Scientists question hydroxychloroquine study
More than 100 scientists and clinicians have questioned the authenticity of a massive hospital database that was the basis for an influential study published last week that concluded the use of chloroquine and hydroxychloroquine to treat people with COVID19 did not help and may have increased the risk of abnormal heart rhythms and death.
In an open letter addressed to The Lancet’s editor, Richard Horton, and the paper’s authors, the scientists asked the journal to provide details about the provenance of the data and called for the study to be independently validated by the World Health Organization or another institution.
Use of the malaria drugs chloroquine and hydroxychloroquine to prevent and treat COVID-19 has been a focus of intense public attention. President Donald Trump has touted the promise of hydroxychloroquine, despite the absence of gold-standard evidence from randomized clinical trials to prove its effectiveness, and has recently said he was taking the drug himself in hopes of preventing coronavirus infection.
The scientists’ challenges to The Lancet paper come at a time of increasing debate about the risks of the rush to publish new medical findings about COVID-19, the disease caused by the coronavirus. The paper, published May 22, included data on tens of thousands of patients hospitalized through April 14, meaning that the authors analyzed the trove of data, wrote the paper and went through the journal’s critical review of its findings in less than six weeks.
The experts who wrote The Lancet also criticized the study’s methodology and the authors’ refusal to disclose information on the hospitals that contributed patient data, or even to name the countries where they were located.
The company that owns the database is Surgisphere, a firm in Chicago that claims to have access to patient medical records from around the world.
“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,” the scientists wrote. “Both the numbers of cases and deaths, and the detailed data collection, seem unlikely.”
A spokeswoman for The Lancet, Emily Head, said in an email that the journal had received numerous inquiries about the paper and had referred the questions to the authors.
“We will provide further updates as necessary,” she said.
Dr. Sapan S. Desai, the owner of Surgisphere and one of the paper’s authors, said the database that was used is an aggregation of the anonymous electronic health records of hospitals that are Surgisphere’s customers.
Contractual agreements with the hospitals bar the sharing of patient level data, Desai added, although it is available to qualified scientists for research purposes.
“Our strong privacy standards are a major reason that hospitals trust Surgisphere, and we have been able to collect data from over 1,200 institutions across 46 countries,” the statement said.
He said the company is certified by the International Organization for Standardization and audited by an external third-party auditor.
“Every aspect of our data acquisition, warehousing and reporting is audited as part of those very strict certifications,” Desai said in an email, adding that mandatory audits take place at least four times a year.