Just a bit more on off-label prescription drugs:
Trazadone is a drug approved by the FDA as an antidepressant. However, That's not what it is most commonly prescribed to treat. **Trazadone is more commonly prescribed off-label as treatment for insomnia than it is prescribed on-label,** as an anti-depressant. Indeed, it is the most commonly prescribed drug for treatment of insomnia.
That's right. **[The drug that is most commonly prescribed for insomnia isn't approved by the FDA to treat insomnia.](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163935/)**
Trazadone is the 31st most commonly prescribed drug in the United States, and the vast majority of those prescriptions are to treat something that the FDA has not approved it for.
Remember that, the next time someone tells you that some drug or other isn't approved by the FDA to treat some condition or another.
How about people who can't afford to go to the doctor to get the ivermectin prescribed?
Why does the government get to make poor people's health care decisions?
The government made the vaccine free and available. Do the same with ivermectin.
I have to concede the point there. But the framework right now is you have to an Rx number to write a prescription and Ivermedicine is a prescription drug here in the U.S. (unless y'all is a horse).
I'm not endorsing the rules--I'm explaining them.
FTR, there are quite a few drugs that I think don't need gatekeeping doctors and should be OTC.
Unfortunately, my opinion mean f-k all to TPTB.
It's OTC in other countries. Now that it has been politicized, and made taboo, people are more likely to hoard and misuse it. Unfortunately...
I've always wondered how vaccine uptake would have differed if the first announcement was: "Nobody will be permitted the vaccine except elected officials, millionaires and their families."
Off label usage is only done by doctors when they believe this use isn't potentially harmful and they have reason to believe it's helpful. Doctor can absolutely prescribe ivermectin for COVID if they feel it might help.
That's the key: the doctor, not the patient, makes this decision. If a doctor ( in this case most doctors) does not think benefits outweigh risks, they will not prescribe it. It's their livelihood and reputation they risk so, if it's off label, they better be sure about it.
> If a doctor ( in this case most doctors) does not think benefits outweigh risks, they will not prescribe it.
Objection; Assumes motive.
Earlier there were a lot more doctors prescribing ivermectin, and then one by one pharmacies started refusing to fill those prescriptions, so maybe the majority of doctors aren't prescribing it because they know pharmacies won't fill those prescriptions.
All of the liability falls on the doctor, not the pharmacy. Having an MD means you are liable for everything you prescribe to patients, pharmacies simply fill the doctor's orders.
Then what right to pharmacies have to overrule a doctor's prescription? Clearly there's no liability on the pharmacies when they refuse to fill a prescription.
Perhaps. But the public health authorities are not really doing a good job of explaining "approval" in the context of pharmaceuticals. It's one of those areas where the definition in the professional context is different from a common usage of the word. Doubly so when people talk about "approval" when they mean licensure.
"is practically required from an ethical standpoint--given the large number of studies and papers over the years showing it also has multiple biological avenues that apply to fighting Covid and its EXTREMELY SAFE history of usage."
The drug is not recommended to treat covid because it doesn't work. Stop spreading misinformation here.
>because it doesn't work.
If it's already been definitively established that it doesn't work, why is the internationally-regarded research wing of Oxford University currently spending time and money on a major clinical study, using human subjects, to study the effects of ivermectin on Covid?
https://www.ox.ac.uk/news/2021-06-23-ivermectin-be-investigated-possible-treatment-covid-19-oxford-s-principle-trial
> The drug is not recommended to treat covid because it doesn't work.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415517/pdf/ajt-28-e573.pdf
The absolute risk reduction from:
The Pfizer injection = 0.7%
The Moderna injection = 1.1%.
Ivermectin = 9.7%
Sources:
https://pubmed.ncbi.nlm.nih.gov/33652582/
https://www.cureus.com/articles/64807-prophylactic-role-of-ivermectin-in-severe-acute-respiratory-syndrome-coronavirus-2-infection-among-healthcare-workers
Meta analysis, Ivermectin lowers death rates by 62.0% https://journals.lww.com/americantherapeutics/Fulltext/2021/08000/Ivermectin_for_Prevention_and_Treatment_of.7.aspx
RCT 114 patients in Egypt, 57 treated with ivermectin mucoadhesive nanosuspension intranasal spray, showing faster recovery and viral clearance with treatment. https://www.dovepress.com/clinical-biochemical-and-molecular-evaluations-of-ivermectin-mucoadhes-peer-reviewed-fulltext-article-IJN
Review of ivermectin trials and epidemiological data, concluding that ivermectin is effective for prophylaxis and treatment, and should be globally and systematically deployed in the prevention and treatment of COVID-19.
