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.
Katherine Seley-Radtke is not a physician,
and yet as an antiTrump Democrat, she
get to play one at The University of Maryland.
Like Yale, this “universities”
push unauthorized people and frauds
to PRETEND they are physicians.
NPR should be defunded.
I'm sorry, a "medicinal chemist" is *not* a medical doctor. This person has no standing to comment on medical treatment.
Chicoms. They don't want us to reopen our economy.
We will be hearing stories like this until Orange Man is gone. Hopefully in 4 (or more) years. Democrats are saying we can’t have an election until this Coronapocalypse is over.
“Never trust a dash woman.”
Agreed.
Niiice!
What are you a Lexicographer?
Sorry, but I’m gonna use that phrase quite a bit.
What is a medical chemist anyway? She works in some lab over a pile of test tubes. Real doctors work in hospitals trying to save human beings. I really believe this woman would prefer that people just die.
I’m 72 Yo...if I get it I’m gona demand I get this drug. This woman is an idiot!!!
that makes sense, too
both Chicoms and SorozNazi would want to pull USA down
“...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.”
WRONG! Chloroquine (Aralen) has the nasty side effects!
Side effects of chloroquine that are different from hydroxychloroquine include irreversible damage to the retina, deafness, tinnitus (ringing in the ears), reduced hearing, increased liver enzymes, loss of appetite, vomiting, and diarrhea.
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.
Biased reporter trying to make it appear this care facility is a sh!t hole. BFD. 98% of all assisted living places have these same violations--most have even more. We've moved my MIL between about 5 different assisted living facilities in the last 4 years. They ALL suck.
"Physician" Seley-Radtke : "Quinine may have been
used safely going back to the Aztecs but it is Orange-Man-Medicine.
Instead, my drugs of untested flexible nucleoside (“fleximers”) and
untested nucleobases (“flex-bases) inhibitors and
thiophene-expanded purines, as well as untested pyrrolo – and
thienopyrimidines designed in our laboratories
will be used for you whether you like it or not."
The DUTY of the physician is to treat the patient in front of him, with the best of his knowledge and ability, using the treatment which, in the doctor’s judgement, creates the best odds of survival and recovery.
“or the centuries of positive use.”
“I just find it amazing that everybody, including the President, thinks that this is just no big deal to go ahead and take this.”
I believe this the same pill that was given to all US forces in Viet Nam.
When did it become so dangerous?
And where are all the studies about the great dangers?
WHAT DIFFERENCE AT THIS POINT DOES IT MAKE?
FU NPR!
You can bet SHE would be taking it if she came down with the coronavirus. What a despicable woman.
If people used the name brand instead of that hard to pronuce lesser generic, more people would reconize it. Niece takes Name brand even on Medicare/Mediciad as her RA doc won't script the crap generic.
So far, coronavirus deaths in States that Trump won are approximately 25%.....States that Hillary won are 75%....so they are killing off their own Blue State voters by making it as difficult as possible to get HCQ.... Sort of like when rioters burn down their own neighborhoods when they’re mad about something
What an absurd bit of reporting.
Every COVID-19+ patient I have seen in the past 3 weeks is on, or has finished, a course of hydroxychloroquine.
It is not at all exceptional, certainly it's not a news story.
1/4 truth.
Drug SALESPEOPLE cannot market to physicians for off label prescribing.
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