The Volokh Conspiracy
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No "Disciplinary Actions Against Physicians Simply Because They Prescribe Ivermectin or Hydroxycholoroquine"
So concludes the Nebraska Attorney General's office, which operates the Nebraska Division of Public Health and is therefore responsible for physician discipline.
From the opinion, released yesterday:
[T]he available data does not justify filing disciplinary actions against physicians simply because they prescribe ivermectin or hydroxychloroquine to prevent or treat COVID-19. If, on the other hand, healthcare providers neglect to obtain informed consent, deceive their patients, prescribe excessively high doses, fail to check for contraindications, or engage in other misconduct, they might be subject to discipline. But based on the evidence that currently exists, the mere fact of prescribing ivermectin or hydroxychloroquine for COVID-19 will not result in our office filing disciplinary actions….
Based on the available data, we do not find clear and convincing evidence that a physician who first obtains informed consent and then utilizes ivermectin or hydroxychloroquine for COVID-19 violates the UCA [Uniform Credentialing Act]. This conclusion is subject to the limits noted throughout this opinion. Foremost among them are that if physicians who prescribe ivermectin or hydroxychloroquine neglect to obtain informed consent, deceive their patients, prescribe excessively high doses, fail to check for contraindications, or engage in other misconduct, they might be subject to discipline, no less than they would be in any other context.
As we have stressed throughout, this opinion is based only on the data and information available at this time. If the relevant medical evidence materially changes, that could impact our conclusions. Also, though an opinion from our office about possible UCA violations would ordinarily focus on healthcare practices within Nebraska, the context of a global pandemic necessitates looking for evidence far beyond our State's borders, as we have done here. Thus, the analytical roadmap in this opinion likely has limited application outside the circumstance of a global pandemic….
[O]ur office is not recommending any specific treatments for COVID-19. That is not our role. There are multiple treatment options outside the scope of this opinion—including treatments that have been officially approved by the FDA—that physicians and their patients should carefully consider. This opinion takes no position on them.
Rather, we address only the off-label early treatment options discussed in this opinion and conclude that the available evidence suggests that they might work for some people. Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained healthcare system.
The opinion is long and highly detailed, with detailed analyses of various other agencies' views on the matter; I can't speak to whether or not it's correct, but if you're interested in the subject, it's worth reading, and I expect that it will prove important, not just in Nebraska. Thanks to James Creigh for the pointer.
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India have a very short covid wave for some reason which is not known at this point. India also has a high usage rate for ivermenctin.
Lupus patients who take Hydx have a lower infection rate than the general population.
So while I see little if any benefit from taking either either drug as medication once covid hits, there does seem to be something connected with those two drugs that somehow inhibit covid from getting a start. Correlation doesnt equate to causation, Though there likely is some factor, not necessarily Iver... or HydrCx , but something that inhibits the initial onslaught
Pretty sure if you take both in moderate amounts, and add an approved vaccine, your chance of serious adverse consequences from Covid will be notably reduced.
I am in agreement that neither drug is likely to be an effective treatment (except for the possibility of a placebo effect).
Only noting that the infection rate for regions of the world with high ivermecntin and lupus patients seems to relatively low (brazil being the exception). There seems to be some factor in those subgroups causing the lower infection rates.
Or, you know, maybe India's data is fraudulent.
https://apnews.com/article/business-science-health-india-pandemics-334c326d86efa73a0631bf7cb6e3f92e
There was only 10% vaccination in India during the period that Tom describes. You comment about vaccines in this context is not relevant
Don Nico, re-read what I wrote, more carefully. Use your normal powers of logic to deduce what I meant.
SL, I thought it was kinda funny ... well played.
Everyone chill out, and try to approach life with at least a tiny sense of humor!
Aside from a large rise in cases in May 2021, the infection rate in India has remained at less than 40 cases/million per day despite the low incidence of vaccination. That rate is considerably less than that of Norway (100 cases/1M), Israel, the UK (500 cases/1M), Germany (100 cases/1M) all of which have roughtly 70% or more of their population fully vaccinated.