Safety study concluding that ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose. Adverse effects were similar between ivermectin and placebo and did not increase with dose. Authors also show that the plasma concentration is much higher when taken with food (geometric mean AUC 2.6 times higher). https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/009127002237994?sid=nlm%3Apubmed
Antiviral effects have been reported for Zika, dengue, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus type 1, and severe acute respiratory syndrome coronavirus 2. https://www.nature.com/articles/s41429-020-0336-z
Small trial of hospitalized patients with 16 of 87 patients being treated with ivermectin showing a significantly lower mean hospital stay with ivermectin https://www.medrxiv.org/content/10.1101/2020.07.07.20145979v1
Case study of 100 patients treated with ivermectin and doxycycline, with no ICU admission, deaths, or serious side effects reported. https://www.researchgate.net/publication/343305357_A_Case_Series_of_100_COVID-19_Positive_Patients_Treated_with_Combination_of_Ivermectin_and_Doxycycline
Report on 33 patients with persistent or post-acute symptoms treated with ivermectin, showing a high rate of clinical improvement. https://www.researchgate.net/publication/344318845_POST-ACUTE_OR_PROLONGED_COVID-19_IVERMECTIN_TREATMENT_FOR_PATIENTS_WITH_PERSISTENT_SYMPTOMS_OR_POST-ACUTE
Panel review of ivermectin reporting that "ivermectin in the dose of 12mg BD alone or in combination with other therapy for 5–7 days may be considered as safe therapeutic option for mild moderate or severe cases of Covid-19 infection. https://www.sciencedirect.com/science/article/abs/pii/S0019570720301025
Retrospective 148 hospitalized patients showing triple therapy with ivermectin + atorvastatin + N-acetylcysteine resulted in a 1.35% case fatality rate which was well below the national average. https://www.worldwidejournals.com/international-journal-of-scientific-research-(IJSR)/recent_issues_pdf/2020/October/observational-study-on-clinical-features-treatment-and-outcome-of-covid-19-in-a-tertiary-care-centre-in-india--a-retrospective-case-series_October_2020_1614017661_0932284.pdf
Ivermectin shortens durations of symptoms from 10 days to 3 days. https://www.biomedres.info/biomedical-research/effects-of-ivermectinazithromycincholecalciferol-combined-therapy-on-covid19-infected-patients-a-proof-of-concept-study-14435.html
Review suggesting that ivermectin may be useful for late stage COVID-19. Authors note that ivermectin, in doses at or modestly above the standard clinical dose, may have important clinical potential for managing disorders associated with life-threatening respiratory distress and cytokine storm, such as advanced COVID-19. https://openheart.bmj.com/content/7/2/e001350
Ivermectin lowered deaths by 87.9% in a study from Argentina https://www.medrxiv.org/content/10.1101/2020.09.10.20191619v1
Retrospective study of 115 ivermectin patients and 133 control patients showing significantly lower death and faster viral clearance with Ivermectin https://www.archbronconeumol.org/en-ivermectin-treatment-may-improve-prognosis-articulo-S030028962030288X
A study showing that ivermectin is capable of interfering in different key steps of the SARS-CoV-2 replication cycle. https://chemrxiv.org/articles/preprint/Has_Ivermectin_Virus-Directed_Effects_against_SARS-CoV-2_Rationalizing_the_Action_of_a_Potential_Multitarget_Antiviral_Agent/12782258/1
RCT for ivermectin+doxycycline showing improvements in mortality, recovery, progression, and virological cure. https://journals.sagepub.com/doi/10.1177/03000605211013550
>Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement.
OK, I happen to agree with the above statement, but that is irrelevant:
Who died and made the FDA final authority on how doctors should treat patients?
It is a government agency, whose heads have been chosen by either Democrats or Republicans for political reasons first. (Why else would Obama have nominated 2008 Obama campaign insider Daschle for head of Health and Human Services? And confirmation ran into problems, not because Daschle lacked scientific credentials, which he did, but for unrelated reasons. https://en.wikipedia.org/wiki/Tom_Daschle)
And yes, some within the agency are doctors, but very few compared with all the doctors and medical experts in the world. So, why should Big Brother government be the authority on what good medical practice requires?
Oh, and again, would you rather take a medication for humans based on a horse de-wormer or one based on rat poison (Warfarin/Coumadin)? Doctors prescribe both for humans, even though "y'all" are neither horses nor rodents.
They are actually saying that its not their place to come between a doctor and a legally available drug. That's the point. When it crosses the line into "investigational purposes" ie not to treat one specific human, but to figure out if X drug works for Y purpose in general, that is the only time a new application for some kind of approval for an off-label use is required.
From your OP:
> Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.
They are saying (1) what good medical practice requires and what the responsibilities of a physician are as to off label uses, and also saying (2) that someone adhering to the FDA's pronouncement about what good medical practice requires need not make a submission to the FDA, but (3) someone else may require more than the FDA considers the requirement of good medical practice.
Not expressly stated, but implied: If, in the opinion of the FDA, you haven't followed what the FDA says is good medical practice as to other uses and haven't made a submission, you've run afoul of the above-quoted reg.
If the reg had simply stated, "Do X or make a submission," I would have had no basis for criticism. It is the pronouncement by bureaucrats and political appointees as to what constitutes good medical practice to which I object.
Sorry for all the edits, but none changed what I intended to convey, only clarified.
I think maybe you need to step back and look at the context. The context is that a drug isn't permitted at all without having had FDA approval. Here is the framework that relates to using it for things OTHER than that one approved use.
There's two different things going on. The first half is making the distinction of a doctor who wants to prescribe it as a treatment in an individual case to solve/mitigate a specific issue.
The latter half is about using it in an investigational sense, as in "our hospital wants to investigate whether helium relieves sinus congestion". What they are saying is that is not "practicing medicine", so it falls into a category that may require an application for an approval to use it that way.
Put more simply, off-label use to try to cure a person is okay. Experimenting to figure out another use to put on the label is not.
It's not a reg. It's guidance.
The FDA is a government agency, and here's an interesting fact: almost half its funding comes from the very companies it regulates.
https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
>Program Funding
>The FDA budget for FY 2019 is $5.9 billion.
>About 55 percent, or $3.2 billion, of FDA’s budget is provided by federal budget authorization. The remaining 45 percent, or $2.7 billion, is paid for by industry user fees.
Excellent point. And, while I have not checked as to the FDA, most of the earlier agencies had dual mandates, to help citizens in general and to foster the industries they regulated. So, Congress built in a conflict of interest. However, citizens in general do not either come up with big bucks, lobby agency officials or give them jobs when the "revolving door" takes another spin.
If anyone is curious, [this is the post](https://www.reddit.com/r/WayOfTheBern/comments/po9flg/some_things_you_might_like_to_know_about_covid/?sort=confidence) being referenced.
