Senators said the drug, which has been vigorously touted by President Donald Trump as a promising treatment for COVID-19 despite sparse evidence, was used in a nursing home after the Food and Drug Administration specifically warned against its use in non-hospital settings.
The Senses. Elizabeth Warren, D-Mass., Bob Casey, D-Pa., And Ron Wyden, D-Ore., Said they found reports citing two separate incidents, which affected more than 200 patients, “of concern.” and sent letters Thursday to federal agencies that regulate nursing homes across the United States. They asked for details of efforts that have been made to ensure that nursing home residents are not subjected to unproven or unsafe treatments for the virus.
“The use of hydroxychloroquine is all the more concerning because of warnings from medical experts about the increased risks facing older people,” the senators wrote.
The Centers for Medicare and Medicaid, the federal agency responsible for overseeing retirement homes, did not immediately respond to ABC News’ request for comment.
Hydroxychloroquine was touted by Trump during coronavirus briefings at the White House. The Food and Drug Administration initially gave emergency clearance for its use at the start of the pandemic. But growing concerns about the drugs’ effectiveness in treating COVID-19 and the risks to patients led to a reversal in April, when the FDA issued new warnings against prescribing hydroxychloroquine for use in drugs. non-hospital settings. In June, the FDA revoked the emergency use authorization, citing evidence that the recommended dose is unlikely to be effective against the virus.
Democratic senators have expressed concern about the incidents at facilities in Pennsylvania and Texas. At the Texas facility, inspectors found that the treatment was being administered without the informed consent of the patients or their families. At the Pennsylvania facility, consent forms were signed, but the state had not signed.
“In a crisis, it is of particular concern that a person does not receive information about the medications they are receiving,” said Patty Ducayet, the long-term care ombudsman for Texas Health and Human Services. “It almost feels like we were collectively in such panic that rushing for treatment makes it all the more important that people have the right information before making a decision. ”
The three Democratic senators cited publicly available reports from the Pennsylvania Department of Health that the Brighton Rehabilitation and Wellness Center in Beaver, Pa., Treated 205 of its 435 residents with hydroxychloroquine without officials’ approval. of State.
“The facility has not obtained the necessary approval from the Pennsylvania Department of Health before administering a drug that is not a generally accepted practice in the medical community,” notes the inspector’s report.
These treatments continued even after the FDA issued its warning against using the drug outside of a hospital, according to the report.
Senators also cited an incident at the Texas City hotel complex indicating that the nursing home was treating dementia patients with “experimental drugs” without the consent of family members.
Although the state inspector’s report does not name hydroxychloroquine as an investigational drug, the senior physician at the same facility was featured in a Houston Chronicle report extolling the use of hydroxychloroquine to treat an outbreak in The Resort.
ABC News did not get an immediate response to either nursing facility’s request for comment.
Throughout the COVID-19 crisis, nursing homes have been a hotbed for the virus, with elderly and vulnerable patients succumbing to COVID at alarming rates. A recent survey of state-reported COVID-19 data found that at least 40% of all COVID-19 deaths in the United States were residents of nursing homes.
Deaths at these facilities remain high despite increased efforts by the Trump administration and individual facilities to provide protective gear and limit outside visitors who can spread the virus asymptomatically.
In their letters, the senators note that although they have documented two cases of patients improperly treated with hydroxychloroquine, they fear that limited inspection and restricted visits could mean there are still more unreported cases. .
While these issues have been addressed by the limited infection control and complaints inspections that have taken place in nursing homes since the start of the pandemic, with regular inspections suspended and visits from families and the ombudsperson In the long term, it is possible that other cases like these have not been verified, ”the senators wrote.