WHO Temporarily Halts Anti-Malarial Drug Trial For Safety Review

The Associated Press: UN Virus Therapy Trial Pauses Hydroxychloroquine Testing
The World Health Organization said Monday that it will temporarily drop hydroxychloroquine — the anti-malarial drug U.S. President Trump says he is taking — from its global study into experimental COVID-19 treatments, saying that its experts need to review all available evidence to date. In a press briefing, WHO director-general Tedros Adhanom Ghebreyesus said that in light of a paper published last week in the Lancet that showed people taking hydroxychloroquine were at higher risk of death and heart problems, there would be “a temporary pause” on the hydroxychloroquine arm of its global clinical trial. (Cheng and Keaten, 5/25)

Reuters: WHO Pauses Trial Of Hydroxychloroquine In COVID-19 Patients Due To Safety Concerns
“The executive group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity trial while the safety data is reviewed by the data safety monitoring board,” Tedros told an online briefing. He said the other arms of the trial - a major international initiative to hold clinical tests of potential treatments for the virus - were continuing. (5/25)

NBC News: WHO Temporarily Halts Trial Of Hydroxychloroquine Over Safety Concerns
Dr. Soumya Swaminathan, the WHO's chief scientist, said the organization's investigators and regulators in individual countries have raised enough red flags to prompt the halt. "So the steering committee met over the weekend and decided that in the light of this uncertainty that we should be proactive, err on the side of caution and suspend enrollment, temporarily, into the hydroxychloroquine arm," she said. (Li, 5/25)

NPR: WHO Stops Study Of Experimental Drug Hydroxychloroquine
The WHO has 3,500 patients from 17 countries enrolled in what it calls the Solidarity Trial. This is an effort overseen by the WHO to find new treatments for COVID-19. The patients in the trial have been randomly assigned to be treated with hydroxychloroquine which is a common malaria drug, or 3 other experimental drugs for treating COVID-19 in various combinations. Only the hydroxychloroquine part of the trial is being put on hold. "The review will consider data collected so far in the Solidarity Trial and in particular robust, randomized available data to adequately evaluate the potential benefits and harms from this drug [hydroxycholoroquine]," WHO Director General Tedros Adhanom Ghebreyesus said during an online press conference from Geneva on Monday. (Beaubien, 5/25)

CIDRAP: Malaria Drugs Tied To Risk Of Death, Heart Problems In COVID-19 Patients
The implications of the findings are limited by the fact that they are from an observational study and not a randomized controlled trial, which is the gold standard for evaluating whether a drug is truly safe and effective against a disease. Still, the authors of the study say they present another case against continued use of the drugs in COVID-19 patients outside of a clinical trial. (Dall, 5/22)

Politico: World Health Organization Pauses Study Of Hydroxychloroquine In Global Trial 
The meeting came a day after the Lancet published the largest observational study of the malaria drugs to date, and as some national regulators began expressing concern about using the drug. WHO officials estimated the pause would last a week or two as the trial’s data safety monitoring board considers information already collected from the Solidarity trial and other ongoing studies to determine whether it’s safe to continue with hydroxychloroquine. (Wheaton, 5/25)

The Hill: WHO Pauses Hydroxychloroquine Trial To Review Safety Data 
The other arms of the "Solidarity Trials" being overseen by the WHO, which involve multiple countries and potential treatments for COVID-19, will continue, Tedros said. "This concern relates to the use of hydroxychloroquine and chloroquine in COVID-19," he added. "I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria." (Wise, 5/25)

Stat: What A Big Covid-19 Study On Malaria Drugs Tells Us — And What It Doesn’t
A new study underlines safety concerns about using the malaria drugs hydroxychloroquine and chloroquine to treat Covid-19, and heightens questions about whether or not the drugs are effective at all. The study, which was published in the Lancet, cannot answer the question of whether or not hydroxychloroquine and chloroquine can help patients fight off Covid-19 or whether the drugs increase or decrease the death rates in those patients. Those answers can only come from large studies in which patients are randomly assigned to either receive the drugs or a placebo. Dozens of such studies are ongoing. (Herper, 5/22)

In other pharmaceutical news —

Reuters: Fujifilm COVID-19 Drug Research Spills Into June, Dashing Hopes Of Quick Approval
Fujifilm Holdings Corp (4901.T) will continue research on Avigan into June, Japan’s government said on Tuesday, effectively dashing hopes by Prime Minister Shinzo Abe that the drug would be approved as a COVID-19 treatment this month. (5/25)

Stat: First Generic Remdesivir Will Be Sold By Bangladesh Drug Maker
A drug maker in Bangladesh has become the first company to sell a generic version of remdesivir, the latest sign of how the push to ensure widespread access to Covid-19 medicines and vaccines has become an urgent issue in poor countries. Following an emergency decree issued by the Bangladesh government, Beximco Pharmaceuticals is donating copies of the Gilead Sciences (GILD) medicine to state-run hospitals free of charge, but will sell the intravenous treatment to private clinics. Moreover, the company is reportedly willing to export its version if other governments request the drug, although it does not have a license from Gilead to do so. (Silverman, 5/22)

Stat: Covid-19 Study Details Benefits Of Remdesivir Treatment, And Also Limitations
Remdesivir, the only drug cleared to treat Covid-19, sped the recovery time of patients with the disease, but its benefit appeared much more limited in patients who needed mechanical ventilation as part of their treatment, according to eagerly awaited results of a clinical trial. Initial results from the study, which led to the drug’s emergency authorization by the Food and Drug Administration, were released late last month. Full data were published late Friday in the New England Journal of Medicine. (Herper, 5/22)