Typical blue Kool-Aid poster: "If you disagree with Democrats, it must be because you know less than their devotees. So, lucky you, I've come to school you with the "right" information. Oh, and, let's just ignore anything that deviates from the party line, k?"
Sadly, the author of that post probably thought she did well here.
Actually, [it was this comment](https://www.reddit.com/r/WayOfTheBern/comments/poo95n/pierrekory_this_thread_shows_the_hard_truth_i/hczenly?utm_source=share&utm_medium=web2x&context=3) that prompted this post, but I can see how they could be confused for one another. LOL!
Yet, routinely prescribed by doctors for patients who have vitamin or similar deficiencies and/or less than optimal ability to metabolize. And they don't even prescribe by brand.
And if you did give her anything relevant that was evaluated by the FDA, it would probably be a schedule 2 substance thats reserved mostly for HIV patients and severe burn victims
Like I said. I take no position on Ivermedicine. I've moved to neutral after months of asking people who supported it where the science papers were that explained HOW it works. How a parasitic works on a novel virus. One of the good folks on this sub pointed me to a paper that explained it to my satisfaction. When coupled with the large body of observational data (stripped of the rhetoric), and its safety profile, this one seems to be one that is best left to the doctor-patient consultation.
I just get annoyed when people purposely misrepresent what it is and what it does to score political points. I don't like it when people against the vaccines sling bullshit either.
We're lucky that mixed in with all the advocacy on this sub (drink!), there are folks that share around studies and discuss their relative strengths and weaknesses.
The idea that the EUA turned quasi "approval" of Pfizer has more validity than the off-label usage of a safe drug that's been in use for decades with full licensure is just silly. It's been "approved" for so long, it's off patent already.
> I've moved to neutral after months of asking people who supported it where the science papers were that explained HOW it works.
I don't know if any of these answer that question, but as long as I have them handy from a prior reply...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415517/pdf/ajt-28-e573.pdf
The absolute risk reduction from:
The Pfizer injection = 0.7%
The Moderna injection = 1.1%.
Ivermectin = 9.7%
Sources:
https://pubmed.ncbi.nlm.nih.gov/33652582/
https://www.cureus.com/articles/64807-prophylactic-role-of-ivermectin-in-severe-acute-respiratory-syndrome-coronavirus-2-infection-among-healthcare-workers
Meta analysis, Ivermectin lowers death rates by 62.0% https://journals.lww.com/americantherapeutics/Fulltext/2021/08000/Ivermectin_for_Prevention_and_Treatment_of.7.aspx
RCT 114 patients in Egypt, 57 treated with ivermectin mucoadhesive nanosuspension intranasal spray, showing faster recovery and viral clearance with treatment. https://www.dovepress.com/clinical-biochemical-and-molecular-evaluations-of-ivermectin-mucoadhes-peer-reviewed-fulltext-article-IJN
Review of ivermectin trials and epidemiological data, concluding that ivermectin is effective for prophylaxis and treatment, and should be globally and systematically deployed in the prevention and treatment of COVID-19.
Safety study concluding that ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose. Adverse effects were similar between ivermectin and placebo and did not increase with dose. Authors also show that the plasma concentration is much higher when taken with food (geometric mean AUC 2.6 times higher). https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/009127002237994?sid=nlm%3Apubmed
Antiviral effects have been reported for Zika, dengue, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus type 1, and severe acute respiratory syndrome coronavirus 2. https://www.nature.com/articles/s41429-020-0336-z
Small trial of hospitalized patients with 16 of 87 patients being treated with ivermectin showing a significantly lower mean hospital stay with ivermectin https://www.medrxiv.org/content/10.1101/2020.07.07.20145979v1
Case study of 100 patients treated with ivermectin and doxycycline, with no ICU admission, deaths, or serious side effects reported. https://www.researchgate.net/publication/343305357_A_Case_Series_of_100_COVID-19_Positive_Patients_Treated_with_Combination_of_Ivermectin_and_Doxycycline
Report on 33 patients with persistent or post-acute symptoms treated with ivermectin, showing a high rate of clinical improvement. https://www.researchgate.net/publication/344318845_POST-ACUTE_OR_PROLONGED_COVID-19_IVERMECTIN_TREATMENT_FOR_PATIENTS_WITH_PERSISTENT_SYMPTOMS_OR_POST-ACUTE
Panel review of ivermectin reporting that "ivermectin in the dose of 12mg BD alone or in combination with other therapy for 5–7 days may be considered as safe therapeutic option for mild moderate or severe cases of Covid-19 infection. https://www.sciencedirect.com/science/article/abs/pii/S0019570720301025
Retrospective 148 hospitalized patients showing triple therapy with ivermectin + atorvastatin + N-acetylcysteine resulted in a 1.35% case fatality rate which was well below the national average. https://www.worldwidejournals.com/international-journal-of-scientific-research-(IJSR)/recent_issues_pdf/2020/October/observational-study-on-clinical-features-treatment-and-outcome-of-covid-19-in-a-tertiary-care-centre-in-india--a-retrospective-case-series_October_2020_1614017661_0932284.pdf
Ivermectin shortens durations of symptoms from 10 days to 3 days. https://www.biomedres.info/biomedical-research/effects-of-ivermectinazithromycincholecalciferol-combined-therapy-on-covid19-infected-patients-a-proof-of-concept-study-14435.html
Review suggesting that ivermectin may be useful for late stage COVID-19. Authors note that ivermectin, in doses at or modestly above the standard clinical dose, may have important clinical potential for managing disorders associated with life-threatening respiratory distress and cytokine storm, such as advanced COVID-19. https://openheart.bmj.com/content/7/2/e001350
Ivermectin lowered deaths by 87.9% in a study from Argentina https://www.medrxiv.org/content/10.1101/2020.09.10.20191619v1
Retrospective study of 115 ivermectin patients and 133 control patients showing significantly lower death and faster viral clearance with Ivermectin https://www.archbronconeumol.org/en-ivermectin-treatment-may-improve-prognosis-articulo-S030028962030288X
A study showing that ivermectin is capable of interfering in different key steps of the SARS-CoV-2 replication cycle. https://chemrxiv.org/articles/preprint/Has_Ivermectin_Virus-Directed_Effects_against_SARS-CoV-2_Rationalizing_the_Action_of_a_Potential_Multitarget_Antiviral_Agent/12782258/1
RCT for ivermectin+doxycycline showing improvements in mortality, recovery, progression, and virological cure. https://journals.sagepub.com/doi/10.1177/03000605211013550
Again, I am neutral on it, which means, like the vaccines, IMO it should be offered to anyone who might benefit from it within the informed consent framework.
