MDedge Rheumatology

Key clinical point: Secukinumab was effective in treating patients with psoriatic arthritis (PsA) in real-world clinical settings and generated high levels of satisfaction among physicians.

Major finding: At treatment initiation, 5.6%, 16.3%, and 8.7% of patients were categorized with mild disease, skin, and joint severity, which increased to 75.5%, 83.6%, and 77.6%, respectively, at the current consultation. Patients with Psoriasis Area Severity Index scores of less than 3 increased from 7.1% at treatment initiation to 64.3% at the current consultation. Physician satisfaction with secukinumab treatment was greater than 90% irrespective of disease severity at initiation and several other clinical parameters.

Study details: Findings are from a retrospective analysis of data collected for 572 patients with mild-to-severe PsA from 294 rheumatologists and 144 dermatologists. Included patients received either secukinumab 300 mg or 150 mg for at least 4 months.

Disclosures: This study was funded by Novartis. Dr. Conaghan and Dr. Kiltz declared receiving consultancy or speaker fees and/or research support from several sources including Novartis.

Source: Conaghan PG et al. Curr Med Res Opin. 2021 Jul 23. doi: 10.1080/03007995.2021.1954500.

Key clinical point: Secukinumab was effective in treating patients with psoriatic arthritis (PsA) in real-world clinical settings and generated high levels of satisfaction among physicians.

Major finding: At treatment initiation, 5.6%, 16.3%, and 8.7% of patients were categorized with mild disease, skin, and joint severity, which increased to 75.5%, 83.6%, and 77.6%, respectively, at the current consultation. Patients with Psoriasis Area Severity Index scores of less than 3 increased from 7.1% at treatment initiation to 64.3% at the current consultation. Physician satisfaction with secukinumab treatment was greater than 90% irrespective of disease severity at initiation and several other clinical parameters.

Study details: Findings are from a retrospective analysis of data collected for 572 patients with mild-to-severe PsA from 294 rheumatologists and 144 dermatologists. Included patients received either secukinumab 300 mg or 150 mg for at least 4 months.

Disclosures: This study was funded by Novartis. Dr. Conaghan and Dr. Kiltz declared receiving consultancy or speaker fees and/or research support from several sources including Novartis.

Source: Conaghan PG et al. Curr Med Res Opin. 2021 Jul 23. doi: 10.1080/03007995.2021.1954500.

Key clinical point: Secukinumab was effective in treating patients with psoriatic arthritis (PsA) in real-world clinical settings and generated high levels of satisfaction among physicians.

Major finding: At treatment initiation, 5.6%, 16.3%, and 8.7% of patients were categorized with mild disease, skin, and joint severity, which increased to 75.5%, 83.6%, and 77.6%, respectively, at the current consultation. Patients with Psoriasis Area Severity Index scores of less than 3 increased from 7.1% at treatment initiation to 64.3% at the current consultation. Physician satisfaction with secukinumab treatment was greater than 90% irrespective of disease severity at initiation and several other clinical parameters.

Study details: Findings are from a retrospective analysis of data collected for 572 patients with mild-to-severe PsA from 294 rheumatologists and 144 dermatologists. Included patients received either secukinumab 300 mg or 150 mg for at least 4 months.

Disclosures: This study was funded by Novartis. Dr. Conaghan and Dr. Kiltz declared receiving consultancy or speaker fees and/or research support from several sources including Novartis.

Source: Conaghan PG et al. Curr Med Res Opin. 2021 Jul 23. doi: 10.1080/03007995.2021.1954500.

Key clinical point: Independent of loading dose, secukinumab provided low rates of radiographic progression over 2 years in patients with active psoriatic arthritis (PsA).

Major finding: At 2 years, proportions of patients with no radiographic progression with secukinumab 300 mg, 150 mg, and 150 mg no load were 89.5%, 82.3%, and 81.1%, respectively. Radiographic damage assessed by the mean change from baseline in van der Heijde-modified total Sharp score was 0.10±1.74, 0.52±2.66, and 0.41±2.20 in the secukinumab 300 mg, 150 mg, and 150 mg no-load groups, respectively.

Study details: Findings are end-of-study results from the phase 3 FUTURE 5 trial including 783 patients with active PsA who were randomly assigned to receive secukinumab 300 mg, secukinumab 150 mg with/without loading dose, or placebo for 4 consecutive weeks and every 4 weeks subsequently.

