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      Science at Warp Speed: Medical Research, Publication, and Translation During the COVID-19 Pandemic

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          Abstract

          In response to the COVID-19 pandemic, there has been a rapid growth in research focused on developing vaccines and therapies. In this context, the need for speed is taken for granted, and the scientific process has adapted to accommodate this. On the surface, attempts to speed up the research enterprise appear to be a good thing. It is, however, important to consider what, if anything, might be lost when biomedical innovation is sped up. In this article we use the case of a study recently retracted from the Lancet to illustrate the potential risks and harms associated with speeding up science. We then argue that, with appropriate governance mechanisms in place (and adequately resourced), it should be quite possible to both speed up science and remain attentive to scientific quality and integrity.

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          Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19

          Mandeep R. Mehra, Sapan S. Desai, SreyRam Kuy … (2020)
          Abstract Background Coronavirus disease 2019 (Covid-19) may disproportionately affect people with cardiovascular disease. Concern has been aroused regarding a potential harmful effect of angiotensin-converting–enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) in this clinical context. Methods Using an observational database from 169 hospitals in Asia, Europe, and North America, we evaluated the relationship of cardiovascular disease and drug therapy with in-hospital death among hospitalized patients with Covid-19 who were admitted between December 20, 2019, and March 15, 2020, and were recorded in the Surgical Outcomes Collaborative registry as having either died in the hospital or survived to discharge as of March 28, 2020. Results Of the 8910 patients with Covid-19 for whom discharge status was available at the time of the analysis, a total of 515 died in the hospital (5.8%) and 8395 survived to discharge. The factors we found to be independently associated with an increased risk of in-hospital death were an age greater than 65 years (mortality of 10.0%, vs. 4.9% among those ≤65 years of age; odds ratio, 1.93; 95% confidence interval [CI], 1.60 to 2.41), coronary artery disease (10.2%, vs. 5.2% among those without disease; odds ratio, 2.70; 95% CI, 2.08 to 3.51), heart failure (15.3%, vs. 5.6% among those without heart failure; odds ratio, 2.48; 95% CI, 1.62 to 3.79), cardiac arrhythmia (11.5%, vs. 5.6% among those without arrhythmia; odds ratio, 1.95; 95% CI, 1.33 to 2.86), chronic obstructive pulmonary disease (14.2%, vs. 5.6% among those without disease; odds ratio, 2.96; 95% CI, 2.00 to 4.40), and current smoking (9.4%, vs. 5.6% among former smokers or nonsmokers; odds ratio, 1.79; 95% CI, 1.29 to 2.47). No increased risk of in-hospital death was found to be associated with the use of ACE inhibitors (2.1% vs. 6.1%; odds ratio, 0.33; 95% CI, 0.20 to 0.54) or the use of ARBs (6.8% vs. 5.7%; odds ratio, 1.23; 95% CI, 0.87 to 1.74). Conclusions Our study confirmed previous observations suggesting that underlying cardiovascular disease is associated with an increased risk of in-hospital death among patients hospitalized with Covid-19. Our results did not confirm previous concerns regarding a potential harmful association of ACE inhibitors or ARBs with in-hospital death in this clinical context. (Funded by the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital.)
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            Retraction—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis

            Mandeep R. Mehra, Frank Ruschitzka, Amit Patel (2020)
            After publication of our Lancet Article, 1 several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication. We launched an independent third-party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper. Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process. We always aspire to perform our research in accordance with the highest ethical and professional guidelines. We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted. We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.
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              Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2007621.

              Mandeep R. Mehra, Sapan S. Desai, SreyRam Kuy … (2020)
              To the Editor: Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.” 1 We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused.
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                Author and article information

                Contributors
                Wendy Lipworth:
                ORCID: http://orcid.org/0000-0002-0234-657X
                wendy.lipworth@sydney.edu.au
                Journal
                Journal ID (nlm-ta): J Bioeth Inq
                Journal ID (iso-abbrev): J Bioeth Inq
                Title: Journal of Bioethical Inquiry
                Publisher: Springer Singapore (Singapore )
                ISSN (Print): 1176-7529
                ISSN (Electronic): 1872-4353
                Publication date (Electronic): 25 August 2020
                Pages: 1-7
                Affiliations
                [1 ]GRID grid.1013.3, ISNI 0000 0004 1936 834X, Sydney Health Ethics, Faculty of Medicine and Health, , University of Sydney, ; Medical Foundation Building (K25), Sydney, NSW 2006 Australia
                [2 ]PRAXIS Australia Ltd, Adelaide, Australia
                [3 ]GRID grid.1013.3, ISNI 0000 0004 1936 834X, Sydney Health Ethics, Faculty of Medicine and Health, , University of Sydney, ; Sydney, Australia
                [4 ]GRID grid.412703.3, ISNI 0000 0004 0587 9093, Royal North Shore Hospital, ; Sydney, Australia
                [5 ]GRID grid.1013.3, ISNI 0000 0004 1936 834X, Sydney Law School, , University of Sydney, ; Sydney, Australia
                Author information
                http://orcid.org/0000-0002-0234-657X
                Article
                Publisher ID: 10013
                DOI: 10.1007/s11673-020-10013-y
                PMC ID: 7445735
                PubMed ID: 32840838
                SO-VID: dc611a54-e0bc-46dd-8402-f510e0134aff
                Copyright © © Journal of Bioethical Inquiry Pty Ltd. 2020
                License:

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                Date received : 8 June 2020
                Date accepted : 3 August 2020
                Funding
                Funded by: National Health and Medical Research Council
                Award ID: APP1141943
                Award Recipient :
                Categories
                Subject: Symposium: COVID-19

                ScienceOpen disciplines: Ethics
                Keywords: covid-19,pandemic,research quality,research governance,research integrity,biomedical publication
                Data availability:
                ScienceOpen disciplines: Ethics
                Keywords: covid-19, pandemic, research quality, research governance, research integrity, biomedical publication

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