Two of the world’s heading pharmaceutical journals on Tuesday showed concern about potential flaws in the data and covid studies provided by a little company to draw meaningful judgments about COVID-19 — that particular heart medications are safe, and that the malaria drug hydroxychloroquine is not. The last finding led to the pause of an indispensable consideration of hydroxychloroquine by the World Health Organization.
“Severe issues have been asked about the reliability of the conclusions reached in this paper,” Richard Horton, the editor of the Lancet, where the hydroxychloroquine research was written, wrote on Twitter.
Eric Rubin, the editor of the New England Journal of Medicine, which published the research of heart drug safety, struck a similar tone.
Big Data Covid Studies
“Substantive companies have been raised about the quality of the data in that database,” Rubin wrote in the so-called expression of concern published by the journal. “We have requested the authors to provide evidence that the data are secure.”
The companies built over the past many days on social media, highlight more critical issues with using big databases to stop medicines. This program has been gaining rigor in the era of big data. Authorities warn that managing such studies accurately is far more complicated than it seems. Big data is currently rather well-spread throughout the pharmaceptical world, and applying such data is a unique chance to be aware of all the changes and misunderstandings.
“This is not for the faint of heart,” stated Harlan Krumholz, the manager of the Center for Outcomes Research and Evaluation at Yale-New Haven Hospital. “This is not only a material of dial-a-study when you get introduced to data.
Well-done studies are based on knowing the provenance of the data, and making sure what you are doing is right. There is good science to be done with big databases, but critical mistakes are also made. The question is: What happened here?”
Both subjects used data from Surgisphere, a little-known organization based in Chicago that was required in the Lancet study to have data from 671 hospitals in six regions. The Lancet paper found that the malaria drugs chloroquine and hydroxychloroquine, which had been investigated as possible treatments for COVID-19, did not agree with enhanced results for sufferers, and were also linked with higher mortality.
The paper in the New England Journal of Medicine stated that blood pressure medicines were not affiliated with worse outcomes in sufferers with COVID-19. The studies share some of the same authors, including Sapan Desai, who runs the Surgisphere.
A Clinical Case
After rejecting the clinical case arm centered on hydroxychloroquine, the WHO said it would examine the data produced so far. That portion of the WHO’s multidrug Solidarity Trial endures paused, delaying answers on a drug that has become a political flashpoint even as the data on its potential advantages and opportunities is murky.
But data reports and experts have asked questions about the integrity of the Surgisphere data. For instance, the Guardian reported discrepancies in data said to come from Australia in the Lancet study. The Lancet study’s authors have changed errors about the number of members, but have stood behind their results.