Original story below.
Medical journal The Lancet on May 29 issued a correction to a recent study which found that antimalarial drugs Hydroxychloroquine and chloroquine were linked with an increased risk of mortality in hospitals, and an increased frequency of irregular heart rhythms.
Patients receiving the anti-malarials were put in four different groups: chloroquine alone, chloroquine with a macrolide, hydroxychloroquine alone, or hydroxychloroquine with a macrolide. Patients who received none of the treatments formed a control group. Researchers found the 14,888 patients in the treatment group suffered higher mortality when compared to the control group of over 80,000.
“We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19,” the researchers wrote.
The study led the World Health Organization to temporarily suspend the trial of hydroxychloroquine on COVID-19 patients, and to the UK regulatory body, MHRA, requesting the temporary pause of recruitment into all hydroxychloroquine trials in the UK. France also changed its national recommendation of the drug in COVID-19 treatments and halted all trials.
These included the fact that there was “no ethics review,” and “unusually small reported variances in baseline variables, interventions and outcomes,” as well as “no mention of the countries or hospitals that contributed to the data source and no acknowledgments to their contributions.” A request to the authors for information on the contributing centers was denied, the letter said.
Among the scientists other concerns were that the average daily doses of hydroxychloroquine were higher than the FDA-recommended amounts and that data reportedly from Australian patients did not seem to match data from the Australian government.
“Too many cases for just five hospitals, more in hospital deaths than had occurred in the entire country during the study period,” they wrote, noting that Surgisphere, a healthcare data analytics company, has since stated this was an error of classification of one hospital from Asia. “This indicates the need for further error checking throughout the data base,” they wrote.
The scientists also said the authors “have not adhered to standard practices in the machine learning and statistics community. They have not released their code or data.”
“Data from Africa indicate that nearly 25% of all COVID-19 cases and 40% of all deaths in the continent occurred in Surgisphere-associated hospitals which had sophisticated electronic patient data recording, and patient monitoring able to detect and record ‘nonsustained [at least 6 secs] or sustained ventricular tachycardia or ventricular fibrillation.’ Both the numbers of cases and deaths, and the detailed data collection, seem unlikely.”
The Lancet’s study was informed by data from Surgisphere of which Sapan Desai, the president and Chief Executive Officer, is listed as one of the four authors.
“This hospital was properly reclassified in our database. The findings of the paper are unaffected by this update,” the company said.
“The appendix has also been corrected. An incorrect appendix table S3 was included, originally derived from a propensity score matched and weighted table developed during a preliminary analysis. The unadjusted raw summary data are now included.”
The Lancet added that there “have been no changes to the findings of the paper,” and that the corrections have been made to the online version and will also be made to the printed version.
