The effectiveness of a drug promoted by right-wing figures around the world to treat Covid-19 is in serious doubt after a major study suggesting the treatment is effective against the virus was withdrawn due to “ethical concerns “.
The preprint study on the efficacy and safety of ivermectin – a drug used against parasites such as worms and lice – in the treatment of Covid-19, led by Dr Ahmed Elgazzar of the University Benha in Egypt, was posted on the Research Square website in November.
It claimed to be a randomized controlled trial, a crucial type of study in medicine because it is considered to provide the most reliable evidence on the effectiveness of interventions due to the minimal risk of confounding factors influencing the outcome. Elgazzar is listed as an editor of the Benha Medical Journal, and is a member of the editorial board.
The study found that hospital-treated Covid-19 patients who “received ivermectin early reported substantial recovery” and that there was “substantial improvement and reduction in the rate of 90% mortality in the ivermectin-treated groups.
But the drug’s promise as a treatment for the virus is in serious doubt after the Elgazzar study was removed from the Research Square website on Thursday “For ethical reasons”. Research Square did not specify what these concerns were.
London medical student Jack Lawrence was among the first to identify serious concerns about the document, leading to withdrawal. He first learned about Elgazzar’s prepublication when it was given to him by one of his teachers for a mission that was part of his masters. He discovered that the introductory section of the document appeared to have been almost entirely plagiarized.
It appeared that the authors had spent entire paragraphs of press releases and websites about ivermectin and Covid-19 through a thesaurus to change keywords. “This led them, humorously, to change ‘severe acute respiratory syndrome’ to ‘extreme intense respiratory syndrome’ on one occasion,” Lawrence said.
The data looked suspicious for Lawrence as well, with the raw data apparently contradicting the study protocol on several occasions.
“The authors claimed that they only conducted the study on people between the ages of 18 and 80, but at least three patients in the data set were under the age of 18,” Lawrence said.
“The authors claimed to have conducted the study between June 8 and September 20, 2020, but most of the deceased patients were admitted to hospital and died before June 8 according to the raw data. The data was also terribly formatted, and includes a patient who was discharged from the hospital on the non-existent date of 6/31/2020.
There were other concerns.
“In their article, the authors claim that four in 100 patients died in their standard treatment group for mild and moderate Covid-19,” Lawrence said. “According to the original data, the number was 0, the same as the ivermectin treatment group. In their ivermectin treatment group for severe Covid-19, the authors claim two patients died, but the number in their raw data is four. “
Lawrence and the Guardian sent Elgazzar a full list of questions about the data, but did not receive a response. The university press service also did not respond.
Lawrence contacted Australian chronic disease epidemiologist at the University of Wollongong, Gideon Meyerowitz-Katz, and a data analyst affiliated with Linnaeus University in Sweden who examines scientific papers for errors, Nick Brown, for his assistance in further analyzing the data and study results.
Brown created a complete document revealing many data errors, discrepancies and concerns, which he provided to the Guardian. According to his findings, the authors had clearly repeated the data between patients.
“The main mistake is that at least 79 of the patient records are obvious clones of other records,” Brown told The Guardian. “This is certainly the most difficult to explain as an innocent mistake, especially since the clones aren’t even pure copies. There are signs that they’ve tried changing a field or two to make them look more natural.
Further studies on ivermectin are still ongoing. UK, Oxford University is testing whether people with Covid-19 are given ivermectin prevents them from ending up in the hospital.
The Elgazzar study was one of the largest and most promising to show that the drug can help Covid patients, and has often been cited by supporters of the drug as evidence of its effectiveness. This despite a peer-reviewed article published in the journal Clinical Infectious Diseases in June, concluding that ivermectin is “not a viable option for treating COVID-19 patients”.
Meyerowitz-Katz told The Guardian that “this is one of the largest studies on ivermectin,” and he believed the data was “totally falsified.” It was worrying because two meta-analyzes of ivermectin to treat Covid-19 included the Elgazzar study in the results. A meta-analysis is a statistical analysis that combines the results of several scientific studies to determine what the overall scientific literature has found about a treatment or intervention.
“Because the Elgazzar study is so large and so overwhelmingly positive – showing a 90% reduction in mortality – it skews the evidence tremendously in favor of ivermectin,” Meyerowitz-Katz said.
“If you remove this study from the scientific literature, suddenly there are very few positive randomized controlled trials of ivermectin for Covid-19. Indeed, if you just get rid of that research, most meta-analyzes that found positive results would see their conclusions entirely reversed. “
Kyle Sheldrick, a doctor and researcher from Sydney, also independently raised concerns about the document. He found that the numbers provided by the authors for several standard deviations – a measure of variation in a group of data points – mentioned in the tables in the article were “mathematically impossible” given the range of numbers provided in the same table.
Sheldrick said the completeness of the data was further evidence suggesting possible fabrication, noting that under real-world conditions this was nearly impossible. He also identified the duplication of deaths and patient data.
Ivermectin has gained ground across Latin America and India, largely based on evidence from pre-publication studies. In March, the World Health Organization warned against using ivermectin outside well-designed clinical trials.
Australian Conservative MP Craig Kelly, who has also promoted the use of the antimalarial drug hydroxychloroquine to treat Covid-19 – although there is no evidence that it works – has been among those promoting ivermectin . Several Indian media outlets published articles on Kelly last week after he asked Uttar Pradesh to loan the Chief Minister of State, Adityanath, to Australia to release ivermectin.
Lawrence said what started out as a simple academic mission led to a thorough investigation into apparent scientific fraud at a time when “there is all the hype about ivermectin … dominated by a mix of right-wing figures, anti-vaccines and outright plotters ”. .
“Although science tends towards self-correction, something is clearly broken in a system that can allow a study as fraught with problems as the Elgazzar article to go unchallenged for seven months,” he said. he declares.
“Thousands of highly skilled scientists, doctors, pharmacists and at least four major drug regulators missed a fraud so apparent it could just as easily have been accompanied by a flashing neon sign. That all of this has happened in the midst of a global health crisis of epic proportions is all the more terrifying. “