by Vanessa Romo
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.
Robin Armstrong (born April 22, 1969) is an African-American politician and physician who served as vice chairman of the Republican Party of Texas from 2006 to 2010. He was elected at the state convention held in San Antonio on June 3, 2006, to succeed the term-limited David Barton from Aledo in Parker County west of Fort Worth. Armstrong defeated Internet grassroots organizer, Bobby Eberle of Pearland near Houston.
In April 2020, Mr. Armstrong garnered controversy by utilizing his personal political connections to conduct a non-clinical study over the effectiveness of chloroquine, an unproven medical treatment purported by President Donald Trump for COVID19 despite it causing deaths elsewhere
Armstrong was born in Texas City and reared in nearby La Marque in Galveston County. He has a bachelor’s degree in microbiology from Texas A&M University in College Station and a medical degree from the University of Texas Medical Branch in Galveston. He did his residency in internal medicine. He is on the staff of Mainland Medical Center in Texas City. The hospital is located down the street from his boyhood home. He was the 2006 president of the Galveston County Medical Society.
He graduated from La Marque High School, at which he was a wide receiver on the Cougars football team that played in the 5A state championship in 1987; he also ran the 800 meters and the two-mile relay in track and field.
Armstrong became a Christian during his sophomore year at Texas A&M and has traveled on missionary journeys to Africa and Nicaragua. He has worked in inner city and youth ministry at his church, the Abundant Life Christian Center in La Marque, Texas, where he leads a men’s Bible study group.
On June 14, 2008, Armstrong was elected to a second term as vice chairman at the state Republican convention held in Houston. Tina Benkiser, a Houston attorney, was elected to her third full term as state party chairman. Under Texas law, each major party must at all times have a woman as either its chairman or vice chairman. One of the two positions must be held by a man.
Benkiser resigned as chairman on October 5, 2009, to join the reelection campaign of Governor Rick Perry. Under party rules, the chairman must remain neutral in primary election campaigns. Perry faced a challenge from U.S. Senator Kay Bailey Hutchison in the Republican primary held on March 2, 2010. Benkiser was succeeded by Cathie Adams, a conservative activist and Republican national committeewoman from Plano. Adams was elected to fill the position by the Republican State Executive Committee at a special meeting at party headquarters in Austin. She served until the state convention held on June 12, 2010, when she was unseated by Steve Munisteri of Houston.
At the 2006 convention, Texas Republicans affirmed their opposition to affirmative action in their state platform and then chose Armstrong, who is African-American, as vice chairman.
Armstrong has been active in the grassroots of the GOP, as a city chair, an election judge, a precinct chair, a poll watcher, a convention delegate, a Senatorial District Convention chairman, and most recently as the State Republican Executive committeeman for Texas Senate District 11, which covers parts of Galveston, Harris, and Brazoria counties. He is a member of the Galveston Pachyderm Club, and the Texas Eagle Forum. He opposes abortion.
He was reared in a political household. His father, Robert Armstrong, was a member of the nonpartisan La Marque Independent School Board. Armstrong said that he hoped to see the United States stop its “drifting away from the values that made her great.” According to Armstrong, the GOP must “expand our conservative base to maintain our party’s success in the future. It is not enough to preach to the choir; we must continue to grow by reaching out to people of faith, professional groups, and minorities who have been abandoned by liberalism.” Armstrong said that he would work closely with Benkiser to win the “cultural war” and to secure GOP majorities into the future.
In March 2015, Armstrong, along with Jared Woodfill of Harris County and Wade Emmert, chairman of Dallas County, was an unsuccessful candidate for state Republican chairman. The 62-member Republican Executive Committee instead chose Tom Mechler of Amarillo to fill the position on the third secret ballot in a special meeting in Austin. The vacancy occurred when Steve Munisteri stepped down to become a consultant to U.S. Senator Rand Paul of Kentucky. Mechler and Cathie Adams had lost the chairmanship race to Munisteri at the 2010 convention in Dallas. In 2017, Mechler resigned as chairman.
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:
- The facility did not properly care for residents needing special services, including: injections, colostomy, ureterostomy, ileostomy, tracheostomy care, tracheal suctioning, respiratory care, foot care and prostheses.
- The facility did not store, cook and give out food in a safe and clean way.
- The facility was not designed, built, equipped or well-kept to protect the health and safety of residents, workers and the public.