Wow! This is the answer why ivermectin was ignored! This is bombshell material.

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Ok TrumplyftAlles, for someone who otherwise seems to support IVM your comment here could lead some ppl to believe there is nothing behind the claim that IVM can save lives. Which would be a shame because IVM holds so much potential.

I don’t have the legal knowledge to know whether the FDA statement is a legal constraint or not. From my perspective, there seems to be more than enough evidence to support an emergency authorisation for IVM, as well as pouring a big chunk of money into conducting larger trials and fast. But this is not happening.

The point is not that IVM will replace the need for a safe and effective vaccine. The point is that IVM can actually prevent illness and death NOW. Not next month, not next year, now. Does it really seem so far off to suspect that had IVM received the same level of financial investment, it would have already been possible to roll it out and promote it as an effective treatment? And if that were the case, would many people perhaps opt for the therapeutic option rather than a fast-tracked experimental vaccine? I am pretty sure that had the FDA or whoever approved IVM, vaccine uptake would be even worse than it already is. Don’t you think Big Pharma and our leaders might want to avoid this?

Yes, still too few people in relevant positions actually know about IVM, which will be in part due to the Lancet-fiasco but also a result of systematic (social) media censoring and the focus on vaccines as the only silver bullet.

It’s all wrong. But things are starting to change. More ppl are talking about IVM and are questioning the safety of a vaccine that has no data on long-term effects.

FDA involvement or not. There are definitely financial interests at play here and it is not acceptable.

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This is my theory as well to explain why there is so little interest in early treatment or prophylaxis, not only for ivermectin but for everything. Health authorities decided from March the answer to this was to lockdown to control the spread as needed until vaccines came out. Governments preordered millions of doses of vaccines, so they didn't bother funding early treatment or prophylactic trials not to discover something that would throw a wrench in their plans due to high effectiveness at preventing the disease (not infection, but the disease).

It's the only thing that makes sense.

https://www.reddit.com/r/ivermectin/comments/id9u9k/ivermectin_conversations_a_place_for_exchanging/gg49llc/?utm_source=reddit&utm_medium=web2x&context=3

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I was aware of it, yes.

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The NIH guidelines say IVM should not be used outside of a randomized clinical trial. Fair enough, normally. There are, however, 11 randomized clinical trials of varying quality from other countries that suggest it is highly effective. Small trials, yes. Possible publication bias, yes. But combined with the absence of reported adverse effects in Covid patients, impossible to ignore.So how many trials is the NIH funding? NIL According to clinicaltrials.gov, there are TWO trials currently enrolling that will investigate outcomes (plus another trial that will assess benefit only from how complete some urinary marker of disease severity improves after 10 days). Proposed N for the two trials? • N=240 to study four agents, parallel assignment, open label (U. Kentucky); last data point to be collected at day 40. • N=30 to study a proprietary mix of IVM, doxy, zinc, D3, C with blinding and placebo control. These two studies will add next to nothing to our knowledge about proper treatment of the disease, even when they ARE complete no sooner than two months from now. PS: The second study must now be considered unethical given current knowledge. You can't ethically withhold vitamin D3 from anyone, given the huge amount of information supporting the importance of adequate vitamin D nutrition in minimizing Covid severity (recently reviewed thoroughly by Dr. Roger Seheult on the MedCram channel). It is criminal that the NIH has not put out an emergency call for at least two large blinded studies with full funding. In these trials everyone would get D3, C, and zinc (which is simply good nutrition) and would be randomized to either placebo or IVM. They are showing institutional arrogance by failing to revise their guidelines in light of new knowledge that has emerged in the last 3 months.

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I don't believe this is why ivermectin hasn't gotten FDA approval.

Look, guys, we're pouring over $8 billion into vaccines, so we need to suppress ivermectin; otherwise, we can't legally issue an EUA for the vaccines.

IMO that's ridiculous.

First, the quoted FDA statement is just a general description of policy about EUAs. It isn't a legal constraint. The FDA can hand out EUAs whenever it deems that appropriate. No court is going to tell the FDA that they can't issue a EUA for a vaccine because it has already done an EUA for a drug that (barely) arguably competes with the vaccine.

