The WHO previously halted its global trial over safety concerns.
Hydroxychloroquine has had a bit of a notorious reputation since the drug was first proposed as a treatment for COVID-19. Without much experience to go on, researchers and doctors jumped into trials in the hopes that the malaria medicine would be able to combat the novel coronavirus, and politicians, including President Trump, publicly touted its potential benefits.
But while this isn’t the first or only indication that the drug might be dangerous, outside experts have questioned the validity of The Lancet study’s conclusions. Patient data for the research paper came from a small, relatively unknown company called Surgisphere. According to STAT, researchers have found inconsistencies in the patient data, as well as a lack of information on where it actually came from.
During a press briefing Wednesday, WHO director general Tedros Adhanom Ghebreyesus announced that the organization would resume its hydroxychloroquine trial, given the recent re-examination of the large study. Known as the Solidarity Trial, the WHO’s study involves thousands of patients between 400 hospitals in 35 countries.
In March, when researchers were grasping at straws to identify drugs that would help patients with COVID-19 fare better, anecdotal evidence and small studies suggested hydroxychloroquine could help. The hope was that experience and data would further support its use.
The paper in The Lancet, whose results have now been called into question, looked at 96,032 people worldwide with COVID-19 of whom almost 15,000 took hydroxychloroquine. Overall, people who took the drug had a higher mortality rate than those with COVID-19 who didn’t take the medication. Hydroxychloroquine-treated patients also had a higher incidence of cardiac arrhythmias (a known side-effect of the drug) than those that didn’t take it.
Until we know more about the quality of the study, its impossible to base any conclusions about hydroxychloroquine’s potential as a treatment for COVID-19 on it. However, The Lancet study is not the first to bring up concerns over the safety of the antimalarial drug. In the United States, use of hydroxychloroquine for COVID-19 is allowed under the FDA’s emergency-use authorization. According to Reuters, however, the agency warned that because of known safety issues (noting specifically the potential for cardiac problems), the drug should be limited to clinical trials and hospitalized patients only. So while the dubious nature of the results reported in The Lancet may cast enough doubt for the WHO to proceed with trials, there are still scant indications that the drug is particularly effective—and plenty of reason to think it might be dangerous.