MDedge Rheumatology

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.

Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.

John Fedele/Getty Images

In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.

These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.

Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.

When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.

“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”

The COVID-19 pandemic put to the test physicians’ ability to speak publicly about troublesome issues. In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.

Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
 

The case of one physician who spoke out

One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.

In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
 

Postings on Facebook

Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.

Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.

He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.

Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.

In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
 

How employers react to physicians who speak out

Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.

“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”

Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.

Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.

“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
 

Administrator fires back

Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.

Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”

Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”

Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
 

Doctor allegedly offered “misinformation”

At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”

PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”

Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.

“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”

Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
 

Doctor gets a warning

Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.

Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.

“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.

“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.

Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.

In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.

Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.

Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.

Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”

He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
 

Do doctors who speak out have any rights?

Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.

The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.

The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.

In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.

Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
 

Conclusion

To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.

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

In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.

John Fedele/Getty Images

In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.

These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.

Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.

When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.

“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”

The COVID-19 pandemic put to the test physicians’ ability to speak publicly about troublesome issues. In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.

Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
 

The case of one physician who spoke out

One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.

In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
 

Postings on Facebook

Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.

Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.

He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.

Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.

In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
 

How employers react to physicians who speak out

Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.

“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”

Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.

Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.

“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
 

Administrator fires back

Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.

Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”

Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”

Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
 

Doctor allegedly offered “misinformation”

At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”

PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”

Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.

“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”

Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
 

Doctor gets a warning

Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.

Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.

“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.

“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.

Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.

In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.

Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.

Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.

Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”

He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
 

Do doctors who speak out have any rights?

Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.

The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.

The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.

In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.

Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
 

Conclusion

To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.

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

In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.

John Fedele/Getty Images

In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.

These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.

Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.

When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.

“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”

The COVID-19 pandemic put to the test physicians’ ability to speak publicly about troublesome issues. In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.

Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
 

The case of one physician who spoke out

One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.

In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
 

Postings on Facebook

Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.

Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.

He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.

Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.

In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
 

How employers react to physicians who speak out

Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.

“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”

Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.

Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.

“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
 

Administrator fires back

Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.

Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”

Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”

Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
 

Doctor allegedly offered “misinformation”

At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”

PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”

Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.

“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”

Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
 

Doctor gets a warning

Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.

Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.

“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.

“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.

Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.

In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.

Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.

Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.

Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”

He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
 

Do doctors who speak out have any rights?

Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.

The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.

The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.

In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.

Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
 

Conclusion

To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.

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

A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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

A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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

A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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