Tom,
In fact India had three substantial waves in 2021, one in April, one in May and 1 in June. Those waves corresponded in spikes in the daily case fatality rate from roughly 0.8% to as much as 2.2%. Only during the first of those spikes was the rate of infection high (almost 300 cases/1M). During the other spikes in virulence the case rate was low (<40 cases per 1 M).
None of these had anything to do with vaccination. One would be hard pressed to prove that the behavior had anythingto do with medications of highly questionable value with respect to SARS-CoV-2
Well, good. It is really bad that the left is now using professional credentialing to silence critics. This is no different than the NY bar suspending Rudi Guliani’s law license because he had the effrontery of claiming that the 2020 election was stolen from Trump, which very much, given the AZ audit and canvas, plus statistical analysis, appears very likely true.
In this case, ad far as I understand it, the three vaccines are available under Emergency Use Authorizations (EUAs), which, by statute and regulation, are only available if there are no viable alternatives available. So, if either ivermectin or hydroxychloroquine works, esp alongside zinc and vitamins C and D, then the EUAs shouldn’t be available for the vaccines. The thing is, that these two drugs have far better defined risk profiles than the three vaccines. That probably means that they are safer, if taken according to the documented cautions. Many millions, if not billions (of humans, as well as horses, etc), have taken these drugs safely. And there is a huge amount of anecdotal evidence that they do work well at significantly reducing the impact of the virus. And some clinical trial information too.
The bottom line though is that the war on these two drugs is being waged by the forces that are pushing the vaccines so aggressively, including into demographics that face negligee risk from the virus itself, and possibly significant danger from side effects of the vaccines. And the use of professional licensing to force compliance with the Biden Administration’s vaccination policies, based on minimal actual science, is a really bad trend.
I considered responding to this in depth, but it's wearying to deal with constant right-wing conspiratorial bullshit. Sure, there have been multiple trial studies that show hydroxychloroquin worthless - including a recent one in Norway - but Bruce Hayden obviously doesn't care about clinical trials. After all, if you can't own the Libs with clinical trials, what use are they? They're as worthless as an election audit that shows the exact opposite of MAGA fever dream fantasies.
https://www.uspharmacist.com/article/more-evidence-that-remdesivir-hcq-not-effective-against-covid19s
PS : Speaking of fantasy, what is a "negligee risk" anyway?
"PS : Speaking of fantasy, what is a “negligee risk” anyway?"
And how kinky would a double blind study be in this context?
I think that most here realized that I meant “negligible” risk.
For example, so far, roughly 600 people under 18 have died in this country WITH COVID-19, out of a population of roughly 60 million. That works out to (very roughly) 1/100,000. Similarly, there are roughly 1.6 million active military, and fewer than 20 have died WITH COVID-19. Again the death toll is roughly 1/100,000.
To calibrate numbers, most flu seasons have 120-160 flu deaths in that age range, but some annualized years are higher (2012-2013: 1161 estimated, 2017-2018: 526 estimated).
Sure, which is why we're cracking jokes about it.
As I understand it, the problem here is that the study was of HCQ after catching COVID-19 and going into the hospital, and the HCQ claimS are that it lessens the chances of getting sick from the virus in the first place, and then getting as bad of a case of it. So, yes, classical misdirection, claiming that something is tested and debunked, when something similar, with significant differences, is what was tested.
You can’t test the ability of a drug (etc) to prevent cases of a disease, by waiting until people catch the disease and go into the hospital. Going into the hospital in the first place is part of what the drug is supposed to reduce or prevent. I should add, that at least where I live, the goal is to keep people out of hospitals who catch COVID-19, because the longer you are in the hospital with it, the more likely you are going to die of it, or of something else (e.g. MRSA, etc). To test this, you need to somehow compare one large population against another one. A clinical/hospital setting just can’t test to debunk the claims.
"You can’t test the ability of a drug (etc) to prevent cases of a disease, by waiting until people catch the disease and go into the hospital."
Correct, except the part where you're completely wrong and misleading. That is *exactly* how vaccines are tested. Before covid, for covid, and after covid.
You do know what a double-blind study is, correct? You know, basic terminology? Fundamental scientific methodology? Why a double-blinded randomized clinical study is called a "gold standard" for making this sort of determination?
