This is a huge can of worms.
When Larry Edrozo got a phone call from his mother’s nursing home in Texas City telling him she was being treated for the novel coronavirus with an unproven pharmaceutical drug, he had two questions: why was she getting the drug if she had not been showing symptoms, and who gave consent?
Helen Edrozo, 87, is one of 56 residents at the Resort at Texas City who tested positive for the coronavirus, and one of 39 residents being medicated with hydroxychloroquine, a drug typically used to treat malaria and lupus that has shown some evidence of possibly tamping down symptoms of the virus.
The use of hydroxychloroquine to treat coronavirus patients has drawn controversy globally as the medical community and public debate the ethics of testing a medication before significant research is available — and in the case of elderly patients such as those at The Resort at Texas City, on a population that is statistically more vulnerable to the virus. While President Donald Trump has touted the drug’s benefits, a large controlled study of hydroxychloroquine has not yet been completed, and some doctors warn the drug combination used for the experimental treatment could have severe, potentially deadly side effects.
Larry Edrozo was initially told by an administrator at the nursing home that Helen would not eligible for hydroxychloroquine treatment because she was not showing symptoms. But on Monday, a nurse at the facility phoned him to tell him that his mother’s carbon monoxide levels in her blood had elevated slightly and that she had already begun a hydroxychloroquine dose.
Edrozo was stunned. His mother has dementia, meaning that, as her power of attorney, he is supposed to sign off on any medical treatment she receives at the nursing home.
“I (told the nurse), ‘OK, well, since you’ve already started (treatment), I guess I would write in my notes that the question was raised about consent and what happened to that?’” Edrozo said. “I have not received a call back.”
Dr. Robin Armstrong, the medical director at The Resort, who prescribed the medication shortly after Amneal Pharmaceuticals donated 1 million tablets to the Texas Department of State Health Services pharmacy, said the decision was between him and his patients. He said he did not notify families before the drugs were administered because it was not necessary and time consuming.
“If I had to call all the families for every medicine that I started on a patient, I wouldn’t be treating any patients at all; I would just be talking to families all the time,” Armstrong said
But ethicists say informed consent is one of the most important factors in any treatment, and several people with family members at the Resort at Texas City being treated with hydroxychloroquine say that they were not asked to give consent, despite having power of attorney over their sick relatives.
Still, faced with the desperation of potentially losing his mother to the coronavirus, Edrozo felt he had no other choice than accept this course of treatment.
“When the people are blasting the doctors and the governor’s office about human guinea pigs, I’m sort of there with them,” Edrozo said. “But then I want to ask them, ‘What if it was your mother, or your spouse or your child?’”
As the kids say, there’s a lot to unpack here. At the most basic level, there’s nothing but anecdotal evidence that hydroxychloroquine has any effect on coronavirus. There are no studies worthy of the name showing that it would help. Maybe it will, maybe it won’t, we just don’t know. And that’s without taking into account the inability of these patients on whom the tratment is being tested to give informed consent for their participation. Or the fact that hydroxychloroquine is an actual drug used by people suffering from lupus and malaria, and Donald Trump’s obsession with it as an unproven treatment for COVID-19 means potential shortages for those patients. Did I mention that the doctor leading this effort is a Republican activist who got a supply of the drugs through political connections, and who therefore has a vested interest in making Trump and his hydroxychloroquine predictions look good? All this, and even if it does help some of these patients it won’t tell us anything about the effectiveness of hydroxychloroquine as a treatment because this isn’t a controlled study. Keep in mind, everyone who has recovered from COVID-19 has done so on their own. We’ll have no way of knowing whether the people at The Resort who recover would have done so anyway – that’s why doing controlled studies matter, so you can make valid comparisons. I very much get Larry Edrozo’s dilemma, but he and everyone else involved in this deserved to have full knowledge of the risks and benefits so they could make their own decision.
“I very much get Larry Edrozo’s dilemma….”
I think we all understand the dilemma. I also understand the supervising doctor’s point. His ‘memory care’ patients can’t give consent. I know some folks have DNR’s on file when they enter a medical facility, but I don’t remember ever being asked about specific medicines, either the one time I was in the hospital or the several times I have had loved ones in the hospital.
Does Edrozo think he should be asked to sign off every time his mother is to get an aspirin? If the doctor wants to up the mother’s dose of thyroid medicine, does he expect to sign off on that first?
It seems understood when we entrust our care to a medical professional, we give them certain leeway to treat us as they see fit. Discussing a surgery beforehand? Yes, absolutely. Consent for each and every pill prescribed? I think that’s too much.
