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Sarasota Thursday, Sep. 2, 2021 1 month ago

OPINION: Ivermectin II: Cons and pros

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Readers chastised us, saying we were promoting a COVID-19 drug that’s dangerous and unproven. Dr. Pierre Kory addresses those concerns.
by: Matt Walsh Editor & CEO

Two weeks ago, we published on this page our urging to readers to read a long magazine article on the use of the drug ivermectin to treat COVID-19 — “The Drug That Cracked COVID.” You can read it at rescue.substack.com.

Written by New York Times bestselling author and journalist Michael Capuzzo for his and his wife Teresa’s Pennsylvania magazine, Mountain Home, the article chronicled the struggles of renowned academic medical researchers and physicians Drs. Pierre Kory and Paul Malik and others to convince public health agencies in the U.S. and around the world of the efficacy of ivermectin in the treatment of COVID-19 and that this FDA-approved, generic drug should be authorized for doctors to prescribe.

As expected, we received numerous letters and emails. Some applauded us for bringing the story to light and told us how the drug had saved people they knew.

Others stridently chastised us, accusing us of promoting the use of the drug and promoting it over vaccines. We were doing neither.

Our intent was to expose our readers to a story about a drug that has gone through extensive clinical trials, proven to be effective against COVID-19 and yet the medical establishment and national media have dismissed it as quackery.

As fair-minded journalists would, we felt it worthy to expose our readers to another side of this larger story.

What’s more, knowing we would receive negative responses, this week we are publishing letters and emails of those who opposed what we did, along with Kory’s responses to readers’ concerns and criticisms.

In addition, we are publishing one letter (of several we received) in support of our publishing Capuzzo’s story.

Because of space constraints, we are publishing in print only one email, that from Stephen Cooper, professor emeritus at the University of Michigan, and Kory’s response. — M.W.

 

Abomination and drivel

Your article pushing ivermectin as a “cure” or “preventive” or whatever for COVID was an abomination.

There has been a large increase in calls to the Poison Control Line from people taking that compound. It is not approved and has not been shown to be effective against viruses, in particular against COVID-19 or its variants.

You did a disservice to the community for writing that drivel, which will hurt more than help. Vaccines should be promoted as the only proven way to stop this pandemic.

I hope that soon you will publish an article retracting your views on ivermectin and set the record straight.

— Stephen Cooper, emeritus professor, microbiology/immunology, University of Michigan

 

Dr. Pierre Kory responds:

The most easily quantifiable way to describe the indefensible lack of “approval” for ivermectin in COVID-19 is to note the actual amount of supportive clinical trials evidence in COVID-19, both randomized (31) and observational (32), including more than 26,000 patients with the near majority of all studies finding at least some important benefit with treatment.

Then compare that evidence to the average amount of evidence relied upon to formulate the treatment guidelines of the Infectious Disease Society of America:

In a 2010 review of 65 of its most recent guidelines, the IDSA found that 50% of guideline recommendations were made without any trials evidence in support and were termed “expert opinion only.”

Another 31% of guideline recommendations were based solely on observational studies, while only 16% of all recommendations were based on at least one randomized controlled trial.

In other words, the number of legitimate clinical trials for ivermectin have been far superior to those for the IDSA’s treatment guidelines.

Furthermore, ivermectin was approved for the treatment of scabies by the World Health Organization based only on 10 randomized controlled trials, including 852 patients. Despite the fact that these trials found ivermectin inferior to the cream it was being tested against, it still won approval due to its low cost and ease of administration.

We cannot recall the last pandemic of scabies that cratered health care systems and societies across the world. Yet the WHO was able to arrive at such a bold recommendation without the pressure of a pandemic, given it was based on such a seemingly small evidence base.

We also emphasize that the NIH Guidelines for COVID-19 have multiple strength levels of recommendation available to them, from weak/“consider” to making use near mandatory. The public should demand from the IDSA and NIH credible explanations for this monstrous anomaly of not arriving at even a weak recommendation for ivermectin, one of the safest, inexpensive and widely available medicines known to man.

What you are witnessing is just the most absurd example of a decadeslong war on re-purposed (aka “non-profitable”) medicines.

Finally, no credible physician or journalist recommends that people self-prescribe with veterinary forms of ivermectin. Experts, such as the Front Line COVID-19 Critical Care Alliance, have been working tirelessly for months to persuade the public health agencies to provide more specific guidance to physicians on using ivermectin to treat patients with COVID-19.

The increasing calls to poison control centers are a direct result of their failure to provide such guidance and education to U.S. citizens.

 

Irresponsible and just plain wrong!

Your piece on ivermectin is irresponsible and just plain WRONG.

Sooner than regurgitate misinformation, a few minutes research would give you this on Wikipedia, in addition to pieces discrediting your erroneous conclusions in reputable journals such as Nature: Nature.com/articles/d41586-021-02081-w.

Also, read this from The Washington Post: “Ivermectin in Mississippi: Livestock drug is ‘crazy’ covid treatment used by some people, state says.”

