One of the world’s leading medical journals, the Lancet, has reformed its editorial policies following a shocking case of apparent research misconduct involving the study of hydroxychloroquine as a treatment for Covid-19.
In May, the Lancet published a peer-reviewed study about the controversial drug hydroxychloroquine, which concluded Covid-19 patients who received the drug were dying at higher rates and experiencing more heart-related complications than other virus patients.
The large observational study analysed data purported to be 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.
This data was recorded by hospitals around the world in a database by a US data analytics company known as “Surgisphere”, the Lancet paper said. The findings prompted the World Health Organization to halt its clinical trials of the drug, given the paper’s findings that it was linked with deaths and complications.
But days after the paper was published, Guardian Australia revealed issues with the Australian data in the study. Figures on the number of Covid-19 deaths and patients in hospital cited by the authors did not match up with official government and health department data. Senior clinicians involved in Covid-19 research told Guardian Australia they had never heard of the Surgisphere database.
Researchers from other countries identified similar issues with the data from their hospitals, and a further Guardian Australia investigation revealed doubts over whether the database used by the study authors even existed. Sapan Desai was a co-author of the paper and founder of the Surgisphere database. Following the revelations, information about Surgisphere was deleted from the internet.
It was also revealed that none of the co-authors of the paper had seen the Surgisphere data for themselves, and they said that Desai did not give them access to it even after questions about the paper were raised by Guardian Australia and the research community. The paper’s co-authors, which included a highly respected vascular surgeon, supported the retraction of the paper and distanced themselves from the data.
While the latest available data shows hydroxychloroquine does not reduce deaths among severely unwell patients in hospital with Covid-19, the higher death rates among those given the drug outlined in the Surgisphere study have never been replicated.
The publication of the Surgisphere study by the Lancet meant well-controlled studies to definitely determine the drug’s efficacy in preventing or treating the virus were stopped prematurely. Given the drug has been highly politicised by figures such as US president Donald Trump, rigorous studies into the drug remain important.
World Health Organization studies into hydroxychloroquine resumed following Guardian Australia’s Surgisphere investigation, and the Lancet retracted the Surgipshere paper and vowed to review its publication policy. Such rapid retractions are rare, and followed pressure from the international research community who questioned how the study passed quality control processes.
The new policy, published three months after the study was retracted, requires that more than one author on a paper must directly access and verify the data reported in the manuscript.
“For research articles that are the result of an academic and commercial partnership, one of the authors named as having accessed and verified data must be from the academic team,” the policy states. “In addition, all authors will be asked to sign the author statements form to confirm they had full access to the data reported in their article, and accept responsibility for submitting the article for publication.”
One of the questions raised by the publication of the Surgisphere paper was how the paper passed the peer-review process.The Lancet has made one of the biggest retractions in modern history. How could this happen?Read more
The Lancet has updated its peer-review policy, stating: “Editors will ensure that at least one peer reviewer is knowledgable about the details of the dataset being reported and can understand and comment on its strengths and limitations in relation to the research question being addressed.”
For studies that use very large datasets, such as the Surgisphere dataset, editors will ensure that in addition to statistical peer review, a review from an expert in data science is obtained.
“Finally, we will explicitly ask reviewers if they have concerns about research integrity or publication ethics regarding the manuscript they are reviewing,” the new policy states.
The new policy is effective immediately.