable about broaching the subject to his supervisee. In this case, the older physician was prescribing name brand medications, and the committee that appointed Dr. Wallace wanted him to encourage the physician to prescribe a generic medication first and reserve brand prescriptions only for cases in which the generic was ineffective.

He acknowledges that he thought the generic was equivalent to the branded product in safety and efficacy.

“I always felt this to be a delicate discussion, whatever the age of the physician, because I didn’t like the idea of telling a doctor that they have to change how they practice so as to save money. I would never want anyone to feel they’re providing a lower level of care.”

The fact that this was an older physician – in his 60s – compounded his hesitancy. “Older physicians have a lot more experience than what I had in my 30s,” Dr. Wallace said. “I could talk to them about studies and outcomes and things like that, but a large part of medicine is the experience you gain over time.

“I presented it simply as a cost issue raised by the committee and asked him to consider experimenting with changing his prescribing behavior, while emphasizing that ultimately, it was his decision,” says Dr. Wallace.

The supervisee understood the concern and agreed to the experiment. He ended up prescribing the generic more frequently, although perhaps not as frequently as the committee would have liked.

Respectful, authentic, honest communication is important in any leadership situation but especially in those in which younger physicians are supervising physicians who are old enough to be their parents, says Ted Epperly, MD, a family physician in Boise, Idaho, and president and CEO of Family Medicine Residency of Idaho.

Dr. Wallace said that older physicians, on coming out of training, felt more respected, were better paid, and didn’t have to continually adjust to new regulations and new complicated insurance requirements. Today’s young physicians coming out of training may not find the practice of medicine as enjoyable as their older counterparts did, but they are accustomed to increasingly complex rules and regulations, so it’s less of an adjustment. But many may not feel they want to work 80 hours per week, as their older counterparts did.
 

Challenges of technology

Technology is one of the most central areas where intergenerational differences play out, says Tracy Clarke, chief human resources officer at Kitsap Mental Health Services, a large nonprofit organization in Bremerton, Wash., that employs roughly 500 individuals. “The younger physicians in our practice are really prepared, already engaged in technology, and used to using technology for documentation, and it is already integrated into the way they do business in general and practice,” she said.

Dr. Epperly noted that Gen X-ers are typically comfortable with digital technology, although not quite as much as the following generation, the millennials, who have grown up with smartphones and computers quite literally at their fingertips from earliest childhood.

Dr. Epperly, now 67, described the experience of having his organization convert to a new EHR system. “Although the younger physicians were not my supervisors, the dynamic that occurred when we were switching to the new system is typical of what might happen in a more formal reporting structure of older ‘supervisee’ and younger supervisor,” he said. In fact, his experience was similar to that of Dr. J.

“Some of the millennials were so quick to learn the new system that they forgot to check in with the older ones about how they were doing, or they were frustrated with our slow pace of learning the new technology,” said Dr. Epperly. “In fact, I was struggling to master it, and so were many others of my generation, and I felt very dumb, slow, and vulnerable, even though I usually regard myself as a pretty bright guy.”

Dr. Epperly encourages younger physicians not to think, “He’s asked me five times how to do this – what’s his problem?” This impatience can be intuited by the older physician, who may take it personally and feel devalued and disrespected.

Joy Engblade, an internal medicine physician and CMO of Northern Inyo Hospital, Bishop, Calif., said that when her institution was transitioning to a new EHR system this past May, she was worried that the older physicians would have the most difficulty.

Ironically, that turned out not to be the case. In fact, the younger physicians struggled more because the older physicians recognized their limitations and “were willing to do whatever we asked them to do. They watched the tutorials about how to use the new EHR. They went to every class that was offered and did all the practice sessions.” By contrast, many of the younger ones thought, “I know how to work an EHR, I’ve been doing it for years, so how hard could it be?” By the time they needed to actually use it, the instructional resources and tutorials were no longer available.

Dr. Epperly’s experience is different. He noted that some older physicians may be embarrassed to acknowledge that they are technologically challenged and may say, “I got it, I understand,” when they are still struggling to master the new technology.

Ms. Clarke notes that the leadership in her organization is younger than many of the physicians who report to them. “For the leadership, the biggest challenge is that many older physicians are set in their ways, and they haven’t really seen a reason to change their practice or ways of doing things.” For example, some still prefer paper charting or making voice recordings of patient visits for other people to transcribe.

Ms. Clarke has some advice for younger leaders: “Really explore what the pain points are of these older physicians. Beyond their saying, ‘because I’ve always done it this way,’ what really is the advantage of, for example, paper charting when using the EHR is more efficient?”

Daniel DeBehnke, MD, is an emergency medicine physician and vice president and chief physician executive for Premier Inc., where he helps hospitals improve quality, safety, and financial performance. Before joining Premier, he was both a practicing physician and CEO of a health system consisting of more than 1,500 physicians.

“Having been on both sides of the spectrum as manager/leader within a physician group, some of whom are senior to me and some of whom are junior, I can tell you that I have never had any issues related to the age gap.” In fact, it is less about age per se and more about “the expertise that you, as a manager, bring to the table in understanding the nuances of the medical practice and for the individual being ‘managed.’ It is about trusting the expertise of the manager.”
 

Before and after hourly caps

Dr. Engblade regards “generational” issues to be less about age and birth year and more about the cap on hours worked during residency.

Dr. Engblade, who is 45 years old, said she did her internship year with no hourly restrictions. Such restrictions only went into effect during her second year of residency. “This created a paradigm shift in how much people wanted to work and created a consciousness of work-life balance that hadn’t been part of the conversation before,” she said.

When she interviews an older physician, a typical response is, “Of course I’ll be available any time,” whereas younger physicians, who went through residency after hourly restrictions had been established, are more likely to ask how many hours they will be on and how many they’ll be off.

Matt Lambert, MD, an independent emergency medicine physician and CMO of Curation Health, Washington, agreed, noting that differences in the cap on hours during training “can create a bit of an undertow, a tension between younger managers who are better adjusted in terms of work-life balance and older physicians being managed, who have a different work ethic and also might regard their managers as being less trained because they put in fewer hours during training.”

It is also important to be cognizant of differences in style and priorities that each generation brings to the table. Jaciel Keltgen, PhD, assistant professor of business administration, Augustana University, Sioux Falls, S.D., has heard older physicians say, “We did this the hard way, we sacrificed for our organization, and we expect the same values of younger physicians.” The younger ones tend to say, “We need to use all the tools at our disposal, and medicine doesn’t have to be practiced the way it’s always been.”

Dr. Keltgen, whose PhD is in political science and who has studied public administration, said that younger physicians may also question the mores and protocols that older physicians take for granted. For example, when her physician son was beginning his career, he was told by his senior supervisors that although he was “performing beautifully as a physician, he needed to shave more frequently, wear his white coat more often, and introduce himself as ‘Doctor’ rather than by his first name. Although he did wear his white coat more often, he didn’t change how he introduced himself to patients.”

Flexibility and mutual understanding of each generation’s needs, the type, structure, and amount of training they underwent, and the prevailing values will smooth supervisory interactions and optimize outcomes, experts agree.
 

Every generation’s No. 1 concern

For her dissertation, Dr. Keltgen used a large dataset of physicians and sought to draw a predictive model by generation and gender as to what physicians were seeking in order to be satisfied in their careers. One “overwhelming finding” of her research into generational differences in physicians is that “every single generation and gender is there to promote the health of their patients, and providing excellent care is their No. 1 concern. That is the common focus and the foundation that everyone can build on.”

Dr. J agreed. “Had I felt like a valued collaborator, I might have made a different decision.” He has begun to consider reentering clinical practice, perhaps as locum tenens or on a part-time basis. “I don’t want to feel that I’ve been driven out of a field that I love. I will see if I can find some type of context where my experience will be valued and learn to bring myself up to speed with technology if necessary. I believe I still have much to offer patients, and I would like to find a context to do so.”

A version of this article first appeared on Medscape.com.

Morton J, MD, a 68-year-old cardiologist based in the Midwest, saw things become dramatically worse when his nine-physician practice was taken over by a large health system.

“Everything changed. My partners and I lost a lot of autonomy. We had a say – but not the final say-so in who we hired as medical assistants or receptionists. We had to change how long we spent with patients and justify procedures or tests – not just to the insurance companies, which is an old story, but to our new employer,” said Dr. J, who asked to remain anonymous.

Worst of all, “I had to report to a kid – a doctor in his 30s, someone young enough to be my son, someone with a fraction of the clinical training and experience I had but who now got to tell me what to do and how to run my practice.”

The “final straw” for Dr. J came when the practice had to change to a new electronic health record (EHR) system. “Learning this new system was like pulling teeth,” he said. His youthful supervisor was “obviously impatient and irritated – his whole attitude and demeanor reflected a sense that he was saddled with a dinosaur.”

After much anguishing and soul-searching, Dr. J decided to retire. “I was already close to retirement age, and I thought it would be nice to spend more time with my grandchildren. Feeling so disrespected was simply the catalyst that brought the decision to a head a couple of years sooner than I had planned.”
 

Getting through a delicate discussion

This unfortunate situation could have been avoided had the younger supervisor shown more sensitivity, says otolaryngologist Mark Wallace, DO.

Dr. Wallace is speaking from personal experience. Early in his career, he was a younger physician who was forced to discuss a practice management issue with an older physician.

Dr. Wallace was a member of a committee that was responsible for “maximizing the efficiency of good care, while still being aware of cost issues.” When the committee “wanted one of the physicians in the group to change their behavior to improve cost savings, it was my job to discuss that with them.”

Dr. Wallace, who today is a locum tenens physician and a medical practice consultant to Physicians Thrive – an advisory group that helps physicians with financial and practice management problems – recalls feeling uncomfortable about broaching the subject to his supervisee. In this case, the older physician was prescribing name brand medications, and the committee that appointed Dr. Wallace wanted him to encourage the physician to prescribe a generic medication first and reserve brand prescriptions only for cases in which the generic was ineffective.

He acknowledges that he thought the generic was equivalent to the branded product in safety and efficacy.

“I always felt this to be a delicate discussion, whatever the age of the physician, because I didn’t like the idea of telling a doctor that they have to change how they practice so as to save money. I would never want anyone to feel they’re providing a lower level of care.”

The fact that this was an older physician – in his 60s – compounded his hesitancy. “Older physicians have a lot more experience than what I had in my 30s,” Dr. Wallace said. “I could talk to them about studies and outcomes and things like that, but a large part of medicine is the experience you gain over time.

“I presented it simply as a cost issue raised by the committee and asked him to consider experimenting with changing his prescribing behavior, while emphasizing that ultimately, it was his decision,” says Dr. Wallace.

The supervisee understood the concern and agreed to the experiment. He ended up prescribing the generic more frequently, although perhaps not as frequently as the committee would have liked.

Respectful, authentic, honest communication is important in any leadership situation but especially in those in which younger physicians are supervising physicians who are old enough to be their parents, says Ted Epperly, MD, a family physician in Boise, Idaho, and president and CEO of Family Medicine Residency of Idaho.

Dr. Wallace said that older physicians, on coming out of training, felt more respected, were better paid, and didn’t have to continually adjust to new regulations and new complicated insurance requirements. Today’s young physicians coming out of training may not find the practice of medicine as enjoyable as their older counterparts did, but they are accustomed to increasingly complex rules and regulations, so it’s less of an adjustment. But many may not feel they want to work 80 hours per week, as their older counterparts did.
 

Challenges of technology

Technology is one of the most central areas where intergenerational differences play out, says Tracy Clarke, chief human resources officer at Kitsap Mental Health Services, a large nonprofit organization in Bremerton, Wash., that employs roughly 500 individuals. “The younger physicians in our practice are really prepared, already engaged in technology, and used to using technology for documentation, and it is already integrated into the way they do business in general and practice,” she said.

Dr. Epperly noted that Gen X-ers are typically comfortable with digital technology, although not quite as much as the following generation, the millennials, who have grown up with smartphones and computers quite literally at their fingertips from earliest childhood.

Dr. Epperly, now 67, described the experience of having his organization convert to a new EHR system. “Although the younger physicians were not my supervisors, the dynamic that occurred when we were switching to the new system is typical of what might happen in a more formal reporting structure of older ‘supervisee’ and younger supervisor,” he said. In fact, his experience was similar to that of Dr. J.

“Some of the millennials were so quick to learn the new system that they forgot to check in with the older ones about how they were doing, or they were frustrated with our slow pace of learning the new technology,” said Dr. Epperly. “In fact, I was struggling to master it, and so were many others of my generation, and I felt very dumb, slow, and vulnerable, even though I usually regard myself as a pretty bright guy.”

Dr. Epperly encourages younger physicians not to think, “He’s asked me five times how to do this – what’s his problem?” This impatience can be intuited by the older physician, who may take it personally and feel devalued and disrespected.

