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Business Observer Wednesday, Sep. 8, 2021 2 weeks 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.

 

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.

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 “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.

 

Consider counterviews

Thank you for all you are doing to ensure you are giving voice to diverse people and viewpoints.

I am forwarding articles I think you might need when considering delivering a counterview to the ivermectin story:

—Kristin K. "Kiki" Grossman, J.D., LL.M., Esq., Orlando

 

Kory responds: The reader offers four articles that could support a counter view against ivermectin. Let us review their content for substance:

1.  In the first, she offers an article about a physician who finds ivermectin to be highly effective but then the article goes on to describe the scientist as “fringe,” is “against forced mask wearing of children” and is “affiliated with controversial groups.”

These are classic propaganda tactics intended to discredit non-conforming scientific views by conflating them with topics and issues independent of the actual scientific opinion.

So let’s stick to the single issue by pointing out there are many “non-fringe” doctors in “non-controversial groups” who understand the high efficacy of  ivermectin, such as the Front Line COVID-19 Critical Care Alliance, or the large, international BIRD group of scientists (British Ivermectin Recommendation Development Group. 

The FLCCC is a group of five  highly published leaders in the field of critical care medicine and are among the foremost ex-perts on ivermectin in COVID-19, having published the first definitive review of the ivermectin evidence base, as of January 2021. 

Currently the paper’s altimetric popularity score among all 18.8 million scientific publications over the past 10 years sits at #45.

2. For the second article, the reader refers to a TV interview with Dr. Anthony Fauci, a man who has previously touted the $3,000-a-dose Remdesivir as a “game-changer” based on a manipulated study of about 1,000 patients where it led to maybe two days fewer in the hospital and no impact on mortality. 

Numerous outlets have highlighted the ties of the NIH guideline committee to Gilead, maker of Remdesivirt.

Almost all follow-up studies have found Remdesivir to be ineffective. The World Health Organization does not recommend its use in hospitals. 

Despite all of this, it still remains firmly at the core of the NIH (Fauci’s agency) treatment guideline. It is one of the most striking examples of a health system that favors for-profit medicines over non-profit medicines.  

In this TV interview, Fauci also says, “There is no evidence whatsoever that  ivermectin works.” 

This is one of the most absurd, easily disprovable lies ever uttered by a government official, and it should not be allowed to stand uncorrected. 

Beyond the FLCCC’s review paper, many systematic reviews and meta-analyses find immense positive impacts of ivermectin in COVID-19, such as this one.

The best way to review the existing evidence of effectiveness is the FLCCC’s “Summary of Evidence of Ivermectin on COVID-19."

Finally, note this TV interview was also based on a lie about people overdosing  on ivermectin and filling emergency rooms. 

This was best articulated by the Rolling Stone’s retraction, written after the hospital mentioned in the article put out a statement saying not one overdose EVER showed up in its ER and the doctor interviewed had not worked there there for the past two months. Yet hundreds of news outlets across the world ran the story, without checking first.

3. Regarding the FDA’s statement on its website, it also tries to conflate ivermectin with animal medicine despite the fact ivermectin’s discoverers won the Nobel Peace Prize for transforming the health status of humans by eradicating disfiguring and blinding parasitic diseases across a number of continents. 

There are numerous other misleading statements by the FDA:

  • It implies that FDA approval is needed to prescribe a drug. This is false; 20% of all prescriptions in the United States are written for indications without FDA approval. This is called “off-table use” and is perfectly legal. 
  • The FDA also implies it is responsible for reviewing the scientific data on ivermectin in COVID-19. That is also false. 

No application for FDA approval currently exists. It knows this.  

  • Further, since that post originally went up on the FDA’s site, for months it had the following statement in it, which was recently removed: “The FDA has not reviewed the data for ivermectin in COVId-10.”

It no longer says that, but instead parrots the other agencies with a new declarative statement that “ivermectin is not effective in COVID-19.”

This statement is firmly at odds with the opinion of the Indian Council of Medical Research, the apex body of biomedical research in India, which, after analyzing the data of ivermectin’s instrumental role in beating back India’s spring surge, has now included it on its list of essential medicines in COVID-19.

4) The Cochrane Library review that the writer offers up as “proof” of ivermectin ineffectiveness fails to note that Cochrane is an organization funded by one of the most vocal proponents of the vaccination industry in the world, and this review can be considered a “hit piece,” given that it willfully looked at fewer than half of the existing number of randomized controlled trials available

A detailed critique by world expert systematic reviewers Andrew Bryant and Tess Lawrie, who have done many dozens of Cochrane Reviews and WHO guidelines themselves, is a must read to understand how willfully damaging that paper is to the worlds critical need for understanding the potent role of ivermectin in this disease.

 

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

 

Patients deserve a choice

Finally, a brave, real journalist who will most likely be ostrasized for your fair and well-written article. 

I have been reading about the efficacy of ivermectin, and how the lamestream media and government continue to castigate it. 

The suppression of any potential low-cost drug to fight COVID is wrong. It should be a permitted use at the discretion of he individual. That is called choice.  

Thanks for your bravery in standing up to the elites who have ben pushing us around.

— Tom Santoro, Jacksonville

 

Media blackout is a disgrace

Thank you for having the courage to write that piece. The media blackout is as disgraceful as the government’s ignoring of the science. And to think this is happening in America is scary.  

—David Heekin, Jacksonville

 

An ice breaker

I very much appreciate your publishing the message about ivermectin. 

The linked articles are fantastic.

The article lays out the story so anyone can become an activist for freedom and truth during this questionable crisis.  

I’ve followed Dr. Pierre Kory for some time, and the skepticism is hard to break through, even with his exceptional testimony. 

Your setting this issue within the Observer is brilliant. It will help “break the ice” with many of my friends, co-workers and faithful.  

—Carl Weirich, Winter Garden

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