Medical journal retracts major hydroxychloroquine study for data inconsistencies

One of the world’s top medical journals retracted a major study Thursday on the antimalarial drug hydroxychloroquine — touted as a potential coronavirus treatment — after the authors were unable to sort through inconsistencies in the data.

“[The authors] were unable to complete an independent audit of the data underpinning their analysis,” The Lancet said in a statement. “As a result, they have concluded that they ‘can no longer vouch for the veracity of the primary data sources.’”

The May paper seemed to reveal that confirmed-positive patients who received variations of hydroxychloroquine had a higher risk of death than those who did not, and a significantly higher risk of heart arrhythmia, McClatchy News previously reported.

It was deemed one of the most comprehensive reviews of the drug after observing medical records of about 96,000 coronavirus patients in six continents.

Shortly after The Lancet announced its decision, the New England Journal of Medicine retracted a separate coronavirus study on blood pressure medications that used the same analytics company and included some of the same authors as in the first study on hydroxychloroquine.

The Lancet’s retraction comes after outside experts noticed inconsistencies in the number of patients involved and the prescribed drug dosages, Science reported.

A Chicago-based company called Surgisphere collected the data used in the study and has failed to properly explain how it sourced its data to peer reviewers, the authors said in a statement, according to Stat.

The Lancet said it “takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were allegedly included in this study.”

On Wednesday, the journal released “an expression of concern” to “alert readers to the fact that serious scientific questions have been brought to our attention.”

However, the researchers, who are not affiliated with Surgisphere, said “ our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process,” they wrote in a statement, Stat reported.

For one, the reported dosages given to patients in North America appeared to be higher than U.S. Food and Drug Administration guidelines, Nicholas White, a malaria researcher at Mahidol University in Bangkok, told Science.

White also raised doubts about Africa’s ability to record “detailed” electronic health records of the 4,402 African patients the study claims to have provided data for.

Other researchers flagged that the study does not provide information about how much sicker patients receiving the drugs were compared to controls, which could change the understanding of the drugs’ effects, Science reported.

Surgisphere has provided data for other coronavirus papers, as well.

“This is not for the faint of heart,” Harlan Krumholz, director of the Center for Outcomes Research and Evaluation at Yale New Haven Hospital, told Stat. “Well-done studies are based on understanding the provenance of the data and making sure what you are doing is reasonable. There is good science to be done with big databases, but there are also major mistakes to be made. The question is: What happened here?”

The Lancet study’s release prompted the World Health Organization to temporarily pause international hydroxychloroquine trials on May 25 for further review of the harmful consequences the study had reported.

But that decision was overturned Wednesday when the The Data Safety Monitoring Board at WHO concluded there was no reason to discontinue them.

“The executive group received this recommendation and endorsed the continuation of all arms of solidarity trial including hydroxychloroquine,” WHO Director-General Dr. Tedros Adhanom Ghebreyesus said during a press conference, CNBC reported.

Despite the inconsistencies, a separate study released Wednesday in the New England Journal of Medicine showed, again, that hydroxychloroquine — which President Donald Trump said he was taking as a precaution — does not prevent coronavirus infection.

The researchers enrolled 821 adults from the U.S. and Canada who had been exposed to COVID-19, the study said, and who received either a placebo or hydroxychloroquine tablet four days after exposure.

“After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with COVID-19 or confirmed infection,” the study said.

The Lancet is no stranger to retractions.

In 2010, the journal retracted a 12-year-old “landmark” study that claimed the vaccine for measles, mumps and rubella caused autism, noting “several elements ... are incorrect, contrary to the findings of an earlier investigation.”

Last year, the journal retracted a study on cardiac stem cells due to issues in data.