Consent
INFORMED CONSENT FOR OFF-LABEL TREATMENT
Off-label drugs are used every day in the US and make up more than 20% of all prescriptions, BUT they are usually widely affirmed by nearly all physicians and pharmacists to be safe and have enough data backing them up to argue for their off-label use.
This is NOT the case with off-label prescribing for COVID-19. It is a highly charged subject and most doctors and pharmacists DO NOT agree with using ANY off-label drugs for COVID-19 aside from over-the-counter medications for symptom control.
You can expect some pharmacists to REFUSE to fill any or all of these medications when they suspect they are being used for COVID-19 prevention or treatment. So far it has always been possible to find some nearby pharmacy to fill the prescriptions as some pharmacists either look the other way or are on board with our effort to treat COVID-19.
IVERMECTIN (IVM):
Ivermectin is a generally safe medication and has been used in millions of people around the world for over 30 years.
IVM appears to be close to 100% effective in preventing COVID19. 788 front line health workers in Argentina took it for 3 months and none of them got COVID19 compared to about 58% COVID infections in the group that didn’t take IVM.
It also reduces the severity of COVID 19 when taken in acute infection and reduces death from severe COVID19 by 85%. In one study it was also 95% effective for long COVID symptoms.
For treatment: 1 dose daily for 2-5 days. With this I will include 5 day supply with 2 refills in case you develop long COVID symptoms that persist more than 2 weeks after the first symptoms and you want to repeat a short 2 day course as has been done successfully in some small studies.
I can’t guarantee your pharmacy will have your medication in stock and have no way of checking which pharmacies in your area have a supply on hand. Best to check with the pharmacies first, but you can easily transfer the prescription if needed.
IVM SAFETY
Based on data compiled by various physicians around the world we believe Ivermectin is effective at preventing and treating COVID19 at every stage and can be safely used off-label in humans for this indication.
The non-partisan British Ivermectin Recommendation Development Panel (BIRD) has recommended ivermectin for prevention and treatment. The FLCCC in the US recommends ivermectin for treatment. There have been multiple meta-analyses of 27 randomized controlled trials showing ivermectin decreases risk of death by more than 80%.
Ivermectin is a safe medication and has been used in millions of people for 30 years now.
IVM appears to be very effective in preventing COVID19. 788 front line health workers in Argentina took it for 3 months and none of them got COVID19 compared to about 58% COVID infections in the group that didn’t take IVM.
It also reduces the severity of COVID 19 when taken in acute infection and reduces death from severe COVID19 by 85%. In one small study it was also 95% effective for long COVID symptoms.
The NIH just changed its official recommendation on ivermectin from “against” to “neither for nor against”, as of early 2021 this was the same NIH stance on commonly used therapies for COVID19 like convalescent plasma and monoclonal antibodies.
According to the FDA it is allowed as an off-label drug.
To those of us prescribing Ivermectin the chance it is not beneficial at all in COVID19 appears to be vanishingly small, one group estimated a 1 in 4 billion likelihood it doesn’t help at all.
Still studies may be published in the future with poor trial design that appear to discredit Ivermectin. It is also possible excellent quality studies are published in the future that prove Ivermectin doesn’t work.
However Ivermectin does have a 30 year history of safe use in humans and the side effect profile appears mlld for the most part, so we believe it is probably at least as safe as using over the counter painkillers for a headache (over the counter painkillers have been associated with some serious side effects like liver failure, heart failure and even heart attacks, but this has not outlawed their use so far).
Still when used on a new disease, side effects could be different than those recorded in the past. For example the most severe side effects of ivermectin in the past were only seen in the setting of treatment for a certain parasitic disease. The other possible side effect that has been seen in the past elevated liver function which could indicate liver damage, reported in 2% of patients. Safest route would be to get liver function tests done on a monthly basis, which we could order for you. There are a number of other more severe side effects seen less than 1% of the time. All that being said, regular Tylenol and Advil use has been shown to increase the risk of heart failure and death as well and those are available over the counter. So all medications do carry some risk that you should be aware of and in our judgement the risk is acceptable given the disease being prevented.
IVM Interactions and safe usage notes:
Alcohol can increase the blood levels of ivermectin, but it’s unlikely to create any out and out toxicity if you don’t over do it.
Using alcohol with Ivermectin may increase the risk of mild to moderate side effects.
These are the common side effects reported with ivermectin in general:
Cardiovascular: Tachycardia (4%), peripheral edema (3%), facial edema (1%), orthostatic hypotension (1%)
Central nervous system: Dizziness (3%)
Gastrointestinal: Diarrhea (2%), nausea (2%)
Not to be used in pregnancy, or by those who might become pregnant – sexually active women should use contraception.