Read the following and get back to us:
https://en.wikipedia.org/wiki/Blinded_experiment
If:
1) 100 people get vax'd and 100 don't
2) of those 100 each: 20 unvax'd people go to the hospital, and 2 vax'd people go to the hospital
3) of those 20 unvax'd, 5 die; of the 2 vax'd, 0 die
4) come on! show us your science chops. Is the vaccine effective or not?
I can already hear you whining "but 2 people went to the hospital, it's not perfect!" ... duh. No vaccine is perfect. Is it *effective* or not? C'mon, blind us with your science.
"In this case, ad far as I understand it, the three vaccines are available under Emergency Use Authorizations (EUAs), which, by statute and regulation, are only available if there are no viable alternatives available."
The FDA has *fully*approved* the Pfizer vaccine for persons 16 and up ... outdated "emergency use only" arguments aren't too convincing anymore:
"On August 23, 2021, the Food and Drug Administration granted full approval of the Pfizer-BioNTech COVID-19 vaccine for persons aged ≥16 years."
https://www.cdc.gov/mmwr/volumes/70/wr/mm7038e2.htm
Except that the Pfizer approval isn’t for the Pfizer vaccine that they have made tens of millions doses of. It’s for a very slightly different version that they haven’t made any of.
Smoke and mirrors again.
Liar, liar, pants on fire. The Pfizer approval is for the Pfizer vaccine that they have made tens of millions of doses of. There is no "slightly different version."
To DavidN and also Zarniwoop:
Legally, he is correct. Under FDA regs, the BNT162b2 product currently available under EUA is not the same product as Comirnaty, which has full approval.
The emergency approval for BNT162b2 now further includes children as young as age 12. The full FDA approval for Comirnaty does not.
Strictly speaking, then, if Comirnaty were now available on the market, using it on a 12 year old would be an off-label use, whereas using BNT162b2 on a 12 year old is fully permitted under the emergency approval.
Isn't this a `site frequented by large numbers of lawyers who are accustomed to splitting legal hairs?
This one isn't even a close question. Legally, the two products are not the same thing.
First, source info please.
What is the difference, and how is it legally different?
And if it's "legally" different, is it *medically* relevant according to the FDA's guidelines for medication production?
If there's FDA approval of a pill with 300mg of drug XYZ and 1 gram of binder, and the pill manufacturer switches to 300mg of drug XYZ and 1.05g of binder (under allowable FDA regs for altering a formulation) ... I'd concede that change does constitute a "legal" (if technical) difference.
And I'd also ask "so what? Is the 1.0g vs 1.05g of binder medically relevant?"
But regardless, the blanket assertion that "there is no FDA approved vaccine" is demonstrably incorrect. If the actual claim is that the currently-distributed Pfizer product is slightly different in a non-biologically-functional manner ... well that doesn't sound nearly as scary, does it. And maybe BH should say what he means, instead of lying about it.
Oh, lookee here. Which irrelevant legal hairs are you trying to split here?
"Comirnaty has the same formulation as Pfizer-BioNTech COVID-19 Vaccine that continues to be available under emergency use authorization for the two-dose primary series in individuals 12 years of age"
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine-frequently-asked-questions
Again, this sounds like covid conspiracists desperate to latch onto any perceived difference, while ignoring plain-language info from the actual FDA.
Put up or shut up.
"Put up or shut up"
Um, what you "put up" supports my position. Legally Comirnaty is not the same as the product available under the EUA. It's right there in what you cut-n-pasted.
Something tells me you've never done any kind of regulatory law.
BH "there's no FDA approved vaccine"
ZW "here's the CDC talking about the FDA approval of the Pfizer vaccine"
BH "mumbles some incoherent and unsourced conspiracy-theory hand-wavy drivel to claim the the approval isn't 'real', in some unclear fashion"
WTactualF, dude. Is objective reality really that hard for you to acknowledge?
There's an FDA approved covid vaccine, end of story. Plus, water is still wet and 2+2 still equal 4.