Joy Engblade, an internal medicine physician and CMO of Northern Inyo Hospital, Bishop, Calif., said that when her institution was transitioning to a new EHR system this past May, she was worried that the older physicians would have the most difficulty.

Ironically, that turned out not to be the case. In fact, the younger physicians struggled more because the older physicians recognized their limitations and “were willing to do whatever we asked them to do. They watched the tutorials about how to use the new EHR. They went to every class that was offered and did all the practice sessions.” By contrast, many of the younger ones thought, “I know how to work an EHR, I’ve been doing it for years, so how hard could it be?” By the time they needed to actually use it, the instructional resources and tutorials were no longer available.

Dr. Epperly’s experience is different. He noted that some older physicians may be embarrassed to acknowledge that they are technologically challenged and may say, “I got it, I understand,” when they are still struggling to master the new technology.

Ms. Clarke notes that the leadership in her organization is younger than many of the physicians who report to them. “For the leadership, the biggest challenge is that many older physicians are set in their ways, and they haven’t really seen a reason to change their practice or ways of doing things.” For example, some still prefer paper charting or making voice recordings of patient visits for other people to transcribe.

Ms. Clarke has some advice for younger leaders: “Really explore what the pain points are of these older physicians. Beyond their saying, ‘because I’ve always done it this way,’ what really is the advantage of, for example, paper charting when using the EHR is more efficient?”

Daniel DeBehnke, MD, is an emergency medicine physician and vice president and chief physician executive for Premier Inc., where he helps hospitals improve quality, safety, and financial performance. Before joining Premier, he was both a practicing physician and CEO of a health system consisting of more than 1,500 physicians.

“Having been on both sides of the spectrum as manager/leader within a physician group, some of whom are senior to me and some of whom are junior, I can tell you that I have never had any issues related to the age gap.” In fact, it is less about age per se and more about “the expertise that you, as a manager, bring to the table in understanding the nuances of the medical practice and for the individual being ‘managed.’ It is about trusting the expertise of the manager.”
 

Before and after hourly caps

Dr. Engblade regards “generational” issues to be less about age and birth year and more about the cap on hours worked during residency.

Dr. Engblade, who is 45 years old, said she did her internship year with no hourly restrictions. Such restrictions only went into effect during her second year of residency. “This created a paradigm shift in how much people wanted to work and created a consciousness of work-life balance that hadn’t been part of the conversation before,” she said.

When she interviews an older physician, a typical response is, “Of course I’ll be available any time,” whereas younger physicians, who went through residency after hourly restrictions had been established, are more likely to ask how many hours they will be on and how many they’ll be off.

Matt Lambert, MD, an independent emergency medicine physician and CMO of Curation Health, Washington, agreed, noting that differences in the cap on hours during training “can create a bit of an undertow, a tension between younger managers who are better adjusted in terms of work-life balance and older physicians being managed, who have a different work ethic and also might regard their managers as being less trained because they put in fewer hours during training.”

It is also important to be cognizant of differences in style and priorities that each generation brings to the table. Jaciel Keltgen, PhD, assistant professor of business administration, Augustana University, Sioux Falls, S.D., has heard older physicians say, “We did this the hard way, we sacrificed for our organization, and we expect the same values of younger physicians.” The younger ones tend to say, “We need to use all the tools at our disposal, and medicine doesn’t have to be practiced the way it’s always been.”

Dr. Keltgen, whose PhD is in political science and who has studied public administration, said that younger physicians may also question the mores and protocols that older physicians take for granted. For example, when her physician son was beginning his career, he was told by his senior supervisors that although he was “performing beautifully as a physician, he needed to shave more frequently, wear his white coat more often, and introduce himself as ‘Doctor’ rather than by his first name. Although he did wear his white coat more often, he didn’t change how he introduced himself to patients.”

Flexibility and mutual understanding of each generation’s needs, the type, structure, and amount of training they underwent, and the prevailing values will smooth supervisory interactions and optimize outcomes, experts agree.
 

Every generation’s No. 1 concern

For her dissertation, Dr. Keltgen used a large dataset of physicians and sought to draw a predictive model by generation and gender as to what physicians were seeking in order to be satisfied in their careers. One “overwhelming finding” of her research into generational differences in physicians is that “every single generation and gender is there to promote the health of their patients, and providing excellent care is their No. 1 concern. That is the common focus and the foundation that everyone can build on.”

Dr. J agreed. “Had I felt like a valued collaborator, I might have made a different decision.” He has begun to consider reentering clinical practice, perhaps as locum tenens or on a part-time basis. “I don’t want to feel that I’ve been driven out of a field that I love. I will see if I can find some type of context where my experience will be valued and learn to bring myself up to speed with technology if necessary. I believe I still have much to offer patients, and I would like to find a context to do so.”

A version of this article first appeared on Medscape.com.

Morton J, MD, a 68-year-old cardiologist based in the Midwest, saw things become dramatically worse when his nine-physician practice was taken over by a large health system.

“Everything changed. My partners and I lost a lot of autonomy. We had a say – but not the final say-so in who we hired as medical assistants or receptionists. We had to change how long we spent with patients and justify procedures or tests – not just to the insurance companies, which is an old story, but to our new employer,” said Dr. J, who asked to remain anonymous.

Worst of all, “I had to report to a kid – a doctor in his 30s, someone young enough to be my son, someone with a fraction of the clinical training and experience I had but who now got to tell me what to do and how to run my practice.”

The “final straw” for Dr. J came when the practice had to change to a new electronic health record (EHR) system. “Learning this new system was like pulling teeth,” he said. His youthful supervisor was “obviously impatient and irritated – his whole attitude and demeanor reflected a sense that he was saddled with a dinosaur.”

After much anguishing and soul-searching, Dr. J decided to retire. “I was already close to retirement age, and I thought it would be nice to spend more time with my grandchildren. Feeling so disrespected was simply the catalyst that brought the decision to a head a couple of years sooner than I had planned.”
 

Getting through a delicate discussion

This unfortunate situation could have been avoided had the younger supervisor shown more sensitivity, says otolaryngologist Mark Wallace, DO.

Dr. Wallace is speaking from personal experience. Early in his career, he was a younger physician who was forced to discuss a practice management issue with an older physician.

Dr. Wallace was a member of a committee that was responsible for “maximizing the efficiency of good care, while still being aware of cost issues.” When the committee “wanted one of the physicians in the group to change their behavior to improve cost savings, it was my job to discuss that with them.”

Dr. Wallace, who today is a locum tenens physician and a medical practice consultant to Physicians Thrive – an advisory group that helps physicians with financial and practice management problems – recalls feeling uncomfortable about broaching the subject to his supervisee. In this case, the older physician was prescribing name brand medications, and the committee that appointed Dr. Wallace wanted him to encourage the physician to prescribe a generic medication first and reserve brand prescriptions only for cases in which the generic was ineffective.

He acknowledges that he thought the generic was equivalent to the branded product in safety and efficacy.

“I always felt this to be a delicate discussion, whatever the age of the physician, because I didn’t like the idea of telling a doctor that they have to change how they practice so as to save money. I would never want anyone to feel they’re providing a lower level of care.”

The fact that this was an older physician – in his 60s – compounded his hesitancy. “Older physicians have a lot more experience than what I had in my 30s,” Dr. Wallace said. “I could talk to them about studies and outcomes and things like that, but a large part of medicine is the experience you gain over time.

“I presented it simply as a cost issue raised by the committee and asked him to consider experimenting with changing his prescribing behavior, while emphasizing that ultimately, it was his decision,” says Dr. Wallace.

The supervisee understood the concern and agreed to the experiment. He ended up prescribing the generic more frequently, although perhaps not as frequently as the committee would have liked.

Respectful, authentic, honest communication is important in any leadership situation but especially in those in which younger physicians are supervising physicians who are old enough to be their parents, says Ted Epperly, MD, a family physician in Boise, Idaho, and president and CEO of Family Medicine Residency of Idaho.

Dr. Wallace said that older physicians, on coming out of training, felt more respected, were better paid, and didn’t have to continually adjust to new regulations and new complicated insurance requirements. Today’s young physicians coming out of training may not find the practice of medicine as enjoyable as their older counterparts did, but they are accustomed to increasingly complex rules and regulations, so it’s less of an adjustment. But many may not feel they want to work 80 hours per week, as their older counterparts did.
 

Challenges of technology

Technology is one of the most central areas where intergenerational differences play out, says Tracy Clarke, chief human resources officer at Kitsap Mental Health Services, a large nonprofit organization in Bremerton, Wash., that employs roughly 500 individuals. “The younger physicians in our practice are really prepared, already engaged in technology, and used to using technology for documentation, and it is already integrated into the way they do business in general and practice,” she said.

Dr. Epperly noted that Gen X-ers are typically comfortable with digital technology, although not quite as much as the following generation, the millennials, who have grown up with smartphones and computers quite literally at their fingertips from earliest childhood.

Dr. Epperly, now 67, described the experience of having his organization convert to a new EHR system. “Although the younger physicians were not my supervisors, the dynamic that occurred when we were switching to the new system is typical of what might happen in a more formal reporting structure of older ‘supervisee’ and younger supervisor,” he said. In fact, his experience was similar to that of Dr. J.

“Some of the millennials were so quick to learn the new system that they forgot to check in with the older ones about how they were doing, or they were frustrated with our slow pace of learning the new technology,” said Dr. Epperly. “In fact, I was struggling to master it, and so were many others of my generation, and I felt very dumb, slow, and vulnerable, even though I usually regard myself as a pretty bright guy.”

Dr. Epperly encourages younger physicians not to think, “He’s asked me five times how to do this – what’s his problem?” This impatience can be intuited by the older physician, who may take it personally and feel devalued and disrespected.

Joy Engblade, an internal medicine physician and CMO of Northern Inyo Hospital, Bishop, Calif., said that when her institution was transitioning to a new EHR system this past May, she was worried that the older physicians would have the most difficulty.

Ironically, that turned out not to be the case. In fact, the younger physicians struggled more because the older physicians recognized their limitations and “were willing to do whatever we asked them to do. They watched the tutorials about how to use the new EHR. They went to every class that was offered and did all the practice sessions.” By contrast, many of the younger ones thought, “I know how to work an EHR, I’ve been doing it for years, so how hard could it be?” By the time they needed to actually use it, the instructional resources and tutorials were no longer available.

Dr. Epperly’s experience is different. He noted that some older physicians may be embarrassed to acknowledge that they are technologically challenged and may say, “I got it, I understand,” when they are still struggling to master the new technology.

Ms. Clarke notes that the leadership in her organization is younger than many of the physicians who report to them. “For the leadership, the biggest challenge is that many older physicians are set in their ways, and they haven’t really seen a reason to change their practice or ways of doing things.” For example, some still prefer paper charting or making voice recordings of patient visits for other people to transcribe.

Ms. Clarke has some advice for younger leaders: “Really explore what the pain points are of these older physicians. Beyond their saying, ‘because I’ve always done it this way,’ what really is the advantage of, for example, paper charting when using the EHR is more efficient?”

Daniel DeBehnke, MD, is an emergency medicine physician and vice president and chief physician executive for Premier Inc., where he helps hospitals improve quality, safety, and financial performance. Before joining Premier, he was both a practicing physician and CEO of a health system consisting of more than 1,500 physicians.

“Having been on both sides of the spectrum as manager/leader within a physician group, some of whom are senior to me and some of whom are junior, I can tell you that I have never had any issues related to the age gap.” In fact, it is less about age per se and more about “the expertise that you, as a manager, bring to the table in understanding the nuances of the medical practice and for the individual being ‘managed.’ It is about trusting the expertise of the manager.”
 

Before and after hourly caps

Dr. Engblade regards “generational” issues to be less about age and birth year and more about the cap on hours worked during residency.

Dr. Engblade, who is 45 years old, said she did her internship year with no hourly restrictions. Such restrictions only went into effect during her second year of residency. “This created a paradigm shift in how much people wanted to work and created a consciousness of work-life balance that hadn’t been part of the conversation before,” she said.

When she interviews an older physician, a typical response is, “Of course I’ll be available any time,” whereas younger physicians, who went through residency after hourly restrictions had been established, are more likely to ask how many hours they will be on and how many they’ll be off.

Matt Lambert, MD, an independent emergency medicine physician and CMO of Curation Health, Washington, agreed, noting that differences in the cap on hours during training “can create a bit of an undertow, a tension between younger managers who are better adjusted in terms of work-life balance and older physicians being managed, who have a different work ethic and also might regard their managers as being less trained because they put in fewer hours during training.”