PRESCRIBING
I am prescribing Ivermectin EITHER for COVID19 treatment or prevention:
a. For prevention: take twice 48 hours apart and then every week ongoing (the latest FLCCC prevention protocol at: covid19criticalcare.com). With this I will include 3 month supply of 14 doses.
b. For early treatment: 1 dose daily for 5 days then only stop if you have felt better for 48 hours, otherwise continue until feeling better for 48 hours. With this you will also get 14 doses, though most people only need 5 for a single infection.
I can’t guarantee your pharmacy will have your medication in stock and have no way of checking which pharmacies in your area have a supply on hand. Best to check with the pharmacies first, but you can easily transfer the prescription if needed.
Why 3 months only?
Most ongoing meds are prescribed for 3 months at a time and then require a follow up appointment. This is not just so the doctor can charge again, but for your safety. With Ivermectin we have 30 years of safe use in all age groups, but only with single doses in the vast majority of cases, and hardly any experience with ongoing preventive dosing. Ivermectin can affect liver function in rare cases. So you need to follow up if you need a refill.
HYDROXYCHLOROQUINE (HCQ) SAFETY INFO:
IVM by itself is likely much more effective than HCQ as a preventive and may be 100% effective.
Hydroxychloroquine is considered generally safe and likely effective for prevention and early treatment, but may not be effective later in the course of illness. Side effect risk is higher than with ivermectin, especially with long term use, and unlike IVM it requires knowledge of baseline CBC and CMP (liver and kidney function) and also requires a comprehensive eye exam and muscle strength testing within the first year of use.
Recommended monitoring:
CBC (with differential), liver function, and renal function at baseline and periodically during therapy; blood glucose (if symptoms of hypoglycemia occur); muscle strength (especially proximal, as a symptom of neuromyopathy) during long-term therapy; in patients at elevated risk of QTc prolongation, monitor ECG at baseline and as clinically indicated to mitigate the risk of developing torsades de pointes; certain findings may require not initiating or discontinuing therapy.
Ophthalmologic exam at baseline (fundus examination within the first year plus visual fields and spectral-domain optical coherence tomography if maculopathy is present) to screen for retinal toxicity, followed by annual screening beginning after 5 years of use (or sooner if major risk factors are present) (Marmor [AAO 2016]). If ocular toxicity is suspected, monitor closely (retinal changes and visual disturbances may progress after drug discontinuation). Additionally, the manufacturer recommends an ocular exam include best corrected distance visual acuity and an automated threshold visual field of the central 10 degrees (24 degrees in patients of Asian ancestry as retinal toxicity may appear outside of the macula). Consider annual exams (without deferring 5 years) in patients with significant risk factors (eg, renal disease).
Most adverse effects rare or associated with higher doses over years of use.
Some common adverse effects include stomach upset. dizziness, visual changes and shortness of breath. If visual changes develop it should be stopped immediately and you should see a doctor.
Seen in 1% to 10% of patients: Eye changes: Retinopathy (4%; serum concentration dependent [Petri 2019]; early changes reversible [may progress despite discontinuation if advanced])
Hydroxychloroquine is dispensed by a few pharmacies and you often have to reroute and may need to use a mail order to get it. In any case once your prescription has been sent to 1 pharmacy you can have it transferred to any other.
Based on data compiled by various physicians around the world we believe HCQ is effective at preventing and treating COVID19 in early stages and can be safely used off-label in humans for this indication. One of the most convincing sources of proof of its efficacy is the largest natural observational drug trial ever conducted totaling about 2.5 billion people: https://hcqtrial.com/ The most comprehensive meta analysis of worldwide studies confirms the results: hcqmeta.com
Still studies have already been published appearing to discredit HCQ for various reasons and may be published in the future with poor trial design that appear to further discredit it. It is also possible excellent quality studies are published in the future that conclusively prove it doesn’t work as has happened before in the history of medicine.
Hydroxychloroquine has a very slight risk of prolonged QT and should be used cautiously in people with long QT syndrome or a history of arrhythmias.
FLUVOXAMINE 50mg twice a day for acute COVID-19
As of late April Fluvoxamine has been added to the FLCCC IMask protocol for acute COVID-19.
Trials show this prevents severe disease and reverses COVID symptoms within 3 days if started early. It also seems to reverse long COVID in many patients within days. Dr Drew, a media personality, took it for long COVID and was 80% better within hours of the first dose and 100% better in 12 days.