Disclosures: This study was funded by Novartis Pharma. Some of the authors declared receiving research grants and consulting and speaker fees from various sources including Novartis. Four authors declared being past or current employees and/or shareholders of Novartis.

Source: Mease PJ et al. RMD Open. 2021 Jul 30. doi: 10.1136/rmdopen-2021-001600.

Key clinical point: Independent of loading dose, secukinumab provided low rates of radiographic progression over 2 years in patients with active psoriatic arthritis (PsA).

Major finding: At 2 years, proportions of patients with no radiographic progression with secukinumab 300 mg, 150 mg, and 150 mg no load were 89.5%, 82.3%, and 81.1%, respectively. Radiographic damage assessed by the mean change from baseline in van der Heijde-modified total Sharp score was 0.10±1.74, 0.52±2.66, and 0.41±2.20 in the secukinumab 300 mg, 150 mg, and 150 mg no-load groups, respectively.

Study details: Findings are end-of-study results from the phase 3 FUTURE 5 trial including 783 patients with active PsA who were randomly assigned to receive secukinumab 300 mg, secukinumab 150 mg with/without loading dose, or placebo for 4 consecutive weeks and every 4 weeks subsequently.

Disclosures: This study was funded by Novartis Pharma. Some of the authors declared receiving research grants and consulting and speaker fees from various sources including Novartis. Four authors declared being past or current employees and/or shareholders of Novartis.

Source: Mease PJ et al. RMD Open. 2021 Jul 30. doi: 10.1136/rmdopen-2021-001600.

Key clinical point: Independent of loading dose, secukinumab provided low rates of radiographic progression over 2 years in patients with active psoriatic arthritis (PsA).

Major finding: At 2 years, proportions of patients with no radiographic progression with secukinumab 300 mg, 150 mg, and 150 mg no load were 89.5%, 82.3%, and 81.1%, respectively. Radiographic damage assessed by the mean change from baseline in van der Heijde-modified total Sharp score was 0.10±1.74, 0.52±2.66, and 0.41±2.20 in the secukinumab 300 mg, 150 mg, and 150 mg no-load groups, respectively.

Study details: Findings are end-of-study results from the phase 3 FUTURE 5 trial including 783 patients with active PsA who were randomly assigned to receive secukinumab 300 mg, secukinumab 150 mg with/without loading dose, or placebo for 4 consecutive weeks and every 4 weeks subsequently.

Disclosures: This study was funded by Novartis Pharma. Some of the authors declared receiving research grants and consulting and speaker fees from various sources including Novartis. Four authors declared being past or current employees and/or shareholders of Novartis.

Source: Mease PJ et al. RMD Open. 2021 Jul 30. doi: 10.1136/rmdopen-2021-001600.

Key clinical point: Janus kinase (JAK) inhibitors are an effective and safe treatment option for psoriatic arthritis (PsA).

Major finding: The American College of Rheumatology 20 response was significantly higher with JAK inhibitors vs placebo (odds ratio [OR], 3.78; 95% confidence interval [CI], 2.72-5.24). The risk for serious adverse events was not significantly higher with JAK inhibitors vs placebo (OR, 1.12; 95% CI, 0.14-2.82).

Study details: Findings are from a meta-analysis of 5 randomized controlled trials including 3,293 adult patients with PsA who were treated with JAK inhibitors or placebo.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Campanero F et al. Autoimmun Rev. 2021 Jul 15. doi: 10.1016/j.autrev.2021.102902.

Key clinical point: Janus kinase (JAK) inhibitors are an effective and safe treatment option for psoriatic arthritis (PsA).

Major finding: The American College of Rheumatology 20 response was significantly higher with JAK inhibitors vs placebo (odds ratio [OR], 3.78; 95% confidence interval [CI], 2.72-5.24). The risk for serious adverse events was not significantly higher with JAK inhibitors vs placebo (OR, 1.12; 95% CI, 0.14-2.82).

Study details: Findings are from a meta-analysis of 5 randomized controlled trials including 3,293 adult patients with PsA who were treated with JAK inhibitors or placebo.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Campanero F et al. Autoimmun Rev. 2021 Jul 15. doi: 10.1016/j.autrev.2021.102902.

Key clinical point: Janus kinase (JAK) inhibitors are an effective and safe treatment option for psoriatic arthritis (PsA).

