The publisher of the French study that found hydroxychloroquine could help treat coronavirus patients is now saying the paper ‘did not meet its standards.’
President Donald Trump has hailed the research in tweets and during his daily press conferences as a ‘game changer.’
But in a statement published online, the International Society of Antimicrobial Chemotherapy (ISAC) addressed several new concerns with the research.
Officials say they found out the researchers excluded data on patients who didn’t respond well to the treatment and that they did not clarify what they meant when they said patients were ‘virologically cured.’
A small-scale French study said it found that hydroxychloroquine (file image) could reduce the duration of coronavirus in patients
President Donald Trump has hailed the drug – in combination with azithromycin, an antibiotic – a game changer in treatment. Pictured: Trump speaks about the coronavirus at the White House, April 8
The medical society that published the study now says it ‘does not meet the Society’s expected standard’ because researchers did not include data about six of the 26 patients that ‘left’ the study and did explain what ‘virologically cured’ meant. Pictured: One of the study’s lead researchers, Professor Didier Raoult
The study was first published online in ISAC’s journal, the International Journal of Antimicrobial Agents, on March 20.
Researchers from the Méditerrannée Infection University Hospital Institute in Marseille, France, had 20 patients take hydroxychloroquine in combination with azithromycin, an antibiotic.
They found the the combination was linked to ‘viral load reduction/disappearance in COVID-19 patients.’
The team began with 26 patients but six were ‘lost in follow up during the survey because of early cessation of treatment,’ according to the study.
Three of the six ended up in the intensive care unit, a fourth patient died, one stopped treatment after experiencing nausea and the last ended up not having the virus.
In the US, there are more than 435,000 confirmed cases of the virus and more than 14,000 deaths
‘Although ISAC recognises it is important to help the scientific community by publishing new data fast, this cannot be at the cost of reducing scientific scrutiny and best practices,’ Andreas Voss, the president of the society, wrote in a statement.
He then made note that one of the study’s authors, Jean-Marc Rolain, is editor-in-chief of the journal in which it was published.
‘Despite some suggestions online as to the reliability of the article’s peer review process, the process did adhere to the industry’s peer review rules,’ Voss wrote.
‘Given his role as Editor in Chief of this journal, Jean-Marc Rolain had no involvement in the peer review of the manuscript and has no access to information regarding its peer review.’
Voss did not immediately reply to DailyMail.com’s request for comment.
Arthur Caplan, a bioethics professor in the department of population health at NYU School of Medicine, called the study ‘pathetic’ especially because the results of the six patients that were dropped [were not factored into the study’s final conclusions.]
‘I think [the research is] based on a pathetic study that lost six of the 26 patients,’ Caplan told DailyMail.com.
‘It hid data. It got retracted because it was a farce.’
Trump has said that people ‘have nothing to lose’ by trying the drug, but Caplan disagrees with that statement due to dangerous side effects.
‘Studies in Sweden and Japan [of the drug] have been shut down because [patients[ kept having seizures,’ he said.
‘It was approve for 20-year-olds going on a safari; it was not approved for 74-year-olds with pneumonia.’
Another concern ISAC said it had with the paper is ‘the lack of better explanations of the inclusion criteria.’
The authors wrote in the study that 100 percent of patients who took both drugs were ‘virologically cured’ in comparison with 57.1 percent of patients who just took hydroxychloroquine and 12.5 percent who took neither.
However, the researchers never full explained what of ‘virologically cured’ meant.
Source: Daily Mail | Health News