The staff at the Broomall Rehabilitation and Nursing Center said the drug seemed to be helping the 85-year-old woman’s symptoms. Only later, doctors told the Cains that it was hydroxychloroquine.
For weeks, President Donald Trump had touted the anti-malaria medication as a “game changer” treatment for the coronavirus, despite a lack of clinical evidence that it is effective. Observational studies — including one released Thursday from researchers at Columbia University in New York — have concluded that it is at best ineffective and in some cases may worsen patients’ conditions.
And as Cain and his family learned about its potential side effects — vision changes, muscle weakness and irregular heart rhythms that can result in death — they grew more concerned. No one at the nursing home had contacted them before putting his great-aunt on the drug. And no one informed them about its risks.
“They never called us to say that we’re going to do anything,” Cain said. “They just did it.”
Broomall Rehabilitation — where at least 37 residents have died of COVID-19 — isn’t the only long-term care facility that has relied on hydroxychloroquine in a Hail Mary bid to stem a tide of nursing home coronavirus deaths that has already claimed more than 2,000 lives in Pennsylvania.
More disturbing, say health care advocates, is the growing number of accounts from families such as the Cains who say long-term care facilities across the commonwealth are administering the experimental treatment without legally required consent.
State law requires nursing homes in Pennsylvania to obtain permission from a patient or family members with medical power of attorney before starting experimental treatments, including off-label use of drugs. Such decisions also must be approved by an independent review board set up by the Department of Health.
In Chester County, the state-run Southeastern Veterans’ Center widely gave hydroxychloroquine to some of its sick residents as recently as April 22 — the same week the Food and Drug Administration warned that it should not be administered outside of a hospital setting — according to staff members and relatives of patients there. Members of two families said SEVC employees did not first seek their permission.
“I didn’t have a say. I didn’t know the dosage. I was just caught off guard,” the wife of one veteran put on the drug told The Philadelphia Inquirer. Her husband later died.
Allegations emerged in Beaver County, outside of Pittsburgh, last month that one nursing home, Brighton Rehabilitation and Wellness Center, had dosed most of its roughly 590 residents — sick or not — with the anti-malaria drug amid a coronavirus outbreak so severe that staff had begun to presume every patient was infected.
Those claims were outlined in a lawsuit seeking class-action status in Philadelphia that contends lax oversight by the state Department of Health has enabled what amounts to unsanctioned and unsupervised “biomedical research” on nursing-home residents — a situation the lawyers likened to “the horrors of Nazi experimentation on human subjects.”
It’s unclear how widely hydroxychloroquine has been used in Pennsylvania nursing homes over the last two months. A spokesperson for Health Secretary Rachel Levine did not respond to questions on how many facilities had sought and gained state approval to use the experimental treatment.
With facilities closed to visitors and routine state inspections suspended, obtaining accurate, complete information about what treatments are being administered during the pandemic to Pennsylvania’s 134,000 long-term care residents has proved next to impossible.
“These places have been in lock down for seven or eight weeks now,” said Martin Kardon, one of the lead lawyers in the lawsuit. “Who knows what’s going on in there?”
Annaliese Impink, the chief experience officer for SavaSeniorCare Consulting LLC, which operates the Broomall Rehabilitation and Nursing Center where Cain’s great-aunt lives, confirmed that staff there are using the drug to treat COVID-19 patients.
She declined to comment on specific cases, citing privacy laws, and would not say whether the staff seeks permission before administering hydroxychloroquine.
“Treatment — including the use of hydroxychloroquine in select cases — is directed by attending physicians at their discretion based on their thorough assessment of each individual in their care and under guidance from the state medical board and other federal governing agencies,” Impink said in a statement. “It is our practice to discuss all changes to the care plan, including medication changes, with our residents and or their responsible parties.”
Cain said he is grateful that the drug appears to have either helped or, at least, not hindered his great-aunt’s recovery. But, his mother, Janie, still worries about the potential long-term consequences.
“I mean, if that’s the drug that helped her to get better, that’s fine,” she said. “But there might be other issues we don’t know about.”
