For observation

Oh good, human drug testing without consent at a nursing home, that’s not reminiscent of the Nazis at all.

Concern is mounting after a doctor at a Texas nursing home started giving the anti-malarial drug hydroxychloroquine to dozens of elderly patients diagnosed with COVID-19 and tracking the outcomes in what he’s calling an “observational study.”

Coolio, can we give untested drugs to him in an observational study?

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.

But that’s too long, so let’s just let doctors do “observational studies” on the occupants of their very own nursing homes.

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.

And he knows that’s because of the hydroxychloroquine via special doctors-only Insight.

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.

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.”

So if it’s better to do something than to do nothing, what about giving them Plumber’s Helper? Or motor oil? Or Roundup?

In total, 87 people at The Resort tested positive — 56 of 135 residents as well as 31 staffers. One patient has since died.

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.

In the trade I believe that’s called not donations but free samples.

“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.

And people in the middle stages of dementia make such awesome experiment subjects.

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.

Really? But then what did make him decide to “implement” it? It can’t have been glowing endorsements in medical journals, because there aren’t any. It can’t have been straight news that reports it working, because there isn’t any. So what was it then?

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.

Other than that

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