COVID-19: The Frontline Online
COVID-19: The Frontline Online
Note: this post was meant to be published long ago, and I just saw that it was still in draft form, so I’m releasing it now, even though it’s primarily old news. Maybe it will be of benefit to someone in the distant future sifting through the rubble of our once free society to understand just what went wrong and why.
I’ve been at the forefront of treating and preventing COVID-19 online since early December 2020, when Dr. Pierre Kory of the Frontline Covid-19 Critical Care Alliance (FLCCC) shot to internet fame (and infamy) for his senate testimony on ivermectin (IVM).
After that, social media lit up with talk of ivermectin and there was a rush to get it online, as hardly any primary care docs had ever heard of it being used for COVID-19 and few were willing to prescribe it.
At the same time, there was some renewed interest in hydroxychloroquine (HCQ), which has been touted by some as a medical miracle and vilified by others as false hope.
How We Got Here
Many who had jumped on the HCQ bandwagon early on were severely disappointed when data came out showing it might be harmful, even increasing the risk of death in some scenarios. The drug was also a political hot potato from the get-go and belief in its efficacy was almost guaranteed in red states and sorely lacking in blue ones.
The media played up rare side effects that had never caused anyone with an MD after their name to ever think twice before prescribing it in 99% of cases. It became a cautionary tale: warning others not to jump to conclusions and risk lives with unproven therapies in the midst of a pandemic.
Unfortunately in the US, this put a huge cramp on the practice of medicine as it had been done for a hundred years. Very few physicians or centers continued using hydroxychloroquine or dared try other promising off-label drugs like ivermectin.
However overseas, especially in many resource-poor settings, experimentation continued apace and as the evidence in favor of ivermectin built, a group of prominent academic physicians led by prominent critical care physician and academic, Dr. Paul Marik, began recommending ivermectin.
The Case For Trying Anything and Everything
–19Despite shocking media reports of deaths in children, adolescents, young adults, and the middle-aged, for most people COVID-19 is not a killer disease. Every year some unusual deaths from upper respiratory infections occur in groups not otherwise at high risk, they’re just not newsworthy.
Where COVID-19 differs markedly from other common viral infections is in the development of persistent sometimes debilitating symptoms lasting for months, and at this point who’s to say how long some people will end up suffering from long-COVID symptoms?
After the 2003 SARS pandemic – also caused by a coronavirus – up to 40% of the infected had chronic fatigue lasting for 3.5 years.
The cytokine storm that many severely ill COVID-19 patients suffer through can cause accelerated muscle loss, leaving many severely debilitated.
But even those who are not struck hard can develop prolonged symptoms ranging from loss of taste and smell to fatigue to brain fog and more. Overall, estimates of the incidence of long COVID symptoms range anywhere from 20% to 90% of the recovered.
More worrisome is the unknown – what will the future bring?
Many viruses lay dormant after initial infection only to re-emerge years later causing repeat exacerbations of illness – think chickenpox – that recurs as shingles, or recurrent herpes outbreaks.
Other viruses cause relatively mild acute illnesses in most patients but then years later can cause cancer to develop in affected organs – think Hepatitis C which causes liver cancer.
Some viruses can cause irreversible damage – think mumps orchitis that causes infertility in men.
No wonder so many people are willing to try almost anything that promises to protect them from this new virus.
The Off-label Blues
Many in the media and medical establishment have played up the fact that ivermectin (and earlier hydroxychloroquine) are unproven, off-label, and therefore dangerous therapies.
So what is off-label use anyway?
It just means that the FDA has approved a medication for one use and it is being used for another.
Off-label prescribing is very common, the reason being it costs a lot to fund clinical trials to “prove” a drug is effective for an indication, but if a drug is reasonably safe and there is good reason to believe it might work for a problem (e.g. test tube studies or just general physiological plausibility) physicians try it out on patients, especially when no other medications work.
Common examples of off-label use include all the following:
Aspirin for primary prevention of cardiovascular disease, carotid artery atherosclerosis, carotid artery stenting, primary prevention of colorectal cancer; acute migraine, PCI for stable ischemic heart disease, pericarditis, peripheral vascular disease, polycythemia vera, prevention of preeclampsia, prevention of thrombosis in surgical prosthetic heart valve replacement, transcatheter aortic valve replacement and transcatheter mitral valve repair with MitraClip device; and the prevention of DVT after total hip or knee arthroplasty.
Ivermectin itself for ascariasis, demodicosis, gnathostomiasis, hookworm-related cutaneous larva migrans, lice, mansonella Rizzardi infection, mansonella streptococcal infection, scabies, trichuriasis, and wucheria bancrofti infection (try telling someone with lice or scabies they can’t use a curative course of IVM because it’s off-label and thus unproven and too dangerous).
