Researchers Retract Study Linking Malaria Pill to Heart Risk

(Bloomberg) -- A study that said a malaria drug backed by President Donald Trump to treat and prevent coronavirus raised the risk of heart side effects and death has been retracted by the authors.

The study was published on May 22 in the Lancet, a prestigious U.K. medical journal. Questions soon arose about the accuracy of the underlying data, said researchers led by Mandeep Mehra, the medical director of Brigham and Women's Hospital Heart and Vascular Center, in the retraction note published by the journal Thursday.

While the company that produced the original data, Surgisphere Corp., had signaled that it would cooperate with an independent review, it ultimately reneged and said doing so would violate confidentiality agreements, wrote the study authors. “As such, our reviewers were not able to conduct an independent and private peer review,” the authors said.

“We all entered this collaboration to contribute in good faith and at a time of great need during the Covid-19 pandemic,” the authors said. “We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”

The retraction is the latest turn for a drug that has been followed by controversy since Trump took it up as a possible coronavirus treatment earlier this year. Repeated efforts have been launched to study the drug and whether it might be used as a therapy for patients with the disease or as a preventive.

So far, the results have been largely negative. One large study published this week examining the drug's use as a preventive showed that it didn't stop at-risk people from being infected by the coronavirus.

Controversy has also grown around Surgisphere, a Chicago-based medical data company that says it consolidates medical records from around the world. The company's data was used in another major study of heart drugs called ACE inhibitors, and what impact their use might have on Covid-19 patients.

On Thursday, the New England Journal of Medicine said that study's authors had retracted it, as well.

“Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article,” they wrote.

On Wednesday, Surgisphere CEO Sapan Desai said in an emailed statement that the company “stands behind the integrity of our studies.” Following the retraction, the company said that Desai was “unavailable to make any further public comment at this time.”