FDA Now Cautions Against Ivermectin—the Vested Interests are Circling the Wagons

FDA Now Cautions Against Ivermectin—the Vested Interests are Circling the Wagons

With mass media synchronization, that is recent ivermectin-based articles from both the New York Times and CNN covering negative news, the U.S. Food and Drug Administration (FDA), the Gold Standard global food and drug regulatory body, has issued a cautionary statement targeting ivermectin. The crux of the agency’s concern includes 1) Ivermectin is an off label treatment; 2) taking large doses of the drug can be harmful; 3) ivermectin should be used for “legitimate” source (e.g. anti-parasitic indication); and 4) animal medications should never be taken by humans. The basis for the agency’s warnings are “multiple reports” of individuals that have received either medical support for taking the drug or hospitalization after self-medication with the type needed for animals. No such data backing those reports is included, however—no warning letters, no examples from county or state health agencies or for that matter tangible reports from hospitals. TrialSite’s suggests that the FDA is reacting to growing interest around America about the drug.  Interestingly, as the National Institutes of Health (NIH) declared that there isn’t enough information yet to recommend for or against the use of ivermectin, this now contradicts the FDAs’ more forceful off-label use declaration. The NIH’s stance of course was in the context of physician discretion, consenting patients, etc. As TrialSite suggests, the fix is on, powerful economic and sectoral interests are circling the wagons as drugs, politics and power predicts this particular research pathway doesn’t benefit economic interests during the pandemic and beyond.  

The FDA rightly and correctly cautions against any misinformation and cautions that it’s not okay to take large doses—they are completely correct. Moreover, they correctly identify that ivermectin can interact with other medication and that to date needs to be understood.

Sudden Interest

For several months, TrialSite followed study after study in various parts of the world showing ivermectin had at least some benefit targeting COVID-19. The mainstream media resonponse—crickets. Now  all of a sudden with one Colombian study that doesn’t show stellar results, they take a particularly keen interest in the generic drug used to treat parasites, such as CNN now swooping in on the FDA edict as well as the Cali Colombia study, which statistically didn’t reveal any benefit of the anti-parasite drug.  

Toxic Reactions: Where is the Data behind the incidents?

Unlike some of the hydroxychloroquine debacle where the President of the United States promoted an investigational indication for COVID-19—influencing  abuse of the drug by at least some gullible and misinformed people, in this case TrialSite has sought out the data behind the flurry of concerns of late. While the FDA reports “multiple reports,” it provides no qualitative or quantitative backing for this declaration—no data from state or county health agencies or hospitals for that matter.  

For example, the most recent concerns behind ivermectin correlate with the Business Insider article where ABC News referred to recent incidents reported by the Missouri Poison Center; that is, they reported an increase in self-medication-related abuse of the drug leading to calls into their center. TrialSite reached out to both their Medical Director and Director to inquire about actual data. How many people called in? What was the nature of the incidents? To date and not surprisingly, crickets is the response.

TrialSite doesn’t declare that the Missouri Poison Center story is incorrect but it’s certainly interesting that this one story has led all the way up to a FDA cautionary declaration—with no data to back it—at least data that’s publicly disclosed. In  fact, to date, no media has come up with any actual person that has overdosed due to self-medication, which is strange.

More Research?

Moreover, in the recent edict, FDA directly acknowledged it hasn’t reviewed any Ivermectin research. Really not at all?  In the midst of a pandemic the agency hasn’t looked into the ivermectin studies at all despite the fact that the World Health Organization itself is tracking the studies closely? So TrialSite knows that’s not the case informally as individuals originating from the FDA domain are regulars on the TrialSite News platform, and this particular media reports on ivermectin clinical trials around the world. There are certainly many people at the FDA interested in the ivermectin studies, but they probably dare not utter a word.

TrialSite does have reports from various industry sources that the FDA, or at least certain individuals there, have held meetings about ivermectin research. If these reports are true then the agency in its most recent website declaration isn’t being totally straight with the American public.

Regardless, so while over 40 studies have been completed and a growing number of researchers, physicians and health advocates recommend agencies such as the NIH to at least sponsor research, the FDA formally isn’t interested at all given they haven’t looked into any of it. If they were, some 40 studies with promising results would have triggered at least some initial review. 

