Concern is mounting after a doctor at a Texas nursing home started giving the anti-malaria drug hydroxychloroquine to dozens of elderly patients diagnosed with COVID-19 and tracking the outcomes in what he's calling an "observational study."
Use of the drug to treat coronavirus infections has set up a heated debate between the Trump administration and leading health experts over its efficacy against COVID-19.
President Trump has been an enthusiastic champion of hydroxychloroquine, calling it a "game-changer." But some of the nation's most respected health officials have said there is insufficient evidence showing that the 80-year-old drug, which is typically used to stave off malaria or treat lupus and rheumatoid arthritis, is a viable treatment in battling the new virus.
The Food and Drug Administration has not approved the drug for the treatment of COVID-19. The U.S. National Institutes of Health is currently tracking clinical trials of the drug. Additionally, the University of Minnesota is undertaking a trial and Columbia University is as well. Results are not expected for weeks or months.
The controversial decision to administer hydroxychloroquine at The Resort at Texas City over the last few days was made by Robin Armstrong, a physician and medical director of the nursing home.
"It's actually going well. People are getting better," Armstrong told NPR, adding that after just a handful of days, some of the 39 patients on the medication are showing signs of improvement.
But scientists argue that relying on observational, uncontrolled evidence can be misleading and that the only way to truly prove a drug is working is through carefully controlled clinical trials. And, contrary to Armstrong's assertion that hydroxychloroquine "has virtually no side effects," it is known to have serious negative health impacts. That is why so many in the medical community worry about prescribing it without such proof.
Among them is Katherine Seley-Radtke, who is a medicinal chemist at The University of Maryland, Baltimore County. She specializes in antiviral drug research, including coronaviruses.
"This is really disconcerting," Seley-Radtke told NPR.
Armstrong admits it is difficult to quantify how much of his elderly patients' improvement is due to the malaria drug or how they would have fared without it. Nor can he explain why other patients are not responding to the tablet doses, though he notes many are only halfway through the five-day cycle.
"To be clear, no one is worse than when they started," he said emphatically. "From my perspective, it's irresponsible to sit back and do nothing. The alternative would have been much much worse."
In total, 87 people at The Resort tested positive — 56 of 135 residents as well as 31 staffers. One patient has since died.
"We know how it happened," Armstrong said, explaining that after one staffer tested positive for COVID-19, Galveston County officials tested all other people at the facility on April 2. What they uncovered was one of the largest outbreaks in the Houston region.
"One staffer spread it to other staffers ... and each of them could work with 20 to 30 patients a day," Armstrong said.
Armstrong said he was alarmed by the test results last week and immediately began making calls to track down a source for the medicine, which is in short supply.
That's when his political connections proved useful.
Armstrong, who is a prominent GOP activist, called Republican Lt. Gov. Dan Patrick. He says Patrick reached out to Texas state Sen. Bryan Hughes, also a Republican, who knew someone on the board of the New Jersey-based company Amneal Pharmaceuticals. The company, which makes and distributes the drug, has donated more than a million tablets nationwide, including to the states of Texas and Louisiana.
Two days later, Armstrong had received more than enough medication to begin giving it to patients. He said he started by screening those he believed would benefit most and added more people each day. He monitored their blood oxygen saturation, temperatures and how well they were breathing.
"The people who are on it were getting sicker but were not so sick that they had to go the hospital," Armstrong explained.
He acknowledged that some families were not aware their relatives were put on the drug, saying that "for the most part," he consulted with each nursing home resident prior to giving them on the tablets.
While the "overwhelming majority of them are awake and alert and can actually have a conversation," Armstrong said some suffer from middle stages of dementia. In some cases, he did not discuss prescribing the tablets with anyone at all before doing so. He said it is common for physicians to prescribe new medications to patients without explicit consent from the patient or family members. "It's not required," he said.
He explained he was convinced by clinical studies from Europe and China showing that hydroxychloroquine helps COVID-19 patients recover from the respiratory illness because it works as "essentially an anti-inflammatory drug."
He has some anecdotal evidence: "I've seen it in COVID-19 patients we're treating" at HCA Houston Healthcare Mainland Hospital, Armstrong said.
The health care network confirmed Armstrong is a practicing physician at the hospital but would not comment on treatment of patients because of privacy concerns.
Armstrong said he is tracking the nursing home patients' health changes daily and plans to put his findings in "some kind of report" that he hopes will add to the research on the malarial drug in relation to COVID-19.
"The problem with this is that it's not being conducted in a proper scientific manner," Seley-Radtke said. "It's not being carried out with controls. It's not being carried out under strict testing protocols and using appropriate guidelines."
She noted warnings issued by the FDA that the drug can lead to severe problems for people with heart issues and noted that the agency urges doctors to conduct an EKG before prescribing it. (A step Armstrong said was taken on Thursday.) Another side effect involves damage to the retina.
Because it is still in the experimental stages, how much to use is not clear.
"We know the right dosages for malaria and lupus and rheumatoid arthritis but don't know yet what the right dosages are [for COVID-19], that's why we are doing clinical trials to make sure we get it right," she said.
Seley-Radtke added: "I just find it amazing that everybody, including the President, thinks that this is just no big deal to go ahead and take this."
Armstrong denies he was swayed by politics or Trump's championing of the malaria drug in his decision to implement it at the nursing home before it has been proven safe and effective against COVID-19.
"It's up to a medical professional to determine how and when it would be appropriate to prescribe," Chris Van Deusen, a spokesman for the Texas Department of State Health Services, told NPR.
Armstrong said most COVID-19-positive residents at the nursing home are asking to be on the medication "but we're being very judicious."
Despite the grim tally of positive cases among such a vulnerable population, he said the spread of the virus at the nursing home could have been much worse had staff there not implemented social distancing precautions before they were mandated by the state.
"We took a lot of steps early on that protected a lot of people," he said.
The most recent comprehensive inspection of the facility by Texas Health and Human Services occurred on July 25, 2019, according to a spokesperson.
At the time, the nursing home was cited for 14 violations of state standards. Among them, the report shows:
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