— Paul Wilkinson, Sarasota

 

Kory responds:

The evidence base supporting the use of ivermectin has emerged from many sources beyond just the randomized controlled trials.

A summary of the evidence base with all references hyperlinked for easy access can be found in the “Summary of the Evidence for Ivermectin in COVID-19."

Within the evidence base comprised of just randomized controlled trials, it is indeed true that the integrity of one RCT in Egypt (Elgazzar et al.) was recently called into question. While we share the concerns about this study, the removal of its data from the most comprehensive meta-analyses of RCTs, which included 24 RCTs originally (later recalculated by the lead authors using 23 trials), did not change the conclusion that ivermectin treatment led to a large and statistically significant impact in reducing the mortality of COVID patients.

 

A horrible editorial

Which would you prefer to believe? Your unsubstantiated piece, or this science-based and logically argued piece refuting your claim:

In any event, my point is that you are abusing your position by espousing a treatment protocol that is not fully supported by the scientific community.

This can only serve to discourage your readers from doing what is proven to stop COVID-19, and that is GET THE VACCINE!

Also, look at this from the Food and Drug Administration regarding your right-winged conspiracy theory “miracle drug” you were peddling in another one of your horrible opinion pieces:

Why don’t you keep these types of harmful, BS stories to your Facebook and other social media cesspool groups instead of putting the local community at risk.

You owe us a retraction piece and instead should be pushing the community to be vaccinated against COVID with the authorized drugs that are proven to work.

We all know Florida and Manatee County are going through a health care crisis dealing with delta due to unvaccinated individuals. Do better for your community and promote facts, or just stick to stories about the new restaurant or traffic light that needs installation.

Please just stop spreading misinformation. Bottom line: Not enough evidence, so stop promoting these miracle drugs. You could get someone killed.

What happened to high journalistic standards? At a minimum share the counter argument: FDA doesn’t recommend.

— Cory Supple, Bradenton

 

Kory responds:

Although epidemiologic associations between adoption of a medicine into state or national treatment guidelines and the subsequent rapid decline in case counts and deaths can never be used as definitive “proof” that a medicine is effective, such correlations can be viewed as compelling adjunctive sources of evidentiary support.

This is particularly so when the timing of adoption and the rapid decreases in cases and deaths are so reproducible from states, countries or regions when widespread adoption can be accurately “timed.”

Examples of these tight “temporal associations” can be identified from analyses of publicly available data paired with the timing of ivermectin adoption among numerous countries and states including Peru, India, Argentina and Mexico.

Further, although again not definitive, support can be found from what could be considered “natural experiments,” which arose in India when comparing case and death data from Indian states with widespread adoption of ivermectin to those that prohibited use.

 

Take down article

A family member of mine had a serious case of scabies at a local nursing home in Jacksonville. The nursing home wanted to give her ivermectin. After reading the possible side effects and how those effects related to my family member’s health, I told them to not give her the medicine.

Instead, they ignored my request. As a result of one single dose, my family member was admitted to a hospital and almost died.

Ivermectin is not a cure for COVID. The advice of the majority of physicians with years of education and experience about ivermectin needs to be heeded, not just a handful of doctors hand-picked to support your nonmedical opinion.

These types of COVID misinformation kill folks.

I would like to see you take down this article before someone takes ivermectin at your unprofessional advice, becomes severely ill and possibly dies.

— Tammy Myers, Jacksonville

 

Kory responds:

In nursing homes and prisons throughout the world, during scabies outbreaks, ivermectin is distributed and administered to all residents, inmates and staff as a standard practice for controlling outbreaks.

In fact, one of the first signals of efficacy of ivermectin in COVID-19 came out of a group of nursing homes in France, where one home had suffered a scabies outbreak such that all residents were treated with ivermectin. Administrators noticed that infections were halved (10.6% versus 22.6%), and zero deaths occurred in that home compared to the 4.9% mortality rate among the surrounding nursing homes where residents had not been treated with ivermectin.

Further, ivermectin is one of the safest medicines in history, having been mass-distributed across continents to both young and old, healthy and unwell in the eradication of disfiguring parasitic diseases.

The World Health Organization has stated in its guideline document for scabies that the majority of side effects are “minor and transient.”

Lastly, in the words of Jacques Descotes, a world-famous French toxicologist who just completed a comprehensive review on the safety of ivermectin, “Severe adverse events are unequivocally and exceedingly rare.”

Finally, in that same review, Descotes could not find one provable instance of a death caused by ivermectin, even considering the case reports of massive overdoses.

 

Criticism warranted

Your article on COVID treatment drugs is very complete and points out many of the problems with medicine today.

As an assistant professor at Washington University in St. Louis, I totally support the general and specific criticisms of the medical establishment.

Supportive care for COVID-19 infections never works. That’s why so many people have died.

We need to be proactive, not wait for people to get sicker before treatment. Trying simple, low-cost, safe drugs can never hurt.

I appreciate your voicing the feelings a lot of doctors express. Suppression of information by nonmedical gate keepers is a travesty to our freedom.

— Thomas A. Davis, M.D., St. Louis

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