And again in some Eastern European nations now the drug has been authorized for use against at least mild COVID-19 but those are different legal jurisdictions and don’t matter in America. 

The meta-analyses generated by Dr. Tess Lawrie and Dr. Andrew Hill in the UK to that of the Front Line COVID-19 Critical Care Alliance (FLCCC) in the USA are all but disregarded—even though the NIH did ask the latter to present to the NIH COVID-19 Treatment Guidelines Panel. While the number of studies indicating some benefit of ivermectin targeting COVID-19 is impressive to some, it’s a non-starter for others. And it just so happens the latter have considerably more power, money and influence.

What’s Going On?

The Ivermectin squeeze is on and the long knives are out and ready. The vested industry, government and medicinal industry concerns won’t have any more of it—deviating from the program that unfolds in front of one’s very eyes. It starts with a story in the Business Insider reporting on claims of increases in toxicity involving self-medication-related abuse. While this most certainly could happen, as stated earlier, there is no data at least to date to back up the story.  Ivermectin at recommended doses has a strong safety profile—this has been established over the last few decades. Of course, no one should ever self-medicate, and TrialSite doesn’t doubt that some gullible people out there would improperly engage in this activity. Not a good idea. 

But there is no doubt that ivermectin use is not welcome off label, even with doctor’s discretion. Again, the NIH’s latest guidance basically passed in any direction—they didn’t recommend against or for in the context of off label use for ivermectin. While the FDA now takes a stronger stance, this most certainly will impact American medical society moving forward.  

So as more countries in Eastern Europe, for example, formally embrace the drug and with dozens of studies now indicating positive attributes in the context of COVID-19, powerful vested interests won’t tolerate any possibility of a cheap available alternative—at least not now. Think Merck’s press release, which highlighted the company’s safety concerns for a drug that they not only helped develop but also gave away in the billions of doses—and it has worked incredibly well for that indication. In the few decades of use, few deaths have ever been reported.

Think the censorship indicators, such as Facebook’s algorithms and curators shutting down sites that simply report on Slovakia authoring the use of the drug for COVID-19, for example. Or most recently Facebook blocking Mary Beth Pfieffer’s article on censorship

But the reality is that a combination of vaccines and therapeutics (monoclonal antibodies, etc.) which TrialSite agrees are critically important, represents minimally $100+ billion in revenue over the next five years, if not considerably more. There is no way that any alternative, at least in America and probably Western Europe, will get in the way of that kind of reality. It’s understandable. That’s how the system works.

TrialSite Take

While the FDA isn’t directly criminalizing off label use, they have issued a strong statement that needs to be understood and respected and will serve to stop off label prescriptions by licensed physicians. They are the Gold Standard agency and while they publicly disclose no specific data (e.g. warning letters, specific reports, etc.) for the declaration—only “reports,” they represent the law of the land when it comes to food and drugs.

So while TrialSite is concerned that the agency didn’t share any examples, i.e. they didn’t produce any warning letters targeting firms exploiting the use of ivermectin for pecuniary gain; or they precluded data based on state or county public health agencies, for example, they only reference vague reports. Again, the one report in the press TrialSite could pin down was one from Missouri Poison Center but there is no data backing the claim either, at least that’s been publicly made available. TrialSite’s attempt to inquire with this organization has been ignored to date.

The reality is that no medication for COVID-19 should ever be taken without a doctor’s prescription, period. And as SARS-CoV-2 is a new and dangerous condition, at least in America the regulatory powers haven’t been interested in this investigational approach. 

The fact is that ivermectin-based research has not been formally embraced by most apex research agencies and regulators in the rich economies (USA, Europe, etc.), and most health systems and physicians follow Board or agency guidance. Despite what many consider significantly positive data produced in various meta-analyses, and individual cases such as the lawsuits where judges ordered the use of the drug, which seemed to have led to positive outcomes, these are just one off data points. The drug is being shut out of America for purposes of the novel coronavirus, at least for physician-prescribed, off label use because that’s the effects this latest edict will have.

