TEXAS CITY — When Larry Edrozo got a phone call from his mother’s nursing home in Texas City telling him she was being treated for the novel coronavirus with an unproven pharmaceutical drug, he had two questions: why was she getting the drug if she had not been showing symptoms, and who gave consent?
Helen Edrozo, 87, is one of 56 residents at the Resort at Texas City who tested positive for the coronavirus, and one of 39 residents being medicated with hydroxychloroquine, a drug typically used to treat malaria and lupus that has shown some evidence of possibly tamping down symptoms of the virus.
The use of hydroxychloroquine to treat coronavirus patients has drawn controversy globally as the medical community and public debate the ethics of testing a medication before significant research is available — and in the case of elderly patients such as those at The Resort at Texas City, on a population that is statistically more vulnerable to the virus. While President Donald Trump has touted the drug’s benefits, a large controlled study of hydroxychloroquine has not yet been completed, and some doctors warn the drug combination used for the experimental treatment could have severe, potentially deadly side effects.
Larry Edrozo was initially told by an administrator at the nursing home that Helen would not eligible for hydroxychloroquine treatment because she was not showing symptoms. But on Monday, a nurse at the facility phoned him to tell him that his mother’s carbon monoxide levels in her blood had elevated slightly and that she had already begun a hydroxychloroquine dose.
Edrozo was stunned. His mother has dementia, meaning that, as her power of attorney, he is supposed to sign off on any medical treatment she receives at the nursing home.
“I (told the nurse), ‘OK, well, since you’ve already started (treatment), I guess I would write in my notes that the question was raised about consent and what happened to that?’” Edrozo said. “I have not received a call back.”
Dr. Robin Armstrong, the medical director at The Resort, who prescribed the medication shortly after Amneal Pharmaceuticals donated 1 million tablets to the Texas Department of State Health Services pharmacy, said the decision was between him and his patients. He said he did not notify families before the drugs were administered because it was not necessary and time consuming.
“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,” Armstrong said
But ethicists say informed consent is one of the most important factors in any treatment, and several people with family members at the Resort at Texas City being treated with hydroxychloroquine say that they were not asked to give consent, despite having power of attorney over their sick relatives.
Still, faced with the desperation of potentially losing his mother to the coronavirus, Edrozo felt he had no other choice than accept this course of treatment.
“When the people are blasting the doctors and the governor’s office about human guinea pigs, I’m sort of there with them,” Edrozo said. “But then I want to ask them, ‘What if it was your mother, or your spouse or your child?’”
The success of hydroxychloroquine in treating coronavirus patients has been largely anecdotal. Dr. Philip Keiser, the local health authority for the Galveston County Health District, said that the drug has “some activity against the virus” when observed in test tubes, but to conclusively test its efficacy, a randomized clinical trial would have to be convened.
The county health district partnered with the University of Texas Medical Branch in Galveston to test residents at the Texas City nursing home, and Keiser said he was also part of the discussion as to whether to treat residents with hydroxychloroquine.
“My position on (hydroxychloroquine treatment) is, it’s a legal drug, doctors use drugs for off-label uses all the time and when faced with difficult situations sometimes you’re left with, we could do nothing or we could try this, we don’t know whether it can work or not,” Keiser said.
Indeed, doctors legally can and do prescribe drugs for a different purpose than those formally approved by the FDA. But medical ethicists like Savitri Fedson, associate professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine, say doctors have an obligation to thoroughly explain to patients the risks and benefits and give them a choice about whether to participate.
“The question is: Is he getting consent from these patients? How is he phrasing it to these patients?” Fedson said.
Armstrong said he explained to patients that he believes the drug could help them and told them he was going to prescribe it to them. Kristi Doss’s mother, Janet Thomas, 65, was one of the coronavirus-positive residents placed on the medication after her oxygen levels dropped slightly. Doss asked Thomas whether the drug treatment was presented as an option.
