By Andrew Kragie

Law360 (August 28, 2020, 8:25 PM EDT) -- Three U.S. senators sent letters Thursday asking Trump administration officials about reports that nursing home residents received hydroxychloroquine without consent or authorization after the president claimed it could prevent coronavirus infection, while urging a watchdog to probe the extent and oversight of possible abuses.

The Democratic senators requested any guidance that the Centers for Medicare & Medicaid Services gave to nursing homes about the drug President Donald Trump has frequently touted.

They also asked CMS and the U.S. Department of Health and Human Services inspector general about the prevalence of hydroxychloroquine use in nursing homes and requested all complaints related to the drug, which was once thought promising but later shown to be dangerous for coronavirus treatment.

The lawmakers urged the HHS watchdog to investigate whether nursing homes violated residents' rights by giving the drug without consent and "whether CMS has properly used its authority to hold providers accountable for known misuse of this treatment."

Democratic Sens. Elizabeth Warren of Massachusetts, Ron Wyden of Oregon and Bob Casey of Pennsylvania also asked the U.S. Food and Drug Administration about how it has tracked use of the drug. They requested copies of any related warning letters the FDA sent to nursing homes.

Casey and Warren both sit on the Committee on Health, Education, Labor and Pensions as well as the Special Committee on Aging, where Casey is the top Democrat. Wyden is the top Democrat on the powerful Finance Committee, which oversees some health issues such as drug pricing.

In addition to requesting information, the senators rebuked the Trump administration for "mixed messaging" on the drug, which some continue to promote despite the scientific evidence. They cited Trump's July 28 statement that "I happen to think it works."

"Although the FDA and the scientific community have now concluded that hydroxychloroquine is not an effective treatment for COVID-19 and that it can have serious side effects for some individuals, the Trump administration continues to issue misleading statements regarding the efficacy and safety of this drug as a treatment for COVID-19," the Democrats said.

"This mixed messaging from the Trump administration, coupled with an absence of clear guidance, has led to the drug's continued use, even after the FDA issued warnings about its safety," they added.

Although the senators focused their fire on the president, their letter represents a potent blend of politics, health policy and compliance that could see nursing home operators facing investigations and sanctions.

"Time and again, Republicans and this administration have failed to take the crisis in nursing homes seriously," Casey told Law360 in a statement. "We need to get to the bottom of whether other nursing homes engaged in misconduct in rushing to treat patients with this ineffective and dangerous treatment."

A White House spokesperson previously said "Democrats and the media have mounted a coordinated effort to criticize this president for discussing a proven, safe drug throughout this pandemic as a possible treatment that could save a person's life. While some are rooting for the drug to fail, President Trump is simply offering a consistent message of hope, comfort and optimism while telling Americans to consult with their doctor."

Early in the pandemic, some scientists thought hydroxychloroquine might help treat or prevent COVID-19. Trump heavily promoted the drug, calling it a "game changer" and saying he took it himself.

The FDA gave an emergency use authorization in late March but, within a month, warned of serious and life-threatening side effects such as heart rhythm problems. The agency revoked the authorization in June because studies found "a lack of benefit" and reported the drug might interfere with another drug that did have a benefit, remdesivir.

Medical providers offering an experimental drug with potentially serious side effects must communicate the risks to patients or their legally authorized representatives, Dr. Michael Carome of the Public Citizen advocacy group told Law360, adding that the FDA's emergency authorization only covered hospitalized patients with severe coronavirus cases, not nursing home residents or preventive efforts.

The lawmakers cited two specific instances where journalists and state inspectors reported nursing homes giving hydroxychloroquine to residents, allegedly without consent. 

In a Texas case, the Houston Chronicle reported that the son of an 87-year-old resident at The Resort in Texas City said he was not consulted before his mother was given the drug, even though she did not have capacity to give consent. State inspectors later wrote the facility needed to "ensure that residents are fully informed and understand their health status, care and treatments."

Dr. Robin Armstrong, who is also a state Republican Party official, told the Chronicle he did not notify families before administering the drug, adding: "If I had to call all the families for every medicine that I started on a patient, I wouldn't be treating any patients at all; I would just be talking to families all the time."

The senators also cited Brighton Rehabilitation and Wellness Center in Beaver, Pennsylvania, where state inspectors found the drug was given to consenting residents who may have been exposed to COVID-19. Despite the consent, the state health department said "the facility failed to obtain the necessary approval" for the experimental treatment outside a hospital and "failed to report medication errors and adverse events."

The facility's management team told Law360 it acted appropriately with hydroxychloroquine. In addition to patient consent and the FDA authorization, the team said "the Department of Health approved this well-thought-out and reasoned plan." They said the facility has faced "inaccurate allegations" and "false information."

"While politicians and others debate and recycle a falsehood, the battle against COVID-19 is not yet won. Fortunately, at this time, Brighton remains free from COVID-19," the management team said in a statement Friday. "The facility continues to work with the Department of Health and others to ensure our compliance with COVID-19-related regulations and directives."

The Beaver County Times reported in June that after an outbreak in which 80 residents died, CMS fined the nursing home $62,000 for failing to follow infection control regulations.

Additionally, the Pennsylvania Department of Health faced a lawsuit in late April alleging inspection cutbacks left nursing home residents vulnerable to "unethical biomedical experimentation" with hydroxychloroquine. After a federal judge rejected class certification, the suit was dropped in June.

A spokeswoman for the HHS watchdog said the office "received the [senators'] letter and [is] reviewing it for appropriate action." Trump harshly criticized the acting inspector general, Christi Grimm, after her office reported on hospital supply shortages in early April.

Requests for comment were not immediately returned Friday by The Resort at Texas City, the White House, CMS, the FDA, Pennsylvania GOP Sen. Pat Toomey or Texas Republican Sens. John Cornyn and Ted Cruz. Dr. Robinson could not be reached for comment.

--Editing by Philip Shea.

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