“The study was a complete failure,” he said.
Tracey and Caplan pointed out that several patients who took the drug, and ended up faring poorly, dropped out of the trial, and their outcomes were not factored into the study’s final conclusions.
The International Society of Antimicrobial Chemotherapy published the study online in its journal, the International Journal of Antimicrobial Agents, on March 20.
“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,” according to the April 3 statement by Andreas Voss, the president of the society.
Voss noted that one of the study authors, Jean-Marc Rolain, is editor-in-chief of the medical journal.
“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, Rolain and Didier Raoult, a lead study author, did not immediately respond to CNN emails seeking comment.
Trump’s glowing reviews of an unproven drug
Rarely does one unproven drug make such headlines, but hydroxychloroquine did due to Elon Musk, conservative media and Trump.
Trump’s enthusiasm for hydroxychloroquine hasn’t waned with time, even though it’s one of many drugs being studied to prevent or treat coronavirus, and none of them have been proven to be safe or effective.
Doctor says hydroxychloroquine still worth studying
In its statement, the society that published the paper mentioned concerns about “the lack of better explanations of the inclusion criteria” in the study, which took place at the Méditerrannée Infection University Hospital Institute in Marseille, France.
The study started out with 26 patients taking the hydroxychloroquine, but six were “lost in follow up during the survey because of early cessation of treatment,” according to the study.
Three left because they ended up in the intensive care unit, another patient died, and a fifth stopped treatment due to nausea. It turned out the sixth patient didn’t actually have coronavirus.
Leaving out the five patients who took the drug and didn’t fare well is “cherry picking,” said Caplan, the bioethicist.
“That’s not science,” he said. “You’ve got your thumb on the scale.”
The remaining 20 patients took hydroxychloroquine, some with the antibiotic azithromycin and some without, and their outcomes were compared with patients who did not take either drug.
The study authors wrote that “100%” of patients who took the drug combination were “virologically cured” compared to 57.1% of the patients who took hydroxychloroquine alone and 12.5% of the control group. The authors did not fully explain what they meant by “virologically cured.”
Caplan added that even without the “cherry picking” issue, a study with such a small number of patients is basically meaningless.
“It’s just a jumbled mess,” he said.
Several centers are doing clinical trials on hydroxychloroquine to prevent or treat coronavirus, including Harvard, Columbia, New York University and Henry Ford Health System in Detroit.
Tracey, the researcher at the Feinstein Institutes in New York City, is also conducting a study on the drug. He said despite the French study being “seriously flawed,” it’s still worth looking at hydroxychloroquine to see if it’s safe and effective for a subset of coronavirus patients.
First, he noted that hydroxychloroquine has anti-inflammatory properties. The US Food and Drug Administration has approved its use against lupus and rheumatoid arthritis, both diseases that involve inflammation.
Hydroxychloroquine might help coronavirus patients who experience what’s called a “cytokine storm,” a potentially deadly inflammatory process.
And small studies other than the “seriously flawed” French one have shown that the drug might work, he added.
“There’s a lot of small studies in humans and in the lab that frame an appropriate question that’s never been answered in a clinical trial,” he said. “It’s important to know if it works and if it’s safe in some people with coronavirus.”
Amy Roberts contributed to this story.