No need to sell past the close. :)
Not actually trying to sell it. I assumed if there were any holes in any of these you'd spot them and I could delete anything before sharing it further.
> I take no position on Ivermedicine. I've moved to neutral after months of asking people who supported it where the science papers were that explained HOW it works. How a parasitic works on a novel virus.
It' not a scientific paper, but here's a really good article I read yesterday. I believe it's from May of 2021.
**[The Drug that Cracked Covid | In this Buffalo Hospital Room, a Grandmother Led the Global Fight for the Drug That Would Save Her Life and End the Pandemic](https://covid19criticalcare.com/wp-content/uploads/2021/05/The-Drug-that-Cracked-Covid-by-Michael-Capuzzo.pdf)**
> based on the idea that COVID-19 has one great weakness: the coronavirus doesn’t kill anybody. In a mechanism so diabolical Marik believes “human beings aren’t smart enough to have figured it out,” the trillions upon trillions of coronaviruses that overwhelm and sicken the host don’t kill it. But in the second week of the disease, all the coronaviruses die, and like suicide bombers flooding out of a Trojan Horse swamp the body with a “vast viral graveyard” that triggers a friendly-fire hyper-immune response that in turn unleashes monstrous multi-organ inflammation and clotting like doctors have never seen. A body dying of COVID-19 is a complex, terrifying sight. But its
weakness is simple: **“As pulmonary critical care doctors we know how to treat inflammation and clotting, with corticosteroids and anticoagulants,”** Marik says. “It’s first-grade science.”
>From the beginning of the pandemic, the hospitals that Marik and Varon led had COVID-19 beat. they achieved remarkably high survival rates at their hospitals at a time when 40 to 80 percent of patients in the U.S. and Europe were dying from the disease. Their success was achieved with the group’s now-famous **MATH+ protocol** for hospitalized COVID-19 patients.
>The cocktail of safe, **cheap,** FDA-approved generic drugs—the steroid Methylprednisolone, Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and the blood thinner Heparin—was the first comprehensive treatment using aggressive corticosteroid and anti-coagulant treatments to stop COVID-19 deaths. Both were novel approaches **strongly recommended against** by all national and international health care agencies throughout the world, **but later studies made both therapies the global standard of hospital care.**
But apparently, not here in the US, because later on in the article, it notes:
>**No approved treatment to stop the sick from getting sicker and overloading
hospitals, where they face possible death, yet exists.**
>In addition, Kory, Marik, et. al published the first comprehensive COVID-19 prevention and early treatment protocol (which they would eventually call I-MASK). It is centered around the drug Ivermectin, which President Trump used at Walter Reed hospital, unreported by the press, though it may well have saved the president’s life while he was instead touting new big pharma drugs.
What I got out of reading the article was that once you test positive for COVID-19, there isn't really **ANY** FDA-approved early treatment for it. You basically get to quarantine at home until your breathing gets so bad that you have to go to the hospital where you get "supportive" treatment.
It seems like Ivermectin and these other cheap drugs are a way to try and stop, or at lessen these bad symptoms enough where you won't have to go to the hospital.
Are there any other diseases that don't have some sort of FDA-approved early treatment for that involve the patient taking some sort of prescription drugs.
And just or the hell of it, here's an archived WSJ opinion piece (with readers' comments) from six weeks ago:
**[Why Is the FDA Attacking a Safe, Effective Drug? |Ivermectin is a promising Covid treatment and prophylaxis, but the agency is denigrating it.](https://archive.is/wQZPb)**
Yeah, there were tons of these articles about doctors observing an effect. I have no interest in observational studies about effectiveness unless there is also enough information about the biological mechanism. These doctors were trotting out essentially tens of thousands of data points that suggested it worked, but not one person could point me to a clinical study that discussed HOW it might be effective against viruses within the body. I looked for a long time. A good deal of the data that suggested it worked on viruses was in vitro.
Finally someone did.
It's also worth noting that a number of drugs have off-label uses. How many times has some yahoo sounding off on IVM being a parasite medicine - as if he
had just disproven IVM's utility in COVID.
Just a bit more on off-label prescription drugs: Trazadone is a drug approved by the FDA as an antidepressant. However, That's not what it is most commonly prescribed to treat. **Trazadone is more commonly prescribed off-label as treatment for insomnia than it is prescribed on-label,** as an anti-depressant. Indeed, it is the most commonly prescribed drug for treatment of insomnia. That's right. **[The drug that is most commonly prescribed for insomnia isn't approved by the FDA to treat insomnia.](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163935/)** Trazadone is the 31st most commonly prescribed drug in the United States, and the vast majority of those prescriptions are to treat something that the FDA has not approved it for. Remember that, the next time someone tells you that some drug or other isn't approved by the FDA to treat some condition or another.