Major finding: The American College of Rheumatology 20 response was significantly higher with JAK inhibitors vs placebo (odds ratio [OR], 3.78; 95% confidence interval [CI], 2.72-5.24). The risk for serious adverse events was not significantly higher with JAK inhibitors vs placebo (OR, 1.12; 95% CI, 0.14-2.82).

Study details: Findings are from a meta-analysis of 5 randomized controlled trials including 3,293 adult patients with PsA who were treated with JAK inhibitors or placebo.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Campanero F et al. Autoimmun Rev. 2021 Jul 15. doi: 10.1016/j.autrev.2021.102902.

Key clinical point: Treating skin with biological disease-modifying antirheumatic drugs (bDMARDs) may reduce the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: Patients with psoriasis had a significantly lower risk of developing PsA when treated with bDMARDs vs topics (incidence rate ratio, 0.26; P = .0111). The use of bDMARDs was also protective against PsA development compared with topical/no treatment (hazard ratio, 0.19; P = .025).

Study details: Findings are from a retrospective cohort study including 1,719 patients with psoriasis, of which 1,387, 229, and 103 patients were treated with topics, conventional DMARDs, and bDMARDs, respectively.

Disclosures: This study was supported by a grant from the Pan-American League of Associations for Rheumatology. Few of the authors declared receiving grants, speaker fees, and/or consulting fees outside the submitted work from various sources.

Source: Acosta Felquer ML et al. Ann Rheum Dis. 2021 Jul 19. doi: 10.1136/annrheumdis-2021-220865.

Key clinical point: Treating skin with biological disease-modifying antirheumatic drugs (bDMARDs) may reduce the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: Patients with psoriasis had a significantly lower risk of developing PsA when treated with bDMARDs vs topics (incidence rate ratio, 0.26; P = .0111). The use of bDMARDs was also protective against PsA development compared with topical/no treatment (hazard ratio, 0.19; P = .025).

Study details: Findings are from a retrospective cohort study including 1,719 patients with psoriasis, of which 1,387, 229, and 103 patients were treated with topics, conventional DMARDs, and bDMARDs, respectively.

Disclosures: This study was supported by a grant from the Pan-American League of Associations for Rheumatology. Few of the authors declared receiving grants, speaker fees, and/or consulting fees outside the submitted work from various sources.

Source: Acosta Felquer ML et al. Ann Rheum Dis. 2021 Jul 19. doi: 10.1136/annrheumdis-2021-220865.

Key clinical point: Treating skin with biological disease-modifying antirheumatic drugs (bDMARDs) may reduce the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: Patients with psoriasis had a significantly lower risk of developing PsA when treated with bDMARDs vs topics (incidence rate ratio, 0.26; P = .0111). The use of bDMARDs was also protective against PsA development compared with topical/no treatment (hazard ratio, 0.19; P = .025).

Study details: Findings are from a retrospective cohort study including 1,719 patients with psoriasis, of which 1,387, 229, and 103 patients were treated with topics, conventional DMARDs, and bDMARDs, respectively.

Disclosures: This study was supported by a grant from the Pan-American League of Associations for Rheumatology. Few of the authors declared receiving grants, speaker fees, and/or consulting fees outside the submitted work from various sources.

Source: Acosta Felquer ML et al. Ann Rheum Dis. 2021 Jul 19. doi: 10.1136/annrheumdis-2021-220865.

Key clinical point: Most patients with psoriatic arthritis (PsA) experienced mildly severe psoriasis, but it had an impact on their health-related quality of life (HRQoL) when assessed using a dermatology-specific HRQoL questionnaire (Skindex-17).

Major finding: The majority of patients (71%) had mild psoriasis and remained in this category at 12 months of follow-up. Psoriasis severity did not fluctuate much during the first year with the proportion of patients without psoriasis increasing from 17% at baseline to 34% and those with severe psoriasis remaining stable with 3% at baseline and 2% at 12 months. Psoriasis Area Severity Index score was significantly associated with a psychosocial subscale of Skindex-17 at baseline (incidence rate ratio [IRR], 1.05; 95% confidence interval [CI], 1.02-1.08) and 12 months (IRR, 1.10; 95% CI, 1.05-1.15).

Study details: Findings are from a Dutch cohort including 644 patients with newly diagnosed PsA who were followed up for 1 year.

Disclosures: The study received no specific funding. The authors declared no conflict of interests.

Source: Kasiem FR et al. Rheumatology. 2021 Jul 24. doi: 10.1093/rheumatology/keab606.

