Posted on 04/11/2020 12:08:04 PM PDT by Incorrigible
April 10, 2020
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:
Not for commercial use. For educational and discussion purposes only.
At least they’re getting the drug. Where my daughter works, they can’t even get N95 masks!
Is she a doctor? No, of course not.
So why is this medical chemist telling a medical doctor what they should and shouldn't be prescribing.
This and other media example of this are simply, just...
...bizarre.
These people really are disturbed...
Another reason to stop funding NPR
All these scientist know that it would take 3-5 years for a proper study to be conducted and in fact when a medication shows promising results it is often considered unethical to deny patients the medication or continue with a placebo based study.
Why give people who have a chance to live a placebo. Just use the people who have died without the medication as the designated “test group” for the DR Faust required “study”! There’s plenty of them that have been denied a chance to live!
Doctors could do a 200mg Hydroxychloroquine, 500 mg Azithromycin, and 220mg Zinc sulfate once a day for covid19, and double the dosage for Trump derangement syndrome.
DemocRAT NPR wants Elderly COVID patients to Die. Gee don’t DemocRATS claim Republicans want Grandma to die??
It’s depravity.
And maybe criminal depravity since she’s openly advocating acts and actions that *will* result in deaths in order to further her political and ideological agenda.
But, I’m just a standard issue prol. Us prols aren’t allowed to know what the law says, means or does until we’re dragged up in front of a court and told by those appointed to manage us.
I don’t recall seeing in the article whether this nursing home combined the hydroxychloroquine with the zinc sulfate?
You article started with a lie.
The FDA HAS approved the use of hydrochloroquine to treat COVID19 through an emergency use authorization.
This whole pack of prevarication and liberal pretzel logic is nothing but the fevered ramblings of a misbegotten soul in the end stages of TDS.
Nah...waste of perfectly valuable medication
TDS is terminal, Im afraid
I don’t see mention of the use of Zinc in this study. Bogus.
Every liberal person I know gets their news mainly from NPR. It is a slap in the face to every conservative American that we have to support NPR/PBS. Defund it NOW!
Vanessa Romo, an “disconcerting” vile piece of trash.
Maybe they should put that doctor and all the patients who recovered in jail - that’ll show them to take their health and decisions into their own hands.
NPR...yep, completely unbiased, honest reporting! /sarc
They must pay a price.
NPR is afraid those old people will get better..after all commies see the elderly as wastes of space who need to be killed off
—
If such a simple, cheap drug is an effective treatment, then the terrorization of the people by the media about this virus is *over*, and that’s the last thing the media want because they know then there is time to put the country back to work before the election. The MSM/DNC needs dead people and wants people out of work.
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