It is also important to be cognizant of differences in style and priorities that each generation brings to the table. Jaciel Keltgen, PhD, assistant professor of business administration, Augustana University, Sioux Falls, S.D., has heard older physicians say, “We did this the hard way, we sacrificed for our organization, and we expect the same values of younger physicians.” The younger ones tend to say, “We need to use all the tools at our disposal, and medicine doesn’t have to be practiced the way it’s always been.”

Dr. Keltgen, whose PhD is in political science and who has studied public administration, said that younger physicians may also question the mores and protocols that older physicians take for granted. For example, when her physician son was beginning his career, he was told by his senior supervisors that although he was “performing beautifully as a physician, he needed to shave more frequently, wear his white coat more often, and introduce himself as ‘Doctor’ rather than by his first name. Although he did wear his white coat more often, he didn’t change how he introduced himself to patients.”

Flexibility and mutual understanding of each generation’s needs, the type, structure, and amount of training they underwent, and the prevailing values will smooth supervisory interactions and optimize outcomes, experts agree.
 

Every generation’s No. 1 concern

For her dissertation, Dr. Keltgen used a large dataset of physicians and sought to draw a predictive model by generation and gender as to what physicians were seeking in order to be satisfied in their careers. One “overwhelming finding” of her research into generational differences in physicians is that “every single generation and gender is there to promote the health of their patients, and providing excellent care is their No. 1 concern. That is the common focus and the foundation that everyone can build on.”

Dr. J agreed. “Had I felt like a valued collaborator, I might have made a different decision.” He has begun to consider reentering clinical practice, perhaps as locum tenens or on a part-time basis. “I don’t want to feel that I’ve been driven out of a field that I love. I will see if I can find some type of context where my experience will be valued and learn to bring myself up to speed with technology if necessary. I believe I still have much to offer patients, and I would like to find a context to do so.”

A version of this article first appeared on Medscape.com.

Can you keep it down? I’m trying to be boring

He chides his friends for not looking both ways before crossing the road. He is never questioned by the police because they fall asleep listening to him talk. He has won the office’s coveted perfect attendance award 10 years running. Look out, Dos Equis guy, you’ve got some new competition. That’s right, it’s the most boring man in the world.

For this boring study (sorry, study on boredom) conducted by English researchers and published in Personality and Social Psychology Bulletin, people were surveyed on various jobs and hobbies, ranking them by how exciting or boring they are, as well as how competent someone with those jobs/hobbies would be, their willingness to avoid someone with those jobs/hobbies, and how much they’d need to be paid to spend time with someone who had an undesirable job/hobby.

Courtesy Mohamed Hassan/pxhere

According to the British public, the most boring person in the world is a religious data analyst who likes to sleep and lives in a small town. In fact, spending time with this person is almost a full-time job on its own: To make it worth their while, survey subjects wanted 35 pounds a day. The boring person also was viewed as less competent, as is anyone with a boring job.

Now, there probably aren’t a lot of religious data analysts out there, but don’t worry, there are plenty of other boring jobs – accounting, tax/insurance, cleaning, and banking rounded out the top five (apparently people don’t like finances) – and hobbies – watching TV, observing animals, and mathematics filled out the top five. In case you’re curious, performing artists, scientists, journalists, health professionals, and teachers were viewed as having exciting jobs; exciting hobbies included gaming, reading, domestic tasks (really?), gardening, and writing.

Lead researcher Wijnand Van Tilburg, PhD, made an excellent point about people with boring jobs: They “have power in society – perhaps we should try not to upset them and stereotype them as boring!”

We think they should lean into it and make The Most Boring Man in the World ads: “When I drive a car off the lot, its value increases because I used the correct lending association. Batman trusts me with his Batmobile insurance. I can make those Cuban cigars tax exempt. Stay financially solvent, my friends.”
 

Fungi, but make it fashion

Fashion is an expensive and costly industry to sustain. Cotton production takes a toll on the environment, leather production comes with environmental and ethical/moral conundrums, and thanks to fast fashion, about 85% of textiles are being thrown away in the United States.

Courtesy Akram Zamani

Researchers at the University of Borås in Sweden, however, have found a newish solution to create leather, cotton, and other textiles. And as with so many of the finer things, it starts with unsold bread from the grocery store.

Akram Zamani, PhD, and her team take that bread and turn it into breadcrumbs, then combine it with water and Rhizopus delemar, a fungus typically found in decaying food. After a couple of days of feasting on the bread, the fungus produces natural fibers made of chitin and chitosan that accumulate in the cell walls. After proteins, lipids, and other byproducts are removed, the team is left with a jelly-like substance made of those fibrous cell walls that can be spun into a fabric.

The researchers started small with very thin nonpliable sheets, but with a little layering by using tree tannins for softness and alkali for strength, their fungal leather is more like real leather than competing fungal leathers. Not to mention its being able to be produced in a fraction of the time.

This new fungal leather is fast to produce, it’s biodegradable, and it uses only natural ingredients to treat the materials. It’s the ultimate environmental fashion statement.
 

Who’s afraid of cancer? Not C. elegans

And now, we bring you part 2 of our ongoing series: Creatures that can diagnose cancer. Last week, we discovered that ants are well on their way to replacing dogs in our medical labs and in our hearts. This week, we present the even-more-lovable nematode.

Courtesy Nari Jang

The soil-dwelling nematode Caenorhabditis elegans, which is less than 1 mm long, is known to be “attracted or repelled by certain odors, so we came up with an idea that the roundworm could be used to detect lung cancer,” Shin Sik Choi, PhD, of Myongji University in South Korea, who is the project’s principal investigator, said in a statement on Eurekalert.

Dr. Choi’s team created a “worm-on-a-chip” that allowed the nematodes to choose between a drop of culture media from lung cancer cells and media from normal lung fibroblasts. An hour after being placed in the chip’s central chamber, more nematodes had crawled toward the lung cancer media than the normal-cell sample.

The investigators estimate that the device is about 70% effective at detecting cancer cells, but “they hope to increase both the accuracy and sensitivity of the method by using worms that were previously exposed to cancer cell media and therefore have a ‘memory’ of cancer-specific odor molecules,” according to the statement from the American Chemical Society.

Since C. elegans is easy to grow in a lab and, apparently, easy to train, the researchers hope that the worm-on-a-chip can become a quick, easy, economical, and noninvasive cancer screen.

So watch out cancer, because we never bet against the creepy crawlies.
 

Mosquitoes have us figured out

We are nearing mosquito season; quite possibly the most annoying and itchy time of the year. We stock up on bottles of bug spray, but somehow we still get bite after bite. It appears that mosquitoes are basically able to ignore our bug sprays, which explains why we’re still covered in bites after the Fourth of July fireworks. It turns out mosquitoes are more complex than we thought for such tiny creatures.

Courtesy Jim Gathany/CDC

There’s plenty of research on the best ways to keep mosquitoes away, because not only are they incredibly annoying, but they also carry potentially harmful diseases. In a recent experiment, researchers used mosquitoes that were genetically modified to have an excessive amount of an odor receptor called AgOR2, which responds to the smell of humans.

“AgOR2 overexpression threw a wrench in the whole system by inactivating olfactory receptors in these mosquitoes,” Christopher Potter, PhD, associate professor of neuroscience at Johns Hopkins University, said in a written statement.

After testing how these genetically modified mosquitoes reacted to some of the common smells of bug spray such as lemongrass, they discovered that it’s easy for the mosquitoes to ignore the smell. We wish it were that easy for us to ignore that chemically fruity smell.

Researchers continue to work hard to figure out how to repel mosquitoes and we’re rooting for them as summer approaches, despite the mosquito’s status as a creepy crawly.

Can you keep it down? I’m trying to be boring

He chides his friends for not looking both ways before crossing the road. He is never questioned by the police because they fall asleep listening to him talk. He has won the office’s coveted perfect attendance award 10 years running. Look out, Dos Equis guy, you’ve got some new competition. That’s right, it’s the most boring man in the world.

For this boring study (sorry, study on boredom) conducted by English researchers and published in Personality and Social Psychology Bulletin, people were surveyed on various jobs and hobbies, ranking them by how exciting or boring they are, as well as how competent someone with those jobs/hobbies would be, their willingness to avoid someone with those jobs/hobbies, and how much they’d need to be paid to spend time with someone who had an undesirable job/hobby.

Courtesy Mohamed Hassan/pxhere

According to the British public, the most boring person in the world is a religious data analyst who likes to sleep and lives in a small town. In fact, spending time with this person is almost a full-time job on its own: To make it worth their while, survey subjects wanted 35 pounds a day. The boring person also was viewed as less competent, as is anyone with a boring job.

Now, there probably aren’t a lot of religious data analysts out there, but don’t worry, there are plenty of other boring jobs – accounting, tax/insurance, cleaning, and banking rounded out the top five (apparently people don’t like finances) – and hobbies – watching TV, observing animals, and mathematics filled out the top five. In case you’re curious, performing artists, scientists, journalists, health professionals, and teachers were viewed as having exciting jobs; exciting hobbies included gaming, reading, domestic tasks (really?), gardening, and writing.

Lead researcher Wijnand Van Tilburg, PhD, made an excellent point about people with boring jobs: They “have power in society – perhaps we should try not to upset them and stereotype them as boring!”

We think they should lean into it and make The Most Boring Man in the World ads: “When I drive a car off the lot, its value increases because I used the correct lending association. Batman trusts me with his Batmobile insurance. I can make those Cuban cigars tax exempt. Stay financially solvent, my friends.”
 

Fungi, but make it fashion

Fashion is an expensive and costly industry to sustain. Cotton production takes a toll on the environment, leather production comes with environmental and ethical/moral conundrums, and thanks to fast fashion, about 85% of textiles are being thrown away in the United States.

Courtesy Akram Zamani

Researchers at the University of Borås in Sweden, however, have found a newish solution to create leather, cotton, and other textiles. And as with so many of the finer things, it starts with unsold bread from the grocery store.

Akram Zamani, PhD, and her team take that bread and turn it into breadcrumbs, then combine it with water and Rhizopus delemar, a fungus typically found in decaying food. After a couple of days of feasting on the bread, the fungus produces natural fibers made of chitin and chitosan that accumulate in the cell walls. After proteins, lipids, and other byproducts are removed, the team is left with a jelly-like substance made of those fibrous cell walls that can be spun into a fabric.

The researchers started small with very thin nonpliable sheets, but with a little layering by using tree tannins for softness and alkali for strength, their fungal leather is more like real leather than competing fungal leathers. Not to mention its being able to be produced in a fraction of the time.

This new fungal leather is fast to produce, it’s biodegradable, and it uses only natural ingredients to treat the materials. It’s the ultimate environmental fashion statement.
 

Who’s afraid of cancer? Not C. elegans

And now, we bring you part 2 of our ongoing series: Creatures that can diagnose cancer. Last week, we discovered that ants are well on their way to replacing dogs in our medical labs and in our hearts. This week, we present the even-more-lovable nematode.

Courtesy Nari Jang

The soil-dwelling nematode Caenorhabditis elegans, which is less than 1 mm long, is known to be “attracted or repelled by certain odors, so we came up with an idea that the roundworm could be used to detect lung cancer,” Shin Sik Choi, PhD, of Myongji University in South Korea, who is the project’s principal investigator, said in a statement on Eurekalert.

Dr. Choi’s team created a “worm-on-a-chip” that allowed the nematodes to choose between a drop of culture media from lung cancer cells and media from normal lung fibroblasts. An hour after being placed in the chip’s central chamber, more nematodes had crawled toward the lung cancer media than the normal-cell sample.

The investigators estimate that the device is about 70% effective at detecting cancer cells, but “they hope to increase both the accuracy and sensitivity of the method by using worms that were previously exposed to cancer cell media and therefore have a ‘memory’ of cancer-specific odor molecules,” according to the statement from the American Chemical Society.

Since C. elegans is easy to grow in a lab and, apparently, easy to train, the researchers hope that the worm-on-a-chip can become a quick, easy, economical, and noninvasive cancer screen.

So watch out cancer, because we never bet against the creepy crawlies.
 

Mosquitoes have us figured out

We are nearing mosquito season; quite possibly the most annoying and itchy time of the year. We stock up on bottles of bug spray, but somehow we still get bite after bite. It appears that mosquitoes are basically able to ignore our bug sprays, which explains why we’re still covered in bites after the Fourth of July fireworks. It turns out mosquitoes are more complex than we thought for such tiny creatures.

Courtesy Jim Gathany/CDC

There’s plenty of research on the best ways to keep mosquitoes away, because not only are they incredibly annoying, but they also carry potentially harmful diseases. In a recent experiment, researchers used mosquitoes that were genetically modified to have an excessive amount of an odor receptor called AgOR2, which responds to the smell of humans.