Key clinical point: Most patients with psoriatic arthritis (PsA) experienced mildly severe psoriasis, but it had an impact on their health-related quality of life (HRQoL) when assessed using a dermatology-specific HRQoL questionnaire (Skindex-17).

Major finding: The majority of patients (71%) had mild psoriasis and remained in this category at 12 months of follow-up. Psoriasis severity did not fluctuate much during the first year with the proportion of patients without psoriasis increasing from 17% at baseline to 34% and those with severe psoriasis remaining stable with 3% at baseline and 2% at 12 months. Psoriasis Area Severity Index score was significantly associated with a psychosocial subscale of Skindex-17 at baseline (incidence rate ratio [IRR], 1.05; 95% confidence interval [CI], 1.02-1.08) and 12 months (IRR, 1.10; 95% CI, 1.05-1.15).

Study details: Findings are from a Dutch cohort including 644 patients with newly diagnosed PsA who were followed up for 1 year.

Disclosures: The study received no specific funding. The authors declared no conflict of interests.

Source: Kasiem FR et al. Rheumatology. 2021 Jul 24. doi: 10.1093/rheumatology/keab606.

Key clinical point: Most patients with psoriatic arthritis (PsA) experienced mildly severe psoriasis, but it had an impact on their health-related quality of life (HRQoL) when assessed using a dermatology-specific HRQoL questionnaire (Skindex-17).

Major finding: The majority of patients (71%) had mild psoriasis and remained in this category at 12 months of follow-up. Psoriasis severity did not fluctuate much during the first year with the proportion of patients without psoriasis increasing from 17% at baseline to 34% and those with severe psoriasis remaining stable with 3% at baseline and 2% at 12 months. Psoriasis Area Severity Index score was significantly associated with a psychosocial subscale of Skindex-17 at baseline (incidence rate ratio [IRR], 1.05; 95% confidence interval [CI], 1.02-1.08) and 12 months (IRR, 1.10; 95% CI, 1.05-1.15).

Study details: Findings are from a Dutch cohort including 644 patients with newly diagnosed PsA who were followed up for 1 year.

Disclosures: The study received no specific funding. The authors declared no conflict of interests.

Source: Kasiem FR et al. Rheumatology. 2021 Jul 24. doi: 10.1093/rheumatology/keab606.

Key clinical point: Guselkumab 100 mg every 4 weeks (Q4W) or 8 weeks (Q8W) provided a clinically meaningful reduction in fatigue in patients with active psoriatic arthritis (PsA).

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W (63%; P less than .001) and Q8W (54%; P less than .01) vs placebo (35%) achieved 4-point or higher improvement in Functional Assessment of Chronic Illness Therapy-Fatigue scores in DISCOVER-1. Findings were similar with guselkumab Q4W (60%; P less than .01) and Q8W (61%; P less than .001) vs placebo (46%) in DISCOVER-2. Improvements were maintained until week 52.

Study details: Findings are from the analysis of 2 phase 3 trials (DISCOVER 1 and DISCOVER 2) including 1,120 patients with active PsA who were randomly assigned to guselkumab 100 mg at week 0 and then Q4W, guselkumab 100 mg at weeks 0 and 4 and then Q8W, or placebo Q4W.

Disclosures: This study was funded by Janssen Research & Development, LLC. Some of the authors declared receiving grants, consulting fees, and speaker’s bureau support from various sources including Janssen. Seven of the authors declared being employees and stockholders of Johnson & Johnson.

Source: Rahman P et al. Arthritis Res Ther. 2021 Jul 14. doi: 10.1186/s13075-021-02554-3.

Key clinical point: Guselkumab 100 mg every 4 weeks (Q4W) or 8 weeks (Q8W) provided a clinically meaningful reduction in fatigue in patients with active psoriatic arthritis (PsA).

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W (63%; P less than .001) and Q8W (54%; P less than .01) vs placebo (35%) achieved 4-point or higher improvement in Functional Assessment of Chronic Illness Therapy-Fatigue scores in DISCOVER-1. Findings were similar with guselkumab Q4W (60%; P less than .01) and Q8W (61%; P less than .001) vs placebo (46%) in DISCOVER-2. Improvements were maintained until week 52.

Study details: Findings are from the analysis of 2 phase 3 trials (DISCOVER 1 and DISCOVER 2) including 1,120 patients with active PsA who were randomly assigned to guselkumab 100 mg at week 0 and then Q4W, guselkumab 100 mg at weeks 0 and 4 and then Q8W, or placebo Q4W.

