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Data transparency: “Nothing has changed since Tamiflu”

BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m2279 (Published 09 June 2020) Cite this as: BMJ 2020;369:m2279

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Rapid Response:

Have we abandoned the Inglefinger rule in the COVID era?

Dear Editor

We read with the interest your recent News Analysis titled “Data transparency”: “Nothing has changed since Tamiflu”(1) reporting the recent retraction of two research papers from reputed journals. Of particular interest was a quote by Epidemiologist Jefferson “There is a headlong rush to publish in an emergency, and that is toxic”, which is apt for the current climate. There are daily updates in the world of research and medicine and “breaking news” on latest developments for new drugs, vaccines, and various novel findings on the epidemiology of COVID-19. We were surprised to observe the recent media coverage of a research paper reporting increased risk of mortality due to COVID-19 in South Asian patients (2, 3, 4). Although this study has not yet been peer reviewed and its methodology, findings and interpretation scrutinised, this has received extensive media coverage, and many might infer it as the truth as reported. Interestingly the BBC presenter undertook the peer review live on the Radio 4 programme (3). The presenter was questioning about the potential reasons for the increased mortality observed including the role of diabetes, vitamin D and the dose of exposure – the questions normally will be raised by peer reviewers and not radio presenters! The presenter also commented during the interview with the lead researcher and the first author “Nothing can be done about it (the various risk factors reported in the study). The study is available online as preprint (5) for colleagues to read through although practising clinicians and policy makers may not have the time or the expertise to undertake their own peer review before applying the findings in practice or formulating Public Health policies. Hence the important question arises “What is the objective of rushing and promoting the findings through the media?”

It is relevant here to recall the objectives and principles of the “Inglefinger rule” which has been widely accepted and used by scientific journals since its first introduction by Franz Inglefinger in the New England Journal of Medicine in 1969. The Inglefinger rule stated that articles should “have been neither published nor submitted elsewhere (including news media and controlled-circulation publications)” (6). This was proposed to ensure authenticity, scientific progression, and dissemination of research after standardised peer review and validation.

In the early days of the COVID-19 pandemic, we applauded the entire publishing community for its rapid delivery of SARS-CoV-2 findings to readers (7). However we need to respect and adhere to the Ingelfinger rule to uphold scientific integrity and ensure no harm results from rushed public pronouncements of early findings or declaration by political leaders as was the case in the United States of America related to the ongoing Hydroxy Chloroquine saga (8). Many Journals including the BMJ (9) has a fast track publication process for papers of exceptional clinical importance and urgency or where there is a public policy reason for urgent publication. Editors of the Journals have agonised over the issue of Ingelfinger rule and according to the editor (10) of a leading clinical Journal “On balance, we believe that rigorous review is worth the wait. However, like all good rules, the Ingelfinger rule lives or dies by its exceptions”. The editor goes on to add “We will speed the time to online publication as much as possible, and afterwards, we will do what we can to bring the findings to the public eye including sometimes providing free open access. We hope most journal editors feel the same”.

We have an appeal and call to arms; our appeal is to the researchers to adhere to the Ingelfinger rule at all times and caution against abandoning the rule as a price for quick publicity for their research or to get a prime spot in the news. We call upon the editors and the publishing community to invest in rapid peer review processes to support clinicians and researchers in quality assurance of the research and rapidly disseminating the fruits of their hard labour to benefit the communities we serve and work for. The last thing we want is Ingelfinger turning in his grave, as the clinical and academic community abandons his principles which were founded to protect both the researchers and patients and to uphold humanity’s scientific integrity and the high standards we set for ourselves.

There has also been some welcome development in the form of online research compendium by US academics from (11). According to the “Novel Coronavirus Research Compendium (NCRC”), “as the pandemic unfolds, there has been a rapid proliferation of literature on SARS-CoV-2 and COVID-19. Reliable and rapidly curated evidence is needed to inform the public, programs, policy, and research. Our goal is to provide accurate, relevant information for global public health action by clinicians, public health practitioners, and policy makers”.

References:
1. Wise Jacqui. Data transparency: “Nothing has changed since Tamiflu” BMJ 2020; 369 :m2279 https://www.bmj.com/content/369/bmj.m2279 )

2. Gallagher J. “Coronavirus: South Asian people most likely to die in hospital” BBC Health. 19 June 2020. https://www.bbc.co.uk/news/health-53097676

3. BBC Sounds. 19.06.2020 Today from 1:52:17 to 1:57:14. https://www.bbc.co.uk/sounds/play/m000k2b5

4. South Asians in Britain most likely to die in hospital of Covid-19, study finds. Guardian https://www.theguardian.com/world/2020/jun/19/south-asians-in-uk-most-li...

5. Harrison, Ewen M. and Docherty, Annemarie B et al and Investigators, ISARIC4C, Ethnicity and Outcomes from COVID-19: The ISARIC CCP-UK Prospective Observational Cohort Study of Hospitalised Patients (5/31/2020). Available at SSRN: https://ssrn.com/abstract=3618215 or http://dx.doi.org/10.2139/ssrn.3618215

6. Inglefinger F. Definition of Sole Contribution. N Engl J Med 1969; 281:676-677 https://www.nejm.org/doi/10.1056/NEJM196909182811208

7. Badrinath P. Contribution of publishing community to the evolving COVID-19 epidemic. BMJ 2020;368:m606 https://www.bmj.com/content/368/bmj.m606/rr

8. Dessem M. “Arizona Man Dies From Chloroquine Overdose After Listening to Trump Coronavirus Press Conference” Slate. March 2020. https://slate.com/news-and-politics/2020/03/arizona-man-dies-chloroquine...

9. Fast track submissions. BMJ https://www.bmj.com/content/suppl/2002/07/18/324.7339.DC2

10. Asch, S.M. It’s OK to Talk About It: Exceptions to the Ingelfinger Rule. J GEN INTERN MED 33, 1825 (2018). https://doi.org/10.1007/s11606-018-4634-0

11. The 2019 Novel Coronavirus Research Compendium (NCRC). John Hopkins Bloomberg School of Public Health. https://ncrc.jhsph.edu/what-we-do/

Dr Asawari Gupta, GP ST1 in Public Health
Dr Padmanabhan Badrinath, Consultant in Public Health Medicine, Suffolk County Council & Associate Clinical Lecturer, University of Cambridge.
Directorate of Public Health, Endeavour House, Suffolk County Council, Ipswich, IP1 2BX. badrishanthi@hotmail.com

Disclaimer: The views expressed here are the personal views the authors and in no way represent the views of their employer, Suffolk County Council.

Competing interests: As Public Health practitioners the authors uphold the view that high quality, peer reviewed clinical and policy research findings are rapidly disseminated to further improve the Clinical and Public Health response to the ongoing pandemic of COVID-19

20 June 2020
Padmanabhan Badrinath
Consultant in Public Health Medicine & Associate Clinical Lecturer
Asawari Gupta
Suffolk County Council & University of Cambridge
Directorate of Public Health, Endeavour House, Russell Road, Ipswich, Suffolk, IP1 2BX