In June of 2020, Australian researchers published a study that showed ivermectin inhibited the replication of SARS-CoV-2 in a laboratory setting. The results were in vitro, which is not the same as testing the drug on humans or animals. The FDA responded by releasing a letter out of concern warning consumers not to self-medicate with ivermectin products intended for animals.
Six months have passed since then, thousands of Americans have died and this article is a direct call on the FDA for an explanation. Why was ivermectin not immediately placed into sanctioned human trials? It is approved for use in humans by the FDA, and the in vitro results should have pointed to a possible candidate to treat Covid. Clearly, six months later, nothing has been done and this raises very worrying questions,
If a candidate like ivermectin has been ignored, what other drugs has the FDA blindsided? Why is there no official NIH or FDA body to examine the efficacy of existing drugs and fairly evaluate any that show potential to combat covid? Could this simply be another of the many administrative oversights or is there something more sinister lurking behind it? Read on, as we examine the ivermectin issue.
An introduction
I am thrilled we have the covid vaccines being released into the public as I write this. It’s a technical miracle and evidence of what a community can achieve with a common goal, the proper motivation, and the removal of restrictive red tape, which, under normal circumstances, is required to safeguard us. The vaccines are however going to take months before their effects become evident in the general population.
While individual states dick about with their vaccination strategies, sell vaccines to wealthy donors and country club members, and try their best to get all the healthcare workers vaccinated, despite some trying to sabotage the process, people are still contracting Covid at record numbers in the US. Hospitals are nearing, or at capacity in many states, and Americans are dying in record numbers from Covid-19. On the 7th of January, more than 4000 Americans died in a single day.
That shouldn’t be acceptable in anyone’s eyes and every action we can possibly take to prevent these deaths needs to be explored. Explored thoroughly, so that it can either be discounted or implemented and we don’t have time to waste, people are dying. Trials need to be rapidly implemented with the active approval and involvement of the FDA.
It’s not as though we don’t have a queue of willing trial subjects. People are literally dying to try anything that suggests even a hint of efficacy.
Months ago (April) I wrote an article on Ivermectin and the success the drug had shown in-vitro against the coronavirus. I was excited when I came across the study as I have had personal experience with this drug and its efficacy against Nile River Blindness in the human population. It works spectacularly well, so much so that it won the Nobel Prize. It is not hydroxychloroquine.
In fact, in the world of drugs, Ivermectin is something of a fairy tale story, literally picked up out of the soil by a Japanese scientist and carried to glory on the first philanthropic donation of drugs in the world by Merck.
We know a great deal about Ivermectin’s safety in human use. Its application is in the destruction of nasty parasitic visitors and reactions to the drug are for the most part associated with the parasites attacking their hosts on the way out, rather than the drug affecting the host. Arguably, without parasites present, the risk of adverse reactions to Ivermectin would decrease significantly.
So back to my opening question. Why hasn’t the FDA and NIH trialed this drug in hospitals across the US, six months after in vitro trials suggested it as a possible candidate? To be clear, if Ivermectin can save one life in fifty, then it’s a worthy treatment. If it does more and is proven to show prophylactic properties, then that is a huge win.
Every additional benefit is a win, but the point is this. Until we actually try it, WE DO NOT KNOW! And in case I didn’t stress this sufficiently, people are dying daily, by the thousands.
I was sent a link this morning to a video posted by a Republican senator, Ron Johnson, chair of a Senate committee entitled ‘Early Outpatient Treatment: An Essential Part of a COVID-19 Solution’. I’ve included it below and before we get to it, I’ve done a little homework on your behalf regarding referenced materials in the video and the doctor presenting it, Pierre Kory, and his organization, the AFCCC. Here are the facts as they now stand, note, not my interpretation, but actual facts.
Who is Dr. Pierre Kory?
Dr. Pierre Kory is an Associate Professor of Medicine at St. Luke’s Aurora Medical Center in Milwaukee. He testified on December 8, 2020, at the U.S. Senate Committee on Homeland Security and Governmental Affairs. You can view the Committee’s entire hearing by following this link or you can download a transcript of Dr. Kory’s testimony here.
Kory is a founding member of FLCCC or in long-form, Front Line COVID-19 Critical Care Alliance. Their stated goal on their website is this. ”Prophylaxis & Treatment Protocols for COVID-19″. Let’s first deal with this entity and its members.
FLCCC push their treatment protocols for early intervention in covid patients requiring supplemental oxygen. This article isn’t about the FLCCC’s credibility or agendas, which may or may not be above reproach. Nor does it speak to Dr. Kory’s credentials. This is about Ivermectin and its potential as a covid treatment.
Clearly, as can be seen from the FLCCC site, Ivermectin is one of the treatments they recommend. They claim to base this on their actual experience and various trials, some of which we will examine below,
Let’s get to the Kory video, here it is, and you can watch it now or later.
The response to Kory’s claims around Ivermectin has been as follows from the medical community, the FDA, and NIH. Firstly, from infectious disease expert at John Hopkins University, Dr. Amesh Adalja. who said most of the research around ivermectin at the moment is made up of anecdotes and studies that are not the gold standard in terms of how to use ivermectin.
“We need to get much more data before we can say this is a definitive treatment,” he said. “We would like to see more data before I recommend it to my patients.”
