Surgisphere issues public statement defending integrity of coronavirus study published in the Lancet
www.theguardian.com
More than 120 researchers and medical professionals from around the world have written an open letter to the editor of the Lancet raising serious concerns about a large and widely publicised global study that prompted the World Health Organisation to halt several Covid-19 clinical trials.
On Thursday
Guardian Australia revealed that the Australian data in the
study, published last week, did not reconcile with health department records or databases.The study found Covid-19 patients who received the malaria drug hydroxychloroquine were dying at higher rates and experiencing more heart-related complications than other virus patients. The large observational study analysed data from nearly 15,000 patients with Covid-19 who received the drug alone or in combination with antibiotics, comparing this data with 81,000 controls who did not receive the drug.Questions about
the paper’s statistical modelling were also raised by Columbia University in the US, prompting Surgisphere, the company that manages the database of patients used to inform the study, to
issue a public statement defending the integrity of the study.
But now further questions have been raised about the Surgisphere database and the study methodology. The signatories to the open letter, directed to the Lancet and the study authors, include prominent sceptics of the value of using hydroxychloroquine to treat Covid-19. The letter lists 10 major concerns about the statistical analysis and data integrity of the study.
“The authors have not adhered to standard practices in the machine learning and statistics community,”
the letter states. “They have not released their code or data.” The Lancet is among the many signatories
to a statement on data sharing for Covid-19 studies. “There was no ethics review,” the letter continues. “There was no mention of the countries or hospitals that contributed to the data source and no acknowledgments to their contributions. A request to the authors for information on the contributing centres was denied. Data from Australia are not compatible with government reports. Surgisphere
have since stated this was an error of classification of one hospital from Asia. This indicates the need for further error checking throughout the database.”
The letter also states that the data from Africa in the study indicates that nearly 25% of all Covid-19 cases and 40% of all deaths in the continent occurred in Surgisphere-associated hospitals which had sophisticated electronic patient data recording, and patient monitoring. “Both the numbers of cases and deaths, and the detailed data collection, seem unlikely,” the letter says. The letter also expressed concern about unusually small reported variances in baseline variables, interventions and outcomes between continents, despite significant differences in demographics.