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 Table of Contents  
EDITORIAL
Year : 2020  |  Volume : 15  |  Issue : 1  |  Page : 3-4

To Act…….or to wait for the evidence: Ethics in the time of covid-19!


Department of Clinical Immunology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India

Date of Web Publication30-Mar-2020

Correspondence Address:
Dr. Vikas Agarwal
Department of Clinical Immunology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow - 226 014, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/injr.injr_53_20

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How to cite this article:
Misra DP, Agarwal V. To Act…….or to wait for the evidence: Ethics in the time of covid-19!. Indian J Rheumatol 2020;15:3-4

How to cite this URL:
Misra DP, Agarwal V. To Act…….or to wait for the evidence: Ethics in the time of covid-19!. Indian J Rheumatol [serial online] 2020 [cited 2020 May 29];15:3-4. Available from: http://www.indianjrheumatol.com/text.asp?2020/15/1/3/281586



The ongoing pandemic of coronavirus disease 19 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has brought to light ethical issues driving patient care as well as research.[1] In this editorial, we discuss the salient ethical standpoints related to this, some of which might be applicable for any pandemic in general.

Respiratory failure due to acute respiratory distress syndrome is a devastating feature of COVID-19. Often, these patients require ventilatory support.[2] When a pandemic of this intensity afflicts the globe, it is but natural that fixed resources such as ventilators will be in limited supply. Moreover, the disease generally affects the elderly and those with comorbidities with a greater severity, who inherently have a worse prognosis and greater risk of complications should they require ventilatory support.[3] What does one do when faced with a shortage of ventilators? Is it ethical to provide those with a better chance of outcomes the best available limited treatments based on the principle of justice, or should everyone's right to live be respected instead?[4] Similar considerations also hold true for testing for the SARS-CoV-2, which involves the complicated technique of polymerase chain reaction. When limited testing facilities are available, is it ethical to test everyone with symptoms, or to limit testing to the sickest, most at-risk groups? There are not and cannot be any clear answers to these moral dilemmas which clinicians are facing and will continue to face worldwide in the coming months.

There has been an explosion of the recent literature with respect to potential therapeutic targets for COVID-19. Most of these treatments are untested in patients with this disease, and clinical trials are urgently needed. Studies are also needed to understand the pathogenesis of this disease and may simply require observation of patients and their blood parameters or involve testing of blood or other body fluids collected during routine sampling. Some of these patients may be too sick to understand or provide informed consent.[5] In such instances, it is ethical to waive informed consent from participants in the interest of the greater good for humanity, violating the principle of autonomy?[4] Some studies have gone down this route, with their ethical committees waiving the requirement for informed consent due to the consideration of an emerging infectious disease.[6] Similarly, because most therapies are untested, is there any evidence base to guide their use? Does a clinician's judgment, as was the norm in the days before evidence-based medicine, take precedence over the lack of evidence? The recent trial of lopinavir–ritonavir failed to demonstrate a benefit in survival over the standard of care; however, the confidence margins favored the drug over placebo.[7] In such circumstances, does the lack of statistical evidence of benefit prevent the clinician from further investigating such therapies? A recent instance of apparently successful repurposing of drugs used in HIV infection for treating COVID-19 from an Indian hospital is notable, considering the lack of evidence for such therapies before using them.[8] Emerging hypotheses suggest that a proportion of patients with severe COVID-19 may be dying due to secondary hemophagocytic lymphohistiocytosis (HLH).[9] As such, the evidence base to guide the management of infection-associated HLH is sparse.[10] Therefore, at what threshold does the clinician decide to embark on high-dose glucocorticoids, cyclosporine, tocilizumab, or other therapies to treat secondary HLH in individuals with COVID-19 undergoing a cytokine storm? Will there ever be an evidence base to guide such decisions? Does one consider the fact that therapies for secondary HLH described above, and other postulated to help reduce SARS-CoV-2 infection like baricitinib, may also potentially flare up coexisting bacterial infections and precipitate sepsis? The demarcation line regarding beneficence versus nonmaleficence is blurred in such situations and will rely on the individual clinician's judgment.[4] It is necessary to consider that the minds of the clinician and other health-care personnel are also likely to be stressed not only by the sickness of the patients they are dealing with but also the specter of them or their family and friends being afflicted with the highly infective SARS-CoV-2 infection. Would ethics committees be brave enough in the contemporary environment of litigation and compensation to permit rapid clinical trials on COVID-19?