“AgOR2 overexpression threw a wrench in the whole system by inactivating olfactory receptors in these mosquitoes,” Christopher Potter, PhD, associate professor of neuroscience at Johns Hopkins University, said in a written statement.

After testing how these genetically modified mosquitoes reacted to some of the common smells of bug spray such as lemongrass, they discovered that it’s easy for the mosquitoes to ignore the smell. We wish it were that easy for us to ignore that chemically fruity smell.

Researchers continue to work hard to figure out how to repel mosquitoes and we’re rooting for them as summer approaches, despite the mosquito’s status as a creepy crawly.

Can you keep it down? I’m trying to be boring

He chides his friends for not looking both ways before crossing the road. He is never questioned by the police because they fall asleep listening to him talk. He has won the office’s coveted perfect attendance award 10 years running. Look out, Dos Equis guy, you’ve got some new competition. That’s right, it’s the most boring man in the world.

For this boring study (sorry, study on boredom) conducted by English researchers and published in Personality and Social Psychology Bulletin, people were surveyed on various jobs and hobbies, ranking them by how exciting or boring they are, as well as how competent someone with those jobs/hobbies would be, their willingness to avoid someone with those jobs/hobbies, and how much they’d need to be paid to spend time with someone who had an undesirable job/hobby.

Courtesy Mohamed Hassan/pxhere

According to the British public, the most boring person in the world is a religious data analyst who likes to sleep and lives in a small town. In fact, spending time with this person is almost a full-time job on its own: To make it worth their while, survey subjects wanted 35 pounds a day. The boring person also was viewed as less competent, as is anyone with a boring job.

Now, there probably aren’t a lot of religious data analysts out there, but don’t worry, there are plenty of other boring jobs – accounting, tax/insurance, cleaning, and banking rounded out the top five (apparently people don’t like finances) – and hobbies – watching TV, observing animals, and mathematics filled out the top five. In case you’re curious, performing artists, scientists, journalists, health professionals, and teachers were viewed as having exciting jobs; exciting hobbies included gaming, reading, domestic tasks (really?), gardening, and writing.

Lead researcher Wijnand Van Tilburg, PhD, made an excellent point about people with boring jobs: They “have power in society – perhaps we should try not to upset them and stereotype them as boring!”

We think they should lean into it and make The Most Boring Man in the World ads: “When I drive a car off the lot, its value increases because I used the correct lending association. Batman trusts me with his Batmobile insurance. I can make those Cuban cigars tax exempt. Stay financially solvent, my friends.”
 

Fungi, but make it fashion

Fashion is an expensive and costly industry to sustain. Cotton production takes a toll on the environment, leather production comes with environmental and ethical/moral conundrums, and thanks to fast fashion, about 85% of textiles are being thrown away in the United States.

Courtesy Akram Zamani

Researchers at the University of Borås in Sweden, however, have found a newish solution to create leather, cotton, and other textiles. And as with so many of the finer things, it starts with unsold bread from the grocery store.

Akram Zamani, PhD, and her team take that bread and turn it into breadcrumbs, then combine it with water and Rhizopus delemar, a fungus typically found in decaying food. After a couple of days of feasting on the bread, the fungus produces natural fibers made of chitin and chitosan that accumulate in the cell walls. After proteins, lipids, and other byproducts are removed, the team is left with a jelly-like substance made of those fibrous cell walls that can be spun into a fabric.

The researchers started small with very thin nonpliable sheets, but with a little layering by using tree tannins for softness and alkali for strength, their fungal leather is more like real leather than competing fungal leathers. Not to mention its being able to be produced in a fraction of the time.

This new fungal leather is fast to produce, it’s biodegradable, and it uses only natural ingredients to treat the materials. It’s the ultimate environmental fashion statement.
 

Who’s afraid of cancer? Not C. elegans

And now, we bring you part 2 of our ongoing series: Creatures that can diagnose cancer. Last week, we discovered that ants are well on their way to replacing dogs in our medical labs and in our hearts. This week, we present the even-more-lovable nematode.

Courtesy Nari Jang

The soil-dwelling nematode Caenorhabditis elegans, which is less than 1 mm long, is known to be “attracted or repelled by certain odors, so we came up with an idea that the roundworm could be used to detect lung cancer,” Shin Sik Choi, PhD, of Myongji University in South Korea, who is the project’s principal investigator, said in a statement on Eurekalert.

Dr. Choi’s team created a “worm-on-a-chip” that allowed the nematodes to choose between a drop of culture media from lung cancer cells and media from normal lung fibroblasts. An hour after being placed in the chip’s central chamber, more nematodes had crawled toward the lung cancer media than the normal-cell sample.

The investigators estimate that the device is about 70% effective at detecting cancer cells, but “they hope to increase both the accuracy and sensitivity of the method by using worms that were previously exposed to cancer cell media and therefore have a ‘memory’ of cancer-specific odor molecules,” according to the statement from the American Chemical Society.

Since C. elegans is easy to grow in a lab and, apparently, easy to train, the researchers hope that the worm-on-a-chip can become a quick, easy, economical, and noninvasive cancer screen.

So watch out cancer, because we never bet against the creepy crawlies.
 

Mosquitoes have us figured out

We are nearing mosquito season; quite possibly the most annoying and itchy time of the year. We stock up on bottles of bug spray, but somehow we still get bite after bite. It appears that mosquitoes are basically able to ignore our bug sprays, which explains why we’re still covered in bites after the Fourth of July fireworks. It turns out mosquitoes are more complex than we thought for such tiny creatures.

Courtesy Jim Gathany/CDC

There’s plenty of research on the best ways to keep mosquitoes away, because not only are they incredibly annoying, but they also carry potentially harmful diseases. In a recent experiment, researchers used mosquitoes that were genetically modified to have an excessive amount of an odor receptor called AgOR2, which responds to the smell of humans.

“AgOR2 overexpression threw a wrench in the whole system by inactivating olfactory receptors in these mosquitoes,” Christopher Potter, PhD, associate professor of neuroscience at Johns Hopkins University, said in a written statement.

After testing how these genetically modified mosquitoes reacted to some of the common smells of bug spray such as lemongrass, they discovered that it’s easy for the mosquitoes to ignore the smell. We wish it were that easy for us to ignore that chemically fruity smell.

Researchers continue to work hard to figure out how to repel mosquitoes and we’re rooting for them as summer approaches, despite the mosquito’s status as a creepy crawly.

Seroprevalence surveys suggest that, from the beginning of the pandemic to 2022, more than a third of the global population had been infected with SARS-CoV-2. As large numbers of people continue to be infected, the efficacy and duration of natural immunity, in terms of protection against SARS-CoV-2 reinfections and severe disease, are of crucial significance. The virus’s epidemiologic trajectory will be influenced by the trends in vaccine-induced and hybrid immunity.

Omicron’s immune evasion

Cases of SARS-CoV-2 reinfection are increasing around the world. According to data from the U.K. Health Security Agency, 650,000 people in England have been infected twice, and most of them were reinfected in the past 2 months. Before mid-November 2021, reinfections accounted for about 1% of reported cases, but the rate has now increased to around 10%. The reinfection risk was 16 times higher between mid-December 2021 and early January 2022. Experts believe that this spike in reinfections is related to the spread of Omicron, which overtook Delta as the dominant variant. Nonetheless, other aspects should also be considered.

Omicron’s greater propensity to spread is not unrelated to its ability to evade the body’s immune defenses. This aspect was raised in a letter recently published in the New England Journal of Medicine. The authors reported that the effectiveness of previous infection in preventing reinfection against the Alpha, Beta, and Delta variants was around 90%, but it was only 56% against Omicron.
 

Natural immunity

Natural immunity showed roughly similar effectiveness regarding protection against reinfection across different SARS-CoV-2 variants, with the exception of the Omicron variant. The risk of hospitalization and death was also reduced in SARS-CoV-2 reinfections versus primary infections. Observational studies indicate that natural immunity may offer equal or greater protection against SARS-CoV-2 infections, compared with immunization with two doses of an mRNA vaccine, but the data are not fully consistent.

Natural immunity seems to be relatively long-lasting. Data from Denmark and Austria show no evidence that protection against reinfections wanes after 6 months. Some investigations indicate that protection against reinfection is lowest 4-5 months after initial infection and increases thereafter, a finding that might hypothetically be explained by persistent viral shedding; that is, misclassification of prolonged SARS-CoV-2 infections as reinfections. While no comparison was made against information pertaining to unvaccinated, not previously-infected individuals, preliminary data from Israel suggest that protection from reinfection can decrease from 6 to more than 12 months after the first SARS-CoV-2 infection. Taken together, epidemiologic studies indicate that protection against reinfections by natural immunity lasts over 1 year with only moderate, if any, decline over this period. Among older individuals, immunocompromised patients, and those with certain comorbidities or exposure risk (for example, health care workers), rates of reinfection may be higher. It is plausible that reinfection risk may be a function of exposure risk.

There is accumulating evidence that reinfections may be significantly less severe than primary infections with SARS-CoV-2. Reduced clinical severity of SARS-CoV-2 reinfections naturally also makes sense from a biologic point of view, inasmuch as a previously primed immune system should be better prepared for a rechallenge with this virus.
 

Vaccine-induced immunity

The short-term (<4 months) efficacy of mRNA vaccines against SARS-CoV-2 is high and varies from 94.1% (Moderna) to 95% (BioNTech/Pfizer). This has been confirmed by randomized controlled trials and was subsequently confirmed in effectiveness studies in real-world settings. Waning efficacy was observed with respect to protection against SARS-CoV-2 infections (for example, only approximately 20% after about half a year in Qatar), whereas protection against severe disease was either sustained or showed only a moderate decline.

In individuals who received two doses of the BioNTech/Pfizer vaccine at least 5 months earlier, an additional vaccine dose, a so-called booster, significantly lowered mortality and severe illness. These findings suggest that the booster restored and probably exceeded the initial short-term efficacy of the initial vaccination.

Data are still emerging regarding the efficacy of boosters against the Omicron variants. Preliminary data suggest a far lower ability to restore protection from infection and vaccination. However, fatalities and hospitalizations remain low.
 

Natural immunity vs. vaccine-induced immunity

Comparisons of natural immunity with vaccine-induced immunity are complicated by a series of biases and by combinations of biases – for example, the biases of comparisons between infected and uninfected, plus the biases of comparisons between vaccinated and nonvaccinated, with strong potential selection biases and confounding. Of particular note, the proportion of people previously infected and/or vaccinated may influence estimates of effectiveness. Regarding this point, one study compared unvaccinated patients with a prior SARS-CoV-2 infection and vaccinated individuals followed up from a week after the second vaccine dose onward versus a group of unvaccinated, not previously infected individuals. The findings showed that, compared with unvaccinated, not previously infected individuals, the natural immunity group and the vaccinated group had similar protection of 94.8% and 92.8% against infection, of 94.1% and 94.2% against hospitalization, and of 96.4% and 94.4% against severe illness, respectively.

Hybrid immunity

The combination of a previous SARS-CoV-2 infection and a respective vaccination is called hybrid immunity. This combination seems to confer the greatest protection against SARS-CoV-2 infections, but several knowledge gaps remain regarding this issue.

Data from Israel showed that, when the time since the last immunity-conferring event (either primary infection or vaccination) was the same, the rates of SARS-CoV-2 infections were similar in the following groups: individuals who had a previous infection and no vaccination, individuals who had an infection and were then vaccinated with a single dose after at least 3 months, and individuals who were vaccinated (two doses) and then infected. Severe disease was relatively rare overall.

Data on the efficacy of hybrid immunity point in the direction of hybrid immunity being superior, as compared with either vaccine-induced (without a booster) immunity or natural immunity alone. Timing and mode of vaccination of previously infected individuals to achieve optimal hybrid immunity are central questions that remain to be addressed in future studies.

Given that vaccination rates are continuously increasing and that, by the beginning of 2022, perhaps half or more of the global population had already been infected with SARS-CoV-2, with the vast majority of this group not being officially detected, it would appear logical that future infection waves, even with highly transmissible variants of SARS-CoV-2, may be limited with respect to their maximum potential health burden. The advent of Omicron suggests that massive surges can occur even in populations with extremely high rates of previous vaccination and variable rates of prior infections. However, even then, the accompanying burden of hospitalizations and deaths is far less than what was seen in 2020 and 2021. One may argue that the pandemic has already transitioned to the endemic phase and that Omicron is an endemic wave occurring in the setting of already widespread population immunity.

A version of this article first appeared on Medscape.com.

Seroprevalence surveys suggest that, from the beginning of the pandemic to 2022, more than a third of the global population had been infected with SARS-CoV-2. As large numbers of people continue to be infected, the efficacy and duration of natural immunity, in terms of protection against SARS-CoV-2 reinfections and severe disease, are of crucial significance. The virus’s epidemiologic trajectory will be influenced by the trends in vaccine-induced and hybrid immunity.

