A controversial, very influential trial of the drug hydroxychloroquine for the treatment of Covid-19, which has helped launch months of research and failed clinical trials, has now been sharply criticized on the pages of the same scientific journal that published it. The new Post-peer review highlights a number of serious shortcomings in the study and concludes that the authors were “totally irresponsible” in presenting their results.
The original paper, written by a team of researchers in France, was released End of March in the International Journal of Antimicrobial Agents. It was said that 20 hospitalized patients with confirmed Covid-19 were treated with hydroxychloroquine, some of whom also received the antibiotic azithromycin. The study found that those who received hydroxychloroquine had lower virus levels on average or cleared the infection more quickly than a control group of patients. The addition of azithromycin was associated with an even faster recovery.
Although there had previously been promising studies with hydroxychloroquine to treat Covid-19 in other parts of the world, the French study sparked massive scientific and political interest in the drug. President Trump tweeted himself about the study the day after the release, he announced combination therapy as a “game changer” for the pandemic. Soon after, the U.S. government and others, including the World Health Organization, announced that they would start large-scale studies to test hydroxychloroquine and the related drug chloroquine.
But it wasn’t long before other scientists started Ask questions about the study, its implementation, and the scientists who conducted it, particularly the lead author, a doctor and microbiologist named Didier Raoult. Although Raoult had really contributed to important research in the past, so was he and his laboratory previously accused of blatant mistakes and misconduct in her published work, with one episode leading to a one-year ban on a well-known journal of microbiology. When his hydroxychloroquine study made waves, the researchers discovered other alleged examples of data falsification in some of his earlier research.
Since then, evidence that hydroxychloroquine could help with Covid-19 has been largely (but not completely) improved, especially in severe cases. the WHO completed The hydroxychloroquine clinical trial last month after the data showed no real benefit while other countries like the US stopped recommend its benefit. But that still leaves the study that started it all.
Although the paper was peer-reviewed, this process was also subject to criticism after it emerged that one of Raoult’s co-authors, Jean-Marc Rolain, was also the editor-in-chief of the magazine in which it was published. On April 3, the International Society for Antimicrobial Chemotherapy, which manages the magazine, specified that the study did not meet its “expected standard” for publication, but that Rolain had no role in the peer review process.
Although post-release peer reviews are not common, they are gaining increasing attention to address many of the problems and gaps that occur in the standard process. In this case, the study was reviewed by Frits Rosendaal, a clinical epidemiologist at Leiden University Hospital in the Netherlands.
Rosendaal’s devastating review reflects many of the same criticisms that external scientists have made after the study was published. In particular, he condemns Raoult’s team’s decision to exclude from the final results of the study six patients taking hydroxychloroquine, including four whose condition worsened, one of which eventually died during the study period (none in the control group died). There were other inconsistencies, such as B. Supplementary material mentioning that a number of asymptomatic patients were enrolled in the study, while the actual language of the study claimed to be an examination of hospitalized patients (people without symptoms were probably not diagnosed with Covid-19 taken to the hospital). .
These and other problems with the data were enough to make the study “almost, if not completely informative,” wrote Rosendaal. The overly rosy tone of the paper when promoting hydroxychloroquine as a Covid-19 treatment was not only unfounded, he added: “Given the desperate demand for treatment for Covid-19 in connection with the potentially serious side effects of hydroxychloroquine, it was completely irresponsible. “
Another new one paper, also published yesterday, similarly criticizes the French study, noting that “this study has several important methodological issues, including design, measurement of results, and statistical analysis.”
Although the main impacts of this research appear to have come and gone and most countries are no longer enthusiastic about hydroxychloroquine and other medicines that have shown promise in the treatment of Covid-19, the effects can last much longer.
There are still die-hard supporters of the drug, including President Trump. According to the Washington Post, Trump and members of his government are push for the Food Drug Administration to re-approve the drug as an emergency treatment for Covid-19, according to a quickly criticized The study (and non-clinical study) published last week found some evidence of its benefits. Raoult himself continues Supporting his research and promoting the drug, he claimed in late June that he had successfully treated over 3,700 people.
It is currently unclear whether reviewing Raoult’s work will lead to further action by the magazine. Neither tThe International Society for Antimicrobial Chemotherapy still Elsevier, who co-published the diary, replied to a request for comment from Gizmodo.