The medical director at a Texas City nursing home says some COVID-19 patients on an unproven drug are showing signs of improvement and that he’s prescribed it to another dozen patients.

Dr. Robin Armstrong said the first group of nine patients at The Resort at Texas City — where 56 residents tested positive for the disease — finished their five-day treatment with the anti-malarial drug hydroxychloroquine on Wednesday and are stable.

“It seems like the patients are maintaining pretty steady and not having any difficulty, so that’s good,” Armstrong said, though he added that he can’t determine how much their improvement is attributable to the drug. “They seem to be getting better … We're just continuing to monitor them.”

None of their respiratory problems have grown more severe, Armstrong said, addressing one of the most serious complications of the virus.

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As he expands the number of patients in the treatment group from 27 to 39, Armstrong continues to prescribe the medication after conversations with only the patients and without notifying families, which he says is not necessary and too 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 around him, a fierce debate has emerged. The use of hydroxychloroquine to treat coronavirus patients has drawn controversy globally as the medical community and public debate the ethics of trying out a medication before significant research is available — and in the case of elderly patients such as those in the Texas City nursing home, on a population that is statistically more vulnerable to the virus.

Some see it as questionable, others say patients ought to be able to decide whether they want to accept the risk for the possibility of a good outcome.

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While hydroxychloroquine has been used for decades to treat malaria, it is not approved for treating COVID-19, which so far has no cure. But small studies have suggested it could be effective in managing the symptoms.

Still, a large controlled study has not yet been completed, and some doctors warn the drug combination used for the experimental treatment could have severe, potentially deadly side effects.

Informed consent is one of the most important factors in any treatment, especially experimental ones, said Savitri Fedson, associate professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

Doctors legally can and do prescribe drugs for a different purpose than those formally approved by the FDA. But, Fedson said, 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.

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He'd tell them: “You tested positive for COVID virus, and we're going to put you on some medications to try and treat it.”

Most accepted. If patients wanted to refuse, he said he believes they knew they could.

“I know some families were upset, but these are medications that are fairly routine and not dangerous at all,” Armstrong said. “I think most of the families are upset because they’re hearing about controversy in the media. All they would have to do is call.

“There are blood pressure medications that people take every day that are more dangerous,” Armstrong said. “Aspirin has bad side effects as well. We’re starting these medications urgently in people who are having symptoms, who we think are about to get worse, get sicker.”

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If a patient has the ability to consent, Fedson said a doctor is not required to inform anyone else, such as that patient’s family, 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 to the doctor.

“More so than anything else, they may feel that their trust has been violated,” Fedson said. “They also might feel that this guy is really looking out for my mother, my father, and they really want to do what’s best. It might go both ways, but the concern is how much he was upfront about it and whether or not they were aware they were taking anything.”

For a procedure or surgery, Armstrong said he would have contacted power of attorney, but not a change of medication, which happens routinely.

The concept of informed consent has long been a keystone of research ethics, learned over the years by scientists after the historical wrongs of studies such as the U.S. government's infamous 40-year Tuskegee syphilis experiment. In that 1932 study, medical workers withheld treatment for hundreds of black men with a sexually transmitted disease without their consent, allowing many to die just so they could research the illness' effects on their bodies.

Without the typical markers of a clinical trial or other scientific study, such as a control group or high amounts of data collection, the results of Armstrong’s treatment will likely not be revelatory, Fedson said. Depending on how much data is collected, the information could be used as group case study, known as a case series, she said.

Armstrong said what he’s doing was not intended as an experiment, but nonetheless he plans to release the results in case they’re useful.

“We’ll kind of write down our observations and everything we’ve seen and write that up and send it out, so hopefully it can help other folks,” Armstrong said.

The outbreak at the home was found about three weeks ago after an employee came up positive for the virus and Galveston County health officials rushed to test 146 residents and employees. Fifty-six were positive as of this week, and one has died. At least three people from the home have been hospitalized this week, but Armstrong said none were on the medication.

One of the concerns about hypodroxychloroquine is that used in combination with the antibiotic azithromycin, it could cause heart rhythm problems and have serious implications for people with heart disease. Armstrong said electrocardiogram, or EKG, tests, which measure electric signals in the heart, have not shown such issues.

“The biggest side effect that most people were concerned about, at least that I’ve heard, appears to not have been happening,” Armstrong said. “So that’s a great development for them. I’m happy about that.”

Note: A previous version of this story incorrectly stated the number of residents at The Resort at Texas City who had tested positive for COVID-19. Fifty-six residents, not including employees, have tested positive.

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