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.
what dose size did they give?
and World Wars I and Ii and Korea?
Inasmuch as NPR & PBS are NOTHING MORE than HOUSE ORGANS of the DIMocRAT Party “propaganda machine”, DEFUND both networks & let the DIMs pay for both is my suggestion.
Yours, TMN78247
Here are some more anecdotal results:
In Marseille the IHU-Méditerrannée Infection, the institute where dr Raoult is employed, has up until midday 11 April treated 2401 cases of COVID19 with the HCQ/AZ combination with 10 fatalities (0.4%). In the state and university hospitals in Marseille not affiliated with this institute 4100 cases have been treated with 63 deaths (1.5%).
It should be noted that both results so far are good.
Obviously factors such as age, comorbidities, other medication etc must be taken into account when comparing the two populations, however just making an initial comparison between the rough numbers tells us that the likelihood of such a difference occurring by chance alone is less than 0.0002 (ie 2 chances in 10 000).
Again, calculating from the rough numbers alone, dr Raoult's institute ought to have seen 37 fatalities. Thus, 27 people were saved by treating 2401 patients to a cost in medication per saved patient of less than $1800.
Now, we know from the latest publication by dr Raoult that he certainly did also treat the elderly and patients with other illnesses. So, what is going on here - and why are the leading medical authorities so negative?
PS Yes, chloroquine and hydroxychloroquine have side effects, and some are serious. However, in almost all cases I've been able to find they have either been described in conjunction with malaria treatment where the acute dosage is many times what has been proposed for the COVID19 patients, or they have occurred only after many years during chronic treatment (RA, lupus) with doses more reminicient of what is given to the COVID19-patients for a few days up to a week.
I was not talking about a test for hydroxychloroquine,which Fauci dismisses as anecdotally successful, and wants clinically tested.
I was sarcastically suggesting a test for chloroquine sulphate , a fish tank cleaner which killed a man and made his wife deathly sick.
If anecdotes don't count why dismiss 65 years of successful millions of uses of hydroxychloroquine as just anecdotal but tell people not to use the poisonous fish tank cleaner chloroquine sulphate,because of an anecdote.
My sarcastic suggestion for a study was on the poison and not on the well proven hydroxychloroquine wich works for Rheumatoid Arthriis, and Lupus, as well as covid19. -Tom
STOP FUNDING NPR NOW!!
*************
GOP will NEVER do it. They have had countless chances to stop funding this liberal propaganda machine and did nothing — which is the only thing the GOP is consistent at.
GOP = Fake Party.
what dose size did they give?
They gave us a large pink(IIRC) tablet once a week and small whites ones every day.
I know nothing about the actual tablets except the size and color.
https://www.cdc.gov/malaria/resources/pdf/fsp/drugs/hydroxychloroquine.pdf
According to the CDC:
Who can take hydroxychloroquine? Hydroxychloroquine can be prescribed to adults and children of all ages. It can also be safely taken by pregnant women and nursing mothers.
Who should not take hydroxychloroquine? People with psoriasis should not take hydroxychloroquine.
Who are you gonna believe, the CDC or some medical chemist?
Why are my tax dollars paying NPR to spew non-stop anti Trump propaganda?
Defund. Now.
Is hydroxychloroqine use common enough by doctors now that it could be called a standard treatment for COVID-19? If it’s not yet, I bet it’s getting there.
Sounds like a pre-med degree.
“Those infected with Trump Derangement Syndrome (TDS) would rather people die than Trump be correct”
Absolutely Correct.
Still More ComDem Insanity! Hate Driven, Anti-Trumpers.
Here’s an article from NPR reporting on Remdesivir being used by Gilead Sciences in a clinical trial with Covid-19 infected human guinea pigs. Despite admitting there were side effects including severe kidney damage in some patients, they don’t show nearly as much concern for safety of this brand new drug as they do hydroxychloroquine which has a 60 year track record of safe use. Not surprisingly, NPR has plenty of concern that Gilead might profit from the drug
“This facility and doctor must be destroyed and these residents must be sacrificed for the leftist narrative of “Orange Man Bad”.”
—Well put.
If NPR can’t be defunded, can’t President Trump clean out the leadership and replace with sane Americans? I know President Bush tried that and couldn’t take the heat, but President Trump actually has balls.
Thanks ScaniaBoy.
Just rename the Drug Obamachloroquine and it’s all good.
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