Publishing society: In hindsight, that famous French hydroxychloroquine study didn’t meet our standards

Via Retraction Watch, I missed this when it was published a few days ago but it seems kind of relevant to the great hydroxychloroquine debate now raging here in the U.S. The French study touting hydroxychloroquine’s supposed benefits in treating coronavirus isn’t the only one out there; there are some small trials from China that also found that the drug showed promise as a therapeutic. (There are small trials from China that say the opposite as well.) But the French study is the most famous, having been hyped by Tucker Carlson’s program in mid-March for its finding of a recovery rate of 100 percent among patients who’d received the drug.

Complaints about the study’s methodology began to appear within a week or so of its publication in the International Journal of Antimicrobial Agents (IJAA). I flagged this one in a post on March 24. Another critique published that same day flagged various issues, from the fact that a “14-day study” appeared to take place over only 10 days to the fact that the group that received HCQ differed from the control group in certain important ways to the not so minor detail that some patients whose conditions worsened were excluded from the study as it progressed.

The International Society of Antimicrobial Chemotherapy, which publishes the IJAA, finally issued a statement a few days ago addressing the criticism. Verdict: They now agree that the French study, which ignited international interest in hydroxychloroquine as a potential miracle drug, didn’t meet its “standard.”

ISAC shares the concerns regarding the above article published recently in the International Journal of Antimicrobial Agents (IJAA). The ISAC Board believes the article does not meet the Society’s expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety…

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. Both Editors in Chief of our journals (IJAA and Journal of Global Antimicrobial Resistance) are in full agreement.

No harm done, I suppose. Just a public furor led by the president of the United States resulting in a drug shortage and possible side effects to untold numbers of Americans now taking the drug as a prophylaxis against COVID-19.

There was another (very) small study of hydroxychloroquine from France published recently. This one wasn’t as encouraging:

First up is this study from France. It’s another very small one, and all the usual warnings apply because of that. It’s from a team at the University of Paris and Saint-Louis Hospital there, and they evaluated 11 consecutive patients admitted there with the same course of treatment as the Marseilles group first reported (hydroxychloroquine 600mg/day and azithromycin, 500mg the first day and 250 mg/day thereafter). The mean age of their patients was 58.7 years, and (notably) 8 of the 11 had significant comorbidities (two obese, 5 with various forms of cancer, one with HIV). That’s a tough population, and unfortunately, the HCQ/AZ combination did nothing. One patient died (and two others went on to the ICU) and of the ten remaining, 8 were still positive for the virus by nasal swab on days 5/6 after treatment. One patient had to discontinue therapy on day 4 because of QT prolongation, a known side effect of hydroxychloroquine that can lead to fatal heart arrhythmia.

So while this is a small study and not a perfect match, it provides no evidence to show that the HCQ/AZ combination had any benefit at all.

The same author notes that a small trial at NYU found that 30 percent of coronavirus patients who were given hydroxychloroquine and azithromycin experienced “notable” QT prolongation, i.e. a longer than usual gap between heartbeats, with another 11 percent at risk of arrhythmia. The drug really can backfire in the wrong patient.

But that’s not to say it shouldn’t be tried on people who’ve been hospitalized. Dan McLaughlin is right to warn against its politicization: “Instead, there’s been a stampede among Trump supporters and advocates to embrace hydroxycholoroquine: The Hero must always be right! And there has been a reflexive reaction among the president’s critics: The Villain must always be wrong!” It’s not wrong to give it to people who are already sick in the absence of any other proven therapeutic. It might help. Via Dan Foster, watch the clip below for an explanation of how HCQ might derail replication by COVID-19. The drug is a vehicle to deliver zinc into cells; the zinc, not the hydroxychloroquine itself, potentially shuts down the viral process. The objection to hydroxychloroquine isn’t about keeping it away from hospital patients, it’s about keeping it in the hands of people who need it and away from otherwise healthy people who might be hurt by it *and* not forcing health officials to chase this rabbit if they’re focused on more promising therapeutics, like antibody treatments, instead. Nothing would be dumber than prioritizing a single drug because it’s captured the president’s imagination when untested alternatives might deliver us from this mess more expeditiously. Now that the French study is in question, maybe Trump will reprioritize. Although probably not.

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