The remdesivir trial had just over 1000 patients, half with and half with a placebo. The anomalies you mention didn't seem to be an issue when granting that a licence.
What study? Did you even click on the link you posted?
You may want to go back a few posts, where we discussed this study, that has nothing whatsoever to do with Covid, in detail.
The horse paste thing only came up because more and more actual idiots here in the real world are buying it and ingesting it. Because, you know, vaccines are not really safe. Horse paste is. 🙄🙄🙄
Nobody here, ever, questioned the efficacy of Ivermectin for River Blindness.
I think people fail to realize how relying on small trials cause anomalies. Take 2 participants, 1 takes a green tictac daily, one takes an orange one.
At some point in time, one may contact covid, at which point the other one proves a certain colour tictak is effective vs Covid.
Wasn't there only issues with one trial in the meta analysis and the head of that is currently disputing the claims against it, so in the air. Also, why are they too small, wasn't the remdesiver study confined to a tiny group of subjects?
https://www.nature.com/articles/ja201711
Interesting article about Ivermectin from 2017, back before we had all the intellectual powerhouses around to give us their “lol horse paste” takes.
Yes indeed that would be correct .... IF there was a requirement to get the blood concentrations up to that level.
Fortunately that is not the case, as multiple studies have shown, and this is attributed by many to the multiple mechanisms present in the human body that were not present in the petri dish.
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.
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.
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.
Arstechnica:
Key points (quotes):
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.
Let me add to that:
New Report from HIQA - Bedtime covid reading.
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.
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.
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.
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.
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?
Didn't know this either but this article seems to explain it:
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.
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?
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"
Hmmm. OK, here are the flaws with this study;
I have no idea if ivermectin works or does not work, but this study does not really add anything to the evidence.
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.
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.
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.
What is the conspiracy here exactly?
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.
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.
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?
OK, let's look at the facts.
The study is available here:
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.
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