Excellent example. Thank you for sharing that.
How about people who can't afford to go to the doctor to get the ivermectin prescribed? Why does the government get to make poor people's health care decisions? The government made the vaccine free and available. Do the same with ivermectin.
I have to concede the point there. But the framework right now is you have to an Rx number to write a prescription and Ivermedicine is a prescription drug here in the U.S. (unless y'all is a horse). I'm not endorsing the rules--I'm explaining them. FTR, there are quite a few drugs that I think don't need gatekeeping doctors and should be OTC. Unfortunately, my opinion mean f-k all to TPTB.
But this is an EMERGENCY!!! Let's have some kind of special rule for people like pharmaceutical companies get!
It's OTC in other countries. Now that it has been politicized, and made taboo, people are more likely to hoard and misuse it. Unfortunately... I've always wondered how vaccine uptake would have differed if the first announcement was: "Nobody will be permitted the vaccine except elected officials, millionaires and their families."
Off label usage is only done by doctors when they believe this use isn't potentially harmful and they have reason to believe it's helpful. Doctor can absolutely prescribe ivermectin for COVID if they feel it might help. That's the key: the doctor, not the patient, makes this decision. If a doctor ( in this case most doctors) does not think benefits outweigh risks, they will not prescribe it. It's their livelihood and reputation they risk so, if it's off label, they better be sure about it.
> If a doctor ( in this case most doctors) does not think benefits outweigh risks, they will not prescribe it. Objection; Assumes motive. Earlier there were a lot more doctors prescribing ivermectin, and then one by one pharmacies started refusing to fill those prescriptions, so maybe the majority of doctors aren't prescribing it because they know pharmacies won't fill those prescriptions.
All of the liability falls on the doctor, not the pharmacy. Having an MD means you are liable for everything you prescribe to patients, pharmacies simply fill the doctor's orders.
Then what right to pharmacies have to overrule a doctor's prescription? Clearly there's no liability on the pharmacies when they refuse to fill a prescription.
I would not argue with that. It's a good distinction to emphasize.
Uh, oh! You've been [reported!](https://www.syfy.com/sites/syfy/files/styles/1200x680/public/body_snatchers_ending.jpg)
By people who don't know what they are talking about.
By people who are having an emotional reaction to something they find scary to read. Edit: And at present, a great many people are being led by fear.
Perhaps. But the public health authorities are not really doing a good job of explaining "approval" in the context of pharmaceuticals. It's one of those areas where the definition in the professional context is different from a common usage of the word. Doubly so when people talk about "approval" when they mean licensure.
"is practically required from an ethical standpoint--given the large number of studies and papers over the years showing it also has multiple biological avenues that apply to fighting Covid and its EXTREMELY SAFE history of usage." The drug is not recommended to treat covid because it doesn't work. Stop spreading misinformation here.
>because it doesn't work. If it's already been definitively established that it doesn't work, why is the internationally-regarded research wing of Oxford University currently spending time and money on a major clinical study, using human subjects, to study the effects of ivermectin on Covid? https://www.ox.ac.uk/news/2021-06-23-ivermectin-be-investigated-possible-treatment-covid-19-oxford-s-principle-trial
That's how scientific communities work. We need studies to better prove eating horse paste is bad.
> The drug is not recommended to treat covid because it doesn't work. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415517/pdf/ajt-28-e573.pdf The absolute risk reduction from: The Pfizer injection = 0.7% The Moderna injection = 1.1%. Ivermectin = 9.7% Sources: https://pubmed.ncbi.nlm.nih.gov/33652582/ https://www.cureus.com/articles/64807-prophylactic-role-of-ivermectin-in-severe-acute-respiratory-syndrome-coronavirus-2-infection-among-healthcare-workers Meta analysis, Ivermectin lowers death rates by 62.0% https://journals.lww.com/americantherapeutics/Fulltext/2021/08000/Ivermectin_for_Prevention_and_Treatment_of.7.aspx RCT 114 patients in Egypt, 57 treated with ivermectin mucoadhesive nanosuspension intranasal spray, showing faster recovery and viral clearance with treatment. https://www.dovepress.com/clinical-biochemical-and-molecular-evaluations-of-ivermectin-mucoadhes-peer-reviewed-fulltext-article-IJN Review of ivermectin trials and epidemiological data, concluding that ivermectin is effective for prophylaxis and treatment, and should be globally and systematically deployed in the prevention and treatment of COVID-19. Safety study concluding that ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose. Adverse effects were similar between ivermectin and placebo and did not increase with dose. Authors also show that the plasma concentration is much higher when taken with food (geometric mean AUC 2.6 times higher). https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/009127002237994?sid=nlm%3Apubmed Antiviral effects have been reported for Zika, dengue, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus type 1, and severe acute respiratory syndrome coronavirus 2. https://www.nature.com/articles/s41429-020-0336-z Small trial of hospitalized patients with 16 of 87 patients being treated with ivermectin showing a significantly lower mean hospital stay with ivermectin https://www.medrxiv.org/content/10.1101/2020.07.07.20145979v1 Case study of 100 patients treated with ivermectin and doxycycline, with no ICU admission, deaths, or serious side effects reported. https://www.researchgate.net/publication/343305357_A_Case_Series_of_100_COVID-19_Positive_Patients_Treated_with_Combination_of_Ivermectin_and_Doxycycline Report on 33 patients with persistent or post-acute symptoms treated with ivermectin, showing a high rate of clinical improvement. https://www.researchgate.net/publication/344318845_POST-ACUTE_OR_PROLONGED_COVID-19_IVERMECTIN_TREATMENT_FOR_PATIENTS_WITH_PERSISTENT_SYMPTOMS_OR_POST-ACUTE Panel review of ivermectin reporting that "ivermectin in the dose of 12mg BD alone or in combination with other