Nursing homes in Texas and Pennsylvania administered hydroxychloroquine to residents battling novel coronavirus without first gaining needed approvals, according to state inspector reports highlighted by a group of Democratic senators Thursday.
The senators said the drug, which has been aggressively touted by President Donald Trump as a promising treatment for COVID-19 despite sparse evidence, was used in one nursing home after the Food and Drug Administration specifically warned against its use in non-hospital settings.
Sens. Elizabeth Warren, D-Mass., Bob Casey, D-Pa., and Ron Wyden, D-Ore., said they found the reports citing two separate incidents, which impacted over 200 patients, “concerning” and sent letters Thursday to federal agencies that regulate nursing homes across the U.S. They requested details on what efforts have been made to insure nursing home residents are not being subjected to unproven or unsafe treatments for the virus.
“The use of hydroxychloroquine is all the more concerning due to warnings from medical experts about the increased risks seniors face from the drug,” the senators wrote.
The Centers for Medicare and Medicaid, the federal agency tasked with oversight of nursing homes, told ABC News they are carefully reviewing the letter and will respond directly to Warren, Casey and Wyden.
Hydroxychloroquine was touted by Trump during coronavirus briefings at the White House. The Food and Drug Administration initially gave emergency authorization for its use early in the pandemic. But mounting concerns about the drugs effectiveness in treating COVID-19 and risks to patients led to a reversal in April, when the FDA issued new warnings against prescribing hydroxychloroquine for use in non-hospital settings. In June, the FDA revoked emergency use authorization, citing evidence that the recommended dose is unlikely to be effective against the virus.
The Democratic senators raised concerns about incidents at facilities in Pennsylvania and Texas. At the Texas facility, inspectors found that treatment was administered without the informed consent of patients or their families. At the Pennsylvania facility, consent forms were signed but the state had not signed off.
“In a crisis, it’s particularly concerning that a person wouldn’t be given information about what drugs they’re being given,” said Patty Ducayet, the long-term care ombudsman for Texas Health and Human Services. “It almost feels like we collectively were in such a panic that rushing to treatments, it just becomes all the more important that people have good information before making a decision.”