Drugs, Power, Politics

The development of drugs is a big, important business. Economically, this sector is worth over $1.2 trillion dollars and contributes not only to the incredible advances in medicines and technologies but also economies. As advanced economies morph into large, state-mediated ones, the vested interests of industry and government becomes ever more entangled and intertwined. The notion of a democratic and free market harkens to perhaps a different more innocent time—or perhaps one that never existed frankly in any modern form.

But based on TrialSite’s research in places like Africa, where several billion in so-called “Vaccine Bonds” will be floated to procure vaccine product to drug’s like remdesivir that generate okay results at best in treatment results yet were supported by the state (e.g. federal government actors) each and every step during the pandemic while promising generic off label approaches are all but ignored, this pandemic represents massive business and financial opportunity in addition to an unprecedented platform for research and development-based innovation in medicinal advancement—think mRNA-based vaccines developed in just months.

That the pandemic may actually lead to an economic boom of unprecedented proportions as capital, technicality and talent are unleashed based on the focused activities during the pandemic in the life sciences sector is not lost on many forces in society.  The culture of medicine, drugs and health itself is complex, with a myriad of tangled interests, regulatory and administrative constructs, specialized scientific and medicinal knowledge, and rapidly advancing technologies that are hard to keep up with. The stakes are enormous for both human health and economy. A public that seeks economical and available alternatives would pressure their politicians to compel the agencies that the taxpayer actually in fact fund via Congress. That presupposes an organized, mobilized and activated set of public interests that in this case are not present in sufficient force.

Call to Action: With an FDA edict such as the one just issued, TrialSite communicates to its network in America (about 50% of the audience) that they (FDA) have to be respected. They are the Gold Standard regulatory body worldwide and represent the food and drug executive branch enforcement agency set up originally to ensure enforcement of the critically important Pure Food and Drug Act. They represent the law of the land when it comes to food and drugs.

Responses

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  1. Please stick to reporting research. Each political, conspiracy-laced article makes you look as self-interseted as those who you oppose.

    1. Hi Ken. We certain appreciate your feedback. TrialSite doesn’t always agree with you but appreciates your consistent critical inputs. Definitely not a conspiracy but we suspect a confluence of interests that is common in most societies in one way or another (e.g. industry sectors, government, etc.) How else can you explain TrialSite reporting study after study with no media attention and once there is one neutral study CNN and NY Times is all over it? Either way we are glad you are here. Cheers TSN publisher

      1. Mr. O’Connor:
        As a "competent" lawyer, I try not to speculate about anything. I accumulate evidence until I can establish a material fact. I recognize that your publication may have a sizable audience that may prefer the former to the latter. This is not a backhanded insult – it’s merely an attempt to encourage you publication to maintain objectivity – because the world is painfully short on this attribute.
        Thanks for your good work.

        1. Thank you Sir. As mentioned we very much appreciate your continuous feedback. We certainly try to remain as objective as possible but we do have some biases that we slip from time to time (think our POV on Sputnik V and Chinese activities, etc.). Cheers

  2. I disagree with Mr Kaplan below. Our government is THAT corrupt and the choices made to lead its departments are predicated on industry insiders. This has been the case in most federal agency administrators’ positions for decades now. And so the door revolves.
    Take the example alone of Gilead Sciences having numerous GS-funded researchers on the NIH board left to determine ivermectin’s efficacy vs. the $3.2 billion they are said to have already generated in profits for remdisivir. Would you (or could you safely) want to interrupt that kind of profit flow? Or would your interests bend toward the altruistic and scientifically rational? I am compelled by observation to believe the big pharmaceutical companies do what they wish for profits über alles in this vulture capitalist neoliberal environment. Look at the track record of Vioxx, they KNEW it was killing people. They KNEW IT!!
    So the resistance to this and to the FLCC doctors’ reports from around the world is too very, very suspect, and I will conclude is just another example of the rapacious environment in which we "exist."
    Which is why I confidently predict and have since I first heard of the forthcoming Gates Foundation’s ivermectin study, that its results are predetermined as to their logical outcome as Gates began investing in Merck approximately 10 years ago with an initial 500,000 share buy. He’s everywhere now. He even funds those who report on him. He owns the playing field!
    So let’s not be naive, Mr Kaplan. It’s so much easier to sniff at contrarians from a lofty, presupposed higher level of jurisprudence rather than do the grunt work (and it IS hard) of objective researching and "waking up and smelling the coffee’ as to what this nation and its Owner class are up to. The fact is we live in a plutocratic kleptocracy. Perhaps that skipped your attention because of its pernicious ubiquity.
    One more thing, @TrialSite News—you might want to rephrase your assertion of ivermectin’s longevity as being only "a few decades." This does not accurately portray how long it has been in use since its discovery in 1983. Correct me if I’m wrong on that date.
    And thank you for this article.

