The Ivermectin discussion

https://twitter.com/AOlavarria/status/1430869323065741315

New study.

ligind

https://www.boards.ie/discussion/comment/117807989#Comment_117807989

New study that's a year old ?

PureIsle

Would this help to change any minds about the use of Ivermectin?

Tokyo's Medical Assoc. Chairman holds press conference recommending Ivermectin to all COVID patients

Apparently I am unable to post a link now.

"You have to be around for a little while longer before you can post links."

Very odd that.

https://www.youtube.com/watch?v=xkWOpFk1GGk

Anyway have a look at this video on youtube

The Raging Bile Duct

https://www.boards.ie/discussion/comment/117808363#Comment_117808363

https://www.techarp.com/science/greenlight-ivermectin-japan/?amp=1

As of 24 August 2021, Japan still does NOT allow Ivermectin to be used to treat or prevent COVID-19.

https://www.boards.ie/discussion/comment/117808320#Comment_117808320

What?

You understand that the study has to take place over a period of time and then go through analysis, methods/results etc have to be written up by the people running the study, the resulting document has to be edited, proof-read, double-checked by peers, then submitted to a journal where an editorial board will usually take its sweet time scrutinising it before deciding whether or not to push it through to peer-review, the peer-review process takes from weeks to months, depending how long it takes the reviewers to get back, and then eventually, if the report is not rejected at the peer-review stage, it will often be sent back to the scholars for review/revision based on any comments from the peers, and then, if and when the editorial board are satisfied, it'll be published.

It's not a "year old" study. It was published today.

ligind

https://www.boards.ie/discussion/comment/117808441#Comment_117808441

Author said they found it difficult to get it published without funding.

Preprint available since April .

https://www.boards.ie/discussion/comment/117808568#Comment_117808568

Right, but the peer-reviewed study was published today.

Had it been posted here as a pre-print in April, it would have been dismissed outright. "LOL not even peer reviewed. On yer bike, horse paste shill!" etc etc ad intedium.

Unicorn Milk Latte

OK, let's look at the facts.

The study is available here:

https://www.cureus.com/articles/63131-ivermectin-as-a-sars-cov-2-pre-exposure-prophylaxis-method-in-healthcare-workers-a-propensity-score-matched-retrospective-cohort-study

As the title says, it's about a Pre-Exposure Prophylaxis Method - not about treating Covid with Ivermectin. Again, for health care workers.

The study began on June 29, 2020, and ended on July 26, 2020.

Meaning, before vaccines were available as a more effective pre-exposure prophylaxis method.

The 'Limitations' section seems to invalidate all actual findings in the study. Quote:

There was no RT-PCR test at the start or exit of this study, neither in the ivermectin group nor in the control group. There is the possibility that asymptomatic cases were not detected. 

Ivermectin as prophylaxis has been posited. It’s still a positive result (particularly in light of ongoing vaccine data) strongly indicative of antiviral effect.

Healthcare workers make a good study cohort because of their exposure.

The lack of a PCR test at the start and end of the study does not invalidate the study.

Covid cases during the study period were diagnosed with PCR.

Anyone who had a positive PCR prior to the study was excluded.

When the study ended and the Ivermectin group stopped taking it, their infection rate normalised to match that of the control group.

Why are you under the impression that a lack of PCR testing at the start and end of the trial invalidates the whole thing?

Or did you just scroll down to the limitations section for a wee “gotcha” to post?

GooglePlus

https://www.boards.ie/discussion/comment/117808428#Comment_117808428

That fact check page, which is just a technology website, isn't referring to what that video is discussing. Nobody said Japan has given it the greenlight, it's undergoing trial and that chairman of the med association has been pushed it into the public light. This was reported on Nikkei and other reputable sources in Japan.

That fact checking website is about as reliable as a random tweet anyway, it's just one person using their tech site.

Former Former Former

The mad thing is there are literally hundreds of properly organised trials ongoing looking at both new and established medicines for Covid.

The only thing that sets these couple of drugs apart is the absolute chancers relentlessly pushing them, and gullible people falling for it because they want to believe in the conspiracy.