Omicron’s immune evasion

Cases of SARS-CoV-2 reinfection are increasing around the world. According to data from the U.K. Health Security Agency, 650,000 people in England have been infected twice, and most of them were reinfected in the past 2 months. Before mid-November 2021, reinfections accounted for about 1% of reported cases, but the rate has now increased to around 10%. The reinfection risk was 16 times higher between mid-December 2021 and early January 2022. Experts believe that this spike in reinfections is related to the spread of Omicron, which overtook Delta as the dominant variant. Nonetheless, other aspects should also be considered.

Omicron’s greater propensity to spread is not unrelated to its ability to evade the body’s immune defenses. This aspect was raised in a letter recently published in the New England Journal of Medicine. The authors reported that the effectiveness of previous infection in preventing reinfection against the Alpha, Beta, and Delta variants was around 90%, but it was only 56% against Omicron.
 

Natural immunity

Natural immunity showed roughly similar effectiveness regarding protection against reinfection across different SARS-CoV-2 variants, with the exception of the Omicron variant. The risk of hospitalization and death was also reduced in SARS-CoV-2 reinfections versus primary infections. Observational studies indicate that natural immunity may offer equal or greater protection against SARS-CoV-2 infections, compared with immunization with two doses of an mRNA vaccine, but the data are not fully consistent.

Natural immunity seems to be relatively long-lasting. Data from Denmark and Austria show no evidence that protection against reinfections wanes after 6 months. Some investigations indicate that protection against reinfection is lowest 4-5 months after initial infection and increases thereafter, a finding that might hypothetically be explained by persistent viral shedding; that is, misclassification of prolonged SARS-CoV-2 infections as reinfections. While no comparison was made against information pertaining to unvaccinated, not previously-infected individuals, preliminary data from Israel suggest that protection from reinfection can decrease from 6 to more than 12 months after the first SARS-CoV-2 infection. Taken together, epidemiologic studies indicate that protection against reinfections by natural immunity lasts over 1 year with only moderate, if any, decline over this period. Among older individuals, immunocompromised patients, and those with certain comorbidities or exposure risk (for example, health care workers), rates of reinfection may be higher. It is plausible that reinfection risk may be a function of exposure risk.

There is accumulating evidence that reinfections may be significantly less severe than primary infections with SARS-CoV-2. Reduced clinical severity of SARS-CoV-2 reinfections naturally also makes sense from a biologic point of view, inasmuch as a previously primed immune system should be better prepared for a rechallenge with this virus.
 

Vaccine-induced immunity

The short-term (<4 months) efficacy of mRNA vaccines against SARS-CoV-2 is high and varies from 94.1% (Moderna) to 95% (BioNTech/Pfizer). This has been confirmed by randomized controlled trials and was subsequently confirmed in effectiveness studies in real-world settings. Waning efficacy was observed with respect to protection against SARS-CoV-2 infections (for example, only approximately 20% after about half a year in Qatar), whereas protection against severe disease was either sustained or showed only a moderate decline.

In individuals who received two doses of the BioNTech/Pfizer vaccine at least 5 months earlier, an additional vaccine dose, a so-called booster, significantly lowered mortality and severe illness. These findings suggest that the booster restored and probably exceeded the initial short-term efficacy of the initial vaccination.

Data are still emerging regarding the efficacy of boosters against the Omicron variants. Preliminary data suggest a far lower ability to restore protection from infection and vaccination. However, fatalities and hospitalizations remain low.
 

Natural immunity vs. vaccine-induced immunity

Comparisons of natural immunity with vaccine-induced immunity are complicated by a series of biases and by combinations of biases – for example, the biases of comparisons between infected and uninfected, plus the biases of comparisons between vaccinated and nonvaccinated, with strong potential selection biases and confounding. Of particular note, the proportion of people previously infected and/or vaccinated may influence estimates of effectiveness. Regarding this point, one study compared unvaccinated patients with a prior SARS-CoV-2 infection and vaccinated individuals followed up from a week after the second vaccine dose onward versus a group of unvaccinated, not previously infected individuals. The findings showed that, compared with unvaccinated, not previously infected individuals, the natural immunity group and the vaccinated group had similar protection of 94.8% and 92.8% against infection, of 94.1% and 94.2% against hospitalization, and of 96.4% and 94.4% against severe illness, respectively.

Hybrid immunity

The combination of a previous SARS-CoV-2 infection and a respective vaccination is called hybrid immunity. This combination seems to confer the greatest protection against SARS-CoV-2 infections, but several knowledge gaps remain regarding this issue.

Data from Israel showed that, when the time since the last immunity-conferring event (either primary infection or vaccination) was the same, the rates of SARS-CoV-2 infections were similar in the following groups: individuals who had a previous infection and no vaccination, individuals who had an infection and were then vaccinated with a single dose after at least 3 months, and individuals who were vaccinated (two doses) and then infected. Severe disease was relatively rare overall.

Data on the efficacy of hybrid immunity point in the direction of hybrid immunity being superior, as compared with either vaccine-induced (without a booster) immunity or natural immunity alone. Timing and mode of vaccination of previously infected individuals to achieve optimal hybrid immunity are central questions that remain to be addressed in future studies.

Given that vaccination rates are continuously increasing and that, by the beginning of 2022, perhaps half or more of the global population had already been infected with SARS-CoV-2, with the vast majority of this group not being officially detected, it would appear logical that future infection waves, even with highly transmissible variants of SARS-CoV-2, may be limited with respect to their maximum potential health burden. The advent of Omicron suggests that massive surges can occur even in populations with extremely high rates of previous vaccination and variable rates of prior infections. However, even then, the accompanying burden of hospitalizations and deaths is far less than what was seen in 2020 and 2021. One may argue that the pandemic has already transitioned to the endemic phase and that Omicron is an endemic wave occurring in the setting of already widespread population immunity.

A version of this article first appeared on Medscape.com.

Seroprevalence surveys suggest that, from the beginning of the pandemic to 2022, more than a third of the global population had been infected with SARS-CoV-2. As large numbers of people continue to be infected, the efficacy and duration of natural immunity, in terms of protection against SARS-CoV-2 reinfections and severe disease, are of crucial significance. The virus’s epidemiologic trajectory will be influenced by the trends in vaccine-induced and hybrid immunity.

Omicron’s immune evasion

Cases of SARS-CoV-2 reinfection are increasing around the world. According to data from the U.K. Health Security Agency, 650,000 people in England have been infected twice, and most of them were reinfected in the past 2 months. Before mid-November 2021, reinfections accounted for about 1% of reported cases, but the rate has now increased to around 10%. The reinfection risk was 16 times higher between mid-December 2021 and early January 2022. Experts believe that this spike in reinfections is related to the spread of Omicron, which overtook Delta as the dominant variant. Nonetheless, other aspects should also be considered.

Omicron’s greater propensity to spread is not unrelated to its ability to evade the body’s immune defenses. This aspect was raised in a letter recently published in the New England Journal of Medicine. The authors reported that the effectiveness of previous infection in preventing reinfection against the Alpha, Beta, and Delta variants was around 90%, but it was only 56% against Omicron.
 

Natural immunity

Natural immunity showed roughly similar effectiveness regarding protection against reinfection across different SARS-CoV-2 variants, with the exception of the Omicron variant. The risk of hospitalization and death was also reduced in SARS-CoV-2 reinfections versus primary infections. Observational studies indicate that natural immunity may offer equal or greater protection against SARS-CoV-2 infections, compared with immunization with two doses of an mRNA vaccine, but the data are not fully consistent.

Natural immunity seems to be relatively long-lasting. Data from Denmark and Austria show no evidence that protection against reinfections wanes after 6 months. Some investigations indicate that protection against reinfection is lowest 4-5 months after initial infection and increases thereafter, a finding that might hypothetically be explained by persistent viral shedding; that is, misclassification of prolonged SARS-CoV-2 infections as reinfections. While no comparison was made against information pertaining to unvaccinated, not previously-infected individuals, preliminary data from Israel suggest that protection from reinfection can decrease from 6 to more than 12 months after the first SARS-CoV-2 infection. Taken together, epidemiologic studies indicate that protection against reinfections by natural immunity lasts over 1 year with only moderate, if any, decline over this period. Among older individuals, immunocompromised patients, and those with certain comorbidities or exposure risk (for example, health care workers), rates of reinfection may be higher. It is plausible that reinfection risk may be a function of exposure risk.

There is accumulating evidence that reinfections may be significantly less severe than primary infections with SARS-CoV-2. Reduced clinical severity of SARS-CoV-2 reinfections naturally also makes sense from a biologic point of view, inasmuch as a previously primed immune system should be better prepared for a rechallenge with this virus.
 

Vaccine-induced immunity

The short-term (<4 months) efficacy of mRNA vaccines against SARS-CoV-2 is high and varies from 94.1% (Moderna) to 95% (BioNTech/Pfizer). This has been confirmed by randomized controlled trials and was subsequently confirmed in effectiveness studies in real-world settings. Waning efficacy was observed with respect to protection against SARS-CoV-2 infections (for example, only approximately 20% after about half a year in Qatar), whereas protection against severe disease was either sustained or showed only a moderate decline.

In individuals who received two doses of the BioNTech/Pfizer vaccine at least 5 months earlier, an additional vaccine dose, a so-called booster, significantly lowered mortality and severe illness. These findings suggest that the booster restored and probably exceeded the initial short-term efficacy of the initial vaccination.

Data are still emerging regarding the efficacy of boosters against the Omicron variants. Preliminary data suggest a far lower ability to restore protection from infection and vaccination. However, fatalities and hospitalizations remain low.
 

Natural immunity vs. vaccine-induced immunity

Comparisons of natural immunity with vaccine-induced immunity are complicated by a series of biases and by combinations of biases – for example, the biases of comparisons between infected and uninfected, plus the biases of comparisons between vaccinated and nonvaccinated, with strong potential selection biases and confounding. Of particular note, the proportion of people previously infected and/or vaccinated may influence estimates of effectiveness. Regarding this point, one study compared unvaccinated patients with a prior SARS-CoV-2 infection and vaccinated individuals followed up from a week after the second vaccine dose onward versus a group of unvaccinated, not previously infected individuals. The findings showed that, compared with unvaccinated, not previously infected individuals, the natural immunity group and the vaccinated group had similar protection of 94.8% and 92.8% against infection, of 94.1% and 94.2% against hospitalization, and of 96.4% and 94.4% against severe illness, respectively.

Hybrid immunity

The combination of a previous SARS-CoV-2 infection and a respective vaccination is called hybrid immunity. This combination seems to confer the greatest protection against SARS-CoV-2 infections, but several knowledge gaps remain regarding this issue.

Data from Israel showed that, when the time since the last immunity-conferring event (either primary infection or vaccination) was the same, the rates of SARS-CoV-2 infections were similar in the following groups: individuals who had a previous infection and no vaccination, individuals who had an infection and were then vaccinated with a single dose after at least 3 months, and individuals who were vaccinated (two doses) and then infected. Severe disease was relatively rare overall.

Data on the efficacy of hybrid immunity point in the direction of hybrid immunity being superior, as compared with either vaccine-induced (without a booster) immunity or natural immunity alone. Timing and mode of vaccination of previously infected individuals to achieve optimal hybrid immunity are central questions that remain to be addressed in future studies.

Given that vaccination rates are continuously increasing and that, by the beginning of 2022, perhaps half or more of the global population had already been infected with SARS-CoV-2, with the vast majority of this group not being officially detected, it would appear logical that future infection waves, even with highly transmissible variants of SARS-CoV-2, may be limited with respect to their maximum potential health burden. The advent of Omicron suggests that massive surges can occur even in populations with extremely high rates of previous vaccination and variable rates of prior infections. However, even then, the accompanying burden of hospitalizations and deaths is far less than what was seen in 2020 and 2021. One may argue that the pandemic has already transitioned to the endemic phase and that Omicron is an endemic wave occurring in the setting of already widespread population immunity.

A version of this article first appeared on Medscape.com.

Note: In this article, “women” refers to ciswomen – those who identify as women and were assigned female sex at birth. Menopause also affects transmen and nonbinary people, but published research on the menopause experience has included only ciswomen participants.

Gina Brown was boarding an early morning flight in 2016 when suddenly she started to overheat. “As soon as I stepped on the plane, I immediately was drenched in sweat,” she said. Not knowing what to do, she stood still until a fellow female passenger noticed her alarm and asked a flight attendant to grab her a cup of ice. “Is this the first time this has happened to you?” the woman asked, and Ms. Brown nodded. “It’s called a hot flash,” the woman continued, “and you’re going to be okay.”