The 800lb gorilla in the room though, is, would Edrozo even have bothered to write all this if we weren’t talking about the Trump pill? In other words, what if it was a pill prescribed for a UTI, for example? I’m betting we wouldn’t be here discussing that.
Edrozo is conflicted because of the political implications of his mother getting the pills. OMG, what if Trump’s treatment saves his mother? Which is more important, trying to prove Trump wrong or saving his mother?
It’s wild, and I just don’t get it. Let’s say this had all taken place during Obama’s tenure, and Obama promoted a potential cure that had anecdotal evidence behind it. You better believe I’d jump at the chance to take Obama’s miracle pill if I was sick, and would absolutely be OK with my loved ones being given the Obama pill, if it would give them even a chance.
This is outrageous. Trump said ‘use this drug’ so the GOP activist decided to obtain the drug through political channels and treat dementia patients with it. Do I have this correct?
Shut up and go away Bill
Jules,
Answer the apparently uncomfortable question being raised here.
It’s YOUR mother who got diagnosed with the Wuhan flu. Do you get her the treatment, or don’t you? Put yourself in Edrozo’s shoes and make the decision. What do you do?
Same question to you, Tom……what do you do? Arguing politics is fun and games, but now it’s your loved one facing an uncertain future. HCQ, or nah?
“The 800lb gorilla in the room though, is, would Edrozo even have bothered to write all this if we weren’t talking about the Trump pill? In other words, what if it was a pill prescribed for a UTI, for example? I’m betting we wouldn’t be here discussing that.”
The pill prescribed to treat a UTI has undergone clinical trials for that purpose. The use of hydroxychloroquine to treat coronavirus has not. Informed consent matters when you are talking about using an untested drug, regardless of whether Trump is ignorantly touting it.
Bill, glad you agree that it is not the doctor’s decision, but the patient’s or family’s.
Re “Let’s say this had all taken place during Obama’s tenure, and Obama promoted a potential cure that had anecdotal evidence behind it. You better believe I’d jump at the chance to take Obama’s miracle pill if I was sick, and would absolutely be OK with my loved ones being given the Obama pill, if it would give them even a chance.”
This is not a valid hypothetical. Unlike Trump, Obama would not (have) use(d) the bully pulpit to promote an unproven drug. Even though Obama was big on HOPE.
The use of the phrase “The Wuhan flu” tells me all I need to know about Mr Daniel’s political leanings.
Bill do like Jules suggests, shut up and go away.
The drug can be dangerous, the doctor had no business administering the drugs to people incapable of giving consent. He knew he was in dangerous water, in his first interview according to the Chronicle, he stated that they all gave consent. He later changed his story. He is lucky if he does not lose his license.
“Informed consent” means that the risks and potential benefits of a treatment plan were explained to the patient or the person acting on the patient’s behalf, who had an opportunity to ask questions and an opportunity to say “no” if they found those risks unacceptable. It most certainly is a component of the clinical trial of a medication, even the ad hoc trial of something that is already given for some conditions that has significant potential side effects and risks – as this medication does.
If qanonoquine had any efficacy wouldn’t there be triumphant announcements of cures by now, backed by some real numbers and names to go with them? The stuff was purported to have an immediate positive effect and this off-label use has been in progress for at least a month, but crickets. Meanwhile, lupus and RA patients with legit prescriptions can’t even get it because the supply has been sucked up.
Voter,
There have already been plenty of ‘anecdotal’ groups and individuals who took HCQ and got better…..including the Texas City nursing home patients, a Michigan legislator (D), lung damaged Rand Paul, etc. Yale, that bastion of right wing extremism, uses HCQ as their standard protocol when they treat patients. Note that it is NOT FDA approved, and yet, Yale Medical considers HCQ their primary, go to treatment, because the FDA doesn’t HAVE anything approved, other than wait until people are really bad off and can’t breathe, then hey, go ahead and intubate them and wait for most of those on respirators to die.
https://files-profile.medicine.yale.edu/documents/f813a2c5-72bc-4a66-ae41-41249fa51443
There are plenty of other examples I could post, but why bother? It’s really kind of sad, that Trump’s quasi-endorsement of HCQ will probably end up killing die hard liberals like you folks. If Trump mentioned it, heck no we won’t take it if we come down with the virus, because fuck Trump, amirite? You really are that committed, aren’t you? Most people, if frightened with death, will grasp at any possible cure, but no, not you. You’d rather go down without a fight, because Orange Man bad. That’s really stunning. Wow.