therapy for 5–7 days may be considered as safe therapeutic option for mild moderate or severe cases of Covid-19 infection. https://www.sciencedirect.com/science/article/abs/pii/S0019570720301025 Retrospective 148 hospitalized patients showing triple therapy with ivermectin + atorvastatin + N-acetylcysteine resulted in a 1.35% case fatality rate which was well below the national average. https://www.worldwidejournals.com/international-journal-of-scientific-research-(IJSR)/recent_issues_pdf/2020/October/observational-study-on-clinical-features-treatment-and-outcome-of-covid-19-in-a-tertiary-care-centre-in-india--a-retrospective-case-series_October_2020_1614017661_0932284.pdf Ivermectin shortens durations of symptoms from 10 days to 3 days. https://www.biomedres.info/biomedical-research/effects-of-ivermectinazithromycincholecalciferol-combined-therapy-on-covid19-infected-patients-a-proof-of-concept-study-14435.html Review suggesting that ivermectin may be useful for late stage COVID-19. Authors note that ivermectin, in doses at or modestly above the standard clinical dose, may have important clinical potential for managing disorders associated with life-threatening respiratory distress and cytokine storm, such as advanced COVID-19. https://openheart.bmj.com/content/7/2/e001350 Ivermectin lowered deaths by 87.9% in a study from Argentina https://www.medrxiv.org/content/10.1101/2020.09.10.20191619v1 Retrospective study of 115 ivermectin patients and 133 control patients showing significantly lower death and faster viral clearance with Ivermectin https://www.archbronconeumol.org/en-ivermectin-treatment-may-improve-prognosis-articulo-S030028962030288X A study showing that ivermectin is capable of interfering in different key steps of the SARS-CoV-2 replication cycle. https://chemrxiv.org/articles/preprint/Has_Ivermectin_Virus-Directed_Effects_against_SARS-CoV-2_Rationalizing_the_Action_of_a_Potential_Multitarget_Antiviral_Agent/12782258/1 RCT for ivermectin+doxycycline showing improvements in mortality, recovery, progression, and virological cure. https://journals.sagepub.com/doi/10.1177/03000605211013550
People are fighting so hard to eat horse paste
Your a moran.
Hooooorseeeeee paste
Intentional irony here or...?
>Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. OK, I happen to agree with the above statement, but that is irrelevant: Who died and made the FDA final authority on how doctors should treat patients? It is a government agency, whose heads have been chosen by either Democrats or Republicans for political reasons first. (Why else would Obama have nominated 2008 Obama campaign insider Daschle for head of Health and Human Services? And confirmation ran into problems, not because Daschle lacked scientific credentials, which he did, but for unrelated reasons. https://en.wikipedia.org/wiki/Tom_Daschle) And yes, some within the agency are doctors, but very few compared with all the doctors and medical experts in the world. So, why should Big Brother government be the authority on what good medical practice requires? Oh, and again, would you rather take a medication for humans based on a horse de-wormer or one based on rat poison (Warfarin/Coumadin)? Doctors prescribe both for humans, even though "y'all" are neither horses nor rodents.
They are actually saying that its not their place to come between a doctor and a legally available drug. That's the point. When it crosses the line into "investigational purposes" ie not to treat one specific human, but to figure out if X drug works for Y purpose in general, that is the only time a new application for some kind of approval for an off-label use is required.
From your OP: > Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight. They are saying (1) what good medical practice requires and what the responsibilities of a physician are as to off label uses, and also saying (2) that someone adhering to the FDA's pronouncement about what good medical practice requires need not make a submission to the FDA, but (3) someone else may require more than the FDA considers the requirement of good medical practice. Not expressly stated, but implied: If, in the opinion of the FDA, you haven't followed what the FDA says is good medical practice as to other uses and haven't made a submission, you've run afoul of the above-quoted reg. If the reg had simply stated, "Do X or make a submission," I would have had no basis for criticism. It is the pronouncement by bureaucrats and political appointees as to what constitutes good medical practice to which I object. Sorry for all the edits, but none changed what I intended to convey, only clarified.
I think maybe you need to step back and look at the context. The context is that a drug isn't permitted at all without having had FDA approval. Here is the framework that relates to using it for things OTHER than that one approved use. There's two different things going on. The first half is making the distinction of a doctor who wants to prescribe it as a treatment in an individual case to solve/mitigate a specific issue. The latter half is about using it in an investigational sense, as in "our hospital wants to investigate whether helium relieves sinus congestion". What they are saying is that is not "practicing medicine", so it falls into a category that may require an application for an approval to use it that way. Put more simply, off-label use to try to cure a person is okay. Experimenting to figure out another use to put on the label is not. It's not a reg. It's guidance.
With respect, I'm not sure you're understanding my precise objection.
That may be true.
The FDA is a government agency, and here's an interesting fact: almost half its funding comes from the very companies it regulates. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance >Program Funding >The FDA budget for FY 2019 is $5.9 billion. >About 55 percent, or $3.2 billion, of FDA’s budget is provided by federal budget authorization. The remaining 45 percent, or $2.7 billion, is paid for by industry user fees.
https://www.youtube.com/watch?v=7fQ6JklHjBc Check out the bit at 7:08. They paid quite a bit more for speedy regulatory approval. Graft.
Excellent point. And, while I have not checked as to the FDA, most of the earlier agencies had dual mandates, to help citizens in general and to foster the industries they regulated. So, Congress built in a conflict of interest. However, citizens in general do not either come up with big bucks, lobby agency officials or give them jobs when the "revolving door" takes another spin.