As soon as Ms. Brown returned from her trip, she visited her doctor for blood work and learned that her hormone levels were decreasing. “I knew something was going on, but [my provider and I] didn’t have a conversation about menopause,” she said. Ms. Brown, who is 56 years old, has been living with HIV for nearly 28 years, and is part of a growing group of women with HIV now entering menopause.

In 1996, a person diagnosed with HIV at 20 years of age could expect to live only to age 39. Because of antiretroviral therapy (ART), an HIV diagnosis is not nearly so dire. Now, someone with HIV who adheres to the ART regimen is estimated to have a lifespan close to that of the general population.

For women with HIV, this means going through menopause. Though this transition can be challenging for any woman, experiencing menopause with HIV adds another level of complication. On top of adhering to daily ART regimens, the woman must also deal with the hormonal changes of menopause and the symptoms that come with it. And the limited research in this area suggests that women with HIV and their clinicians may not be prepared.

“Those of us long-term survivors who have been around for a while never expected to be here, and I don’t think providers or the health care system expected us to be here,” said Vickie A. Lynn, PhD, 56, who has been living with HIV for 37 years and received an AIDS diagnosis in 1991. Her work focuses on health care interventions for people with HIV. “So now that we’re here, I don’t know that we have enough information or research to inform some of our treatment options.” Instead, these women are met with a series of unknowns due to limited studies and conflicting findings.
 

Earlier menopause?

The onset of menopause can be difficult to determine in women living with HIV, said Sara Looby, PhD, ANP-BC, a researcher at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, both in Boston. Her research focuses on metabolic disorders, including bone loss, cardiovascular disease risk, and menopause in women living with HIV. This population is at an increased risk for amenorrhea, due to both behavioral and clinical factors, and sometimes this amenorrhea is mistakenly assumed to be menopause, she explained. A history of smoking, low weight, methadone use, or use of other psychotropic medications are common in women with HIV and can lead to missed periods. Some factors specific to HIV – including a low CD4 count and a history of an AIDS diagnosis – have also been linked to amenorrhea.

This is likely why research studies on the age of onset of menopause with women with HIV can reach conflicting conclusions. Some studies suggest that women with HIV tend to go through menopause 3-5 years earlier than women without HIV. Other studies suggest no difference in the age of onset in menopause between women living with and without HIV. But how menopause status has been accessed can vary from study to study, Dr. Looby said. Future research needs to consider participants’ complete menstrual and reproductive history, as well as relevant medical, social, and behavioral factors, she added, so that the findings are reliably capturing the age of onset of menopause rather than amenorrhea from other causes.

If menopause does occur earlier in women with HIV, there could be additional health implications. Estrogen regulates bone mass, and some research suggests the hormone may be cardioprotective. Estrogen is also thought to increase production of the neurotransmitter serotonin, which could affect mood and cognition. Women with HIV are already at higher risk for bone loss, cardiovascular disease, and depressed mood compared to women without HIV, Dr. Looby said, and as estrogen levels fall during menopause, these conditions may be deleteriously affected.

“If it is determined that women with HIV experience menopause at an earlier age, maybe early to mid-40s instead of 51 and older, they may be at increased risk for cardiovascular and bone conditions as well as mood symptoms associated with estrogen loss at an earlier age than women without HIV, which could be highly detrimental to their physical and mental health,” Dr. Looby said.
 

More frequent and severe menopausal symptoms?

Women with HIV may not only go through menopause earlier than women without HIV, but their symptoms may also be more frequent and more severe. In a 2017 study of both HIV-positive and HIV-negative Nigerian women, participants with HIV had more menopause symptoms overall and were three times as likely to report severe symptoms compared to women without HIV. A 2005 study conducted in New York found HIV-positive women were 24% more likely to report menopause symptoms compared to HIV-negative women in the study.

Looby’s own research has also found a similar pattern. In a study comparing 33 women with HIV to 33 women without HIV – all were close to menopause and matched for age, race, body mass index, and menstrual patterns – women with HIV reported more severe hot flashes and more days with hot flashes. These women also reported that their hot flashes interfered to a much greater degree with daily activities and quality of life compared to participants without HIV.

But studies of women with HIV who are entering menopause are rare, and most include only small numbers of women. As a result, many women with HIV do not know what to expect entering menopause. “I always say, I wish somebody would do some real research on HIV and menopause, because I want to know if it is worse for us or if it is the same,” said Ms. Brown, who works as the director of strategic partnership and community engagement at the Southern Aids Coalition in Powder Springs, Ga. “I would think it’s worse for me.”

More frequent and severe symptoms can have downstream effects, with some evidence suggesting that women with HIV who experience severe menopause symptoms are less likely to stick to their ART regimen. “There’s a clear picture emerging that menopausal symptoms in this group really matter,” said Shema Tariq, PhD, FRCP, an HIV physician-scientist at the University College London Institute for Global Health in England. “They really impact women’s well-being, as well as impacting their ability to look after their long-term condition.”
 

Providers wary of treating menopause symptoms in women with HIV

The little research we do have about women with HIV experiencing menopause suggests that this population could greatly benefit from treatment prescribed in women without HIV for menopause symptoms and conditions, including hormone replacement therapy (HRT). Women with HIV regularly experience night sweats and hot flashes during the menopause transition and may have more severe symptoms than women not living with the virus. If women with HIV also frequently enter early menopause (entering menopause before the age of 45), then this group meets two indications for hormone replacement therapy.

Despite the potential benefits of HRT in this population, some studies suggest this intervention is underutilized. In Dr. Tariq’s Positive Transitions through Menopause (PRIME) study, which explores how menopause affects more than 800 women living with HIV, only 8% of respondents reported using HRT. In a Canadian study that has not yet gone through peer review, 11.8% of perimenopausal and postmenopausal women reported ever using HRT, about half the rate of women in North America without HIV.

Provider discomfort with managing menopause-related care in women with HIV is one reason for such low HRT use in this population, Dr. Tariq said. In a survey of 88 general practitioners in the United Kingdom, nearly all (> 95%) respondents said they were comfortable managing menopause in a general population, but just 46% said they felt comfortable managing menopause in women with HIV. Their top concerns included the potential for drug-to-drug interactions between ART and HRT, missing an HIV-related diagnosis, and risks of menopausal hormone therapy in HIV. Nearly half of respondents (46%) said only specialists should be providing menopause-related care for women with HIV.

But specialists may also feel conflicted about managing menopause-related care in women with HIV, said Dr. Tariq. “If you’re looking at people who manage HIV, you’re looking primarily at infectious disease physicians and HIV physicians. We’re not trained as gynecologists. We’re not used to prescribing HRT,” she said. “And the problem is gynecologists aren’t used to managing HIV. They get nervous about prescribing anything when they see antiretroviral medication because all that people think of is a drug-drug interaction.”

This leaves women with HIV seeking care and treatment for menopause in a difficult situation, where they are “just being ping-ponged around between different health care providers,” said Susan Cole-Haley, 53, an HIV-activist in London who has been living with the virus for 23 years. “So many women with HIV have multiple health conditions and multiple health care providers, which can just make it really problematic and really exhausting in terms of getting help.”
 

Many unknowns

Providers may also be uncomfortable with prescribing hormone therapy because of alarming research in the early 2000s, which found that hormone replacement therapy increased the risk of breast cancer and cardiovascular disease. Later analyses have found no increased cardiovascular disease risk in women who were younger than 60 or were less than 10 years beyond the onset of menopause. Still, the “media frenzy” around the initial findings “has put off a whole load of patients and a whole load of clinicians from even thinking of HRT,” Dr. Tariq said.

Providers may be even more hesitant because people with HIV already have a higher risk for heart disease, due to behaviors such as smoking and HIV-specific factors. (Research has yet to tease out whether these cardiovascular effects are a result of the virus, a result of the antiretroviral therapy, or a result of both factors.) In addition, there have been no prospective studies looking directly at the efficacy and safety of hormone replacement therapy in women with HIV, so providers generally rely on the guidelines for the use of menopausal hormone therapy for women without HIV. While researchers from Canada and the United Kingdom have compiled recommendations for HRT in women with HIV, there is great need for a large-scale clinical trial to establish consistent guidelines for the use of HRT for women with HIV globally, Dr. Looby said.

There are also hormonal preparations and drug-to-drug interactions to consider, though none of the interactions identified so far rise to the level of contraindications. Because of how the liver metabolizes ART and HRT, hormone doses may need to be adjusted, or perhaps administered transdermally via a patch versus a pill form. (Estrogen delivered via skin patch may have reduced cardiovascular disease risk compared to other methods of delivery, some studies in women without HIV suggest.) These expected interactions are based on data from contraceptives, noted Elizabeth King, MD, whose research at the Women’s Health Research Institute at BC Women’s Hospital in Vancouver, B.C., focuses on menopause and HIV. Studies have not been done on drug-drug interactions between ART and HRT specifically, she said, and formulations for HRT are a bit different from contraceptives.

While these unknowns do need to be discussed in shared decision-making around starting HRT in women with HIV, they should not dissuade providers from considering the treatment, Dr. King said. “If women are having extremely troublesome symptoms, then withholding therapy that is potentially beneficial because of worries about some of the things we do not know – I don’t know if that is any better,” she said.

Many women with HIV may not want to start HRT – as was the case for Dr. Lynn. “I’ve taken a lot of medication in my time, and I really try to avoid it as much as possible,” she said. Uncertainties around drug interactions were the main concern for Dawn Averitt, 53, founder of the Well Project, an HIV nonprofit focused on women and girls. Ms. Averitt has lived with HIV for 34 years. “What if some of the things that I’m dealing with could be managed by HRT?” she said. “Or what if taking it exacerbates problems in a way that nobody knows to look for?” In this case, providers may work with patients to discuss nonhormonal treatment options for menopause symptom management.

While some women with HIV may not want HRT, “It’s important that women have that option, and from what we are seeing right now, not a lot of women are even being offered the therapy,” Dr. King said.

There are other nonhormonal treatments available for managing menopause symptoms, including selective serotonin reuptake inhibitors (SSRIs) as well as nonmedicinal interventions such as cognitive behavioral therapy, but these also have not been studied specifically in women with HIV.
 

The path forward

Dr. Tariq and Dr. Looby agreed the next step in expanding our knowledge around HIV and menopause should be to better engage women with HIV in research and clinical care around their experience with menopause. This includes studies on the symptoms they regularly experience and how these symptoms affect their quality of life, including their physical, psychological, cognitive, and social health. These studies could also help researchers and clinicians understand what these women with HIV want for their menopause care, whether that be medication, psychotherapy, and/or peer support groups. These interventions, whether pharmaceutical based or not, can then be assessed based on outcomes in women with HIV, Dr. Tariq noted.

Another important factor is increasing education, on both the patient and provider side, Dr. Looby said. Many women may not know what menopause is, what symptoms look like, and how these hormonal changes can affect their health. If providers keep an open dialogue with female patients around menopause throughout their adult care, that can better prepare women for the menopause transition and alert them to common symptoms they may experience. There also is a great need for provider education, Dr. Looby added. Infectious disease specialists may need further education on menopause management, while women’s health specialists may need additional training for managing care for patients with HIV. Ideally, this information could be shared among a team of providers, including infectious disease, primary care, and women’s health specialists, so that clinicians can collaborate in prescribing treatment for women with HIV, Dr. Looby said.

Lastly, there needs to be more research funding allocated toward answering questions related to menopause and HIV, including the age of onset of menopause in women with HIV, the severity of symptoms, how HIV may influence the menopause transition and vice versa, and regarding the effectiveness of treatment – pharmaceutical and nonpharmaceutical – for women with HIV going through the menopause transition. “If we don’t have funding for these studies, then we won’t have answers to establish clinical care guidelines necessary to support the health, well-being, and quality of life of women with HIV,” Dr. Looby said.

And the number of women living with HIV entering menopause is expected to keep growing, Dr. King added. “It was only a couple of decades ago when women were being told they wouldn’t even live to experience menopause, and now we are at a point where this is the highest proportion of menopausal women ever that we have seen in our HIV clinics,” she said. “It speaks to the success of antiretrovirals,” Dr. King acknowledged, but that also means identifying new challenges and addressing recognized gaps in care.

“We are charting a new course, in some ways,” she added. “There is a lot of work to be done.”

A version of this article first appeared on Medscape.com.

Note: In this article, “women” refers to ciswomen – those who identify as women and were assigned female sex at birth. Menopause also affects transmen and nonbinary people, but published research on the menopause experience has included only ciswomen participants.

Gina Brown was boarding an early morning flight in 2016 when suddenly she started to overheat. “As soon as I stepped on the plane, I immediately was drenched in sweat,” she said. Not knowing what to do, she stood still until a fellow female passenger noticed her alarm and asked a flight attendant to grab her a cup of ice. “Is this the first time this has happened to you?” the woman asked, and Ms. Brown nodded. “It’s called a hot flash,” the woman continued, “and you’re going to be okay.”

