Coronavirus: Lancet medical journal backtracks over paper which halted hydroxychloroquine trials
Independent peer review of database used for study could not be carried out, leading to retraction
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Your support makes all the difference.A paper published in medical journal The Lancet which halted global trials of hydroxychloroquine as a treatment for coronavirus has been retracted.
An investigation by The Guardian found inconsistencies in the paper’s data, prompting lead author Professor Mandeep Mehra to ask the journal for a retraction as he could no longer vouch for its accuracy.
Hydroxychloroquine, an antimalarial drug, was undergoing trials to find out if it could help treat patients with Covid-19. But after The Lancet published Prof Mehra’s paper, the World Health Organisation and several countries suspended randomised controlled trials, which have now been restarted.
Prof Mehra, of the Brigham and Women’s Hospital in Boston, Massachusetts, said after concerns were raised about the data provided for the research by US company Surgisphere, an independent audit company was called in to examine the database.
The independent audit aimed to ensure the database relied upon did in fact contain data from more than 96,000 Covid-19 patients from 671 hospitals worldwide, and ensure it was accurate and obtained properly.
Surgisphere chief executive Sapan Desai, who was also a co-author of the paper, gave Prof Mehra consent to launch the peer review, but it is claimed Mr Desai then withheld the data from the investigators.
“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,” said Prof Mehra in a statement on Thursday.
“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.
“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.”
Richard Horton, editor of The Lancet, told The Guardian: “This is a shocking example of research misconduct in the middle of a global health emergency.”
The Guardian’s investigation found a list of concerns, including suggestions that several Surgisphere employees had little or no scientific background and the company had barely any online presence despite claiming to run one of the largest hospital databases in the world.
Mr Desai had also been named in three medical malpractice suits, which he described to the Scientist in an interview as “unfounded”.
A statement published on Surgisphere’s website on 29 May, a week after The Lancet published the paper, said the authors “clearly stated that the results of our analyses should not be over-interpreted to those that have yet to develop such a disease or those that have not been hospitalised”.
“We also clearly outlined the limitations of an observational study that cannot fully control for unobservable confounding measures, and we concluded that off-label use of the drug regimens outside of the context of a clinical trials should not be recommended,” it added.
The New England Journal of Medicine also retracted a paper based on a database provided by Surgisphere soon after The Lancet’s retraction, which was also co-authored by Prof Mehra and Mr Desai.
That study, titled “Cardiovascular Disease, Drug Therapy and Mortality in Covid-19”, purportedly included data from coronavirus patients from 169 hospitals in 11 countries. But in a statement, the authors said primary data sources could not be validated as “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”.
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