SortingYouOut

https://www.boards.ie/discussion/comment/117809332#Comment_117809332

What is the conspiracy here exactly?

Lumen

https://www.boards.ie/discussion/comment/117809370#Comment_117809370

The central conspiracy is that the benefits and adoption of Ivermectin as a prophylactic and/or therapy have been systematically ignored/sidelined/derailed because it is not profitable for Big Pharma, who are more interested in pushing expensive "experimental" vaccines, monoclonal antibodies etc.

https://www.boards.ie/discussion/comment/117809370#Comment_117809370

A very small number of people who think Ivermectin might work against covid believe that the reason it's being suppressed is because of financial interests in Big Pharma (or payoffs or whatever), and believe that the reasons Merck disavowed Ivermectin (its own drug) are 1: it's off-patent, so not profitable, 2: they have a contract with BioNTech/Pfizer and Moderna to produce LNPs for their mRNA vaccines, and 3: they entered into a $1.7 billion procurement contract with the US federal govt in June to provide a new, in-patent drug they are currently trialling for mild-to-moderate Covid treatment.

Which would be a conspiracy.

SortingYouOut

https://www.boards.ie/discussion/comment/117809659#Comment_117809659

https://www.boards.ie/discussion/comment/117809626#Comment_117809626

I listened to Pierre Kory allude to that alright and I guess there's never going to be a way to know if it is the case or not. They are a business at the end of the day and are not doing the work they do for the good of our health, it's all about money. You could see why an orally administered drug that shows potential promise and that can be cheaply manufactured anywhere would cause concern for a company looking to release their own anti-viral that's in the pipeline, probably for mega money as well.

That is a conspiracy theory but that being so doesn't make it untrue, pharmaceuticals don't exactly have a good track record when it comes to morals over money.

I thought the poster might have been saying that the conspiracy theory is the fact that Ivermectin shows promise against Covid-19, which wouldn't be true.

Former Former Former

https://www.boards.ie/discussion/comment/117807989#Comment_117807989

Hmmm. OK, here are the flaws with this study;

1. Retrospective, not prospective. When you go looking for an effect in data that already exists, you never get as reliable a result as when you start with a blank slate.
2. Completely unblinded. Everyone knew exactly who was getting what so there is a huge possibility of a placebo effect.
3. Treatment was self-selecting; participants were given the option to take it, not take it or stop treatment, but were then assigned to treatment groups on that basis. That's a serious flaw.
4. No objective analysis of outcomes, i.e. they should have been doing weekly PCR tests. Relying on spontaneous reporting of results by the participants is incredibly unreliable, especially when so many Covid cases are mild or asymptomatic.
5. Size and duration of the study; 540 subjects studied for four weeks isn't nearly enough to normalise for the bias that might be introduced by points 1 - 4. The number of total events (i.e. people getting Covid) in the control group is so small that even a single outbreak e.g. people all working in the same ward, would completely skew results. You would need thousands of people over a period of months to get a reliable outcome.

I have no idea if ivermectin works or does not work, but this study does not really add anything to the evidence.

Former Former Former

https://www.boards.ie/discussion/comment/117809659#Comment_117809659

One thing that the conspiracy overlooks.

If Merck ran a clinical trial and proved that ivermectin works in Covid, they would get market exclusivity on it for a year in both US and Europe. That would be a full year, and probably more, of being the only company allowed to sell ivermectin to treat Covid in the two biggest pharma markets in the world.

And they just don't want to do it?

I don't understand how people reconcile "giant pharma corp only interested in money" with "giant pharma corp leaves billions sitting on the table"

GooglePlus

https://www.boards.ie/discussion/comment/117810146#Comment_117810146

If Merck ran a clinical trial and proved that ivermectin works in Covid, they would get market exclusivity on it for a year in both US and Europe. 

How so?