Ibuprofen for gout and pericarditis (if you’ve had gout you don’t need the FDA telling you high dose ibuprofen works – it’s rather obvious).
Wellbutrin/Bupropion for smoking cessation.
Neurontin/Gabapentin for bipolar, essential tremor, hot flashes, migraine prevention, neuropathic pain, phantom limb syndrome, and restless leg syndrome.
Magnesium sulfate for premature labor and preeclampsia.
Seroquel for insomnia.
Zoloft for premature ejaculation.
None of these would be used if, above all, practical experience, and after that many small, underpowered, and somewhat flawed studies, did not show they worked. Overall around 20% of medications prescribed to the general population are off-label and up to 90% of what’s prescribed to newborns has never been studied and is off-label – we literally have no evidence of its benefit outside of educated speculation – because who wants to subject newborns to a placebo-controlled trial?
Off-label prescribing does not necessarily mean there is not enough data to prove to the FDA that medication works for a new indication. What it really means is there is no one willing to pony up millions of dollars to go through the FDA application process – usually, because the drug is a cheap generic – like ivermectin.
After an exhaustive review of published medical research on therapeutic procedures like surgery and medication, the prestigious Cochrane Review concluded that about 10% of what doctors do is based on high-quality evidence and another 37% on moderate quality evidence. Meaning just over 50% of modern medical practice is based on low or very low-quality evidence.
The point is if we had to wait for what passes for high-quality evidence before treating something we wouldn’t have much to do as physicians.
If something is generally safe, and it has a good chance of working, then where is the harm in trying it when the alternative is taking your chances on a well-known risk? This is the way medical practitioners have viewed off-label prescribing for decades. And until the last year or so, the government didn’t play nanny to doctors.
Actually, far from little or no evidence, there is already a large amount of data on ivermectin, more than we have for a lot of medications we use off-label. Many if not all of the studies are admittedly flawed in some way, but it is possible to get relatively good quality inferences from many less than ideal trials when you lump them together and look for a signal in the noise.
Based on meta-analyses of many trials some groups believe the likelihood that ivermectin is completely ineffective for COVID19 is somewhere between 1 in 60 million and 1 in 4 billion – not exactly betting odds.
Ivermectin vs. Hydroxychloroquine
Ivermectin is more useful in every stage from prevention to treatment (even for Long Covid) and is still easily available from almost all pharmacies (even for a COVID-19 prevention or treatment diagnosis).
Hydroxychloroquine is also considered by many to be safe and effective for prevention and early treatment, but may not be effective later in the course of illness (and might be harmful then as well). Side effect risk is slightly higher than for ivermectin, especially with long-term use when it requires monitoring of various labs.
There were many studies done on HCQ and some were admittedly poorly designed. As I’ve argued elsewhere, medical research is fraught with bias and you can seemingly prove or disprove just about anything – even with a gold-standard randomized controlled trial – only to have your findings later upended by further studies. So although many have passed judgment, I believe the jury is still out and will prescribe it if asked for prevention, though I hesitate to recommend it for treatment, especially when we have ivermectin.
Ivermectin
Ivermectin is a very safe medication – perhaps one of the safest in the world – and has been used in millions of people for 30 years now. In places where parasitic infestations are common it is usually available over the counter without a prescription, and no wonder, as it is probably safer than over-the-counter painkillers which are responsible for such severe adverse effects as liver damage, heart failure, and heart attacks.
You may have heard that ivermectin can affect the liver, but it has never been known to cause outright liver damage (outside of isolated case reports and even then the damage is usually thought due to the interplay between drug and underlying parasitic disease process), only transient and slight elevations in liver enzymes, which can also be seen with prolonged use of Tylenol and after many run of the mill viral infections.
Based on a number of studies in 1000s of patients, IVM appears to be close to 100% effective in preventing COVID-19. For example in the most remarkable such study 788 frontline health workers in Argentina took it for 3 months and none of them got COVID-19, compared to a 58% COVID-19 infection rate in the group that didn’t take IVM. This study was the equivalent of a human challenge trial involving the intentional exposure of a group to the infection.
IVM also reduces the severity of COVID-19 when taken in acute infection and reduces death from severe COVID-19 by up to 85%. In one study it was also 95% effective for long COVID symptoms.
Still, studies may be published in the future with a poor trial design that appears to discredit ivermectin. It is also possible excellent quality studies are published in the future that prove ivermectin doesn’t work.
But for now what we know is that it’s demonstrably safer than that daily baby aspirin so many healthy people took for years and so many still take, despite data of late showing it shouldn’t be used outside of patients with preexisting heart disease due to the risk of GI bleeds outweighing the benefits of heart attack prevention.
