UPDATE: Lancet Retracts Coronavirus Study Following Questionable Data that Halted Studies
This article was originally published on June 4, 2020. It was updated with additional developments on June 5, 2020.
An article raising concern about the safety of using hydroxychloroquine as a treatment of COVID-19 that forced the World Health Organization to temporarily suspend a clinical study involving the drug has been retracted.
On Thursday, days after questions began to be raised regarding the validity of data used in a study published in the noted medical journal The Lancet, several of the authors of the study withdrew the article. According to NPR, some of the study’s authors retracted the paper after the company that provided the data, Surgisphere, refused to release its data, citing confidentiality concerns. Because of this refusal, three of the study’s authors called for the retraction because they “can no longer vouch for the veracity of the primary data sources,” NPR said.
In its own statement about the decision to pull the study, The Lancet said it takes the issue of scientific integrity seriously and noted there are a number of unanswered questions about Surgisphere and the data that it provided for the study.
BioSpace's original article continues below:
Questions continue to arise around a small company called Surgisphere and the data it collected that was used to form the results in two large COVID-19 studies, including one major study involving the use of the antimalarial drug hydroxychloroquine. Investigations are likely imminent as concerns over the data increase.
Two major medical journals, The Lancet and The New England Journal of Medicine, first expressed concerns over some of the data collected by Surgisphere that formed the basis for studies published in their pages. Surgisphere, which was established in 2008 as a medical education company that published textbooks, also owns a data analytics system called QuartzClinical. The system is billed as being capable of collecting massive of datapoints from more than 1,200 hospital. The study in The Lancet was focused on the use of hydroxychloroquine in COVID-19 patients and the study in the NEJM concluded that common blood pressure medications were not associated with in-hospital death among hospitalized patients with COVID-19, MedPage Today reported. Both journals said the Surgisphere database used inflated numbers that were far higher than official counts in those studies. For example, in the blood pressure study, Surgisphere included numbers of COVID19 patients in Turkey that were greater by a factor of 80 than official numbers, MedPage said.
The editors of both The Lancet and NEJM have published “expressions of concern” regarding the published studies and said they would be investigating the data used as the basis for that story.
The hydroxychloroquine data was at the core of a decision made by the World Health Organization to temporarily pause a study of the malaria treatment in COVID-19. The WHO decision was made following a report published in The Lancet last month that showed COVID-19 patients who received the medication in the study were dying at a higher rate than other patients with the disease caused by the novel coronavirus. The study showed that among patients who received hydroxychloroquine, either alone or with a macrolide, the study authors estimated a higher mortality rate. COVID-19 patients who were seriously ill and who were treated with hydroxychloroquine or chloroquine were more likely to die or develop dangerous irregular heart rhythms, the study authors said.
The World Health Organization was not the only one to halt studies of hydroxychloroquine based on this data. Studies in Europe were also paused out of safety concerns raised by the Lancet report. This week the WHO announced it would resume the hydroxychloroquine study.
In addition to these studies, Science reported that a third study using Surgisphere data has also come into question. This data looked at the use of the antiparasitic drug ivermectin in COVID-19 patients. That study concluded that the drug reduced mortality in COVID-19 patients. This study is also being investigated, particularly after some countries recommended the use of ivermectin in treating patients.
Surgisphere has not released the data it used to form the basis of these studies, but Science reported this morning that the Chicago-based company was arranging a nondisclosure agreement that will provide the authors of the NEJM paper with the data access requested by NEJM.”
When concerns first began to circulate about Surgisphere’s data and claims regarding its QuartzClinical capabilities, U.K.-based The Guardian began to investigate the company and found material that “suggests several of Surgisphere’s employees have little or no data or scientific background. An employee listed as a science editor appears to be a science fiction author and fantasy artist. Another employee listed as a marketing executive is an adult model and events hostess.”
Sapan Desai, chief executive officer of Surgisphere, has also been named in three medical malpractice lawsuits. He told The Guardian those suits were “unfounded.”