Morning Briefing
Summaries of health policy coverage from major news organizations
Study Finds Malaria Drug Doesn't Prevent COVID-19 In Latest Knock Against Controversial Treatment
The malaria drug hydroxychloroquine did not prevent Covid-19 in a rigorous study of 821 people who had been exposed to patients infected with the virus, researchers from the University of Minnesota and Canada are reporting on Wednesday. The study was the first large controlled clinical trial of hydroxychloroquine, a drug that President Trump has repeatedly promoted and recently taken himself. Conducted in the United States and Canada, this trial was also the first to test whether the drug could prevent illness in people who have been exposed to the coronavirus. (Grady, 6/3)
“We were disappointed. We would have liked for this to work,” said the study leader, Dr. David Boulware, an infectious disease specialist at the University of Minnesota. “But our objective was to answer the question and to conduct a high-quality study,” because the evidence on the drug so far has been inconclusive, he said. (Marchione, 6/3)
The results were the latest development in a highly charged medical and political issue — the efficacy of hydroxychloroquine in combating covid-19. Trump has repeatedly touted the drug as a “game changer” for covid-19 and recently said he took a course of it. But federal regulators have said it should be used only for hospitalized patients or in clinical trials, because of possible side effects including serious heart-rhythm issues. (McGinley and Cha, 6/3)
Hydroxychloroquine “is not something that worked” against Covid-19 in the study, said David Boulware, an infectious-diseases specialist at the University of Minnesota and lead author, who said public-health authorities shouldn’t use it in a bid to protect people who have been exposed to the virus. “There was no effect.” He said the antimalarial may still work before exposure to the virus, a hypothesis being studied in other trials, including at the University of Minnesota. (Hopkins, 6/3)
In an open letter to Lancet Editor Richard Horton late last week, critics raised concerns about the methodology of the study, asked that a group convened by the World Health Organization (WHO) perform an independent validation of the analysis, and requested that the journal make peer review comments on the study openly available. (Dall, 6/3)
Despite concerns the drug might lead to dangerous heart problems, the researchers did not find that was the case in this study. However, people who received hydroxychloroquine were more likely to have nausea or diarrhea. (Edwards, 6/3)
The World Health Organization will resume its trial of hydroxychloroquine for potential use against the coronavirus, its chief said on Wednesday, after those running the study briefly stopped giving it to new patients over health concerns. (Shields and Farge, 6/3)
The multinational panel overseeing the trial endorsed that finding and will “communicate with the principal investigators in the trial about resuming the hydroxychloroquine arm of the trial,” Tedros said. Hydroxychloroquine is one of four medicines under review as potential coronavirus treatments in the Solidarity trial, which Tedros said has enrolled more than 3,500 participants in 35 countries. (Wheaton, 6/3)
The authors of the journal article tied hydroxychloroquine to higher mortality rates in hospitalized patients with COVID-19, as well as an increased risk of a dangerously abnormal heart rate. As a result, the WHO decided to pause the clinical study and allow the trial’s data safety monitoring board to analyze the results and determine if there were any safety concerns. (Weixel, 6/3)
The hydroxychloroquine investigation is just one arm of the agency’s Solidarity Trial, which is testing different therapies to determine which are beneficial in the disease caused by the novel coronavirus. The WHO last week temporarily suspended the hydroxychloroquine arm after a separate study published in the Lancet raised warnings about the drug’s safety. (Joseph, 6/3)
And in other pharmaceutical news —
Gilead Sciences Inc’s (GILD.O) potential COVID-19 treatment, remdesivir, could bring in more than $7 billion in annual sales by 2022, spurred by governments stockpiling the drug to guard against future outbreaks, SVB Leerink said on Wednesday. Remdesivir has shown improvement in COVID-19 patients in clinical trials and has been cleared for emergency use in severely ill patients in the United States, India and South Korea. Some European nations are using it in compassionate use. (Joseph, 6/3)