Huge ivermectin study for Covid withdrawn due to ethical concerns

On Thursday a Covid-related preprint originally published on the Research Square website in November was withdrawn. The article was titled, “Efficacy and Safety of Ivermectin for Treatment and prophylaxis of COVID-19 Pandemic,” and according to The Guardian, claimed to be a randomized control trial, a type of study crucial in medicine because it is considered to provide the most reliable evidence on effectiveness.

Ivermectin has been enthusiastically touted in the US by Republican Sen. Ron Johnson and others of his party despite the absence of evidence of its efficacy. The withdrawn preprint included claims of substantial recovery and lower mortality rates for patients with Covid-19 treated in hospital with ivermectin. However, major issues have been discovered since the paper’s original publication. (Oral ivermectin is approved by the FDA and other regulatory agencies for humans only for certain parasitic infections. It is not approved for Covid-19 or any other viral infections.)

A medical student, Jack Lawrence, was among the first to identify problems with the preprint. He noticed that the introduction section of the paper appeared to have been almost entirely plagiarized. [Emphasis added] It appeared that the authors had run entire paragraphs from press releases and websites about ivermectin and Covid-19 through a thesaurus to change key words.

“Humorously, this led to them changing ‘severe acute respiratory syndrome’ to ‘extreme intense respiratory syndrome’ on one occasion,” Lawrence said. He went on to review the data and found several apparent contradictions of the study protocol. (A clinical study protocol is a description of the study plan, including number of patients, intended treatments, study sites, etc. Deviations from the protocol during a study are common, but should be discussed in the final study report.)

[Emphasis added] “The authors claimed to have done the study only on 18-80 year olds, but at least three patients in the dataset were under 18,” Lawrence said. “The authors claimed they conducted the study between the 8th of June and 20th of September 2020, however most of the patients who died were admitted into hospital and died before the 8th of June according to the raw data, which also included one patient who left hospital on the non-existent date of 31/06/2020.

Lawrence contacted a colleague, Nick Brown (a data review specialist with a blog article about the article review here). According to Brown’s findings, the authors had clearly repeated data between patients.

“The main error is that at least 79 of the patient records are obvious clones of other records,” Brown told the Guardian. “It’s certainly the hardest to explain away as innocent error, especially since the clones aren’t even pure copies. There are signs that they have tried to change one or two fields to make them look more natural.”

[Image credit, Ars Technica]

Lawrence’s blog article at his site, Grifter Analysis and Review, also notes, “Many of the patients who died appear to be duplicates. For example, according to the original data, there were ‘four’ patients with the initials NME, NEM, and NES (twice), who were all males aged 51 years old, all suffered from diarrhoea, had the same blood haemoglobin levels, were all diagnosed on the 22nd of May, and all died on the 29th of May 2020. They also all share identical values in at least four other data columns.”

The study, led by Dr Ahmed Elgazzar from Benha University in Egypt, was one of the the largest ivermectin Covid studies, and has often been cited by proponents of the drug as evidence of its effectiveness. This is despite a peer-reviewed paper published in the journal Clinical Infectious Diseases in June finding ivermectin is “not a viable option to treat COVID-19 patients”.

Australian chronic disease epidemiologist Gideon Meyerowitz-Katz, of the University of Wollongong, told the Guardian, “This is one of the biggest ivermectin studies out there”, and it appeared to him the data was “just totally faked.”

[Featured image credit Getty via BBC News, “Call for apps to get fake Covid-19 news button

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