Lancet, one of the world's most prestigious medical journals has withdrawn a paper that led to the World Health Organization (WHO) pausing its global trials of anti-malarial drug Hydroxychloroquine (HCQ) in the fight against COVID-19 and raising questions about the efficacy of the drug after three of the paper's authors asked it to be retracted.
The paper that concluded that HCQ in COVID-19 patients was increasing the frequency of ventricular arrhythmia was retracted as the other three scientists could not vouch for the data provided by an American company called Surgisphere. This came after scientists across the world raised questions on the data used in the paper.
Today, three of the authors have retracted "Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis" Read the Retraction notice and statement from The Lancet https://t.co/pPNCJ3nO8n pic.twitter.com/pB0FBj6EXr— The Lancet (@TheLancet) June 4, 2020
Meanwhile, The WHO is restarting its Hydroxychloroquine (HCQ) trials on COVID-19 after the COVID-19 Solidarity Trial Data Safety & Monitoring Committee endorsed the use of the drug.
Based on available data, the #COVID19 Solidarity Trial Data Safety & Monitoring Committee recommended there are no reasons to modify the trial protocol. The Executive Group endorsed the continuation of all arms of the Trial, including the use of hydroxychloroquine. https://t.co/r88DVEvZ3j pic.twitter.com/cYITShxcE7— Tedros Adhanom Ghebreyesus (@DrTedros) June 3, 2020
The Lancet even issued an expression of concern earlier stating that the data and the methodology of the study was being reviewed by independent scientists.
Why Are Scientists Questioning The Paper's Data?
Hydroxychloroquine's use to treat COVID-19 has been debated repeatedly since the American President Donald Trump touted it to be a preventive agent against COVID-19 after a French study found that the drug can be effective against SARS-CoV-2, the virus that causes COVID-19.
The paper published on May 22, discusses that patients over 671 hospitals across six continents were studied to understand the effect of HCQ COVID-19 patients and found that it was more likely to cause ventricual arrhythmia. This paper led to the WHO halting its clinical trials for HCQ which were a part of the solidarity trial
It was later revealed that the data was provided by Surgisphere which calls itself a global healthcare data collaborative platform that claims to provide a real-time database of over 240 million anonymized patient encounters from over1,200 healthcare organizations in 45 countries through its analytical platform QuartzClinical.
The organization was founded in 2008 by Sapan Desai who has co-authored the paper under review. The platform claims to collect data through electronic health records (EHR) from hospitals.
The same four authors also authored a paper on the effect of ivermectin on COVID-19 as well as the contribution of cardiovascular ailments to the deaths of COVID-10 patients whose methodology was also questioned by scientists across the world, as reported by the Guardian. The New England Journal of Medicine, also issued an expression of concern for the data.
The Lancet has not only issued an expression of concern about the paper but also issued a clarification earlier about how an Asian hospital was misrepresented to be an Australian hospital on May 30th.
Surgisphere only gave this clarification after Australian researchers raised red flags about the method of data collection. The paper stated that it had gained data from five Australian hospitals covering over 600 patients and 73 deaths as of April 21. However, official records from Johns Hopkins tracker as searched by Guardian Australia, find that on April 21, Australia had reported only 67 deaths.
The federal health department even confirmed to Guardian Australia that these statistics were not provided by the national departments.
Over 120 MDs, researchers, statisticians, epidemiologists & ethicists from 24 countries globally sent an open letter to the Lancet questioning the integrity of the data.
They pointed that the data does not even divulge the countries from which the data has been collected along with a set of other reasons for not trusting the paper. They felt that along with Australia, Africa's data was also not verified and true.
They also asked for swift recommendations such as an ethics review, provision of data as well as comments of the peer review group.
The other doctors involved in the paper were conducting independent reviews for the data after all these doubts arose. On June 4, they retracted the paper stating that Surgisphere was not helping the independent peer reviewers with full datasets or client contracts citing confidentiality agreements and thus the independent peer reviewers withdrew from the process.
They even informed that they could not vouch for the veracity of the data and thus were retracting the paper.
Surgisphere-Response And History
The company issued a statement that due to their confidentiality statements they do not provide patient or client names but are conducting audits as well as are trying to respond to all queries by maintaining transparency.
Sapan Desai, the founder of Surgisphere has been mired in his own share of controversies. The organization has around 11 employees and a quick Linkedin search indicates that some of them do not have a scientific background.
A blog post by Peter Ellis, Chief Data Scientist at Nous Group, an international management consultancy further highlights all the different types of team members that an organization claiming to collect data from so many hospitals should ideally have and how that Surgisphere provides no such data on its website. LinkedIn has only five listed employees which later dropped down to three as Science Mag noted.
The Guardian also found that Desai a vascular surgeon has three lawsuits filed against him in the US with one claiming negligence. Desai voluntarily resigned from the Northwest Community Hospital in Chicago in Februrary 2020.
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