Three U.S. senators are demanding answers from federal agencies about how they’re tracking and regulating the use of hydroxychloroquine, a drug once touted as an effective treatment for COVID-19, in nursing homes.
U.S. Sens. Elizabeth Warren, Bob Casey and Ron Wyden said they wanted more details about the drug’s use in nursing homes nationwide, after reviewing reports of that they called “inappropriate” use of the drug in Texas and Pennsylvania.
The senators, all Democrats, specifically cited concerns about how the drug was used to treat residents at The Resort at Texas City, site of the first major outbreak of COVID-19 announced in Galveston County.
In letters to the commissioner of the U.S. Food and Drug Administration, the administrator of the Centers for Medicare & Medicaid Services and the inspector general of the Department of Health and Human Services, the senators claimed the facility “was cited for treating cognitively impaired patients for COVID-19 without getting consent from their family or guardians first.”
The senators also cited reports of the use of the drug at a nursing home in Pennsylvania.
“The use of this experimental treatment on patients without proper approval and without their consent is a violation of patient rights,” the senators wrote. Medicare and Medicaid rules provide nursing home residents with the right to be informed of, and to participate in, their own treatments, they said.
The senators called on the inspector general to investigate the use of the drug at nursing homes and for information from the other departments about how the use of the drug is being tracked, studied and, if necessary, stopped.
In the early months of the COVID-19 pandemic, some people, including President Donald Trump, touted hydroxychloroquine, an anti-malarial drug, as an effective treatment for people diagnosed with the virus.
Some health experts warned that the drug was unproven and that it carried dangerous potential side effects. In June, the FDA revoked an emergency use authorization that allowed doctors to use the drug as a COVID treatment.
The Resort at Texas City in April was one of the first Texas nursing homes to report an outbreak of COVID-19 among its residents and staff.
In the days after the outbreak, Dr. Robin Armstrong, the medical director at the nursing home, announced he was treating some of the residents with hydroxychloroquine. The nursing home was able acquire the drug with the help of Texas Lt. Gov. Dan Patrick, according to news reports.
In addition to being a doctor, Armstrong also is a Republican activist and one of two Texas delegates on the Republican National Committee.
The senators’ letters notes news stories raising concerns about the drug’s use in Texas City, as well as a health inspection survey published by the Centers for Medicare & Medicaid Services.
The Resort at Texas City was cited in May for violating regulations requiring it to “ensure that residents are fully informed and understand their health status, care and treatments” and to “develop and implement a complete care plan that meets all the residents’ needs,” according to the inspection survey.
The risks posed by the violations were minimal or only caused the potential for harm, according to the survey.
The survey doesn’t specifically mention COVID-19 or hydroxychloroquine. It doesn’t mention cognitively impaired patients, nor does it provide specific details about who at the nursing home gave informed consent to be treated with the drug.
In interviews with The Daily News and others earlier this year, however, Armstrong said he gave some of his patients hydroxychloroquine without discussing it with patients or their families.
Armstrong in May said he treated 38 people at the facility with hydroxychloroquine after those patients had tested positive for COVID-19. Three of those people later died, and the other 35 recovered, Armstrong said.
He has stood by his use of the drug, even as agencies such as the FDA began warning against using it as a treatment for COVID-19.
As of Aug. 13, 57 residents at The Resort of Texas City had tested positive for COVID-19, according to data from the Texas Department of Health and Human Services. Five of those people died and 52 have recovered. Also 32 employees at The Resort of Texas have tested positive for COVID-19, according to the state data.
As of the latest report, there were no active cases of COVID-19 among the facility’s residents or staff.
Armstrong declined to comment about the senators’ letter when reached by text on Friday. He was flying to Atlanta and had not heard anything about the issue, he said.
The senators asked the federal agencies to respond to their requests by Sept. 10.