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Scientists question validity of major 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 COVID-19 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-in-chief, 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.

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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.

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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, which 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, which he identified as DQS.

“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.

Scientists who wrote and signed the letter criticizing the study included clinicians, researchers, statisticians and ethicists from academic medical centers, including Harvard’s T.H. Chan School of Public Health, the University of Pennsylvania, Vanderbilt University and Duke University.

“In the interests of transparency, we also ask The Lancet to make openly available the peer-review comments” that led to this manuscript’s acceptance for publication, they wrote.

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Allen Cheng, a professor of infectious diseases at Monash University in Melbourne, Australia, who signed the letter, said in an email that the individual hospitals included in the database should be identified.

“Ideally, the database should be made public, but if that isn’t possible, it should at least be independently reviewed and an audit performed,” he said.

The paper’s authors said they had analyzed data gathered from 671 hospitals on six continents that shared granular medical information about nearly 15,000 patients who had received the drugs and 81,000 who did not, while shielding their identities.

Surgisphere’s data was also the basis of a study of coronavirus patients published in the New England Journal of Medicine earlier this month by some of the same authors, including Harvard’s Dr. Mandeep R. Mehra, as well as for two versions of an article on the use of an antimicrobial drug to treat COVID-19 that were not published in an established medical journal.

Although other observational studies had already reported possible harms associated with the malaria drugs and the Food and Drug Administration had issued a safety warning about their use, the WHO suspended clinical trials of the drugs after The Lancet paper was published.

c.2020 The New York Times Company

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