Defense of Dr. Charles Hoffe Vs. The BC College of Physicians and Surgeons - Part 4

The College's expert attacked Dr. Hoffe for misinformation due to his public statements regarding the immense safety of ivermectin. Here is my defense testimony rebutting the College's "expert."

This is the 4th post of my series defending Dr. Charles Hoffe against the accusations by British Columbia’s College of Physicians and Surgeons that his actions and statements during Covid were in violation of the College’s code of conduct. If you have not read it, I suggest you read Part 1 here for the background and context of his case.

SAFETY OF IVERMECTIN

I strongly agree with Dr. Hoffe’s public statement that ivermectin is “very, very safe, very effective treatments for Covid…” and that it is “unbelievably safe.”

Dr. Corneil instead finds that, “Ivermectin, especially at high doses, can be dangerous for humans and may cause serious health problems such as vomiting, diarrhea, low blood pressure, allergic reactions, dizziness, seizures, coma and even death.”

Dr. Corneil’s opinion characterizing Dr. Hoffe’s statement as incorrect, misleading etc. is easily disproven with the available, extensive data on the nearly unparalleled safety of ivermectin in treatment of both Covid and the 40 years history of global use to treat parasitic diseases.

In response to Dr. Corneil’s claim that ivermectin can cause low blood pressure, in this scoping review of the safety of ivermectin, the author states “A sudden and marked drop in blood pressure, severe skin reaction and liver injury have been mentioned in early safety reviews. The clinical experience accumulated over the years showed these severe adverse events are unequivocally extremely rare. The often-reiterated claim, even today, that ivermectin can be lethal in treated patients only rests on a one-page correspondence to the Lancet published in 1997. This claim is deemed to be unfounded as it has never been further substantiated until today and instead, three subsequent publications repeatedly showed this claim was either incorrect or methodologically inaccurate.”

A number of reviews on the safety of ivermectin have been conducted since the onset of the Covid pandemic. One group of toxicologists published a paper finding that  “Ivermectin was generally well tolerated, with no associated CNS toxicity at doses up to 10 times the FDA-approved maximum dose of 200 µg/kg. All doses had a mydriatic effect like a placebo. The adverse experiences between ivermectin and placebo were similar and did not increase with the ivermectin dose.”

Another safety review stated “ The safety, availability, and cost of ivermectin are nearly unparalleled given its low incidence of important drug interactions along with only mild and rare side effects observed in almost 40 years of use and billions of doses administered.”

Further, the safety of standard doses of ivermectin (0.2 mg/kg x 1–2 days) have an unprecedented safety profile historically as evidenced by the following findings:

• WHO Guidelines for Scabies: “the majority of side effects are minor and transient”

• Jacques Descotes, Toxicologist and Expert on Safety of Ivermectin: “severe adverse events are unequivocally and exceedingly rare”

• LiverTox Database: Not considered toxic to the liver

• Nephrotox Database: Not considered toxic to the kidney

• PneumoTox: Not considered toxic to the lungs

Safety of High Dose Ivermectin - COVID-19 Studies

• Randomized controlled trial of ivermectin in COVID using 0.6mg/kg x 5 days reported no differences in side effects

• Randomized controlled trial, with 3 arms; one arm treated with 1.2 mg/kg x 5 days, and another treated with 6mg/kg x 5 days with no differences in side effects.

• A report by the State Health Minister on 3,000 patients in La Pampa, Argentina who were part of a “test and treat” program were given 6 mg/kg daily x 5 days. Liver function tests and significant side effects were closely monitored and none were reported as abnormal

• A report by the Health Minister in Misiones, Argentina, also using 0.6 mg/kg x 5 days with no significant adverse events reported.

Malaria Studies

• Ivermectin alone was safe and well-tolerated in macaques with repeated doses at 3 and 1.2 mg/kg x 7 days, with no signs of neurological, gastroenterological, or hematological complications.

• Study of “Efficacy and Safety of High dose ivermectin for Reducing Malaria Transmission” compared 0, 3 and 0.6 mg/kg x 3 days and found no differences in side effects.

Healthy Volunteers

• Report of a group of healthy adult subjects given up to 10 x standard dose, either 2-4 x the standard dose three times a week or 6–10 x standard dose once and found the doses generally well-tolerated.

