The debated use of chloroquine antimalarial drugs for COVID-19 continues to make global headlines this week. Rick Bright, who’s served as director of the U.S. Biomedical Advanced Research and Development Authority (BARDA) since the Obama administration in 2016, blamed his ouster from the post this week on his refusal to endorse the broad use of hydroxychloroquine and chloroquine in the pandemic. “While I am prepared to look at all options and to think ‘outside the box’ for effective treatments, I rightly resisted efforts to provide an unproven drug on demand to the American public. I insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician,” Bright said Wednesday. “These drugs have potentially serious risks associated with them, including increased mortality observed in some recent studies in patients with COVID-19.” Bright has been reassigned to the NIH where he will be involved in developing diagnostics. Bright said he will ask the Health and Human Services Office of Inspector General to “investigate the manner in which this administration has politicized the work of BARDA and has pressured me and other conscientious scientists to fund companies with political connections as well as efforts that lack scientific merit. Rushing blindly towards unproven drugs can be disastrous and result in countless more deaths.”
U.S. Sens. Mark Warner (D-Va.) and Tim Kaine (D-Va.) wrote to FDA Commissioner Stephen Hahn Wednesday, imploring him to do whatever possible to ensure patients with lupus and rheumatoid arthritis (RA) can continue to fill their prescriptions for hydroxychloroquine and chloroquine as the demand for the drugs as an off-label COVID-19 treatment outstrips the supply. “Hydroxychloroquine is often the only medication that works to increase survival for lupus patients. Shortages could be especially deadly for minority women, as lupus is the fifth leading cause of death in African American and Hispanic-American women,” the senators wrote. While pharmacies and hospitals have purchased “excessive amounts” of the drug, prescribers have reported that local supplies are depleted. “We fear that if this continues, we will have a new public health crisis on our hands on top of the pandemic,” the senators said.
The COVID-19 EMA Pandemic Task Force issued a public health statement Thursday reminding doctors that chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems. The task force advised doctors to closely monitor patients with COVID-19 who are being treated with one of the antimalarials and to take into account pre-existing heart problems that can make patients more prone to arrhythmia. Doctors should consider the possibility of side effects, particularly with higher doses of the drugs, and use extra caution when combining treatment with other medicines, such as the antibiotic azithromycin, that may cause similar heart problems. Since the drugs are being used off-label, the safety and efficacy data of the chloroquines against COVID-19 is still limited and inconclusive. The drugs are being tested in several large randomized trials, often at higher doses than that approved for their labeled uses in malaria, lupus and rheumatoid arthritis. The EMA said it has enhanced its safety monitoring of drugs used to treat COVID-19 so it can take timely action when necessary. Chloroquine and hydroxychloroquine should only be used as a COVID-19 treatment in the EU as part of clinical trials or in line with nationally agreed protocols, the EMA said. They are not to be used without a prescription and supervision by a doctor.
The U.K.’s National Institute for Health and Care Excellence released two new COVID-19 rapid guidelines Thursday. The guideline on gastrointestinal and liver conditions being treated with drugs affecting the immune response advises doctors on how to adjust care to reduce patients’ exposure to COVID-19. It also discusses how to balance the benefits and risks of taking drugs that affect the immune system during the pandemic. The second guideline, on acute myocardial injury, is intended to help providers who are not cardiology specialists identify, monitor and treat heart problems in patients with confirmed or suspected coronavirus infections but with no known history of heart disease. Acute myocardial injury was observed in 9.5% of all hospitalized patients dying in Italy, according to the guideline, and some of the symptoms are similar to those of respiratory complications seen with COVID-19. The guidance also advised that some of the drugs used in COVID-19 trials, including azithromycin and hydroxychloroquine, may lead to arrhythmia.
Republican lawmakers are urging leadership in both the U.S. House and Senate to ensure that no COVID-19 relief funding is sent, directly or indirectly, to China’s Wuhan Institute of Virology. Spurred by reports that the NIH for years has been funding coronavirus-infected bat research at the laboratory, nearly 50 members of the House and five senators signed a letter this week calling for an end to taxpayer funding of a “Chinese state-run bio-agent laboratory that lacks any meaningful oversight from U.S. authorities.” The letter also cited a new report indicating that U.S. State Department cables from 2018 warned of “a SARS-like pandemic” risk related to the lab’s coronavirus research on bats.
The FDA’s ongoing suspension of on-site inspections of drug and device manufacturing facilities both at home and abroad due to the coronavirus pandemic is raising flags about the safety and quality of products on the U.S. market. “Given the uncertainty surrounding COVID-19, and broader vulnerabilities this pandemic highlights with regard to the volatility of the U.S. drug and device supply chain, we are concerned about the sustained safety of FDA-regulated products if staff are pulled from inspections for a longer length of time or if this becomes a recurrence,” several Democratic senators wrote this week to FDA Commissioner Stephen Hahn. The letter asked the agency to provide an update on the steps it’s taking to evaluate manufacturing facilities in lieu of on-site inspections.