"Well, good. It is really bad that the left is now using professional credentialing to silence critics. This is no different than the NY bar suspending Rudi Guliani’s law license because he had the effrontery of claiming that the 2020 election was stolen from Trump, which very much, given the AZ audit and canvas, plus statistical analysis, appears very likely true."
What it must be like to live in your world
"What it must be like to live in your world"
It is not the disaffected, delusional clingers' world. Not nearly. It is their betters' world -- we let them live in it, of course, but solely on our terms.
Which does not include enabling Rudy Giuliani to practice the law any more. He is, however, welcome to model hair dye at the Four Seasons of his choosing.
Artie, you live in the Boomer world. It is time to go. You need to be relaced by a diverse. Doversity is the strength of our country.
Not a substantive response. Just heckling.
Because everything you write is a lie. It's not clear whether you're delusional or dishonest or both, but it's impossible to substantively respond to someone who simply fabricates everything he says.
If you base argument on the demonstrably false premise that there is no FDA approved covid vaccine ... pointing out the error of your factual premise is most definitely a substantive response.
If you were to claim "2+2=7, therefore the rest of my hokey math means faster-than-light travel is real" ... it suffices to point out that 2+2 is in fact 4.
FFS, this is why it's hard to argue with people who deny that reality is real, no matter what side of the political spectrum they're on. And don't get me wrong, there are such idjits on both the far left and the far right.
Indeed, BH's entire modus operandi is to base his arguments on falsehoods and gross misinterpretations of fact
"This is no different than the NY bar suspending Rudi Guliani’s law license because he had the effrontery of claiming that the 2020 election was stolen from Trump, which very much, given the AZ audit and canvas, plus statistical analysis, appears very likely true."
These are the Volokh Conspiracy's peeps.
No wonder this blog has banned the use of the term "sl@ck-j@w" to describe conservatives.
"The thing is, that these two drugs have far better defined risk profiles than the three vaccines. That probably means that they are safer, if taken according to the documented cautions"
Bruce,
I don't see what medical evidence that you have for this claim. Moreover, what does the claim even mean, for the off-label use of these drugs with no measure of efficacy when compared with vaccines of well measured and documented efficacy.
In plain English, the risk associated with doing nothing effective is large
The gene therapy injections masquerading as "vaccines" are extraordinarily dangerous as shown by the 15,000 deaths reported on the Vaccine Adverse Event Reporting System and the 24,000 deaths reported on the European system, along with the hundreds of thousands of neuropathies and blood clots and other injuries. The injections should be removed from the market and replaced by Ivermectin, Vitamin D, and zinc.
Brophy,
If you are implying that MRNA vaccines are Gene therapies you ae dead wrong. These vaccines are not gene therapies, not even close. Learn a bit of biology before you spout nonsense.
In fact your misinformation is downright dangerous. You should be ashamed of yourself.
They sure as hell aren’t classical vaccines either, which are typically deactivated or attenuated/weakened versions of the virus bein vaccinated against. Indeed, two years ago, they weren’t considered “vaccines” anywhere, and less than 2 months ago the FDA changed their definition of vaccines to include them.
Not sure what your are trying to say with your insistence that we learn a bit of biology. I think that you are seriously underestimating how novel these “vaccines” are. In two of the “vaccines”, they are mRNA segments that recognize some of the spike proteins of the virus. Sure sounds like gene therapy to me.
"Classic vaccines"
That they were developed in a different fashion is irrelevant. SO what?
The vaccines are not gene therapy in any fashion whatsoever. They do NOT affect the recipients genes in any way shape or form.
You clearly do not know what gene therapy is, you don't know how these vaccines were made, and you don't know how they function.
Learn some biology instead of demonstrating how little that you know
1) They are not gene therapy.
2) They are vaccines.
3) There are no deaths from the vaccines. That's not how VAERS works.
4) Not surprisingly, Flintstones vitamins and horse dewormer do not prevent or treat covid.
I guess it's lucky that you actually have no credentials of any sort to lose, since you're a liar and a fraud. The Arizona "audit," of course, showed that the election was legitimate and Trump lost. Rudy (not Rudi, no matter how many times you incompetently spell his name) had his license suspended for dishonesty in the practice of law.