As soon as Ms. Brown returned from her trip, she visited her doctor for blood work and learned that her hormone levels were decreasing. “I knew something was going on, but [my provider and I] didn’t have a conversation about menopause,” she said. Ms. Brown, who is 56 years old, has been living with HIV for nearly 28 years, and is part of a growing group of women with HIV now entering menopause.

In 1996, a person diagnosed with HIV at 20 years of age could expect to live only to age 39. Because of antiretroviral therapy (ART), an HIV diagnosis is not nearly so dire. Now, someone with HIV who adheres to the ART regimen is estimated to have a lifespan close to that of the general population.

For women with HIV, this means going through menopause. Though this transition can be challenging for any woman, experiencing menopause with HIV adds another level of complication. On top of adhering to daily ART regimens, the woman must also deal with the hormonal changes of menopause and the symptoms that come with it. And the limited research in this area suggests that women with HIV and their clinicians may not be prepared.

“Those of us long-term survivors who have been around for a while never expected to be here, and I don’t think providers or the health care system expected us to be here,” said Vickie A. Lynn, PhD, 56, who has been living with HIV for 37 years and received an AIDS diagnosis in 1991. Her work focuses on health care interventions for people with HIV. “So now that we’re here, I don’t know that we have enough information or research to inform some of our treatment options.” Instead, these women are met with a series of unknowns due to limited studies and conflicting findings.
 

Earlier menopause?

The onset of menopause can be difficult to determine in women living with HIV, said Sara Looby, PhD, ANP-BC, a researcher at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, both in Boston. Her research focuses on metabolic disorders, including bone loss, cardiovascular disease risk, and menopause in women living with HIV. This population is at an increased risk for amenorrhea, due to both behavioral and clinical factors, and sometimes this amenorrhea is mistakenly assumed to be menopause, she explained. A history of smoking, low weight, methadone use, or use of other psychotropic medications are common in women with HIV and can lead to missed periods. Some factors specific to HIV – including a low CD4 count and a history of an AIDS diagnosis – have also been linked to amenorrhea.

This is likely why research studies on the age of onset of menopause with women with HIV can reach conflicting conclusions. Some studies suggest that women with HIV tend to go through menopause 3-5 years earlier than women without HIV. Other studies suggest no difference in the age of onset in menopause between women living with and without HIV. But how menopause status has been accessed can vary from study to study, Dr. Looby said. Future research needs to consider participants’ complete menstrual and reproductive history, as well as relevant medical, social, and behavioral factors, she added, so that the findings are reliably capturing the age of onset of menopause rather than amenorrhea from other causes.

If menopause does occur earlier in women with HIV, there could be additional health implications. Estrogen regulates bone mass, and some research suggests the hormone may be cardioprotective. Estrogen is also thought to increase production of the neurotransmitter serotonin, which could affect mood and cognition. Women with HIV are already at higher risk for bone loss, cardiovascular disease, and depressed mood compared to women without HIV, Dr. Looby said, and as estrogen levels fall during menopause, these conditions may be deleteriously affected.

“If it is determined that women with HIV experience menopause at an earlier age, maybe early to mid-40s instead of 51 and older, they may be at increased risk for cardiovascular and bone conditions as well as mood symptoms associated with estrogen loss at an earlier age than women without HIV, which could be highly detrimental to their physical and mental health,” Dr. Looby said.
 

More frequent and severe menopausal symptoms?

Women with HIV may not only go through menopause earlier than women without HIV, but their symptoms may also be more frequent and more severe. In a 2017 study of both HIV-positive and HIV-negative Nigerian women, participants with HIV had more menopause symptoms overall and were three times as likely to report severe symptoms compared to women without HIV. A 2005 study conducted in New York found HIV-positive women were 24% more likely to report menopause symptoms compared to HIV-negative women in the study.

Looby’s own research has also found a similar pattern. In a study comparing 33 women with HIV to 33 women without HIV – all were close to menopause and matched for age, race, body mass index, and menstrual patterns – women with HIV reported more severe hot flashes and more days with hot flashes. These women also reported that their hot flashes interfered to a much greater degree with daily activities and quality of life compared to participants without HIV.

But studies of women with HIV who are entering menopause are rare, and most include only small numbers of women. As a result, many women with HIV do not know what to expect entering menopause. “I always say, I wish somebody would do some real research on HIV and menopause, because I want to know if it is worse for us or if it is the same,” said Ms. Brown, who works as the director of strategic partnership and community engagement at the Southern Aids Coalition in Powder Springs, Ga. “I would think it’s worse for me.”

More frequent and severe symptoms can have downstream effects, with some evidence suggesting that women with HIV who experience severe menopause symptoms are less likely to stick to their ART regimen. “There’s a clear picture emerging that menopausal symptoms in this group really matter,” said Shema Tariq, PhD, FRCP, an HIV physician-scientist at the University College London Institute for Global Health in England. “They really impact women’s well-being, as well as impacting their ability to look after their long-term condition.”
 

Providers wary of treating menopause symptoms in women with HIV

The little research we do have about women with HIV experiencing menopause suggests that this population could greatly benefit from treatment prescribed in women without HIV for menopause symptoms and conditions, including hormone replacement therapy (HRT). Women with HIV regularly experience night sweats and hot flashes during the menopause transition and may have more severe symptoms than women not living with the virus. If women with HIV also frequently enter early menopause (entering menopause before the age of 45), then this group meets two indications for hormone replacement therapy.

Despite the potential benefits of HRT in this population, some studies suggest this intervention is underutilized. In Dr. Tariq’s Positive Transitions through Menopause (PRIME) study, which explores how menopause affects more than 800 women living with HIV, only 8% of respondents reported using HRT. In a Canadian study that has not yet gone through peer review, 11.8% of perimenopausal and postmenopausal women reported ever using HRT, about half the rate of women in North America without HIV.

Provider discomfort with managing menopause-related care in women with HIV is one reason for such low HRT use in this population, Dr. Tariq said. In a survey of 88 general practitioners in the United Kingdom, nearly all (> 95%) respondents said they were comfortable managing menopause in a general population, but just 46% said they felt comfortable managing menopause in women with HIV. Their top concerns included the potential for drug-to-drug interactions between ART and HRT, missing an HIV-related diagnosis, and risks of menopausal hormone therapy in HIV. Nearly half of respondents (46%) said only specialists should be providing menopause-related care for women with HIV.

But specialists may also feel conflicted about managing menopause-related care in women with HIV, said Dr. Tariq. “If you’re looking at people who manage HIV, you’re looking primarily at infectious disease physicians and HIV physicians. We’re not trained as gynecologists. We’re not used to prescribing HRT,” she said. “And the problem is gynecologists aren’t used to managing HIV. They get nervous about prescribing anything when they see antiretroviral medication because all that people think of is a drug-drug interaction.”

This leaves women with HIV seeking care and treatment for menopause in a difficult situation, where they are “just being ping-ponged around between different health care providers,” said Susan Cole-Haley, 53, an HIV-activist in London who has been living with the virus for 23 years. “So many women with HIV have multiple health conditions and multiple health care providers, which can just make it really problematic and really exhausting in terms of getting help.”
 

Many unknowns

Providers may also be uncomfortable with prescribing hormone therapy because of alarming research in the early 2000s, which found that hormone replacement therapy increased the risk of breast cancer and cardiovascular disease. Later analyses have found no increased cardiovascular disease risk in women who were younger than 60 or were less than 10 years beyond the onset of menopause. Still, the “media frenzy” around the initial findings “has put off a whole load of patients and a whole load of clinicians from even thinking of HRT,” Dr. Tariq said.

Providers may be even more hesitant because people with HIV already have a higher risk for heart disease, due to behaviors such as smoking and HIV-specific factors. (Research has yet to tease out whether these cardiovascular effects are a result of the virus, a result of the antiretroviral therapy, or a result of both factors.) In addition, there have been no prospective studies looking directly at the efficacy and safety of hormone replacement therapy in women with HIV, so providers generally rely on the guidelines for the use of menopausal hormone therapy for women without HIV. While researchers from Canada and the United Kingdom have compiled recommendations for HRT in women with HIV, there is great need for a large-scale clinical trial to establish consistent guidelines for the use of HRT for women with HIV globally, Dr. Looby said.

There are also hormonal preparations and drug-to-drug interactions to consider, though none of the interactions identified so far rise to the level of contraindications. Because of how the liver metabolizes ART and HRT, hormone doses may need to be adjusted, or perhaps administered transdermally via a patch versus a pill form. (Estrogen delivered via skin patch may have reduced cardiovascular disease risk compared to other methods of delivery, some studies in women without HIV suggest.) These expected interactions are based on data from contraceptives, noted Elizabeth King, MD, whose research at the Women’s Health Research Institute at BC Women’s Hospital in Vancouver, B.C., focuses on menopause and HIV. Studies have not been done on drug-drug interactions between ART and HRT specifically, she said, and formulations for HRT are a bit different from contraceptives.

While these unknowns do need to be discussed in shared decision-making around starting HRT in women with HIV, they should not dissuade providers from considering the treatment, Dr. King said. “If women are having extremely troublesome symptoms, then withholding therapy that is potentially beneficial because of worries about some of the things we do not know – I don’t know if that is any better,” she said.

Many women with HIV may not want to start HRT – as was the case for Dr. Lynn. “I’ve taken a lot of medication in my time, and I really try to avoid it as much as possible,” she said. Uncertainties around drug interactions were the main concern for Dawn Averitt, 53, founder of the Well Project, an HIV nonprofit focused on women and girls. Ms. Averitt has lived with HIV for 34 years. “What if some of the things that I’m dealing with could be managed by HRT?” she said. “Or what if taking it exacerbates problems in a way that nobody knows to look for?” In this case, providers may work with patients to discuss nonhormonal treatment options for menopause symptom management.

While some women with HIV may not want HRT, “It’s important that women have that option, and from what we are seeing right now, not a lot of women are even being offered the therapy,” Dr. King said.

There are other nonhormonal treatments available for managing menopause symptoms, including selective serotonin reuptake inhibitors (SSRIs) as well as nonmedicinal interventions such as cognitive behavioral therapy, but these also have not been studied specifically in women with HIV.
 

The path forward

Dr. Tariq and Dr. Looby agreed the next step in expanding our knowledge around HIV and menopause should be to better engage women with HIV in research and clinical care around their experience with menopause. This includes studies on the symptoms they regularly experience and how these symptoms affect their quality of life, including their physical, psychological, cognitive, and social health. These studies could also help researchers and clinicians understand what these women with HIV want for their menopause care, whether that be medication, psychotherapy, and/or peer support groups. These interventions, whether pharmaceutical based or not, can then be assessed based on outcomes in women with HIV, Dr. Tariq noted.

Another important factor is increasing education, on both the patient and provider side, Dr. Looby said. Many women may not know what menopause is, what symptoms look like, and how these hormonal changes can affect their health. If providers keep an open dialogue with female patients around menopause throughout their adult care, that can better prepare women for the menopause transition and alert them to common symptoms they may experience. There also is a great need for provider education, Dr. Looby added. Infectious disease specialists may need further education on menopause management, while women’s health specialists may need additional training for managing care for patients with HIV. Ideally, this information could be shared among a team of providers, including infectious disease, primary care, and women’s health specialists, so that clinicians can collaborate in prescribing treatment for women with HIV, Dr. Looby said.

Lastly, there needs to be more research funding allocated toward answering questions related to menopause and HIV, including the age of onset of menopause in women with HIV, the severity of symptoms, how HIV may influence the menopause transition and vice versa, and regarding the effectiveness of treatment – pharmaceutical and nonpharmaceutical – for women with HIV going through the menopause transition. “If we don’t have funding for these studies, then we won’t have answers to establish clinical care guidelines necessary to support the health, well-being, and quality of life of women with HIV,” Dr. Looby said.

And the number of women living with HIV entering menopause is expected to keep growing, Dr. King added. “It was only a couple of decades ago when women were being told they wouldn’t even live to experience menopause, and now we are at a point where this is the highest proportion of menopausal women ever that we have seen in our HIV clinics,” she said. “It speaks to the success of antiretrovirals,” Dr. King acknowledged, but that also means identifying new challenges and addressing recognized gaps in care.

“We are charting a new course, in some ways,” she added. “There is a lot of work to be done.”

A version of this article first appeared on Medscape.com.

Note: In this article, “women” refers to ciswomen – those who identify as women and were assigned female sex at birth. Menopause also affects transmen and nonbinary people, but published research on the menopause experience has included only ciswomen participants.

