A study published on 22 May in The Lancet used hospital records procured by a little-known data analytics company called Surgisphere to conclude that coronavirus patients taking chloroquine or hydroxychloroquine were more likely to show an irregular heart rhythm—a known side effect thought to be rare—and were more likely to die in the hospital.
Within days, some large randomized trials of the drugs—the type that might prove or disprove the retrospective study’s analysis—screeched to a halt. Solidarity, the World Health Organization’s (WHO’s) megatrial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm, for example.
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the Lancet results have begun to unravel—and Surgisphere, which provided patient data for two other high-profile COVID-19 papers, has come under withering online scrutiny from researchers and amateur sleuths. They have pointed out
many red flags in the Lancet paper, including the astonishing number of patients involved and details about their demographics and prescribed dosing that seem implausible
The Lancet issued an
Expression of Concern (EOC) saying “important scientific questions have been raised about data” in the paper and noting that “an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly.”
Hours earlier,
The New England Journal of Medicine (NEJM) issued its own EOC about a second study using Surgisphere data, published on 1 May. The paper reported that taking certain blood pressure drugs including angiotensin-converting enzyme (ACE) inhibitors didn’t appear to increase the risk of death among COVID-19 patients, as some researchers had suggested.
Meanwhile, the questions swirling around the Lancet paper have left leaders of the halted chloroquine trials weighing whether to restart.
“The problem is, we are left with all the damage that has been done,” says White, a co-investigator on a trial of hydroxychloroquine for COVID-19 prevention that was halted at the request of U.K. regulators last week.
Headlines proclaiming deadly effects will make it hard to recruit patients to key studies, he says. “The whole world thinks now that these drugs are poisonous.”
Other researchers immediately took issue with the analysis.
The study doesn’t properly control for the likelihood that patients getting the experimental drugs were sicker than the controls, says Matthew Semler, a critical care physician at Vanderbilt University. “If you have a physician sitting with two patients who have coronavirus, and the physician chooses to give one of them hydroxychloroquine, they’re doing it for a reason,” he says. The patient may be relying on high levels of supplemental oxygen, for example, or getting worse over time. But those kinds of details aren’t available about the patients in the Lancet study, he notes.
Other researchers were befuddled by the data themselves. Though 66% of the patients were reportedly treated in North America, the reported doses tended to be higher than the guidelines set by the U.S. Food and Drug Administration, White notes. The authors claim to have included 4402 patients in Africa, 561 of whom died, but it seems unlikely that African hospitals would have detailed electronic health records for so many patients, White says.
The study also reported more deaths in Australian hospitals than the country’s official COVID-19 death statistics,
https://www.sciencemag.org/news/2020...-be-unraveling (much more at link)
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Originally Posted by Geeko Sportivo
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