Accessing unproven interventions in the COVID-19 pandemic: discussion on the ethics of ‘compassionate therapies’ in times of catastrophic pandemics

Zuckerman, Shlomit; Bar-Lavie, Yaron; Niv, Yaron; Arad, Dana; Lev, Shaul

doi:10.1136/medethics-2020-106783

Cited by 7 publications

(6 citation statements)

References 49 publications

(43 reference statements)

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“…Over 90% of doctors used OfLDs for the management of COVID-19 patients. This was similar to how it was done elsewhere in the world [ 8 ]. About 16.9% (71) of doctors agreed that CAM has a beneficial role in COVID-19 infection, which is a matter of some concern because they were allopathic doctors who were not supposed to be prescribing CAMs.…”

Section: Discussionsupporting

confidence: 79%

Use of Off-Label Drugs in COVID-19: Clinicians’ Perceptions Based on a Cross-Sectional Observational Study

Sagar¹,

Sharma²

2023

Cureus

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Introduction The absence of a common National Treatment Guideline during the second wave of the COVID-19 pandemic in India resulted in different treatment strategies, and the use of "off-label drugs" (OfLDs) was one of them. Aims This study aimed to assess the proportion of doctors who prescribed OfLDs, their perceived appropriateness, and the factors leading to their use. Settings and design This is an undergraduate student research project, in which a web-based cross-sectional survey was conducted on doctors who delivered care to COVID-19 patients during the second wave of the pandemic in Uttarakhand, India. Materials and methods The minimum sample size was 370 (for a 95% confidence level, an alpha error of 0.5, and a power of 80%). Data were collected electronically using a validated questionnaire after institutional ethical clearance and the participants' consent. Statistical analysis This is a descriptive-analytical study. Results We received 419 completed responses; all specialties had seen COVID-19 patients, and 91.4% (383) of the doctors had provided care to COVID-19 patients in some way or the other. About 90.7% (380) of the doctors used OfLDs; 62.5% (262) agreed that OfLDs were beneficial, and 78.9% (331) disagreed on universal steroid use. Only 34.1% (143) felt that using OfLDs was ethical. About 16.9% (71) of the doctors believed that alternative medicine was a useful treatment adjunct, and 20% (84) of doctors prescribed OfLDs under duress. About 21.2% (89) believed that Remdesivir was the main treatment for the disease, and 18.6% (78) believed that Tocilizumab was the main treatment for the disease. Personal experience, conviction, or advice from peers were among the various reasons that were put forward for using OfLDs. Conclusions The use of OfLDs during the COVID-19 pandemic in India was extensive. It was done sometimes under pressure and was largely based on confusion (multiplicity of guidelines, many times at variance with each other) as well as on a personal or low level of scientific evidence forwarded to support the use.

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Section: Discussionsupporting

confidence: 79%

Use of Off-Label Drugs in COVID-19: Clinicians’ Perceptions Based on a Cross-Sectional Observational Study

Sagar¹,

Sharma²

2023

Cureus

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“…Our data was collected in the early stage of the pandemic when standard medical strategies were not established with consequent usage of untested medical therapies ( Zuckerman et al, 2022 ). Furthermore, the center-specific anticoagulation regimes began to be used as the pandemic progressed, while patients enrolled in the Ctrl were mainly treated during the very early stage of the study.…”

Section: Discussionmentioning

confidence: 99%

Prophylactic rivaroxaban in the early post-discharge period reduces the rates of hospitalization for atrial fibrillation and incidence of sudden cardiac death during long-term follow-up in hospitalized COVID-19 survivors

et al. 2023

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Introduction: While acute Coronavirus disease 2019 (COVID-19) affects the cardiovascular (CV) system according to recent data, an increased CV risk has been reported also during long-term follow-up (FU). In addition to other CV pathologies in COVID-19 survivors, an enhanced risk for arrhythmic events and sudden cardiac death (SCD) has been observed. While recommendations on post-discharge thromboprophylaxis are conflicting in this population, prophylactic short-term rivaroxaban therapy after hospital discharge showed promising results. However, the impact of this regimen on the incidence of cardiac arrhythmias has not been evaluated to date.Methods: To investigate the efficacy of this therapy, we conducted a single center, retrospective analysis of 1804 consecutive, hospitalized COVID-19 survivors between April and December 2020. Patients received either a 30-day post-discharge thromboprophylaxis treatment regimen using rivaroxaban 10 mg every day (QD) (Rivaroxaban group (Riva); n = 996) or no thromboprophylaxis (Control group (Ctrl); n = 808). Hospitalization for new atrial fibrillation (AF), new higher-degree Atrioventricular-block (AVB) as well as incidence of SCD were investigated in 12-month FU [FU: 347 (310/449) days].Results: No differences in baseline characteristics (Ctrl vs Riva: age: 59.0 (48.9/66.8) vs 57 (46.5/64.9) years, p = n.s.; male: 41.5% vs 43.7%, p = n.s.) and in the history of relevant CV-disease were observed between the two groups. While hospitalizations for AVB were not reported in either group, relevant rates of hospitalizations for new AF (0.99%, n = 8/808) as well as a high rate of SCD events (2.35%, n = 19/808) were seen in the Ctrl. These cardiac events were attenuated by early post-discharge prophylactic rivaroxaban therapy (AF: n = 2/996, 0.20%, p = 0.026 and SCD: n = 3/996, 0.30%, p < 0.001) which was also observed after applying a logistic regression model for propensity score matching (AF: χ2-statistics = 6.45, p = 0.013 and SCD: χ2-statistics = 9.33, p = 0.002). Of note, no major bleeding complications were observed in either group.Conclusion: Atrial arrhythmic and SCD events are present during the first 12 months after hospitalization for COVID-19. Extended prophylactic Rivaroxaban therapy after hospital discharge could reduce new onset of AF and SCD in hospitalized COVID-19 survivors.

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“…The appropriateness of using such unproven COVID-19 therapies (UCT) has been widely debated ( Schellack et al, 2022 , Lim et al, 2022 , Zuckerman et al, 2021 , Al-Heeti et al, 2022 , Mastroleo and Daly, n.d. ). Distrust of clinicians is amplified when patients requests are denied, yet clinicians have an ethical obligation not to prescribe ineffective medications that have risk of side effects.…”

Section: Introductionmentioning

confidence: 99%

A mixed methods study exploring requests for unproven COVID therapies such as ivermectin and healthcare distrust in the rural South

Scoy

Duda

Scott

et al. 2023

Preventive Medicine Reports

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Accessing unproven interventions in the COVID-19 pandemic: discussion on the ethics of ‘compassionate therapies’ in times of catastrophic pandemics

Cited by 7 publications

References 49 publications

Use of Off-Label Drugs in COVID-19: Clinicians’ Perceptions Based on a Cross-Sectional Observational Study

Use of Off-Label Drugs in COVID-19: Clinicians’ Perceptions Based on a Cross-Sectional Observational Study

Prophylactic rivaroxaban in the early post-discharge period reduces the rates of hospitalization for atrial fibrillation and incidence of sudden cardiac death during long-term follow-up in hospitalized COVID-19 survivors

A mixed methods study exploring requests for unproven COVID therapies such as ivermectin and healthcare distrust in the rural South

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