Second, the prophylaxis provided by ivermectin seems promising but it's very far from established by FDA standards. The vaccine trials enroll 30 or 40 thousand people. By comparison, the ivermectin trials are a joke.

Third, ivermectin is not a feasible alternative to vaccines. IVM manufacturing capacity would have to be increased massively to produce the quantities needed. People would have to dose weekly (or every other week or once a month, there's still huge uncertainty about the dosing schedule), which presents the thorny problem that lots of people are terrible about taking their medications. There is no way to monitor that they are doing so. Vaccines are administered in clinics and pharmacies that have computerized record-keeping. If they don't already, those systems will be enhanced to provide reporting to public health agencies tasked with making sure the populace gets vaccinated. To get equivalent monitoring with ivermectin, you'd have to implement the unacceptable practice of requiring people to show up at a clinic or pharmacy every week and take their ivermectin with someone watching and entering that fact into a computer. Or make people place a zoom call to the public health department and swallow their pill on-screen. Crazy suggestions, right? The fact is that ivermectin use cannot be monitored.

Fourth, there's a much simpler explanation for why ivermectin is being ignored by the FDA, NIH, and CDC. The study that initiated interest in ivermectin was the Monash 48 hours study that showed that IVM kills 99.98% of the virus in 48 hours, at a high concentration. It was published on April 3 in Antiviral Research. On April 17, Antiviral Research published two letters that argued that the Monash study shows that the required concentration of ivermectin is too high. In subsequent months, this argument was repeated perhaps 10-15 times in papers and articles. It was a very effective campaign to stop ivermectin in its tracks. The one thing that people who know one thing about ivermectin know, is that the required concentration is too high. It's a bullshit argument, but that "fact" has taken hold and it continues to crop up all the time. I heard it again a couple weeks ago on This Week in Virology.

As a result of the successful CONCENTRATION TOO HIGH!!! campaign, people working at NIH etc. have never taken ivermectin seriously. They simply aren't paying attention. Readers of this sub are aware of the research. Very likely, we know more about ivermectin than anyone at those agencies. Covid19-related papers are being published at the rate of 500 per day. The people working at the agencies cannot read it all. They have to pick and choose. Because of the CTH!!! campaign, they are choosing NOT to read the ivermectin research.

It doesn't help that 98% of the ivermectin research comes from lower- and middle-income countries. The FDA is disinclined to give credence to research done outside the US. The FDA's US-research bias is why there are rampant disparities between US and EU drug policies, e.g. drugs available in the EU are not available in the US because no one has taken them through the FDA approval process. The fact that the EU equivalent of the FDA approves a drug has no weight with the FDA. There are only 3 registered trials in the US and IIRC the soonest any will report is May, if the dates in ClinicalTrials are accurate (they are probably optimistic). EU-based research has more credibility with the FDA than trials done in Argentina or Bangladesh, but only one EU trial has reported, Dr. Chaccour's underpowered (N=24) study which didn't turn up any statistically significant results. If that study had N=3000 and showed massive benefits with p < .05, the FDA might have responded by issuing an EUA for ivermectin. It issued an EUA for dexamethasone based on an EU trial. But Chaccour's trial wasn't big enough to convince anyone of anything.

Look, guys, we're pouring over $8 billion into vaccines, so we need to suppress ivermectin; otherwise, we can't legally issue an EUA for the vaccines.

That conversation never happened because no one at the FDA has an inkling that ivermectin competes with vaccines. I'm fairly on top of the ivermectin research, and I don't think they are competitors.

I'm posting it everywhere.

/u/jewelsn24, you think you have identified a crucial aspect of FDA policy that suggests a conspiracy to suppress ivermectin research. I obviously disagree. We have all heard your theory. Would you PLEASE make this the LAST TIME you post it to the sub?

I'm not going to delete your posts. I ask you to refrain, because IMO you're wasting the sub's readers' time. I get your reasoning. IMO it's just wrong.

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Yup. I was dissapointed my sister wouldn't take it seriously. Even though I called th pandemic a month earlier than most people and am now vaccinated via a trial. Not by some innate ability but by listening to the experts. When will people learn?

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