The U.S. Food and Drug Administration and the National Institutes of Health have said that the drug is not approved for the prevention or treatment of COVID-19. According to the FDA, side effects of the drug include skin rash, nausea, and vomiting. So just exactly what is Ivermectin approved for in the US?
It does have FDA approval. Ivermectin is approved in the U.S. for human consumption in tablet form to treat parasitic worms as well as a topical solution to treat external parasites. The drug is also available for animals, but that’s neither here nor there. Many of the same drugs and antibiotics are used in both human and animal populations.
Documented and Published Studies
You can find links below to various studies that claim to prove the efficacy of Ivermectin against Covid-19. It should be noted that the trials listed below are riddled with flaws and inconsistencies. None, in our opinion, offer conclusive evidence to the efficacy of ivermectin as a treatment or prophylaxis for the coronavirus. They do however hint at a potential that cannot be ignored, particularly given skyrocketing deaths.
November 16, 2020 | Egypt: Efficacy and safety of ivermectin for treatment and prophylaxis of COVID-19 pandemic – Elgazzar A, Basma H, Shaimaa Abo Y, Basma H, Mohy H, Hany M (Research Square; 100956) https://doi.org/10.21203/rs.3.rs-100956/v2
November 3, 2020 | India: Role of Ivermectin in the prevention of COVID-19 infection among health care workers in India – A matched case-control study; Behera P, Patro BK, Singh AK, et al. (medRxiv)https://doi.org/10.1101/2020.10.29.20222661
October 27, 2020 | Iraq: Controlled randomized clinical trial on using ivermectin with doxycycline for treating COVID-19 patients in Baghdad, Iraq – Hashim HA, Maulood MF, Rasheed AM, Fatak DF, Kabah KK, Abdulamir AS (medRxiv) https://doi.org/10.1101/2020.10.26.20219345
October 22 | Peru: Antiviral and anti-inflammatory properties of ivermectin and its potential use in COVID-19 – Portmann-Baracco A, Bryce-Alberti M, Accinelli RA (NCBI/Arch Bronconeumol/ScienceDirect) https://dx.doi.org/10.1016%2Fj.arbr.2020.06.006
October 12, 2020 | USA: Use of ivermectin is associated with lower mortality in hospitalized patients with COVID-19 – Rajter J-C, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter J-J (ICON study; Chest) https://doi.org/10.1016/j.chest.2020.10.009
October 2020 | Peru: Real-world evidence: The case of Peru. Causality between ivermectin and COVID-19 infection fatality rate – Juan Chamie (ResearchGate) https://www.researchgate.net/publication/344469305_Real-World_Evidence_The_Case_of_Peru_Causality_between_Ivermectin_and_COVID-19_Infection_Fatality_Rate
August 24, 2020 | Bangladesh: Clinical trial of ivermectin plus doxycycline for the treatment of COVID-19 infection – Dr. Reaz Mahmud, Dhaka Medical College (ClinicalTrials.gov; NCT04523831) https://clinicaltrials.gov/ct2/show/NCT04523831
June 11, 2020 | Argentina: Usefulness of topical ivermectin and carrageenan to prevent contagion of COVID-19 (IVERCAR) – Hector E Carvallo, Eurnekian Public Hospital (ClinicalTrials.gov; NCT04425850) https://clinicaltrials.gov/ct2/show/NCT04425850
June 9, 2020 | Egypt: Prophylactic Ivermectin in COVID-19 Contacts – Waheed Shouman, Zagazig University (ClinicalTrials.gov; NCT04422561) https://clinicaltrials.gov/ct2/show/NCT04422561
June 2020 | Australia: The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro – Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM (Antiviral Res.; 178:104787) https://doi.org/10.1016/j.antiviral.2020.104787
A very balanced and well-structured analysis of these studies can be found on Rebel EM and we recommend you read it. Their clinical takeaways from the available evidence on ivermectin are as follows. (Bold text highlighted by Medika).
- Evidence for the use of Ivermectin is based on in vitro, prophylaxis, clinical, safety, and large-scale epidemiologic studies (heterogenous populations in multiple different settings) BUT…
- Many of the trials thus far are methodologically flawed without enough information about baseline demographics, multiple primary outcomes, soft/subjective outcomes, convenience samples, and unclear definitions, just to name a few
- Additionally, a valid concern in evaluating the literature is that many of the trials have not yet passed the peer review process and are in pre-print format
- Although Ivermectin is cheap, readily available, with a fairly safe side effect profile, based on the evaluation of the literature above, at this time, Ivermectin should not be recommended outside of a clinical trial to ensure we get a true answer of effect
- Ivermectin is interesting, there is certainly signal to evaluate further, but in our desire to want a treatment option, let’s not continue to do the same thing over and over again, as we saw play out with Hydroxychloroquine
It is perhaps worth mentioning in closing. All across America, many frontline doctors and medical staff are currently using ivermectin as a prophylactic. Is it working? Well, again, we don’t know as it isn’t being studied properly in the U.S.
The point is that this option if it does in fact prove efficacious against coronavirus, should be rolled out to the public. No one else is to blame here for the complete lack of action, other than the FDA and NIH and their hesitancy to encourage proper trials. The ball is firmly in their court.
An interesting footnote (Jan 11,2021)
India has extensive experience with both ivermectin and hydroxychloroquine in the treatment of covid. This mostly anecdotal report from Trialsitenews.com makes for fascinating reading and if anything, highlights the US’s lack of interest in pursuing any course, other than vaccines, in combating covid.
