By Jaimy Lee
A month ago, about 70% of the COVID-19 patients being treated at the 13 hospitals that make up the Hackensack Meridian Health system in New Jersey received hydroxychloroquine as part of their care.
That’s no longer the case. Clinicians and hospital administrators made that decision following a series of clinical studies including internal research published May 27 as a preprint that found the drug, long used as an antimalarial treatment, does not improve outcomes in hospitalized COVID-19 patients, according to Dr. Stuart Goldberg, a physician at Hackensack University Medical Center.
Hydroxychloroquine became a household name back in March when President Donald Trump and other members of the administration’s coronavirus task force first publicly discussed its potential as a COVID-19 treatment. But the drug has since faced steady scientific and political scrutiny over whether it can in fact help treat or prevent infections with the coronavirus. At the same time, there are growing questions about the integrity of medical research during a time of clinical and scientific information overload and the political promotion of unproven therapies.
“Politics were playing a role and driving people to not doing the good science,” Goldberg said. “As a scientist, that makes me angry…It makes the public fearful that the scientists are not doing their job.”
The case for or against hydroxychloroquine has taken a winding road in recent weeks, driven by a growing body of research that has found the drug may not be efficacious in the treatment or prevention of COVID-19. However, a closely watched study published in a prestigious medical journal is now also facing scrutiny over potential inaccuracies in the data and was retracted on Thursday afternoon.
“The advocacy and widespread use of hydroxychloroquine seem to reflect a reasonable fear of SARS-CoV-2 infection,” Dr. Myron Cohen, a physician with the University of North Carolina at Chapel Hill, wrote in a June 3 editorial in the New England Journal of Medicine. “However, it would appear that to some extent the media and social forces — rather than medical evidence — are driving clinical decisions and the global COVID-19 research agenda.”
Here’s a recap of the last two weeks:
• The Lancet published a study that found hydroxychloroquine did not benefit patients hospitalized with COVID-19 and was associated with a higher risk of ventricular arrhythmias and in-hospital death. Hundreds of physicians and researchers sent a letter to The Lancet’s editor raising concerns about the data and the analysts. One correction was made, The Lancet placed what it calls “ an expression of concern ” on the research, and then the authors retracted the study. “We can no longer vouch for the veracity of the primary data sources,” they wrote.
• The study had prompted the World Health Organization (WHO) to pause its own research into the drug. France and several other countries in Europe recommended against use of the drug in COVID-19 patients.
• Then, on Wednesday, the WHO said it would resume the trial. (“On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol,” Dr. Tedros Adhanom Ghebreyesus, WHO’s director-general, wrote on Twitter.)
• Hours later, a highly anticipated University of Minnesota study published in the New England Journal of Medicine found the drug failed to prevent COVID-19 infections. “While we are disappointed that this did not prevent COVID-19, we are pleased that we were able to provide a conclusive answer,” Dr. David Boulware, a senior investigator for the University of Minnesota trial, said in a news release. “Our objective was to find an answer.”
In the weeks during and after administration officials first talked publicly about hydroxychloroquine, Bayer AG /zigman2/quotes/203424967/delayed BAYRY +0.45% , Mylan /zigman2/quotes/209413137/composite MYL +1.39% , and Teva Pharmaceutical Industries Ltd. /zigman2/quotes/205657894/composite TEVA +1.29% committed to donating millions of doses of the drugs to the federal stockpile. (Hydroxychloroquine is commonly used as a treatment for malaria, rheumatoid arthritis and lupus, all indications that have been approved by the Food and Drug Administration.)
A week later, the Food and Drug Administration granted hydroxychloroquine and chloroquine, an older formulation of the same medicine, an emergency use authorization, with some limitations on how it could be prescribed.
Several drugmakers including Novartis AG /zigman2/quotes/203243705/composite NVS -0.35% and Sanofi /zigman2/quotes/201967021/composite SNY -0.53% and medical researchers, as well as the National Institutes of Health and the WHO, have launched clinical trials seeking to evaluate the efficacy of the drug in COVID-19 patients.
Sanofi, like the WHO, paused its study. A spokeswoman for Sanofi said in an email that the company is “reviewing available information and consulting with others in the coming days to reassess our position.”
Novartis said it’s moving forward with its trial.
“We are carefully monitoring our trial as well as other studies being conducted using HCQ to best inform our clinical trial approach and have not seen any controlled study evidence to pause efforts in our trial at this time,” a company spokesperson said by email.
Some analysts have grown increasingly pessimistic about hydroxychloroquine’s potential as a COVID-19 treatment. Raymond James analyst Steven Seedhouse told investors this week that “HCQ is unlikely to be an effective treatment in our view, after infection is established.”