Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

On 4 June 2020, after a week of increasing scientific concern and scrutiny, first The Lancet, then the New England Journal of Medicine, retracted studies that were based on inaccessible data. The studies have been extremely damaging to chloroquine and hydroxychloroquine COVID-19 clinical trials around the globe. MORU researchers played a key role in bringing this scandal to light, whose consequences continue to play out.

Group of article headers about hydroxychloroquine

It has been a wild, rough ride for the COPCOV global prevention study to determine if chloroquine and hydroxychloroquine can prevent Covid-19 in hospital staff working with patients potentially infected with coronavirus.

On 21 May, COPCOV’s UK arm began enrolling participants at two sites, at the Brighton and Sussex University Hospitals and the John Radcliffe Hospital in Oxford, with several more sites slated to come online shortly thereafter.

Then, on 22 May The Lancet published a study by Mehra et al. This paper claimed that hydroxychloroquine significantly increased the risk of death in Covid-19 infected patients.

Immediately following publication of the Lancet article, the UK regulator MHRA ‘paused’ participant enrolment in COPCOV UK. In quick order, the WHO halted the hydroxychloroquine arm of their global SOLIDARITY study, and regulatory authorities in several countries including France asked investigators to pause ongoing randomised controlled clinical trials involving hydroxychloroquine and chloroquine.

Both  the paper in The Lancet and an earlier one in the  New England Journal of Medicine  (NEJM) by three of the same authors as in The Lancet used data provided by the US company Surgisphere – owned by US cardiologist Dr Sapan Desai, the second author in both studies.

MORU researchers thought early on that it seemed likely or even probable that the article was based on flawed data provided by the US company Surgisphere.  James Watson engaged with Columbia University statistician Andrew Gelman and his blog of 40,000 participants. Nick White, Nick Day, Charlie Woodrow, Will Schilling and the COPCOV team worked behind the scenes to closely examine the publication’s data and detail details about Surgisphere and its data. In this ABC Australia interview, James talks about the doubts and what then transpired.

This international effort culminated in an open letter on 28 May signed by over 200  clinicians, medical researchers, statisticians, and ethicists from across the world to the authors and Richard Horton, Editor of the Lancet. Expressing methodological and data integrity concerns, the signatories asked that Surgisphere provide details on data provenance, called for independent validation of the analysis and open access to all data sharing agreements in each jurisdiction cited in the paper to ensure that any mined data was legally and ethically collected.

Weak responses from The Lancet and authors continuing refusal to share the study data by Surgisphere, led to growing examination of Surgisphere and its data by international media and researchers. Many found it surprisingly unlikely that a company of 5 employees could have developed a major global database of confidential hospital records from across the globe, as it claimed.

Attention then turned to a study of coronavirus patients published in the New England Journal of Medicine early May by some of the same authors, including Harvard’s Dr Mandeep R. Mehra. This paper was also based on data from the Surgical Outcomes Collaborative (Surgisphere Corporation, Chicago, IL, USA). This paper had many of same flaws as The Lancet paper. The authors claimed to have electronic patient record data from a high proportion of all hospitalised COVID-19 patients in the countries they are linked with. Yet countries such as UK and Turkey did not have as many hospitalised patients in the entire country as claimed to have been in the Surgisphere linked hospitals at the time of the study.  

On 2 June, James Watson and scientists, researchers, clinical trials experts and statisticians wrote an open letter to the New England Journal and to the authors pointing out the major discrepancies and requesting again that Surgisphere’s data be made public.

The same day, 2 June, the NEJM, followed by The Lancet on 3 June published editorial Expressions of Concern about the two papers.

Pressure continued to increase on the journals and authors. On 4 June, after a review of data, the WHO reversed its decision to halt its global SOLIDARITY hydroxychloroquine trials.

Later that same day, 4 June, after a week of increasing scientific concern and scrutiny, first The Lancet, then a little over an hour later the New England Journal of Medicine, retracted the studies that were based on inaccessible data, provided by the Surgisphere corporation.

Noting that extremely damaging impact of the studies to chloroquine and hydroxychloroquine COVID-19 clinical trials around the globe, MORU made a statement that concluded:

“Many important questions will need to be answered in the coming weeks and months, but we would like to use this unfortunate opportunity to make two relevant recommendations which we believe are in the public interest.

  1. Medical and scientific journals should not accept papers based on inaccessible data
  2. Regulatory authorities and other agencies responding to such reports should satisfy themselves of the veracity and applicability of published data and the correctness of analyses before they act.”

The scandal and its consequences continue to play out. On 8 June, the University of Utah terminated the faculty appointment of Dr Amit Patel, one of the authors of both papers.

As of publication, the MHRA has yet to ‘unpause’ COPCOV UK participant enrolment.

- Nick Day and John Bleho

Similar stories

Study finds steady increase in WHO-validated artemisinin resistance markers in Asia

From 2002-2018, there has been a steady increase in the places and proportion of infected people reporting validated kelch13 (K13) artemisinin resistance markers, according to a study in The Lancet Microbe. This increase in artemisinin resistance threatens efforts to eliminate malaria in Asia by 2030 — and control efforts in other endemic regions. The authors say that more consistent data collection, over longer time periods in the same areas, and rapid sharing of data are needed to map the spread of resistance and better inform policy decisions.

Global Research on AntiMicrobial resistance (GRAM) project

Antimicrobial resistance (AMR) is responsible for at least 1.27 million deaths per year — with over 97,000 deaths in 2019 in SE Asia alone, according to a study published in The Lancet by the Global Research on AntiMicrobial resistance (GRAM) project, who urged urgent action from policymakers and health communities to avoid further preventable deaths.

RECOVERY trial team members appointed MBEs

Two RECOVERY Trial team members have been recognised in the New Year Honours list 2022. RECOVERY Trial coordinator, Professor Richard Haynes, has been appointed Member of the Order of the British Empire (MBE) for services to Global Health, and Senior Clinical Trial Manager, Lucy Fletcher, has been appointed MBE for services to Clinical Trials. The New Year Honours list recognises outstanding achievements by a wide range of extraordinary people from across the United Kingdom. People are awarded honours for achievements in their field of work (including health, education, science and technology), as well as for making a difference to their community.

Susie, Phaik Yeong, Richard and Paul among new full Oxford professors!

In the 2021 Oxford Recognition of Distinction round, four MORU colleagues were awarded Full Professor title.

All-nighter: staying up to fight malaria

Featured in Nature, Victor Chaumeau collects mosquitoes in Myanmar to better understand how to control malaria.

Antibiotic accountability: how countries and companies perform

Patients in north Africa and the Middle East are using antibiotics in sharply rising quantities far beyond the global average, raising concerns over the escalating risks of resistance to medicines to treat bacterial infections. Estimated antibiotic consumption for 204 countries between 2000 and 2018 shows a 46 per cent increase in global antibiotic usage, with a surge in nations including India and Vietnam.