You do not understand it. Just like you don't understand anything else. Pfizer is not available under an EUA. It was approved months ago.
I like to think that most of us would agree that if the patient is adequately informed of the situation with respect to those drugs and there is no FDA restriction on their being prescribed for human consumption that no, there is no reason to sanction physicians from prescribing them.
But that is not the more critical question, which is do the physicians have an obligation to prescribe those drugs to an informed patient when the physician is opposed to them for treating Covid-19 because they believe that the drugs are ineffective thus keeping the patient from receiving proper treatment or are downright dangerous to the patient.
The conservative position, which I subscribe to says the physician may not be so coerced as such a position would violate the rights of the physician, the same way that coercing a physician to perform a legal abortion violates their rights, and besides, that is why the drugs are unavailable without a prescription. Law and practice puts the decision in the hands of the medical practioners, not the patient.
Just so, as the patient is perfectly entitled to take his custom elsewhere if he doesn't like the physician's treatment.
Though this doesn't work so well if various medical boards decide to start disciplining physicians who do not agree with the first physician's notions.
But "and besides, that is why the drugs are unavailable without a prescription. Law and practice puts the decision in the hands of the medical practioners, not the patient" somewhat blurs the paean to the freedom of doctors from state coercion, by celebrating the lack of freedom of patients from state coercion.
Obviously the pros and cons of state licensing of medications are complicated, and involve considerations other than liberty, but there is something of a tension in the state creating a guild and then losing interest in how the members of the guild operate.
Doctors don't refuse to prescribe Ivermectin because they believe that it doesn't work, they refuse because they want to increase the profits of drug companies.
Bye, fool.
It's my understanding doctors prescribe drugs for off-label use all the time.
As a skeptic, this can be a possible snake oil issue, but not a legal one.
Is the conclusion here RATS WE COULDN'T USE THE POWER OF ANGRY, PUNISH-YOUR-OPPONENTS POLITICS to invade medicine?
Yes. For example, one of the drugs most commonly used to induce abortions (misoprostol) is (a) off-label in the US for that purpose and (b) so bad at its on-label use that approximately the only reason it is still on the market is its off-label use as an abortifacient. Also (c) so dangerous that both the WHO and the American College of Obstetricians and Gynecologists say it should never be used in fairly common circumstances.
(Specifically, during the third trimester when uterine scarring is present. It has a tendency to cause uterine rupture then. That is why it will probably never get US approval for inducing abortions: Other drugs are safer and easier to control in such cases. But, hey, that sounds scary, so abortion doctors successfully lobbied the Clinton FDA to keep a warning about that off the label.)
Misoprostol reduces stomach acid and helps protect the stomach from damage that can be caused by taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
Misoprostol is used to prevent stomach ulcers during treatment with aspirin or an NSAID.
Yes, it is remarkably bad at preventing stomach ulcers, and even for non-pregnant patients, its margin of safety is rather small.
Were there actual "plaintiffs" here, asking for disciplinary action?
I mean, beyond the usual noise on twitter and similar circuses.
If you have ever taken an antihistamine to help you sleep you have off-label self medicated.
Generally, if a medicine is approved for use A, a licensed physician may prescribe it for uses B or C or D on up to Omega.
Perhaps there's something special about ivermectin or hydroxychloroquine that would invalidate that practice, but I can't think of what that might be, and apparently neither could the Nebraska AG office.
Of course, that doesn't mean that either of these substances are effective against Covid.
The public health policy argument against drugs like ivermectin and hydorxycholoroquine is not so much that they're dangerous (if administered properly and at the right dosage amounts) but that people will seize on them as more effective than vaccines and mitigation efforts, when stopping the spread.
A lot of people falsely believe that these drugs can save them from advanced stages of the disease, and that is just not what any of the scientific arguments in favor of the drugs claim. Even the scientists who have claimed to find a benefit with these drugs think they are best used prophylactically among people who are at high risks of exposure.
You are right, but only if they have a good faith basis for doing so. They can't just prescribe drugs at random.
All doctors who refuse to prescribe Ivermectin should be disciplined or incarcerated because withholding a medicine that saves lives is murder.