There’s nothing else really ready to go to throw at this, and you don’t want something that has had enough success to be Yale’s go to treatment to be given, because it might make Trump look like he was right, and we absolutely, cannot have that.
Bill, Yale DOES NOT use HCQ as their primary treatment. Yale is running experimental trials to determine whether it provides any benefits. They do not recommend it outside a hospital setting, and are using it for inpatients in the hospital.
And yes, the Orange Man is bad. He’s a narcissistic piece of shit who can’t admit to ever making a mistake. He doesn’t believe science when it conflicts with his gut. He is the absolute worst President in my lifetime, even worse than Jimmy Carter, who was awful. Anyone who thinks he is a great President should probably be tested for presence of a brain. If I worked for a manager like Trump, I would quit and dig ditches. He is a horrible manager, horrible human being, and a pox on this country. The bullshit he pulls may work in NYC real estate, but it’s not appropriate for running a country.
Bill, links from readers of this blog do not constitute what I pointed out is missing:HEADLINES. Where are they? You were right to surmise that additional links would be a waste of time, but then you went off the rails by claiming anyone who is skeptical of medical hocus pocus is willing to die to prove how much they hate Trump. That’s as asinine as liberals accusing Trump supporters of being willing to die for the economy. I actually want to see headlines that COVID-19 patients are reviving after being treated with qanonoquine. You had to deflect because they aren’t there.
People here are saying don’t give unproven drugs to people without informed consent and we need to do proper clinical trials, and you spin that as “giving up without a fight”. Kids, this is your brain on Trumpism, and it isn’t pretty. Or even remotely rational.
Meanwhile, in the world of actual science:
https://www.cebm.net/covid-19/hydroxychloroquine-for-covid-19-what-do-the-clinical-trials-tell-us/
Jury is still out.
Just for you Bill, doctor charged
https://www.cnn.com/2020/04/17/us/doctor-charged-hydroxychloroquine-trump/index.html
Manny,
Good morning! This is from your CNN link:
“The criminal complaint notes the drug hydroxychloroquine has received emergency authorization from the Food and Drug Administration and may be effective in treating those with Covid-19.”
Remember the good old days when the FDA did not authorize the Trump pill to treat the Wuhan virus. Ahh, good times, good times.
This guy was charged with mail fraud:
“In late March, Skinny Beach began sending emails advertising “COVID-19 treatment packs,” described as a “concierge medicine experience” priced at $3,995 for a family of four, that included among other things access to Dr. Staley, the medications hydroxychloroquine and azithromycin, and “anti-anxiety treatments to help you avoid panic if needed and help you sleep.” In a recorded call in which Dr. Staley was selling his services to a would-be customer – in fact, the undercover FBI agent – Dr. Staley described the medication he was offering as “an amazing cure” and a “miracle cure” that would cure COVID-19 “100%.” He added that if you take the medication without having the disease, “you’re immune for at least 6 weeks.” Staley referred to medication he offered as a “magic bullet,” and said, “It’s preventative and curative. It’s hard to believe, it’s almost too good to be true. But it’s a remarkable clinical phenomenon.” Staley also stated, “I’ve never seen anything like this in medicine, just so you know. Really, I can’t think of anything. That, you’ve got a disease that literally disappears in hours.”
Dr. Staley was interviewed a week later by the FBI as part of the overt investigation. When Dr. Staley was asked by agents whether Skinny Beach has told patients that the treatments are a 100% effective cure for COVID-19, Dr. Staley said, “No, that would be foolish. We would never say anything like that.” He also told the FBI that it was “not definitive” that the medication he offered cures COVID-19.
As set out in the complaint, Dr. Staley also offered the would-be customer Xanax (alprazolam) – a Schedule IV controlled substance – as part of his concierge package, and shipped the drug without conducting any sort of medical examination.”
So let’s unpack that. Guy sells Xanax without any medical exam. OK, that’s a crime. Guy overstates the efficacy of the Trump pill. He’s guaranteeing 100% that this FDA approved for Wuhan virus drug is 100% effective. We all know that’s not the case. No drug has 100% efficacy, so I can see where an allegation of fraud can be made. So yes, it’s good this guy was charged with a crime. Thanks for sharing the story, Manny.
Manny,
Here’s a link for you, about the ties between Fauci, Birx, and Bill Gates, the guy noteworthy for his reputation in the vaccine development arena.
https://nationalfile.com/president-trump-vs-bill-gates-on-treatment-fauci-has-a-100-million-conflict-of-interest/
Weird how they all seem to have an interest in discrediting the generic, off patent Trump pill, and gravitate to Bill Gates’ promised vaccine. Weird.
Shut up and go away Bill.