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Covid-19: 146 researchers raise concerns over chloroquine study that halted WHO trial

BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m2197 (Published 02 June 2020) Cite this as: BMJ 2020;369:m2197

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COVID-19 Pandemic and the ‘Quadruple-barrel Tragedy’: Matters still evolving for the works

The World is increasingly enmeshed in the ‘Evolving Difficulties’ in the trail of the ‘Unprecedented Devastating Ravaging 21st Century Scourge’ which necessitates ‘Weathering the Storm’ [1]! The ‘COVID-19 Pandemic’, as the ‘Unbelievable Raging Storm’, is a ‘COVID Phenomenon’ impacting either ‘Negatively’ and ‘Positively’ on ‘Virtually every Aspect of the Existence and Development of Our Common Humanity’ [2]!! The ‘COVID-19 Pandemic Negative Consequences’ have been distilled in previous ‘Communications’ [1,3,4] and several other ‘Communications’ have equally amplified the ‘COVID-19 Pandemic Positive Harvests’ [5-7]!! The ‘Rapidly Dynamically Transmuting COVID-19 Pandemic Information’ throw up ‘Issues’ that are either ‘COVID-19 Research Outcomes’ or the ‘Impetus’ for further ‘COVID-19 Research’ with the result that there is a ‘Deluge of COVID-19 Research Data/ Information’! The increasing ‘COVID-19 Pandemic Research Pressure’ has Tested, Assaulted or Circumvented the ‘Time-honoured and Tested Foundational Pillars’ of ‘Robust Research Governance’ and, for any number of reasons, the World is increasingly treated to ‘Questionable COVID-19 Research Output/ Reports’!! The ‘Unacceptable Avalanche of Bothersome COVID-19 Research Data/ Information’ has been captured in the ‘Evolving COVID-19 Pandemic Literature’ as ‘Waste in COVID-19 Research’ [8]!!

The ‘COVID-19 Pandemic Literature’ is ‘Criticized and Challenged’ in a ‘Joint Open Letter’ addressed to the Authors of a Study and the Publisher, the Lancet Journal! In the ‘Joint Letter’, 146 Clinicians, Medical Researchers, Statisticians and Ethicists [9] expressed their concerns on several ‘Research Issues and Study Flaws/ Deficits’ in a Study: ‘Methodological Exactitude’, ‘Data Integrity’, ‘Ethical Clearance’, ‘Study Confounders’, ‘Data/ Code Sharing’, ‘No Acknowledgements’, ‘Participating Hospitals and Countries are not mentioned and neither is their defined Participation indicated’ etc! The ‘Joint Open Letter’ relates to the ‘Published Chloroquine and Hydroxychloroquine Study’ [10] which disposes ‘Unacceptable Deficits’ in the ‘Research Governance and Data Governance Principles and Pillars’! The ‘Open Letter’, in fact, expresses dissatisfaction with the ‘Attempted Response’ by the Lancet which, as far as the ‘Joint Letter’ is concerned, addresses only 1 out of the 10 ‘Issues’ raised re: ‘Unacceptable Worrisome Deficits’ in ‘Research Governance’ and ‘Data Governance’ [11]! The WHO halted the ‘Hydroxychloroquine and Chloroquine Trial’ based on the ‘Publication’ [10] which is now ‘Jointly Questioned’ by the ‘146 Clinicians, Researchers etc’!! Previous ‘Communications’ [12-15] have similarly alerted the World to the dangerous emergence of a ‘Body of COVID-19 Research Data/ Information’ which MUST be ‘Checked and Challenged’ and should not become part of the ‘COVID-19 Pandemic’-related ‘New Normals’! The emerging and rapidly transmuting ‘COVID-19 Pandemic Literature’ MUST be the ‘Product’ of stiff and rigorous ‘Best Practices Applications’ in ‘Research Governance’, ‘Data Governance’ and ‘Peer-Review Mechanism’!! The ‘Emerging and Evolving COVID-19 Pandemic Literature’ has implications for, and impact on, ‘Human Existential and Developmental Dispositions’!!!