“They weren’t really giving much of a choice, it was just ‘This is the medicine that we have to give you, here’s what it’s for,’” Doss said. “The nurse did tell us that it was doctor’s orders.”
Doss is torn about the unproven treatment. Her mother gets regular dialysis treatment and also has congestive heart failure, two conditions that the FDA highlights as noteworthy enough to inform your medical provider before taking hydroxychloroquine. Doss hasn’t seen her mother in over a month — The Resort barred all visitors on March 12 — and believes the medication might allow her to visit again soon. Still, as her mother’s power of attorney, she is not happy with the lack of consultation.
“We don’t want to have her take this medicine but at the same time the medicine may possibly be the only thing keeping her alive,” Doss said. “It’s a really hard dilemma to be in.”
Others are more desperate. Melissa Dominy’s mother, Shirley, 69, has Alzheimer’s and tested positive for the coronavirus at The Resort. Dominy cares for her father, who has a lower back compression fracture and is unable to move, while also working full-time at Kroger. Her father sits in a chair at her Bacliff home and cries all day, distraught over his wife’s condition and the fact he can’t visit her.
When Dominy found out from a nurse at The Resort that her mother was put on hydroxychloroquine, she was elated at the possibility that they would get to see her again, but acknowledged she would have liked to be informed about the treatment beforehand.
“Yes, there are some side effects but I’d rather her be a little dizzy and lightheaded than to die from (coronavirus), you know?” Dominy said.
If a patient has the ability to consent, Fedson said a doctor is not required to inform anyone else about a particular treatment, she said. Legal guardians or medical power of attorney may need to be consulted, but it depends what kind of permissions they’d previously given the doctor.
For a procedure or surgery, Armstrong said he would have contacted power of attorney, but not a change of medication, which happens routinely. He said the first group of nine patients being treated with the drug finished their five-day treatment on Wednesday and are stable. None of their respiratory problems have grown more severe, Armstrong said, addressing one of the most serious complications of the virus.
But the absence of clear consent in the cases of residents at The Resort being treated with hydroxychloroquine has been exacerbated by the facility’s lack of transparency in the wake of the outbreak a little over a week ago.
More than a dozen people with family members at The Resort interviewed by the Houston Chronicle said they didn’t know whether their relatives had tested positive for the virus until after news was reported on April 2.
While The Resort’s administration has not released any public statement since the outbreak, an April 5 letter obtained by the Chronicle sent from Jan Piveral, executive director of the facility, to family members of residents, acknowledged the communication breakdown.
“Unfortunately, prior to the facility obtaining the results, the number of positive tests were disclosed to the public, of both resident and staff, which created panic, chaos for you and for us,” Piveral wrote. “The facility did not have the results on every resident and was unable to contact you, prior to the public disclosure.”
For Haylee Bulmer, the lack of information about her grandmother’s condition sowed panic and confusion. Katherine Thibodeaux, 77, who has Parkinson’s disease and suffers memory loss, was one of the residents who tested positive for the virus, but Bulmer and her family did not find out until days after they saw the news on TV.
Bulmer, who lives in Nevada, was prepared to fly to surprise Thibodeaux as a late birthday present but moved up her flight a week earlier after the news. At 12 weeks pregnant, Bulmer knew she was taking a risk by flying — she brought her 2-year old daughter as well — but her grandparents raised her and she wanted to provide some comfort to her grandfather.
Shortly after she landed in Houston on April 4, Bulmer’s mother and grandfather were informed that she had tested positive. Days later, they were informed she had already begun hydroxychloroquine treatment. When they visited Thibodeaux that same weekend — visitors are allowed to see residents from outside the facility — it was unclear to Bulmer if she was even aware she had the virus, let alone that she was being treated for it.
“She was trying to tickle my daughter through the window,” Bulmer said. “She was trying to communicate but I’m not 100 percent sure she knows she has the virus. She seems to understand but she forgets too.”