Other facilities contacted by The Inquirer either did not respond or declined to discuss their use of the drug, including Brighton Rehabilitation in Beaver County and St. Monica’s Center for Rehabilitation & Healthcare, a South Philadelphia nursing home. Family members of two patients there said they had been asked to approve its use in treating their loved ones.
But anecdotal evidence is mounting even as lobbyists continue to push Gov. Tom Wolf to grant nursing homes immunity from lawsuits over their response to coronavirus outbreaks within their walls.
“They should not be giving drugs that families didn’t consent to, bottom line,” said Toby Edelman, a senior policy attorney for the nonprofit Center for Medicare Advocacy. “If there’s an emergency and they know some totally approved, recognized solution, you’d say, ‘Yes, I want them to use their medical training.’ But that’s not what this is. These decisions are not made based on known medical science. That’s not this drug.”
The question of how many Pennsylvania nursing homes are using hydroxychloroquine is underscored by the fact that routine inspections have ground to a halt during the pandemic — even as residents of long-term care facilities account for nearly 70% of the state’s COVID-19 deaths.
Normally, the Department of Health would periodically monitor them on criteria such as the types of treatments, the conditions under which they are administered, and whether proper consent has been obtained from patients. But now, said Kardon, very little is known about treatment regimens and conditions in each home.
“If your house is on fire, you want the firefighters directing their stream of water where it’s burning. They need to go where the fire is,” the lawyer said. “These nursing homes are ground zero (and) we’re standing next to a burning building waiting for the fire department to show up.”
The suit he filed with lawyers from across Pennsylvania asks a federal judge to ensure that nursing homes are not using hydroxychloroquine without first obtaining consent and seeks a court order that would compel the Health Department to resume its routine monitoring.
Nate Wardle, a department spokesperson, declined to address the lawsuit’s claims but said the decision to suspend regular inspections was made under guidance from the Centers for Medicare and Medicaid Services. Still, he added, the department has conducted limited on-site inspections of facilities accused of having conditions that are putting patients in “immediate jeopardy.”
Wardle declined to say how many emergency inspections the department has conducted since Wolf’s emergency declaration March 6. One facility in the Philadelphia region that has drawn state scrutiny is the 238-bed Southeastern Veterans’ Center in Spring City, which has been overrun by the coronavirus.
At least 29 residents believed to have the virus were given hydroxychloroquine over the last month, according to a staff member who was not authorized to speak to the media. Of them, 22 did not recover and have since died, the staff member said.
In all, 34 residents who tested positive or were presumed to be infected had died there through May 4, according to the Chester County coroner.
Two relatives of residents who received the drug said that although they are usually kept abreast of any new medications or dosage changes, they were not informed before their loved ones were given the unproven treatment.
“This time, for some reason, I didn’t get a call,” said the wife of one SEVC veteran, who asked that her name not be used to maintain her family’s privacy. She said she learned he’d been taking hydroxychloroquine and azithromycin only when she called for an update on her husband’s condition. He is cognitively impaired and does not have the ability to consent.
Joan Zlogar Nissley, spokesperson for the state Department of Military and Veterans Affairs, which runs SEVC, declined to comment on its use of hydroxychloroquine.
In a memo sent last Tuesday to its nursing staff and obtained by The Inquirer, managers said last month’s state inspection found “no deficient practices … related to our handling of the COVID-19 pandemic.”
State Sen. Katie Muth, a Democrat whose district includes the veterans’ center, still has questions. She has filed a complaint about the facility with the state Attorney General’s Office citing, among other concerns, the use of hydroxychloroquine without permission from families.
“I hope that there is an immediate investigation to ensure the safety and health of both the patients and the workers,” Muth said. “And to bring truth to those who’ve already lost loved ones. It’s hard to grieve without all the answers.”
———
(Philadelphia Inquirer staff writer Sean Collins Walsh contributed to this report.)
———
©2020 The Philadelphia Inquirer
Visit The Philadelphia Inquirer at www.inquirer.com
Distributed by Tribune Content Agency, LLC.
—————
PHOTOS (for help with images, contact 312-222-4194): CORONAVIRUS-PA
