The story of the antimalarial drug — hydroxychloroquine, touted by U.S. President Donald Trump and others as a game-changing treatment for COVID-19, has taken another unexpected turn,media CNET reported. On Tuesday, The Lancet, one of the world’s leading medical journals, published an “editorial concern” that a recent observational study had allegedly linked the drug to an increase in heart disease and mortality in patients with COVID-19 and raised “serious scientific problems.”
The study, originally published May 22 in the Lancet, looked at more than 96,000 patients, nearly 15,000 of whom had been treated with chloroquine or hydroxychloroquine. The study prompted WHO to “suspend” clinical trials of hydroxychloroquine in order to review the safety data it collected.
But on May 28, shortly after the trial was suspended, more than 180 researchers signed an open letter from Richard Horton, editor of The Lancet, raising concerns about the study. The co-authors raised some concerns about the validity of data and the ethical standards of research. A report by the Guardian of Australia shows there are inconsistencies in statistics. The report was subsequently revised, but concerns remained.
The data in the paper was provided by Surgisphere, a Chicago-based company that claims to have used electronic health records in 1,200 hospitals around the world as a basis for analysis. Sapan Desai, one of Surgisphere’s chief executives, is one of the co-authors of the study. Scientists are calling for the data set to be made public for the information provided for the study. But the company said in a statement that its “data usage protocol” prevented data sharing at the patient level.
Another paper, published in the New England Journal of Medicine using data from 169 hospitals and published in the New England Journal of Medicine, was similarly criticized. The paper discusses the harmful effects of ACE inhibitors and AR blockers, a drug that treats hypertension. On Tuesday, the New England Journal of Medicine published its own concerns, asking the authors of the article to “provide evidence that the data is reliable.”
Surgisphere did not immediately respond to a request for comment.
While the controversy has called into question the effectiveness of this hydroxychloroquine study, these concerns are by no means indicative that hydroxychloroquine is safe or effective as a treatment for COVID-19. There is no clear indication that the drug is good for COVID-19 patients, and a few studies have shown negative side effects. Hydroxychloroquine has been granted emergency authorization by the FDA, but in April the FDA highlighted serious concerns about its use outside the hospital.
Researchers are still looking to understand how hydroxychloroquine may benefit PATIENTs with COVID-19, including in combination with the antibiotics azithromycin and zinc. According to the National Institutes of Health’s clinical trial website, more than 150 hydroxychloroquine trials are currently under way, and most of them are evaluating the drug’s effectiveness against COVID-19 infections.