    1. Hi David we believe it was first authorized for animal health in early 1980s and not in humans to treat Onchocerciasis in humans in 1988–so it has a track record of a few decades and some change or more specifically 33 years. Thanks for your participation in the TrialSite Network David!

    2. Mr. Otness: You’re entitled to your opinion, but (1) I don’t appreciate being called naive; and (2) my comments are directed at Trialsite in an effort to encourage the publication to remain an objective news source.
      Re your allegations of wrongdoing by various pharma organizations, I have no comment.

      1. Very well then. I would only conclude with there are many kinds of wars underway in this world right now, many of which remain unacknowledged by most.

  3. Mr. President: I think you need to "clean house" at the FDA.
    Dozens of peer-reviewed prospective studies, population studies, case studies indicate the anti-parasite drug ivermectin is safe and effective against Covid-19. Yet, despite the evidence, the FDA is now cautioning against the use of ivermectin in preventing or treating Covid-19. The FDA is claiming that there are "multiple reports" that required medical support after taking the drug, without supplying the source for the reports; it provides no qualitative or quantitative backing for this declaration—no data from state or county health agencies or hospitals. The agency is ignoring studies that show efficacy of the drug while bringing attention to one neutral study that isn’t particularly well designed, to say the least.
    Of course no one should be self treating Covid-19 without a doctor, no one should be using medications intended for animals, no one should be taking more than the dose deemed safe. This part of the FDA’s stance is perfectly reasonable. But they also say that they have not reviewed the research on ivermectin! Several dozen studies have been published in reputable journals and they haven’t reviewed it? What? Asleep at the switch, I’d say.
    We both know what’s going on here. Your buddies in the US federal government are more interested in stoking the flames of the medical economy, so anything that’s as inexpensive as ivermectin is actively being pushed aside by those in power. I’ve always said that the difference between Democrats and Republicans is what they say, not what they do. Please prove me wrong. DO SOMETHING to reduce human suffering and death by directing the FDA to stop blocking ivermectin’s use in the treatment of Covid-19.

    1. Nice wish. Won’t happen. Not with president, not with the one before him. Yes, it sure seems that several parts of the government are acting oddly, and it is correct of you to ask why, and to easily connect the blatant dots. Half a million Americans have been left to die because of politics and profit motive.
      In many countries IVM is either given away free or is OTC. Both of these result in self-medication. Doing it yourself demands some learning, some careful acts, and some intelligence.
      You will never ever see a paper on a chemical analysis of what is in the animal medication, either the paste kind of the injectable liquid version (that you may not even be able to purchase). AFAIK, there is no special IVM-for-animals-only factory, some filthy germ filled place where psychotics add battery acid and rotting carcasses to the mix. No. Get real. Animal IVM comes from the same pharm factory as human IVM. It’s the exact same drug, made in the same clean and sterile environment, with the same level of quality control. If you have the intelligence to only purchase the "horse paste" with no other added medications, and then read the list of ingredients, look them up, and see if each is safe for human use, and you then make the tiny effort to learn what a proper dosage amount and schedule is, and then have the post-graduate level smarts to turn the dosage ring on the applicator to your approximate body weight, then it is very unlikely that you will have a problem. If you suck down the whole tube, which is usually enough to treat a 1800lb horse, then … well, Darwin has a box of gold medals standing by. It is not the fault of the manufacturer or the retailer if the product is used stupidly.

  4. The bottom line is: if you want any truth concerning Ivermectin do not look to the fda. Personally still trying to understand the FDA authorization of HFCS that is suspiciously on the same time-line as the obesity epidemic which i am completely sure the FDA will dispute. This weird phenomenon of attempting to disprove the obvious with ridiculous unsubstantiated claims has become the canary in the coal mine as to the true motivations of this American academia and other complicit governments.