From the viewpoint of the rheumatology community, it is preferable to adhere to guidance issued by international rheumatology societies (The American College of Rheumatology and the European League against Rheumatism)[11],[12] regarding the special considerations for patients with rheumatic diseases and COVID-19. Rheumatologists should be vigilant since many of our immunosuppressed patients have a greater predisposition to severe infections. In addition, patients with severe COVID-19 who are critically ill may have a cytokine storm due to secondary HLH. As alluded to previously, whether such patients may require existing aggressive immunosuppressive protocols for HLH remains an unanswered question.[9] It is likely that many drugs commonly used in rheumatology, such as hydroxychloroquine, may be repurposed for COVID-19, a case in point being the consideration for the approval of hydroxychloroquine by the United States Food and Drug Administration for COVID-19.[13] Pandemics such as COVID-19 bring in the realization that current ethical principles are not set in black and white. Rather, consideration on a case-to-case basis is the only potential solution. Ethical principles and guidelines will need to evolve in the coming years based on the experiences gathered from the current pandemic.



 
  References Top

1.
Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - An update on the status. Mil Med Res 2020;7:11.  Back to cited text no. 1
    
2.
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med 2020. [Epub ahead of print].  Back to cited text no. 2
    
3.
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet 2020. [Epub ahead of print].  Back to cited text no. 3
    
4.
Avasthi A, Ghosh A, Sarkar S, Grover S. Ethics in medical research: General principles with special reference to psychiatry research. Indian J Psychiatry 2013;55:86-91.  Back to cited text no. 4
[PUBMED]  [Full text]  
5.
Misra DP, Agarwal V. Integrity of clinical research conduct, reporting, publishing, and post-publication promotion in rheumatology. Clinical rheumatology 2020. [Epub ahead of print].  Back to cited text no. 5
    
6.
Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, et al. Dysregulation of immune response in patients with COVID-19 in Wuhan, China. Clin Infect Dis 2020. [Epub ahead of print].  Back to cited text no. 6
    
7.
Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, et al. A trial of Lopinavir-Ritonavir in adults hospitalized with severe Covid-19. N Engl J Med 2020. [Epub ahead of print].  Back to cited text no. 7
    
8.
Repurposing of drugs for Covid-19 at Sawai Man Singh Hospital, Jaipur. Available from: https://www.nationalheraldindia.com/india/covid-19-magic-medicine-of-jaipurs-hospital-cures-3-patients-draws-attention-in-medical-world. [Last accessed on 2020 Mar 20]  Back to cited text no. 8
    
9.
Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ. COVID-19: Consider cytokine storm syndromes and immunosuppression. The Lancet 2020. [Epub ahead of print]. [Doi:10.1016/S0140-6736(20)30628-0].  Back to cited text no. 9
    
10.
Jordan MB, Allen CE, Weitzman S, Filipovich AH, McClain KL. How I treat hemophagocytic lymphohistiocytosis. Blood 2011;118:4041-52.  Back to cited text no. 10
    
11.
EULAR Guidance for Patients during Covid-19 Outbreak. Available from: https://www.eular.org/eular_guidance_for_patients_covid19_outbreak.cfm. [Last accessed on 2020 Mar 19; Last updated on 2020 Mar 17].  Back to cited text no. 11
    
12.
ACR Guidance for Patients during Covid-19 Outbreak. Available from: https://www.rheumatology.org/announcements. [Last accessed on 2020 Mar 19; Last updated on 2020].  Back to cited text no. 12
    
13.
US FDA Considering Hydroxychloroquine for Use in Covid-19. Available from: https://www.thedailybeast.com/anti-malaria-drug-to-be-made-available-to-coronavirus-patients-almost-immediately-trump-says. [Last accessed on 2020 Mar 20].  Back to cited text no. 13
    




 

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