Brophy, are you sure it's only murder? Like, maybe it's terrorism too, doncha think?
Brophy cannot think at all.
LoL. Isn't the doctor-patient relationship sacred anymore? You're going to force docs to prescribe something they think has no efficacy?
I file complaints against entire medical boards for being disruptive physicians, an demand each undergoes a thorough mental examination. These little Democrat tyrants need to be deterred. This opinion will be incorporated into any future complaints.
That being said, I do not support these treatments. To anyone interested in them, make sure you are also getting steroids for inflammation and blood thinners for the microclots in the lung.
I support freedom of speech, and stopping Democrat little tyrant bitches from intimidating doctors to impose their petty tyrannies.
[O]ur office is not recommending any specific treatments for COVID-19. That is not our role.
I mean, that's what they say. The opinion itself might as well have been written by anti-vaxxers hyping the use of ivermectin and hydroxycholoroquine, as it favorably and uncritically cites "pro" studies (even withdrawn studies!) and spends a lot of time criticizing the "anti" studies. The opinion also delves into critiques of the FDA, CDC, and Fauci. Hardly an unbiased take.
But the standard that they need to reach here is not high - the question is whether there is such a clear scientific consensus on not using these drugs to try to treat COVID-19 that it would be "grossly negligent" for doctors to prescribe it. Simply finding the scientific understanding to be developing and the drugs to be safe when administered appropriately is all that the NE AG needed to do. That's why there's the emphasis, here, of the "informed consent" bit - all the AG is saying, "It's okay to experiment with this stuff."
"might as well have been written by anti-vaxxers hyping the use of ivermectin and hydroxycholoroquine, as it favorably and uncritically cites “pro” studies (even withdrawn studies!) and spends a lot of time criticizing the “anti” studies. "
Simon, thanks for pointing out these matters. I (like a lot of readers, I suspect) mainly rely on EV's summary and don't dig into the source documents unless something in the summary piques interest.
If you hadn't mentioned it, I wouldn't have known there's a strong apparent bias in this AG's opinion.
Ivermectin (medically approved in US 1981 for human use)
_ used to treat diseases caused by roundworms and ectoparasites; safe human doses have been set for such use
_ shown by clinical tests in monkey kidney cell cultures to have antiviral effects against viruses including SARS-CoV-2 the cause of COVID-19
_ still being tried in clinical tests against COVID-19 but so far the levels required to affect the virus in live humans may be too high for safe use
Hydroxychloroquine HCQ (medically approved in US 1955 for human use)
_ used to prevent and treat malaria, Q fever, rheumatoid arthritis, lupus, common porphyria
_ tried in clinical tests against COVID-19 with inconclusive results
Neither Ivermectin nor HCQ should be used without the supervision of a personal physician with both knowledge of the patient's medical history and knowledge of the drugs themselves. There are interactions and contraindications PDR.
Probably we won't know if either Ivermectin or HCQ is effective at any level against SARS Corona Virus 2 until after COVID-19 has joined Swine Flu and Spanish Flu in the history of pandemics.
To the news media and opinion influencers on Twitter and Facebook, Ivermectin is Horse Dewormer and HCQ is Fish Tank Cleaner and anyone using them against COVID-19 is a Trumptard using Putin's Puppet's Poisons. (I guess those users include clinical trials by the World Health Organisation (WHO) and others.)
Reports of people overdosing on Ivermectin against COVID-19 are conflated in the media with reports which turn out to be ranchers accidentally exposed to horse level Ivermectin while deworming livestock. Such accidental exposures have occurred seasonally long before the COVID-19 pandemic.
For the record, I was hospitalized in intensive care 3-8 Apr 2020 (age: 72) diagnosed with COVID-19, pneumonia, and UTI. I was in ICU on oxygen with IVs six days. I was treated with antibiotics for pneumonia & UTI. I was treated with HCQ for COVID-19. On the sixth day I was released to home health care with three days of HCQ & antibiotics. After 21 days of frequent visits by home health care people wearing less and less haz mat gear with each visit, I was officially discharged. [sarcasm] I am a living example of the deadliness of HCQ: Trump's Fish Tank Cleaner. [/sarcasm]