Disclosures: This study was funded by Janssen Research & Development, LLC. Some of the authors declared receiving grants, consulting fees, and speaker’s bureau support from various sources including Janssen. Seven of the authors declared being employees and stockholders of Johnson & Johnson.

Source: Rahman P et al. Arthritis Res Ther. 2021 Jul 14. doi: 10.1186/s13075-021-02554-3.

Key clinical point: Guselkumab 100 mg every 4 weeks (Q4W) or 8 weeks (Q8W) provided a clinically meaningful reduction in fatigue in patients with active psoriatic arthritis (PsA).

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W (63%; P less than .001) and Q8W (54%; P less than .01) vs placebo (35%) achieved 4-point or higher improvement in Functional Assessment of Chronic Illness Therapy-Fatigue scores in DISCOVER-1. Findings were similar with guselkumab Q4W (60%; P less than .01) and Q8W (61%; P less than .001) vs placebo (46%) in DISCOVER-2. Improvements were maintained until week 52.

Study details: Findings are from the analysis of 2 phase 3 trials (DISCOVER 1 and DISCOVER 2) including 1,120 patients with active PsA who were randomly assigned to guselkumab 100 mg at week 0 and then Q4W, guselkumab 100 mg at weeks 0 and 4 and then Q8W, or placebo Q4W.

Disclosures: This study was funded by Janssen Research & Development, LLC. Some of the authors declared receiving grants, consulting fees, and speaker’s bureau support from various sources including Janssen. Seven of the authors declared being employees and stockholders of Johnson & Johnson.

Source: Rahman P et al. Arthritis Res Ther. 2021 Jul 14. doi: 10.1186/s13075-021-02554-3.

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

The death ‘dog’

Imagine you’re out in your backyard managing the grill for a big family barbecue. You’ve got a dazzling assortment of meat assorted on your fancy new propane grill, all charring nicely. Naturally, the hot dogs finish first, and as you pull them off, you figure you’ll help yourself to one now. After all, you are the chef, you deserve a reward. But, as you bite into your smoking hot sandwich, a cold, bony finger taps you on the shoulder. You turn and come face to face with the Grim Reaper. “YOU JUST LOST 36 MINUTES,” Death says. “ALSO, MAY I HAVE ONE OF THOSE? THEY LOOK DELICIOUS.”

PxHere

Nonplussed and moving automatically, you scoop up another hot dog and place it in a bun. “WITH KETCHUP PLEASE,” Death says. “I NEVER CARED FOR MUSTARD.”

“I don’t understand,” you say. “Surely I won’t die at a family barbecue.”

“DO NOT CALL ME SHIRLEY,” Death says. “AND YOU WILL NOT. IT’S PART OF MY NEW CONTRACT.”

A new study, published in Nature Food, found that a person may lose up to 36 minutes for every hot dog consumed. Researchers from the University of Michigan analyzed nearly 6,000 different foods using a new nutritional index to quantify their health effects in minutes of healthy life lost or gained. Eating a serving of nuts adds an extra 26 minutes of life. The researchers determined that replacing just 10% of daily caloric intake from beef and processed foods with fruits, vegetables, and nuts can add 48 minutes per day. It would also reduce the daily carbon footprint by 33%.

“So you go around to everyone eating bad food and tell them how much life they’ve lost?” you ask when the Grim Reaper finishes his story. “Sounds like a drag.”

“IT IS. WE’VE HAD TO HIRE NEW BLOOD.” Death chuckles at its own bad pun. “NOW IF YOU’LL EXCUSE ME, I MUST CHASTISE A MAN IN FLORIDA FOR EATING A WELL-DONE STEAK.”
 

More stress, less sex

As the world becomes a more stressful place, the human population could face a 50% drop by the end of the century.

John Hain/Pixabay

Think of stress as a one-two punch to the libido and human fertility. The more people are stressed out, the less likely they are to have quality interactions with others. Many of us would rather be alone with our wine and cheese to watch our favorite show.

Researchers have found that high stress levels have been known to drop sperm count, ovulation, and sexual activity. Guess what? There has been a 50% decrease in sperm counts over the last 50 years. That’s the second punch. But let’s not forget, the times are changing.

“Changes in reproductive behavior that contribute to the population drop include more young couples choosing to be ‘child-free,’ people having fewer children, and couples waiting longer to start families,” said Alexander Suvorov, PhD, of the University of Massachusetts, the paper’s author.