Logistics and Supply
Some patients are concerned that ivermectin may run out as more data is published, which could lead authorities like the NIH to change their tune from “against” to “recommend” – after all as of 1/14/2020 when the NIH updated its official stance on ivermectin, we are already halfway there with the new “neither for nor against” rating.
So, even if you believe ivermectin is near 100% effective as a preventive, it may make sense to get hydroxychloroquine for long-term prevention just in case you run out of IVM before the pandemic runs out of steam.
Ivermectin supplies are running low in some areas, especially at CVS locations where it is frequently being reported on backorder as of January 2021, so occasionally you have to reroute the prescription. I have not yet seen it entirely out of stock at every local pharmacy in any area, but if this were to happen then online delivery pharmacies are a good bet and as a last resort there are always compounding pharmacies, which often have access to large quantities of bulk powders, though they are more expensive.
In Practice
Most of my experience prescribing has been with prevention and after hundreds of prescriptions, as expected, I have not had a single patient yet who started it early and got infected with COVID-19. However, when taken soon after exposure a large percentage of patients do end up contracting the virus.
It is also not a magic bullet in acute infection, some patients recover quickly after starting it and others suffer through a 7 – 10 day illness before gradually improving.
So if considering whether or not to take it for ongoing prevention vs. as needed on exposure or when you get sick – take it now and keep taking it.
In long COVID I have seen and heard of many remarkable recoveries after months of terrible symptoms, often within days of the first dose, but in some cases, patients have had to take it for weeks before symptoms finally resolved.
Protocols
These are the current FLCCC protocols:
a. Prevention: take a dose on days 1 and 3 then a dose every other week ongoing.
b. Post-exposure prophylaxis: take the first dose ASAP after exposure and the second 48 hours later.
c. Early treatment: 1 dose daily for 2 – 5 days.
There are also many other protocols out there being used by frontline physicians all over the world.
Some argue that for an acute illness you should take a dose twice a day for 2 days, others that you should continue doing daily until improvement has been seen for 2 – 3 days in a row.
I have seen patients improve after 1 or 2 doses then stop and worsen again, so I would err on the side of over-treating given the proven safety of ivermectin.
What’s up with only 3 months doc?
For preventive purposes, I prescribe ivermectin for 3 months. 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 taken every 2 weeks for months. The closest we get is in the prevention of river blindness when repeat doses are 6 to 12 months apart. Also, the worst side effects of IVM are related to certain infections, e.g. loa. Here we are dealing with a new disease and despite the likelihood that it is safe, it always pays to be cautious.
Safety
Alcohol can increase the blood levels of ivermectin which may increase the risk of mild to moderate side effects, but it’s unlikely to create any out and out toxicity if you don’t overdo it.
Although it is likely safe, in general (as with many medications where enough data is not available) it is recommended IVM not be used in pregnancy if there are other treatment options available, and sexually active women who can become pregnant should use contraception while on IVM.
These are the most common side effects reported with ivermectin in general:
Cardiovascular: Tachycardia (4%), peripheral edema or swelling of the arms and legs (3%), facial edema or swelling (1%), orthostatic hypotension – i.e. low blood pressure (1%), dizziness (3%), diarrhea (2%), nausea (2%).
Personally, after hundreds of prescriptions written, all I have seen are nausea and dizziness in about 2%, diarrhea in perhaps 1%, and a facial rash in 0.5%. Those with nausea and dizziness found it was easier to split up the doses throughout the day.
Beyond IVM and HCQ
Other prescription drugs
There are other proven and promising drugs out there for COVID including oral and inhaled steroids like prednisone and budesonide to treat the severe immune overreaction that can occur, the powerful anti-inflammatory gout drug colchicine, the antidepressant fluvoxamine, and blood thinners like aspirin and Lovenox to treat micro-clotting.
Some or all of these may have their place in a comprehensive treatment protocol for COVID-19.
Vitamins and Supplements
Zinc 50mg/day prevention and treatment
Vitamin D3 3,000-5,000 IU/day prevention and treatment
Vitamin C 1,000mg twice day prevention and treatment
Quercetin 250mg/day prevention and treatment
Melatonin Prevention dose:
If you don’t usually sleep well every night take the lowest effective dose of melatonin to help you sleep well 6 days a week (skipping a day so your body’s own production doesn’t completely shut down), this is usually 1 – 3 mg for most people.
Melatonin treatment dose:
6 – 10 mg per night before bed x 6 days, then drop down to 1 – 3 mg per night before bed as needed for sleep 6 days a week.
What Next?
If you’ve used a baby aspirin just in case, despite a clean bill of health or due to perceived elevated risk from high cholesterol or hypertension, you’ve been on the off-label bandwagon before and IVM use should come naturally.
Register here to discuss with me for free.
You can learn more about ivermectin and see Dr. Kory’s senate testimony at the website of the FLCCC where you will also find the review paper on worldwide data supporting the use of IVM.