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.
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.
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.
A 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.