Fluvoxamine is an old psychiatric drug that blocks the cytokine storm from COVID-19 in the brain and body by its action on the Sigma 1 receptor – this is helpful because Ivermectin does not work in the brain where much of the damage can occur, especially with long COVID. A number of studies and case series on Fluvoxamine showing 100% efficacy in preventing hospitalization with COVID-19 as well as long COVID symptoms beyond 2 weeks. See skirsch.io and: tinyurl.com/COVIDFluvox for more details. The 50 mg dose is smaller than that normally used for OCD and has no side effects for the vast majority of patients. Also there are no psychiatric effects with a short 2 week course. Mirtazapine – another psychiatric drug once every night for 14 days is a recommended adjunct to this as it is complementary and lessens any side effects of fluvoxamine (rare to begin with).
When taking fluvoxamine:
NO CAFFEINE ALLOWED (or very very little – 1/10 of a cup)
Fluvoxamine prevents the metabolism of caffeine so levels can build up and make you very uncomfortable after a while.
First, patients should avoid caffeine while taking fluvoxamine. It prevents the body from properly metabolizing caffeine, making it stay in the system 5 times as long as expected. This is not dangerous but can cause insomnia and jitteriness. If they must have caffeine, they should limit their intake to ½ of a small cup of coffee, or one can of soda, or one tea, in the morning. They can return to their regular caffeine intake once they have stopped taking fluvoxamine.
Side effects: Uncommon Side Effects of FLUVOXAMINE (1-10%)
Dizziness, Weight loss or loss of appetite, Agitation, nervousness, or anxiety, Yawning, Trouble sleeping or excessive sleepiness, Tremor, Headache, Palpitations (feeling your heart beating), High heart rate, Diarrhea or constipation, Sweating, Weakness or feeling of malaise, Dry mouth, Nausea, Vomiting, Sexual dysfunction (delayed orgasm or reduced libido)
Rare (< 1%) — painful joints, hallucinations, confusion, drop in blood pressure while standing, edema (build up of fluid), rash or itchy skin, main (elevated mood), seizures, abnormal liver function, light sensitivity.
Secondary Medications for patients who cannot take ivermectin and/or fluvoxamine
AMANTADINE
An antiviral that is used most frequently in Parkinson’s patients shows activity against COVID-19:
Possible side effects:
>10%:
Cardiovascular: Orthostatic hypotension (≤29%; may be more common in men), presyncope (≤29%), syncope (≤29%), peripheral edema (1% to 16%)
Central nervous system: Dizziness (≤29%), delusions (≤25%), hallucination (≤25%), illusion (≤25%), paranoia (≤25%), falling (13%)
Gastrointestinal: Xerostomia (1% to 16%; may be more common in women), constipation (1% to 13%)
1% to 10%:
Cardiovascular: Livedo reticularis (1% to 6%; may be more common in women)
Central nervous system: Insomnia (5% to 10%), anxiety (1% to 7%), depression (1% to 6%), headache (1% to 6%), abnormal dreams (1% to 5%; may be more common in women), agitation (1% to 5%), ataxia (1% to 5%; may be more common in men and adults ≥65 years old), confusion (1% to 5%), drowsiness (1% to 5%), fatigue (1% to 5%), irritability (1% to 5%), nervousness (1% to 5%), dyschromia (3%), dystonia (3%), apathy (2%), suicidal ideation (≤2%)
Gastrointestinal: Nausea (5% to 10%; may be more common in women), decreased appetite (6%), anorexia (1% to 5%), diarrhea (1% to 5%), vomiting (3%)
Genitourinary: Urinary tract infection (10%), benign prostatic hypertrophy (6%)
Hematologic & oncologic: Bruise (6%)
Neuromuscular & skeletal: Joint swelling (3%), muscle spasm (3%)
Ophthalmic: Blurred vision (4%), cataract (3%; may be more common in women), xerophthalmia (3%)
Respiratory: Dry nose (1% to 5%), cough (3%)
LOWDOSE STEROID
COLCHICINE
The COLCORONA trial showed colchicine is effective at preventing progression to severe COVID-19.
COLCHICINE has some stomach side effects that can be mild to severe including nausea vomiting diarrhea and stomach pain in some patients, it can also cause liver heart and kidney problems in patients who already have problems in those organs. In all patients taking it long term for months labs (CBC, CMP) should be checked after a month then every 3 months.
BUDESONIDE steroid inhaler for acute COVID-19:
Mirtazapine: Helps with side effects of fluvoxamine like insomnia and may strengthen the action of fluvoxamine in COVID19. It is also an SSRI and has similar possible side effects as fluvoxamine.
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