Let’s summarize: The more stress we’re dealing with, the less people want to deal with each other.

Who would have thought the future would be less fun?
 

‘You are not a horse. You are not a cow. Seriously, y’all. Stop it.’

WARNING: The following descriptions of COVID-19–related insanity may be offensive to some readers.

Greetings, ladies and gentlemen! Welcome to the first round of Pandemic Pandemonium. Let’s get right to the action.

South_agency/Getty Images

This week’s preshow match-off involves face mask woes. The first comes to us from Alabama, where a woman wore a space helmet to a school board meeting to protest mask mandates. The second comes from Australia, in the form of mischievous magpies. We will explain.

It is not uncommon for magpies to attack those who come too close to their nests in the spring, or “swooping season,” as it’s affectionately called. The magpies are smart enough to recognize the faces of people they see regularly and not attack; however, it’s feared that mask wearing will change this.

While you’re chewing on that exciting appetizer, let’s take a look at our main course, which has a distinct governmental flavor. Jeff Landry is the attorney general of Louisiana, and, like our space-helmet wearer, he’s not a fan of mask mandates. According to Business Insider, Mr. Landry “drafted and distributed sample letters intended to help parents evade mask-wearing ordinances and COVID-19 vaccination requirements for their children in schools.”

Up against him is the Food and Drug Administration’s Twitter account. In an unrelated matter, the agency tweeted, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This was in response to people using the nonhuman forms of ivermectin to treat very human COVID-19.

Well, there you have it. Who will win tonight’s exciting edition of Pandemic Pandemonium? The first reader to contact us gets to decide the fate of these worthy contestants.
 

From venomous poison to heart drug

It’s not likely that anyone who sees a giant, venomous spider is thinking, “Hey! That thing could save my life!” It’s usually quite the opposite. Honestly, we would run away from just about any spider. But what if one of the deadliest spiders in the world could also save you from dying of a heart attack?

PxHere

You probably don’t believe us, right? That’s fair, but the deadly Fraser Island (K’gari) funnel web spider, might also be the most helpful. Investigators from the University of Queensland in Australia have found a way to extract a molecule from the spider’s venom that might help stop damage from heart attacks and may even preserve hearts being used for transplants. “The Hi1a protein from spider venom blocks acid-sensing ion channels in the heart, so the death message is blocked, cell death is reduced, and we see improved heart cell survival,” Nathan Palpant, PhD, of the university, noted in a written statement.

No one has ever developed a drug to stop the “death signal,” so maybe it’s time to befriend spiders instead of running away from them in horror. Just leave the venom extraction to the professionals.

The death ‘dog’

Imagine you’re out in your backyard managing the grill for a big family barbecue. You’ve got a dazzling assortment of meat assorted on your fancy new propane grill, all charring nicely. Naturally, the hot dogs finish first, and as you pull them off, you figure you’ll help yourself to one now. After all, you are the chef, you deserve a reward. But, as you bite into your smoking hot sandwich, a cold, bony finger taps you on the shoulder. You turn and come face to face with the Grim Reaper. “YOU JUST LOST 36 MINUTES,” Death says. “ALSO, MAY I HAVE ONE OF THOSE? THEY LOOK DELICIOUS.”

PxHere

Nonplussed and moving automatically, you scoop up another hot dog and place it in a bun. “WITH KETCHUP PLEASE,” Death says. “I NEVER CARED FOR MUSTARD.”

“I don’t understand,” you say. “Surely I won’t die at a family barbecue.”

“DO NOT CALL ME SHIRLEY,” Death says. “AND YOU WILL NOT. IT’S PART OF MY NEW CONTRACT.”

A new study, published in Nature Food, found that a person may lose up to 36 minutes for every hot dog consumed. Researchers from the University of Michigan analyzed nearly 6,000 different foods using a new nutritional index to quantify their health effects in minutes of healthy life lost or gained. Eating a serving of nuts adds an extra 26 minutes of life. The researchers determined that replacing just 10% of daily caloric intake from beef and processed foods with fruits, vegetables, and nuts can add 48 minutes per day. It would also reduce the daily carbon footprint by 33%.

“So you go around to everyone eating bad food and tell them how much life they’ve lost?” you ask when the Grim Reaper finishes his story. “Sounds like a drag.”

