Report: Brighton knew it didn’t have state OK to use experimental drug on residents

On May 1, just over a month after Brighton Rehabilitation and Wellness Center in Beaver County began giving nearly half of its 435 residents hydroxychloroquine in an effort to stave off the COVID-19 that was ravaging the building, the nursing home’s medical director told a state inspector he knew that he did not have state approval to give them the drug, according to a state inspection posted online Tuesday.

During a 10-minute interview on May 1 with Brighton’s director of nursing Eve Hamilton and administrator Dana Wittman, Dr. Dave Thimons, Brighton’s medical director, “confirmed” to the unnamed state inspector that “... the facility failed to obtain the necessary approval from the Pennsylvania Department of Health prior to starting the Experimental Post Exposure Prophylaxis treatment” of hydroxychloroquine with zinc, according to the inspection report, which is also called a “survey.”

But then in the report’s “Plan of Correction” — a section that is completed by the facility to explain how it is going to correct the violations detected — Brighton wrote, in part: “Preparation, submission and implementation of this plan of correction does not constitute an admission of or agreement with the facts and conclusion set forth on the survey report.”

Brighton’s management said in a statement earlier this month Brighton had “notified” the state it was using hydroxychloroquine, a statement Brighton reiterated again Tuesday, writing that it had “made the Department of Health aware of all plans for administration of the therapy.”

But the inspection report — which notes that 205 of the nursing home’s 435 residents were given hydroxychloroquine by April 29 — quotes directly from the “residents’ rights” section of the state’s nursing home regulations: “Experimental research or treatment in a nursing home may not be carried out without the approval of the Department and without the written approval of the resident after full disclosure.”

Asked on Tuesday to provide any evidence that the state was “notified” or “aware” of its plans, or had state “approval” to administer hydroxychloroquine with zinc to residents, Brighton management did not respond.

Dr. Thimons did not respond to a request for comment.

The state’s report also noted that the U.S. Food and Drug Administration had not authorized the use of hydroxychloroquine outside of a hospital.

The report noted that even as an experimental drug for short-term use, it had been found to have multiple side effects, including those as mild as an upset stomach, but also “some more serious side effects such as injury to the heart may occur. In addition to these risks it may harm you in unknown ways and cause serious injury, sickness, permanent injuries and/or death.”

The FDA had in March granted Emergency Use Authorization for hydroxychloroquine but withdrew the EUA on June 15 because it found that it was “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.”

The state also found Brighton failed to properly report any medication errors or adverse events during its use of hydroxychloroquine.

Brighton said in a statement Tuesday it had neither medication errors nor adverse events during its use of the drug.

Jodi Gill, the Beaver County woman who first brought Brighton’s use of hydroxychloroquine to light when she filed a federal lawsuit noting the state failed to properly oversee the nursing home, said Tuesday the report validated what she tried to do in her lawsuit, which she withdrew earlier this month.

Although she had been notified by the state Department of Health in June that it had found Brighton in violation of regulations through the use of hydroxychloroquine, “I got much more validation seeing it in print in a formal report,” she said.

“It showed that what I did was right [by filing the lawsuit], and my concerns were justified,” she said.

She filed the lawsuit on April 28 on behalf of her father, Glenn, 81, who still lives at Brighton, after she was asked to sign a consent form to allow Dr. Thimons’ staff to use the drug. But she had talked to a state Department of Health official five days earlier, on April 23, about her concerns with the way Brighton was asking families to approve use of the drug, which she felt was coercive.

Her attorney, Bob Daley, said the full report “was quite clear that what Brighton did to 205 residents was experimental research, and I think that’s part of what we’ve been saying all along.”

He said he was pleased that the state got all of Brighton’s administrators in on the interview and that Dr. Thimons acknowledged that he did not have state approval.

“This is what happens when the Department of Health gets in there and does its job: People tell the truth,” he said.