The emergence of the ‘Deluge of Questionable COVID-19 Research Data/ Information’ has the POTENTIALITY of growing the ‘COVID-19 Infodemic’: Misinformation, Disinformation, Inappropriately Contextualized Concepts, Unscientific Claims, Misleading Communication, Myths, Rumours, Memes, Downplayed Information, Politically-influenced Information, ‘Conspiracy Theories’, Information Toxicity etc!! While the World grapples with the ‘Global Fight’ against the ‘COVID-19 Pandemic’ and the ‘Unseen Enemy’, another equally impactful ‘War’ MUST be waged against the ‘COVID-19 Infodemic’ which can also rapidly spread within Populations and wreak ‘Monumental Havoc’ as part of the ‘COVID-19 Pandemic Ravaging Devastations’!! The ‘COVID-19 Infodemic’ spreads like an ‘Uncontrolled Ravaging Inferno’ matching, or possibly out-pacing the spread of the ‘COVID-19 Pandemic’!!!

Worse still is the fact that the World needs to ‘Conceptualize, Contextualize and Technicalize’ on the worrisome existence of a ‘COVID-19 Pandemic Quadruple-barrel Tragedy’ in order to ‘Fight’ and ‘Win’ the ‘War’ against the ‘COVID-19 Pandemic’. The ‘Quadruple-barrel Tragedy’ that MUST be addressed include:

1. The ‘COVID-19 Scourge as a Pandemic’
2. The ‘COVID-19 Infodemic’
3. The ‘COVID-19 Research Waste’ and
4. The ‘COVID-19 Interventional Precocity in Easing Lockdowns’!!

A ‘Tantalizing Teaser’ will be disposed to amplify each ‘Component’ of the ‘COVID-19 Pandemic Quadruple-barrel Tragedy’!! The ‘COVID-19 Scourge’ has been repeatedly disposed as the ‘Coronavirus Disease 2019 (COVID-19)’ caused by the ‘Coronavirus (SARS-CoV-2)’ with its ‘Untoward Unprecedented Devastations’ with ‘Global Spread and Involvement’ qualifying it for a ‘Pandemic’ [1,3,4]! The World mounts a ‘Global Fight’ as an imperative against the ‘Invisible Enemy’! The ‘COVID-19 Infodemic’ is an ‘Enlarging Body of COVID-19 Inappropriate Information’ on the ‘Pandemic’ which is ‘Another Invisible Enemy’ that MUST be contended with in the ‘COVID-19 Pandemic Era’!! If the evolving ‘Avalanche of Questionable COVID-19 Research Harvests’ is unchecked and allowed to soar into colouring the ‘Determinant COVID-19 Pandemic Literature’, the World will be drawing a blank in the ‘War’ against the ‘Unprecedented Pandemic’. As widely acclaimed, ‘Information is Power’ and with ‘Appropriate Information’, People are empowered to ‘Take the Right Decisions’ and are consequently ‘Facilitated to Effect the Desired Impactful Actions’!! One of the ‘Components’ of the ‘Effective Non-Pharmaceutical Interventions (NPIs)’ is ‘Lockdown’, which, however, imposes ‘Economic Burden and other Negative Consequences’ on the Populace [16]!! The ‘Stratified Shielding’ of the Populace has been proposed as a ‘Public Health Intervention’ to minimize these ‘Population-related Consequences’ [17,18]! The ‘Stratified Shielding’ as ‘Differential Interventional Lockdown’ requires critical scrutiny and needs attention to several ‘Unresolved Determinant Issues’ [19]!! Certainly, ‘Interventional Precocity’ in the ‘Easing of Lockdown’ is not an option in the envisioned ‘Successful Fight’ against the ‘COVID-19 Pandemic’ [20]!!! For ‘Appropriate Easing from Lockdown’, the persistently desired ‘Low Numbers’ of ‘New COVID-19 Cases and Deaths’ on the ‘Descending Limb’ of the ‘COVID-19 Epidemic Curve’ MUST be evident and unquestionably, there MUST be adequate Testing/Treatment/ Isolation for ‘Containment’ and Tracing/ Tracking/ Quaratining for ‘Mitigation’ to avoid ‘Programmatic Interventional Precocity’ in ‘Easing from Lockdowns’!!

To ‘Weather the Unprecedented 21st Century Storm’ [1], the World MUST regard and address the ‘COVID-19 Pandemic Quadruple-barrel Tragedy’ and this may be perceived as an ‘Over-Reaction’! For ‘COVID-19 Pandemic’, ‘Under-Reaction’ is not an option and is more catastrophic than ‘Over-Reaction’!! The ‘Quadruple-barrel Tragedy’ presents further ‘Matters for the Works’ that cannot be ignored ‘Programmatically’ in the ‘COVID-19 Pandemic Interventions’!!!