Systematic Reviews

• A systematic review and meta-analysis of high dose ivermectin found no difference in side effects between dose of up to 0.4 mg/kg and higher doses (up to 0.8 mg/kg doses every 3 days)

• A comprehensive review of 350 articles by the famous French toxicologist Jacques Descotes was presented in March 2021. In this document, he states,

1. “Based on all the data presented above, the author of this report believes it is fair to say that ivermectin did not directly induce an excess of deaths in treated groups of human subjects. Statements, past or present, that ivermectin can kill patients, are therefore considered to be misleading as they do not take into account all the medical information that has been accumulated over the last decades.“

2. “Only very few cases of accidental human overdose have been reported despite the wide availability of ivermectin as a veterinary and human medicine [Hall et al., 1985; Graeme et al., 2000; Deraemecker et al., 2014; Goossens et al., 2014]. Usually, moderate neurotoxic manifestations with rapid recovery after unspecific supportive measures were the predominating course of events. No accidental overdose including in infants and young children had a lethal outcome.”

Case Series

1) A case series of 3 children with relapsed leukemia treated with high dose (1.0 mg/kg) ivermectin daily for between 2 weeks and 6 months reported no significant adverse events.

Further, Ivermectin is on the WHO’s list of essential medicines, has been given nearly 4 billion times around the globe and is widely considered a safe drug. According to the WHO, it is safer than both aspirin and Tylenol. Its discoverers were honored with the Nobel Prize in 2015 for the drug’s global and historic impacts in eradicating endemic parasitic infections in many parts of the world. There is good scientific evidence that the escalating doses required to maintain antiviral levels have been subjected to considerable testing and are in fact safe.

To better understand the overall safety signal in Covid it is useful to look at absolute numbers in data from the FDA Adverse Events Reporting System (FAERS). While poison control calls and FAERS each suffer from limitations, it is notable that reports for products containing ivermectin actually fell slightly in 2020 and 2021, despite greatly increased use and dosing (see below data demonstrating the massive rise in ivermectin prescriptions in the U.S), with a combined total of 503 adverse reports which was at an annual rate that is less than 2017-2019. Reports did not rise post-COVID-19, but actually fell.

Safety Comparisons with Other Covid Treatment Options

As per above table using data from the WHO’s Vigiaccess surveillance database as of today January 12, 2023: there have been 16 deaths attributed to ivermectin over a 30-year period, while there have been 11,056 deaths attributed to Remdesivir though it was only approved by FDA on October 22, 2020 and given to far fewer patients. Remdesivir, which is considered the “standard of care,” was approved contrary to WHO recommendations against its use and a significant body of literature finding its risks outweigh any benefit.

The level of side effects in such approved drugs is one of the reasons that the Nebraska Attorney General found that ivermectin prescribing was proper and his Opinion puts the ivermectin data into stark perspective by comparing them with far more numerous adverse events from Remdesivir’s use in COVID-19.

Paxlovid is contraindicated if a patient is taking a significant list of other drugs and has a higher risk. Since its approval in 2022 it has already had 21,249 adverse event reports to Vigiaccess, which is three times the amount reported for ivermectin over the past 30 years. Molnupiravir has not shown high levels of effectiveness, shows 2,677 adverse events, and has not shown significant efficacy at reducing death rates.

Studies are continually published showing poor safety and effectiveness, for example a recent study in Lancet showing that “Molnupiravir did not reduce the frequency of COVID-19-associated hospitalizations or death among high-risk vaccinated adults in the community.” While these drugs may have a role to play in treatment, a fair comparison shows that ivermectin is more effective and demonstrably safer than other available treatments and far safer than the one drug–Remdesivir–that the FDA initially approved for use against COVID.

Notably, there have been 100 studies with over 135,000 patients listed at

https://c19ivm.org/ without a significant safety signal emerging.

Further, the principal investigator of the largest trial on ivermectin in Covid, Ed Mills, stated in March of 2022, during an NIH Collaboratory: “I would say that the safety analysis, you know, ivermectin does not appear to cause much of a safety concern. That argument that has been put forward by people I don't think holds very well at all.”

The concluding sentence of Jacques Descotes review of the safety of ivermectin: “the author of the present analysis of the available medical data concludes that the safety profile of ivermectin has so far been excellent in the majority of treated human patients so that ivermectin human toxicity cannot be claimed to be a serious cause for concern.

Finally, in a meta-analysis of 11 RCT’s in Covid, assessing 1533 participants, there was no significant difference between ivermectin and control in the risk of severe adverse events (aRR 1.65, 95% CI 0.44–6.09; I² = 0%).

Thus, it is clear from the accumulated and published evidence that Dr. Hoffe’s statement is highly scientifically accurate, unlike the conclusion of Dr. Corneil.

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