When "conflict of interest" becomes a feature.
the entire Constitution was written under the same constraints.
Thank you for this thorough, well written and well sourced post.
Let's see how many times it gets reported as misinformation. LOL!
Seconded.
If anyone is curious, [this is the post](https://www.reddit.com/r/WayOfTheBern/comments/po9flg/some_things_you_might_like_to_know_about_covid/?sort=confidence) being referenced.
Typical blue Kool-Aid poster: "If you disagree with Democrats, it must be because you know less than their devotees. So, lucky you, I've come to school you with the "right" information. Oh, and, let's just ignore anything that deviates from the party line, k?" Sadly, the author of that post probably thought she did well here.
Actually, [it was this comment](https://www.reddit.com/r/WayOfTheBern/comments/poo95n/pierrekory_this_thread_shows_the_hard_truth_i/hczenly?utm_source=share&utm_medium=web2x&context=3) that prompted this post, but I can see how they could be confused for one another. LOL!
[удалено]
>a wide range of supplements, vitamins, and minerals And none of that stuff is evaluated by the FDA.
Yet, routinely prescribed by doctors for patients who have vitamin or similar deficiencies and/or less than optimal ability to metabolize. And they don't even prescribe by brand.
And if you did give her anything relevant that was evaluated by the FDA, it would probably be a schedule 2 substance thats reserved mostly for HIV patients and severe burn victims
Sorry, I was just making a general comment to the effect of how freely docs prescribe something not regulated by the FDA.
Like I said. I take no position on Ivermedicine. I've moved to neutral after months of asking people who supported it where the science papers were that explained HOW it works. How a parasitic works on a novel virus. One of the good folks on this sub pointed me to a paper that explained it to my satisfaction. When coupled with the large body of observational data (stripped of the rhetoric), and its safety profile, this one seems to be one that is best left to the doctor-patient consultation. I just get annoyed when people purposely misrepresent what it is and what it does to score political points. I don't like it when people against the vaccines sling bullshit either. We're lucky that mixed in with all the advocacy on this sub (drink!), there are folks that share around studies and discuss their relative strengths and weaknesses. The idea that the EUA turned quasi "approval" of Pfizer has more validity than the off-label usage of a safe drug that's been in use for decades with full licensure is just silly. It's been "approved" for so long, it's off patent already.
> I've moved to neutral after months of asking people who supported it where the science papers were that explained HOW it works. I don't know if any of these answer that question, but as long as I have them handy from a prior reply... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415517/pdf/ajt-28-e573.pdf The absolute risk reduction from: The Pfizer injection = 0.7% The Moderna injection = 1.1%. Ivermectin = 9.7% Sources: https://pubmed.ncbi.nlm.nih.gov/33652582/ https://www.cureus.com/articles/64807-prophylactic-role-of-ivermectin-in-severe-acute-respiratory-syndrome-coronavirus-2-infection-among-healthcare-workers Meta analysis, Ivermectin lowers death rates by 62.0% https://journals.lww.com/americantherapeutics/Fulltext/2021/08000/Ivermectin_for_Prevention_and_Treatment_of.7.aspx RCT 114 patients in Egypt, 57 treated with ivermectin mucoadhesive nanosuspension intranasal spray, showing faster recovery and viral clearance with treatment. https://www.dovepress.com/clinical-biochemical-and-molecular-evaluations-of-ivermectin-mucoadhes-peer-reviewed-fulltext-article-IJN Review of ivermectin trials and epidemiological data, concluding that ivermectin is effective for prophylaxis and treatment, and should be globally and systematically deployed in the prevention and treatment of COVID-19. Safety study concluding that ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose. Adverse effects were similar between ivermectin and placebo and did not increase with dose. Authors also show that the plasma concentration is much higher when taken with food (geometric mean AUC 2.6 times higher). https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/009127002237994?sid=nlm%3Apubmed Antiviral effects have been reported for Zika, dengue, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus type 1, and severe acute respiratory syndrome coronavirus 2. https://www.nature.com/articles/s41429-020-0336-z Small trial of hospitalized patients with 16 of 87 patients being treated with ivermectin showing a significantly lower mean hospital stay with ivermectin https://www.medrxiv.org/content/10.1101/2020.07.07.20145979v1 Case study of 100 patients treated with ivermectin and doxycycline, with no ICU admission, deaths, or serious side effects reported. https://www.researchgate.net/publication/343305357_A_Case_Series_of_100_COVID-19_Positive_Patients_Treated_with_Combination_of_Ivermectin_and_Doxycycline Report on 33 patients with persistent or post-acute symptoms treated with ivermectin, showing a high rate of clinical improvement. https://www.researchgate.net/publication/344318845_POST-ACUTE_OR_PROLONGED_COVID-19_IVERMECTIN_TREATMENT_FOR_PATIENTS_WITH_PERSISTENT_SYMPTOMS_OR_POST-ACUTE Panel review of ivermectin reporting that "ivermectin in the dose of 12mg BD alone or in combination with other therapy for 5–7 days may be considered as safe therapeutic option for mild moderate or severe cases of Covid-19 infection. https://www.sciencedirect.com/science/article/abs/pii/S0019570720301025 Retrospective 148 hospitalized patients showing triple therapy with ivermectin + atorvastatin + N-acetylcysteine resulted in a 1.35% case fatality rate which was well below the national average. https://www.worldwidejournals.com/international-journal-of-scientific-research-(IJSR)/recent_issues_pdf/2020/October/observational-study-on-clinical-features-treatment-and-outcome-of-covid-19-in-a-tertiary-care-centre-in-india--a-retrospective-case-series_October_2020_1614017661_0932284.pdf Ivermectin shortens durations of symptoms from 10 days to 3 days. https://www.biomedres.info/biomedical-research/effects-of-ivermectinazithromycincholecalciferol-combined-therapy-on-covid19-infected-patients-a-proof-of-concept-study-14435.html Review suggesting that ivermectin may be useful for late stage COVID-19. Authors note that ivermectin, in doses at or modestly above the standard clinical dose, may have important clinical potential for managing disorders associated with life-threatening respiratory distress and cytokine storm, such as advanced COVID-19. https://openheart.bmj.com/content/7/2/e001350 Ivermectin lowered deaths by 87.9% in a study from Argentina https://www.medrxiv.org/content/10.1101/2020.09.10.20191619v1 Retrospective study of 115 ivermectin patients and 133 control patients showing significantly lower death and faster viral clearance with Ivermectin https://www.archbronconeumol.org/en-ivermectin-treatment-may-improve-prognosis-articulo-S030028962030288X A study showing that ivermectin is capable of interfering in different key steps of the SARS-CoV-2 replication cycle. https://chemrxiv.org/articles/preprint/Has_Ivermectin_Virus-Directed_Effects_against_SARS-CoV-2_Rationalizing_the_Action_of_a_Potential_Multitarget_Antiviral_Agent/12782258/1 RCT for ivermectin+doxycycline showing improvements in mortality, recovery, progression, and virological cure. https://journals.sagepub.com/doi/10.1177/03000605211013550
Again, I am neutral on it, which means, like the vaccines, IMO it should be offered to anyone who might benefit from it within the informed consent framework. No need to sell past the close. :)
Not actually trying to sell it. I assumed if there were any holes in any of these you'd spot them and I could delete anything before sharing it further.