The Raging Bile Duct

https://www.boards.ie/discussion/comment/117810261#Comment_117810261

Didn't know this either but this article seems to explain it:

https://www.lw.com/upload/pubcontent/_pdf/pub2655_1.pdf

The Drug Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, passed in 1984, provides up to fve years market exclusivity to companies introducing a new chemical entity to the market (NCE Exclusivity) and up to three years’ market exclusivity for conducting clinical trials to support changes to products already on the market (Clinical Investigation or CI Exclusivity). Pharmaceutical companies are not required to apply for these Hatch-Waxman exclusivities.

Former Former Former

https://www.boards.ie/discussion/comment/117810261#Comment_117810261

Yep, there are incentives in place for pharma companies (since long before Covid) to repurpose existing drugs for new uses. The idea is to get companies to run clinical trials and generate good quality evidence, rather than the wild west approach of just throwing unproven drugs into patients.

As noted above, it's actually three years in the USA. Three years of sales in the USA, for a drug that's already sitting in their warehouse... and they're just not bothered?

Stormyteacup

https://www.boards.ie/discussion/comment/117810506#Comment_117810506

But if the drug sitting in their warehouse has run out of patent then anyone can produce and sell, presumably. If they repurpose/tweak existing drug, or introduce something brand new, they get three years of market exclusivity?

At least that’s how it reads. 3 years of market exclusivity is surely worth orders of magnitude more to them than competing in the market with all other pharma companies.

The Raging Bile Duct

https://www.boards.ie/discussion/comment/117810739#Comment_117810739

Looked a bit more into this and for a generic drug, an Abbreviated New Drug Application (ANDA) would give you 180 days exclusivity which would be a major money spinner for any company if they could prove first that the drug was an effective treatment for Covid.

https://www.nuventra.com/resources/blog/types-of-marketing-exclusivity/

Generic Drugs

Under the Hatch-Waxman act, the first company to submit an Abbreviated New Drug Application (ANDA) to the FDA has the exclusive right to market the generic drug for 180 days. While this exclusivity period pales in comparison to the longer exclusivities enjoyed by branded drugs and biologics, the 180 days of exclusivity is significant in the world of generic drugs. One of the main advantages is that this period allows for the establishment of that first generic drug as the primary low-cost alternative to the branded drug and facilitates early adoption by hospitals and retail pharmacies.

https://www.boards.ie/discussion/comment/117810506#Comment_117810506

I guess it would depend. They have Phase III trials running on a different therapeutic drug that would be patented and they have the contracts to produce LNPs for prophylactic mRNA injections. Assuming that Ivermectin were a prophylactic and therapeutic drug in relation to Covid-19, they would almost certainly stand to gain more from those two than from a limited-time repurposing exclusivity where price gouging would be immediately obvious and threaten to destroy the reputation of a company that is only really just recovering from previous reputation damage that occurred when they purposely suppressed unfavourable cardiovascular safety information about one of their drugs. So the profit motive would seem to be in favour of new drug + LNP production.

The main reason I can see for the theory being BS is that Ivermectin will likely, at some in the near future, be proven effective or ineffective against Covid (in whatever capacity). So IF Merck thought that it was effective it would be an incredibly stupid move to say that it wasn't while working on an (ostensible) competitor drug that will be more expensive and more difficult to initially produce at scale. It doesn't strike me as the sort of gamble even a profit-driven "big pharma" company with some disgustingly shady history would take.

https://www.hiqa.ie/sites/default/files/2021-08/Evidence-summary_Interventions-to-prevent-COVID-19.pdf

New Report from HIQA - Bedtime covid reading.

Unicorn Milk Latte

https://www.boards.ie/discussion/comment/117809702#Comment_117809702

Let me add to that:

• the study did not look into the efficacy of Ivermectin, but into the efficacy of a combination of Ivermectin plus Iota-Carrageenan 6 nasal sprays, administered daily. Meaning, any efficacy results could mean that Ivermectin is completely ineffective, the observed effect is exclusively due to the nasal spray. Or vice versa. Or a combination - works only when both components are involved
• no PCR before and after means that you cannot know anything about actual effectiveness
• the study did not look into the efficacy of any other measures, meaning, which test subjects used masks, used different types of masks, took other medications
• the study did not look into which subjects were exposed to super spreaders, the results could be caused by exposure, rather than medication efficacy
• it was not a randomised study