Gina Brown was boarding an early morning flight in 2016 when suddenly she started to overheat. “As soon as I stepped on the plane, I immediately was drenched in sweat,” she said. Not knowing what to do, she stood still until a fellow female passenger noticed her alarm and asked a flight attendant to grab her a cup of ice. “Is this the first time this has happened to you?” the woman asked, and Ms. Brown nodded. “It’s called a hot flash,” the woman continued, “and you’re going to be okay.”

As soon as Ms. Brown returned from her trip, she visited her doctor for blood work and learned that her hormone levels were decreasing. “I knew something was going on, but [my provider and I] didn’t have a conversation about menopause,” she said. Ms. Brown, who is 56 years old, has been living with HIV for nearly 28 years, and is part of a growing group of women with HIV now entering menopause.

In 1996, a person diagnosed with HIV at 20 years of age could expect to live only to age 39. Because of antiretroviral therapy (ART), an HIV diagnosis is not nearly so dire. Now, someone with HIV who adheres to the ART regimen is estimated to have a lifespan close to that of the general population.

For women with HIV, this means going through menopause. Though this transition can be challenging for any woman, experiencing menopause with HIV adds another level of complication. On top of adhering to daily ART regimens, the woman must also deal with the hormonal changes of menopause and the symptoms that come with it. And the limited research in this area suggests that women with HIV and their clinicians may not be prepared.

“Those of us long-term survivors who have been around for a while never expected to be here, and I don’t think providers or the health care system expected us to be here,” said Vickie A. Lynn, PhD, 56, who has been living with HIV for 37 years and received an AIDS diagnosis in 1991. Her work focuses on health care interventions for people with HIV. “So now that we’re here, I don’t know that we have enough information or research to inform some of our treatment options.” Instead, these women are met with a series of unknowns due to limited studies and conflicting findings.
 

Earlier menopause?

The onset of menopause can be difficult to determine in women living with HIV, said Sara Looby, PhD, ANP-BC, a researcher at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, both in Boston. Her research focuses on metabolic disorders, including bone loss, cardiovascular disease risk, and menopause in women living with HIV. This population is at an increased risk for amenorrhea, due to both behavioral and clinical factors, and sometimes this amenorrhea is mistakenly assumed to be menopause, she explained. A history of smoking, low weight, methadone use, or use of other psychotropic medications are common in women with HIV and can lead to missed periods. Some factors specific to HIV – including a low CD4 count and a history of an AIDS diagnosis – have also been linked to amenorrhea.

This is likely why research studies on the age of onset of menopause with women with HIV can reach conflicting conclusions. Some studies suggest that women with HIV tend to go through menopause 3-5 years earlier than women without HIV. Other studies suggest no difference in the age of onset in menopause between women living with and without HIV. But how menopause status has been accessed can vary from study to study, Dr. Looby said. Future research needs to consider participants’ complete menstrual and reproductive history, as well as relevant medical, social, and behavioral factors, she added, so that the findings are reliably capturing the age of onset of menopause rather than amenorrhea from other causes.

If menopause does occur earlier in women with HIV, there could be additional health implications. Estrogen regulates bone mass, and some research suggests the hormone may be cardioprotective. Estrogen is also thought to increase production of the neurotransmitter serotonin, which could affect mood and cognition. Women with HIV are already at higher risk for bone loss, cardiovascular disease, and depressed mood compared to women without HIV, Dr. Looby said, and as estrogen levels fall during menopause, these conditions may be deleteriously affected.

“If it is determined that women with HIV experience menopause at an earlier age, maybe early to mid-40s instead of 51 and older, they may be at increased risk for cardiovascular and bone conditions as well as mood symptoms associated with estrogen loss at an earlier age than women without HIV, which could be highly detrimental to their physical and mental health,” Dr. Looby said.
 

More frequent and severe menopausal symptoms?

Women with HIV may not only go through menopause earlier than women without HIV, but their symptoms may also be more frequent and more severe. In a 2017 study of both HIV-positive and HIV-negative Nigerian women, participants with HIV had more menopause symptoms overall and were three times as likely to report severe symptoms compared to women without HIV. A 2005 study conducted in New York found HIV-positive women were 24% more likely to report menopause symptoms compared to HIV-negative women in the study.

Looby’s own research has also found a similar pattern. In a study comparing 33 women with HIV to 33 women without HIV – all were close to menopause and matched for age, race, body mass index, and menstrual patterns – women with HIV reported more severe hot flashes and more days with hot flashes. These women also reported that their hot flashes interfered to a much greater degree with daily activities and quality of life compared to participants without HIV.

But studies of women with HIV who are entering menopause are rare, and most include only small numbers of women. As a result, many women with HIV do not know what to expect entering menopause. “I always say, I wish somebody would do some real research on HIV and menopause, because I want to know if it is worse for us or if it is the same,” said Ms. Brown, who works as the director of strategic partnership and community engagement at the Southern Aids Coalition in Powder Springs, Ga. “I would think it’s worse for me.”

More frequent and severe symptoms can have downstream effects, with some evidence suggesting that women with HIV who experience severe menopause symptoms are less likely to stick to their ART regimen. “There’s a clear picture emerging that menopausal symptoms in this group really matter,” said Shema Tariq, PhD, FRCP, an HIV physician-scientist at the University College London Institute for Global Health in England. “They really impact women’s well-being, as well as impacting their ability to look after their long-term condition.”
 

Providers wary of treating menopause symptoms in women with HIV

The little research we do have about women with HIV experiencing menopause suggests that this population could greatly benefit from treatment prescribed in women without HIV for menopause symptoms and conditions, including hormone replacement therapy (HRT). Women with HIV regularly experience night sweats and hot flashes during the menopause transition and may have more severe symptoms than women not living with the virus. If women with HIV also frequently enter early menopause (entering menopause before the age of 45), then this group meets two indications for hormone replacement therapy.

Despite the potential benefits of HRT in this population, some studies suggest this intervention is underutilized. In Dr. Tariq’s Positive Transitions through Menopause (PRIME) study, which explores how menopause affects more than 800 women living with HIV, only 8% of respondents reported using HRT. In a Canadian study that has not yet gone through peer review, 11.8% of perimenopausal and postmenopausal women reported ever using HRT, about half the rate of women in North America without HIV.

Provider discomfort with managing menopause-related care in women with HIV is one reason for such low HRT use in this population, Dr. Tariq said. In a survey of 88 general practitioners in the United Kingdom, nearly all (> 95%) respondents said they were comfortable managing menopause in a general population, but just 46% said they felt comfortable managing menopause in women with HIV. Their top concerns included the potential for drug-to-drug interactions between ART and HRT, missing an HIV-related diagnosis, and risks of menopausal hormone therapy in HIV. Nearly half of respondents (46%) said only specialists should be providing menopause-related care for women with HIV.

But specialists may also feel conflicted about managing menopause-related care in women with HIV, said Dr. Tariq. “If you’re looking at people who manage HIV, you’re looking primarily at infectious disease physicians and HIV physicians. We’re not trained as gynecologists. We’re not used to prescribing HRT,” she said. “And the problem is gynecologists aren’t used to managing HIV. They get nervous about prescribing anything when they see antiretroviral medication because all that people think of is a drug-drug interaction.”

This leaves women with HIV seeking care and treatment for menopause in a difficult situation, where they are “just being ping-ponged around between different health care providers,” said Susan Cole-Haley, 53, an HIV-activist in London who has been living with the virus for 23 years. “So many women with HIV have multiple health conditions and multiple health care providers, which can just make it really problematic and really exhausting in terms of getting help.”
 

Many unknowns

Providers may also be uncomfortable with prescribing hormone therapy because of alarming research in the early 2000s, which found that hormone replacement therapy increased the risk of breast cancer and cardiovascular disease. Later analyses have found no increased cardiovascular disease risk in women who were younger than 60 or were less than 10 years beyond the onset of menopause. Still, the “media frenzy” around the initial findings “has put off a whole load of patients and a whole load of clinicians from even thinking of HRT,” Dr. Tariq said.

Providers may be even more hesitant because people with HIV already have a higher risk for heart disease, due to behaviors such as smoking and HIV-specific factors. (Research has yet to tease out whether these cardiovascular effects are a result of the virus, a result of the antiretroviral therapy, or a result of both factors.) In addition, there have been no prospective studies looking directly at the efficacy and safety of hormone replacement therapy in women with HIV, so providers generally rely on the guidelines for the use of menopausal hormone therapy for women without HIV. While researchers from Canada and the United Kingdom have compiled recommendations for HRT in women with HIV, there is great need for a large-scale clinical trial to establish consistent guidelines for the use of HRT for women with HIV globally, Dr. Looby said.

There are also hormonal preparations and drug-to-drug interactions to consider, though none of the interactions identified so far rise to the level of contraindications. Because of how the liver metabolizes ART and HRT, hormone doses may need to be adjusted, or perhaps administered transdermally via a patch versus a pill form. (Estrogen delivered via skin patch may have reduced cardiovascular disease risk compared to other methods of delivery, some studies in women without HIV suggest.) These expected interactions are based on data from contraceptives, noted Elizabeth King, MD, whose research at the Women’s Health Research Institute at BC Women’s Hospital in Vancouver, B.C., focuses on menopause and HIV. Studies have not been done on drug-drug interactions between ART and HRT specifically, she said, and formulations for HRT are a bit different from contraceptives.

While these unknowns do need to be discussed in shared decision-making around starting HRT in women with HIV, they should not dissuade providers from considering the treatment, Dr. King said. “If women are having extremely troublesome symptoms, then withholding therapy that is potentially beneficial because of worries about some of the things we do not know – I don’t know if that is any better,” she said.

Many women with HIV may not want to start HRT – as was the case for Dr. Lynn. “I’ve taken a lot of medication in my time, and I really try to avoid it as much as possible,” she said. Uncertainties around drug interactions were the main concern for Dawn Averitt, 53, founder of the Well Project, an HIV nonprofit focused on women and girls. Ms. Averitt has lived with HIV for 34 years. “What if some of the things that I’m dealing with could be managed by HRT?” she said. “Or what if taking it exacerbates problems in a way that nobody knows to look for?” In this case, providers may work with patients to discuss nonhormonal treatment options for menopause symptom management.

While some women with HIV may not want HRT, “It’s important that women have that option, and from what we are seeing right now, not a lot of women are even being offered the therapy,” Dr. King said.

There are other nonhormonal treatments available for managing menopause symptoms, including selective serotonin reuptake inhibitors (SSRIs) as well as nonmedicinal interventions such as cognitive behavioral therapy, but these also have not been studied specifically in women with HIV.
 

The path forward

Dr. Tariq and Dr. Looby agreed the next step in expanding our knowledge around HIV and menopause should be to better engage women with HIV in research and clinical care around their experience with menopause. This includes studies on the symptoms they regularly experience and how these symptoms affect their quality of life, including their physical, psychological, cognitive, and social health. These studies could also help researchers and clinicians understand what these women with HIV want for their menopause care, whether that be medication, psychotherapy, and/or peer support groups. These interventions, whether pharmaceutical based or not, can then be assessed based on outcomes in women with HIV, Dr. Tariq noted.

Another important factor is increasing education, on both the patient and provider side, Dr. Looby said. Many women may not know what menopause is, what symptoms look like, and how these hormonal changes can affect their health. If providers keep an open dialogue with female patients around menopause throughout their adult care, that can better prepare women for the menopause transition and alert them to common symptoms they may experience. There also is a great need for provider education, Dr. Looby added. Infectious disease specialists may need further education on menopause management, while women’s health specialists may need additional training for managing care for patients with HIV. Ideally, this information could be shared among a team of providers, including infectious disease, primary care, and women’s health specialists, so that clinicians can collaborate in prescribing treatment for women with HIV, Dr. Looby said.

Lastly, there needs to be more research funding allocated toward answering questions related to menopause and HIV, including the age of onset of menopause in women with HIV, the severity of symptoms, how HIV may influence the menopause transition and vice versa, and regarding the effectiveness of treatment – pharmaceutical and nonpharmaceutical – for women with HIV going through the menopause transition. “If we don’t have funding for these studies, then we won’t have answers to establish clinical care guidelines necessary to support the health, well-being, and quality of life of women with HIV,” Dr. Looby said.

And the number of women living with HIV entering menopause is expected to keep growing, Dr. King added. “It was only a couple of decades ago when women were being told they wouldn’t even live to experience menopause, and now we are at a point where this is the highest proportion of menopausal women ever that we have seen in our HIV clinics,” she said. “It speaks to the success of antiretrovirals,” Dr. King acknowledged, but that also means identifying new challenges and addressing recognized gaps in care.

“We are charting a new course, in some ways,” she added. “There is a lot of work to be done.”

A version of this article first appeared on Medscape.com.