REFERENCES
1. Godlee F. COVID-19: Weathering the storm. BMJ 2020; 368:m1199 of 26th March 2020
2. Eregie C. O. COVID Phenomenon: An innovative conceptual coinage in human development and sustainable development in the 21st Century. https://www.bmj.com/content/368/bmj.m1199/rr-17 of 9th April 2020
3. Eregie C.O. COVID-19 Pandemic: Still on the difficult unresolved increasing challenges in weathering the storm. https://www.bmj.com/content/368/bmj.m1199/rr-13 of 2nd April 2020
4. Eregie C.O. COVID-19 Pandemic: Further perspectives on the difficult unresolved increasing challenges in weathering the storm. https://www.bmj.com/content/368/bmj.m1199/rr-16 of 5th April 2020
5. Kickbusch I, Leung GM, Bhutta ZA, Matsoso MP, Ihekweazu C, Abbasi K. Covid-19: how a virus is turning the world upside down. BMJ 2020; 369:m1336 of 3rd April 2020
6. Eregie C.O. COVID-19 Pandemic: The daunting challenges of assuring sustainable benefits from weathering the storm. https://www.bmj.com/content/368/bmj.m1199/rr-14 of 8th April 2020
7. Nelson B. The positive effects of covid-19. BMJ 2020; 369:m1785
8. Glasziou PP, Sanders S, Hoffmann T. Waste in covid-19 research. BMJ 2020; 369:m1847
9. Mahase E. COVID-19: 146 researchers raise concerns over chloroquine study that halted WHO trial. BMJ 2020; 369:m2197
10. Mehra MR, Desai SD, Ruschitzka F, Patel AN. Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. Lancet 2020 May. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6
11. Department of error. Lancet 2020 May 30. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31249-6
12. Clinical Trials.gov. History of changes for study. NCT04280705, 1 May 2020. https://clinicaltrials.gov/ct2/history/NCT04280705?A=10&B=15&C=Side-by-S....
13. Yan W. Coronavirus tests science’s need for speed limits. New York Times 2020 Apr 14. https://www.nytimes.com/2020/04/14/science/coronavirus-disinformation.html
14. Hoffmann T, Glasziou P. What if the vaccine or drugs don’t save us? Plan B for coronavirus means research on alternatives is urgently needed. The Conversation, 21 Apr 2020. https://theconversation.com/what-if-vaccine-or-drugs-dont-save-us-plan-b...
15. Eregie CO. COVID-19 Pandemic: The multifaceted picture of compromised COVID-19 research and the ‘COVID Phenomenon’. https://www.bmj.com/content/369/bmj.m1847/rr-12 of 10th June 2020
16. Ioannidis JPA. Coronavirus disease 2019: The harms of exaggerated information and non-evidence-based measures. Eur J Clin Invest 2020; 50:e13222
17. McKeigue PM, Colhoun HM. Evaluation of ‘stratify and shield’ as a policy option for ending the COVID-19 lockdown in the UK. medRxiv 2020.0425.20079913 (Preprint) doi:10.1101/2020.04.25.20079913
18. Smith GD, Spiegelhalter D. Shielding from covid-19 should be stratified by risk. BMJ 2020; 369:m2063
19. Eregie CO. COVID-19 pandemic and stratified shielding: some mor matters for the works. https://www.bmj.com/content/369/bmj.m2063/rr-2 of 18th June 2020
20. Eregie CO. COVID-19 Pandemic Interventions: Lockdown is not lockout; avoid interventional precocity with easing lockdowns. https://www.bmj.com/content/369/bmj.m2202/rr-4 of 14th June 2020

Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria.
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria.
UNICEF-Trained BFHI Master Trainer,
ICDC-Trained in Code Implementation,
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria.
*No Competing Interests.

Competing interests: No competing interests

19 June 2020
CHARLES OSAYANDE EREGIE
MEDICAL DOCTOR
Professor of Child Health and Neonatology, University of Benin and Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria. Also, UNICEF-Trained BFHI Master Trainer and ICDC-Trained in Code Implementaion. Also a Technical Expert/ Consultant on FMOH-UNICEF-NAFDAC Project on Code Implementation in Nigeria
Institute of Child Health, College of Medical Sciences, University of Benin, Benin City, Nigeria.