PureIsle

Horse Paste indeed!

www.nature.com/articles/ja201711

Acknowledgements

Having spent a good deal of time during the past 25 years among remote rural communities in Africa while following the ivermectin story, I wish to convey to Satoshi Ōmura the grateful thanks of millions of men, women and children in such communities whose health, nutrition, education, economic situation and social status have been immeasurably improved by their access to ivermectin. Without his innovation, vision, drive and unwavering commitment, their lives and livelihoods would still be blighted by disease and misery. I also wish to convey my profound thanks to him for the opportunity of working alongside him and for his personal friendship, chivalry and tutelage in the art of interpersonal respect and understanding in the pursuit of all partnerships and collaborative endeavors.

Unicorn Milk Latte

Arstechnica:

https://arstechnica.com/science/2021/08/more-people-are-poisoning-themselves-with-horse-deworming-drug-to-thwart-covid/

Key points (quotes):

• In humans, the FDA has approved ivermectin tablets to treat conditions caused by parasitic intestinal worms as well as topical formulations for some external parasites, like head lice
• At low concentrations, the drug interferes with specific ion channels that are found in parasitic nematode worms, but not in people or animals.
• ivermectin drugs available to people involve relatively small doses and are in formulations known to be safe for human use
• The over-the-counter livestock drugs .. are not formulated for human use and have much larger doses for the animals' much larger bodies
• At higher concentrations, ivermectin begins to interfere with not just nematode ion channels, but other types of critical channels in humans and animals, like neurotransmitter channels. This can be extremely dangerous.
• preliminary data suggested that the drug could thwart the pandemic coronavirus, SARS-CoV-2—at least in petri dishes
• drug studies suggest that getting blood concentrations of ivermectin high enough to replicate the SARS-CoV-2-thwarting effects seen in petri dishes would "require administration of doses up to 100-fold higher than those approved for use in humans."

Unicorn Milk Latte

https://www.boards.ie/discussion/comment/117812332#Comment_117812332

This Nature article describes what I just mentioned in the Arstechnica summary: that Ivermectin has been used successfully in the poorest countries, for the purpose that it was created for - treating parasitic intestinal worms.

The article is from 2017, and has nothing to do with Covid. It states:

 Ivermectin is a broad-spectrum anti-parasitic agent, primarily deployed to combat parasitic worms in veterinary and human medicine.

Perhaps more than any other drug, ivermectin is a drug for the world’s poor. For most of this century, some 250 million people have been taking it annually to combat two of the world’s most devastating, disfiguring, debilitating and stigma-inducing diseases, Onchocerciasis and Lymphatic filariasis. Most of the recipients live in remote, rural, desperately under-resourced communities in developing countries and have virtually no access to even the most rudimentary of medical interventions.

Onchocerciasis and Lymphatic filariasis are caused by parasitic worms.

Ivermectin was a revelation. It had a broad spectrum of activity, was highly efficacious, acting robustly at low doses against a wide variety of nematode, insect and acarine parasites.

The African Programme for Onchocerciasis Control was created in 1995 to establish community-directed treatment with ivermectin to control Onchocerciasis as a public health problem in African nations that represented 80% of the global disease burden. For long the sole agent used in control efforts, ivermectin has been so successful that the goal has now switched from disease control to worldwide disease elimination.

It goes on about potential future use, that includes antiviral effects.

GooglePlus

https://www.boards.ie/discussion/comment/117813325#Comment_117813325

drug studies suggest that getting blood concentrations of ivermectin high enough to replicate the SARS-CoV-2-thwarting effects seen in petri dishes would "require administration of doses up to 100-fold higher than those approved for use in humans."

The human dosing for Covid-19 treatment has been within safe levels, I don't think anyone is advising someone to take a dose fit for a horse. The petri-dish experiement is one thing, but there are plenty of human dose trials that have shown it to be effective.

is_that_so

https://www.boards.ie/discussion/comment/117814174#Comment_117814174

Not big enough or issues with data is the common retort to that. If it is really that good a quality clinical trial will show it.