“IT IS. WE’VE HAD TO HIRE NEW BLOOD.” Death chuckles at its own bad pun. “NOW IF YOU’LL EXCUSE ME, I MUST CHASTISE A MAN IN FLORIDA FOR EATING A WELL-DONE STEAK.”
 

More stress, less sex

As the world becomes a more stressful place, the human population could face a 50% drop by the end of the century.

John Hain/Pixabay

Think of stress as a one-two punch to the libido and human fertility. The more people are stressed out, the less likely they are to have quality interactions with others. Many of us would rather be alone with our wine and cheese to watch our favorite show.

Researchers have found that high stress levels have been known to drop sperm count, ovulation, and sexual activity. Guess what? There has been a 50% decrease in sperm counts over the last 50 years. That’s the second punch. But let’s not forget, the times are changing.

“Changes in reproductive behavior that contribute to the population drop include more young couples choosing to be ‘child-free,’ people having fewer children, and couples waiting longer to start families,” said Alexander Suvorov, PhD, of the University of Massachusetts, the paper’s author.

Let’s summarize: The more stress we’re dealing with, the less people want to deal with each other.

Who would have thought the future would be less fun?
 

‘You are not a horse. You are not a cow. Seriously, y’all. Stop it.’

WARNING: The following descriptions of COVID-19–related insanity may be offensive to some readers.

Greetings, ladies and gentlemen! Welcome to the first round of Pandemic Pandemonium. Let’s get right to the action.

South_agency/Getty Images

This week’s preshow match-off involves face mask woes. The first comes to us from Alabama, where a woman wore a space helmet to a school board meeting to protest mask mandates. The second comes from Australia, in the form of mischievous magpies. We will explain.

It is not uncommon for magpies to attack those who come too close to their nests in the spring, or “swooping season,” as it’s affectionately called. The magpies are smart enough to recognize the faces of people they see regularly and not attack; however, it’s feared that mask wearing will change this.

While you’re chewing on that exciting appetizer, let’s take a look at our main course, which has a distinct governmental flavor. Jeff Landry is the attorney general of Louisiana, and, like our space-helmet wearer, he’s not a fan of mask mandates. According to Business Insider, Mr. Landry “drafted and distributed sample letters intended to help parents evade mask-wearing ordinances and COVID-19 vaccination requirements for their children in schools.”

Up against him is the Food and Drug Administration’s Twitter account. In an unrelated matter, the agency tweeted, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This was in response to people using the nonhuman forms of ivermectin to treat very human COVID-19.

Well, there you have it. Who will win tonight’s exciting edition of Pandemic Pandemonium? The first reader to contact us gets to decide the fate of these worthy contestants.
 

From venomous poison to heart drug

It’s not likely that anyone who sees a giant, venomous spider is thinking, “Hey! That thing could save my life!” It’s usually quite the opposite. Honestly, we would run away from just about any spider. But what if one of the deadliest spiders in the world could also save you from dying of a heart attack?

PxHere

You probably don’t believe us, right? That’s fair, but the deadly Fraser Island (K’gari) funnel web spider, might also be the most helpful. Investigators from the University of Queensland in Australia have found a way to extract a molecule from the spider’s venom that might help stop damage from heart attacks and may even preserve hearts being used for transplants. “The Hi1a protein from spider venom blocks acid-sensing ion channels in the heart, so the death message is blocked, cell death is reduced, and we see improved heart cell survival,” Nathan Palpant, PhD, of the university, noted in a written statement.

No one has ever developed a drug to stop the “death signal,” so maybe it’s time to befriend spiders instead of running away from them in horror. Just leave the venom extraction to the professionals.

The death ‘dog’

Imagine you’re out in your backyard managing the grill for a big family barbecue. You’ve got a dazzling assortment of meat assorted on your fancy new propane grill, all charring nicely. Naturally, the hot dogs finish first, and as you pull them off, you figure you’ll help yourself to one now. After all, you are the chef, you deserve a reward. But, as you bite into your smoking hot sandwich, a cold, bony finger taps you on the shoulder. You turn and come face to face with the Grim Reaper. “YOU JUST LOST 36 MINUTES,” Death says. “ALSO, MAY I HAVE ONE OF THOSE? THEY LOOK DELICIOUS.”

PxHere

Nonplussed and moving automatically, you scoop up another hot dog and place it in a bun. “WITH KETCHUP PLEASE,” Death says. “I NEVER CARED FOR MUSTARD.”

“I don’t understand,” you say. “Surely I won’t die at a family barbecue.”

