Trending

Negative hydroxychloroquine study retracted over questions about source of the data

A study that found hydroxychloroquine increased the risk of death in COVID-19 patients has been withdrawn from a medical journal after the data used in the study could not be verified.

The Lancet on Thursday retracted a report on the drug at the request of its authors.

The medical journal pulled the report after its authors said the company, Surgisphere, was unable to verify how it had collected the data upon which their report was based, according to a story by The Guardian

The study claimed that the malaria drug was associated with higher rates of heart issues as well as higher rates of death when given to COVID-19 patients in hospital settings around the world.

Based on the findings of that study, the World Health Organization’s Director-General, Tedros Adhanom Ghebreyesus, paused a study on hydroxychloroquine over concerns the drug was killing patients.

WHO officials said Thursday that the organization would resume hydroxychloroquine trials.

The New England Journal of Medicine recently published a paper on blood pressure drugs and COVID-19 treatment from the same authors of the hydroxychloroquine study. The authors used data from Surgisphere for that paper.

The Journal on Thursday retracted that paper, saying, "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, 'Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.' We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused."

The drug came to the attention of the public when President Donald Trump touted the use of hydroxychloroquine in COVID-19 patients. Trump mentioned the drug several times in his then-daily Coronavirus Task Force briefings.

Trump announced last month that he had been taking the drug to help stave off the virus. He said last week that he is no longer taking hydroxychloroquine.

Hydroxychloroquine is an anti-malarial drug that some doctors of COVID-19 patients have had success using in an off-label setting, meaning using the drug for treatment of a disease for which it was not developed.

The U.S. Food and Drug Administration issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and a similar drug, chloroquine, which they claimed included “serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. These risks, which are in the drug labels for their approved uses, maybe mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19.”

The results of the study led not only the WHO to end its study, but also several governments to ban the use of hydroxychloroquine.

Surgisphere claimed to have analyzed data from nearly 96,000 patients on six continents.

A study out of Oxford released this week said that there is no evidence that hydroxychloroquine benefits COVID-19 patients.

To read The Guardian’s investigative report, click here.