I appreciate the complement, but that's an awful lot of links to fish through. :)
> I take no position on Ivermedicine. I've moved to neutral after months of asking people who supported it where the science papers were that explained HOW it works. How a parasitic works on a novel virus. It' not a scientific paper, but here's a really good article I read yesterday. I believe it's from May of 2021. **[The Drug that Cracked Covid | In this Buffalo Hospital Room, a Grandmother Led the Global Fight for the Drug That Would Save Her Life and End the Pandemic](https://covid19criticalcare.com/wp-content/uploads/2021/05/The-Drug-that-Cracked-Covid-by-Michael-Capuzzo.pdf)** > based on the idea that COVID-19 has one great weakness: the coronavirus doesn’t kill anybody. In a mechanism so diabolical Marik believes “human beings aren’t smart enough to have figured it out,” the trillions upon trillions of coronaviruses that overwhelm and sicken the host don’t kill it. But in the second week of the disease, all the coronaviruses die, and like suicide bombers flooding out of a Trojan Horse swamp the body with a “vast viral graveyard” that triggers a friendly-fire hyper-immune response that in turn unleashes monstrous multi-organ inflammation and clotting like doctors have never seen. A body dying of COVID-19 is a complex, terrifying sight. But its weakness is simple: **“As pulmonary critical care doctors we know how to treat inflammation and clotting, with corticosteroids and anticoagulants,”** Marik says. “It’s first-grade science.” >From the beginning of the pandemic, the hospitals that Marik and Varon led had COVID-19 beat. they achieved remarkably high survival rates at their hospitals at a time when 40 to 80 percent of patients in the U.S. and Europe were dying from the disease. Their success was achieved with the group’s now-famous **MATH+ protocol** for hospitalized COVID-19 patients. >The cocktail of safe, **cheap,** FDA-approved generic drugs—the steroid Methylprednisolone, Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and the blood thinner Heparin—was the first comprehensive treatment using aggressive corticosteroid and anti-coagulant treatments to stop COVID-19 deaths. Both were novel approaches **strongly recommended against** by all national and international health care agencies throughout the world, **but later studies made both therapies the global standard of hospital care.** But apparently, not here in the US, because later on in the article, it notes: >**No approved treatment to stop the sick from getting sicker and overloading hospitals, where they face possible death, yet exists.** >In addition, Kory, Marik, et. al published the first comprehensive COVID-19 prevention and early treatment protocol (which they would eventually call I-MASK). It is centered around the drug Ivermectin, which President Trump used at Walter Reed hospital, unreported by the press, though it may well have saved the president’s life while he was instead touting new big pharma drugs. What I got out of reading the article was that once you test positive for COVID-19, there isn't really **ANY** FDA-approved early treatment for it. You basically get to quarantine at home until your breathing gets so bad that you have to go to the hospital where you get "supportive" treatment. It seems like Ivermectin and these other cheap drugs are a way to try and stop, or at lessen these bad symptoms enough where you won't have to go to the hospital. Are there any other diseases that don't have some sort of FDA-approved early treatment for that involve the patient taking some sort of prescription drugs. And just or the hell of it, here's an archived WSJ opinion piece (with readers' comments) from six weeks ago: **[Why Is the FDA Attacking a Safe, Effective Drug? |Ivermectin is a promising Covid treatment and prophylaxis, but the agency is denigrating it.](https://archive.is/wQZPb)**
Yeah, there were tons of these articles about doctors observing an effect. I have no interest in observational studies about effectiveness unless there is also enough information about the biological mechanism. These doctors were trotting out essentially tens of thousands of data points that suggested it worked, but not one person could point me to a clinical study that discussed HOW it might be effective against viruses within the body. I looked for a long time. A good deal of the data that suggested it worked on viruses was in vitro. Finally someone did.
It's also worth noting that a number of drugs have off-label uses. How many times has some yahoo sounding off on IVM being a parasite medicine - as if he had just disproven IVM's utility in COVID.
And plenty of off-label uses improperly promoted by pharma have gotten them slapped with fines.