“DO NOT CALL ME SHIRLEY,” Death says. “AND YOU WILL NOT. IT’S PART OF MY NEW CONTRACT.”

A new study, published in Nature Food, found that a person may lose up to 36 minutes for every hot dog consumed. Researchers from the University of Michigan analyzed nearly 6,000 different foods using a new nutritional index to quantify their health effects in minutes of healthy life lost or gained. Eating a serving of nuts adds an extra 26 minutes of life. The researchers determined that replacing just 10% of daily caloric intake from beef and processed foods with fruits, vegetables, and nuts can add 48 minutes per day. It would also reduce the daily carbon footprint by 33%.

“So you go around to everyone eating bad food and tell them how much life they’ve lost?” you ask when the Grim Reaper finishes his story. “Sounds like a drag.”

“IT IS. WE’VE HAD TO HIRE NEW BLOOD.” Death chuckles at its own bad pun. “NOW IF YOU’LL EXCUSE ME, I MUST CHASTISE A MAN IN FLORIDA FOR EATING A WELL-DONE STEAK.”
 

More stress, less sex

As the world becomes a more stressful place, the human population could face a 50% drop by the end of the century.

John Hain/Pixabay

Think of stress as a one-two punch to the libido and human fertility. The more people are stressed out, the less likely they are to have quality interactions with others. Many of us would rather be alone with our wine and cheese to watch our favorite show.

Researchers have found that high stress levels have been known to drop sperm count, ovulation, and sexual activity. Guess what? There has been a 50% decrease in sperm counts over the last 50 years. That’s the second punch. But let’s not forget, the times are changing.

“Changes in reproductive behavior that contribute to the population drop include more young couples choosing to be ‘child-free,’ people having fewer children, and couples waiting longer to start families,” said Alexander Suvorov, PhD, of the University of Massachusetts, the paper’s author.

Let’s summarize: The more stress we’re dealing with, the less people want to deal with each other.

Who would have thought the future would be less fun?
 

‘You are not a horse. You are not a cow. Seriously, y’all. Stop it.’

WARNING: The following descriptions of COVID-19–related insanity may be offensive to some readers.

Greetings, ladies and gentlemen! Welcome to the first round of Pandemic Pandemonium. Let’s get right to the action.

South_agency/Getty Images

This week’s preshow match-off involves face mask woes. The first comes to us from Alabama, where a woman wore a space helmet to a school board meeting to protest mask mandates. The second comes from Australia, in the form of mischievous magpies. We will explain.

It is not uncommon for magpies to attack those who come too close to their nests in the spring, or “swooping season,” as it’s affectionately called. The magpies are smart enough to recognize the faces of people they see regularly and not attack; however, it’s feared that mask wearing will change this.

While you’re chewing on that exciting appetizer, let’s take a look at our main course, which has a distinct governmental flavor. Jeff Landry is the attorney general of Louisiana, and, like our space-helmet wearer, he’s not a fan of mask mandates. According to Business Insider, Mr. Landry “drafted and distributed sample letters intended to help parents evade mask-wearing ordinances and COVID-19 vaccination requirements for their children in schools.”

Up against him is the Food and Drug Administration’s Twitter account. In an unrelated matter, the agency tweeted, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This was in response to people using the nonhuman forms of ivermectin to treat very human COVID-19.

Well, there you have it. Who will win tonight’s exciting edition of Pandemic Pandemonium? The first reader to contact us gets to decide the fate of these worthy contestants.
 

From venomous poison to heart drug

It’s not likely that anyone who sees a giant, venomous spider is thinking, “Hey! That thing could save my life!” It’s usually quite the opposite. Honestly, we would run away from just about any spider. But what if one of the deadliest spiders in the world could also save you from dying of a heart attack?

PxHere

You probably don’t believe us, right? That’s fair, but the deadly Fraser Island (K’gari) funnel web spider, might also be the most helpful. Investigators from the University of Queensland in Australia have found a way to extract a molecule from the spider’s venom that might help stop damage from heart attacks and may even preserve hearts being used for transplants. “The Hi1a protein from spider venom blocks acid-sensing ion channels in the heart, so the death message is blocked, cell death is reduced, and we see improved heart cell survival,” Nathan Palpant, PhD, of the university, noted in a written statement.

No one has ever developed a drug to stop the “death signal,” so maybe it’s time to befriend spiders instead of running away from them in horror. Just leave the venom extraction to the professionals.