ON THE UPSIDE, THE REPORT GENERATED HEADLINES AND FUD AT THE EXPENSE OF AN INEXPENSIVE, GENERIC, OFF-PATENT TREATMENT FOR A WIDELY FEARED DISEASE: A mysterious company’s coronavirus papers in top medical journals may be unraveling.
On its face, it was a major finding: Antimalarial drugs touted by the White House as possible COVID-19 treatments looked to be not just ineffective, but downright deadly. 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.
But just as quickly, 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. “It began to stretch and stretch and stretch credulity,” says Nicholas White, a malaria researcher at Mahidol University in Bangkok.
Today, 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.”
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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.”
Mission accomplished. But whose mission?
Related: Surgisphere and their data.
Meanwhile, from a new Indian study on HCQ prophylaxis in health care workers: “Consumption of four or more maintenance doses of HCQ was associated with a significant decline in the odds of getting infected.”