Food and Drug Administration — lazy, corrupt and incompetent — ivermectin, with an illustrating aside about fluvoxamine

09 March 2021

Let's start backwards . . .

. . . going from a pertinent example of how frontline COVID research really works — and on to my ultimate point about the obstructive uselessness of American government. Here exemplified by the FDA.

First — where the majority of real COVID pandemic investigative work has been done

COVID-19 therapeutic progress has mostly come from on-scene medical providers.

A major international emphasis has been upon repurposing existing, inexpensive generic drugs for COVID use. That's because most people and most of the world are poor.

Scientifically minded physicians, during pandemic times, often look at various drugs' biochemical methods of action. They evaluate whether those biomolecular specifics might be effective against the new illness's emerging physiological mechanisms of action.

An example of this kind of thinking showed up in 60 Minutes' examination of accumulating evidence in fluvoxamine's COVID favor:

60 Minutes, COVID-19 research points to repurposed drugs, cbsnews.com (07 March 2021)

In watching the above video . . .

Notice that fluvoxamine's trek through America's regulatory obstructionism had to be sponsored by a handful of determined front-line medical providers. Who — in turn — have been financially supported by Silicon Valley entrepreneur Steve Kirsch's COVID-19 Early Treatment Fund.

In short, the entirety of research in repurposing generic drugs (for COVID) comes courtesy of randomly distributed charitable feeling. And virtually none from Government or Big Pharma.

That seems backwards to me.

This is the Useless Government pattern that has plagued COVID therapeutics across much of the world. It has been, for the most part, medical providers — living at the bottom of the prestige chain — who are doing the investigative and public health thinking that Government should be — but is not.

In fact, as we will see, Government and Big Pharma continually get in these solution-providing providers' ways. While, hundreds of thousands — to millions — of people continue to die.

US incompetence

Institutionalized bureaucratic idiocy in the United States — with its flaunted lack of sensibly applied investigative and economic will — has managed to kill off about 540,000 of us, so far.

And from the beginning, the FDA has been doing its obstructive (Big Pharma-supporting part) to passively keep this extermination going.

Most recently so, by suppressing the internationally supported use of (inexpensive) ivermectin in preventing and treating early-on SARS-CoV-2 infections.

Consider, for example, the following FDA statement

Filled, as it is, with lying distortions — as well as with a shameless admission of its own medical malpractice:

There seems to be a growing interest in a drug called ivermectin to treat humans with COVID-19. Ivermectin is often used in the U.S. to treat or prevent parasites in animals.

The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.

FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans.

Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea.

Ivermectin is not an anti-viral (a drug for treating viruses).

Taking large doses of this drug is dangerous and can cause serious harm.

The FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19; however, some initial research is underway.

First, look at the lies

I, and others, have looked for examples of these reports of animal ivermectin (in humans) overdoses. Curiously, there appear to be none. At least not, publicly available. And certainly not cited by the FDA.

True, there are online mentions of how to get the drug from veterinarians — in its animal forms — for anticipated use in humans, who are trying to protect themselves from COVID-19. But nothing about people keeling over, after having treated themselves with the animal-intended substance.

Second, ivermectin is one of the planet's safer drugs. It has a many-decades-long record for safety under intense anti-parasitic use, particularly in the tropics.

The FDA's statement about overdosing assumes that people are — evidently due to their inferred ignorance — and are paying the price for that.

A saner way of looking at the potential problem is to recognize that the people doing animal ivermectin are trying to copy human ivermectin doses gathered from COVID therapeutics literature.

If so, the FDA's assumption that these are all ignorant klutzes seems far-fetched to me. No one in that literature-seeking crew is going to sign up for a 'horse dose', when they already have the sophistication to track down current therapeutics, regarding evolving COVID treatments.

The FDA's fearmongering parallels that which American agencies previously did in hysteria-mongering about hydroxychloroquine.

Hydroxychloroquine is a generic drug that also has exhibited a many decades-long record of safety, which far exceeds anything that remdesivir and any of the new COVID vaccines can yet demonstrate.

Third, contrary to the FDA's claim that "Ivermectin is not an anti-viral" — it is exactly that, in some contexts. See, for example:

Fatemeh Heidary and Reza Gharebaghi, Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen, Journal of Antibiotics 73(9): 593-602, DOI: 10.1038/s41429-020-0336-z (12 June 2020)

Fabio Rocha Formiga, Roger Leblanc, Juliana de Souza Rebouças, Leonardo Paiva Farias, Ronaldo Nascimento de Oliveira and Lindomar Pena, Ivermectin: an award-winning drug with expected antiviral activity against COVID-19, Journal of Controlled Release, vol 329: 758-761, https://doi.org/10.1016/j.jconrel.2020.10.009 (10 January 2021)

Fourth, international data regarding ivermectin's suspected effectiveness in treating COVID is widely available. See here, for example.

FDA's glaring confession of sloth-filled incompetence

"The FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19," they tell us.

Yet, ivermectin has been on the COVID horizon for almost a full year, with regard to COVID. Physicians in other countries have been using it with apparent success.

In sum, we have a major American public health agency confessing that it:

does not comprehend ivermectin's long-demonstrated biochemical methods of action — including its use in some antiviral contexts

is not interested in how other nations (evidently successfully) treat COVID

and

has ignored (President of the Frontline COVID-19 Critical Care Alliance, FLCCC) Dr. Pierre Kory's Congressional testimony in ivermectin's favor —

while simultaneously

demonstrating no sense of moral and professional duty

to promote research into effective ways to convert cheap generic drugs into anti-pandemic uses.

In short, the FDA's has been a typically American failure of institutional ethics, societal purpose and energy.

That is your FDA

Corrupt to its obstructive, Big Pharma-controlled core.

Deliberately cherry-picking bad evidence?

From scientifically botched sources?

The FDA (possibly) and the Lamestream (overtly) may be treating a recently ivermectin-dismissing Colombian study — as if that one report should outweigh better-conducted evidence-gathering from other sources.

Humorously, from my jaded perspective, the Colombian study contained the following, self-confessed weaknesses:

This study has several limitations.

First, the study was not conducted or completed according to the original design, and the original primary outcome to detect the ability of ivermectin to prevent clinical deterioration was changed 6 weeks into the trial. In the study population, the incidence of clinical deterioration was below 3%, making the original planned analysis futile. Ultimately, findings for primary and secondary end points were not significantly different between the ivermectin and placebo groups.

Second, the study was well-powered to detect an HR [hazard ratio] for resolution of symptoms of 1.4 in the ivermectin vs placebo groups, but may have been underpowered to detect a smaller but still clinically meaningful reduction in the primary end point.

Third, virological assessments were not included, but the clinical characteristics that were measured indirectly reflect viral activity and are of interest during the pandemic.

Fourth, the placebo used in the first 65 patients differed in taste and smell from ivermectin. However, patients from the same household were not included until the placebo with the same organoleptic properties was available, and the lack of effect of ivermectin on the primary outcome was similar when compared with either formulation of placebo.

Fifth, 2 secondary outcomes used an 8-category ordinal scale that in initial stages requires patient self-reporting and thus allows subjectivity to be introduced.

Sixth, data on the ivermectin plasma levels were not collected.

Seventh, as already noted, the study population was relatively young and results may differ in an older population.

© 2021 Eduardo López-Medina, Pío López, Isabel C. Hurtado, Diana M Dávalos, Oscar Ramirez, Ernesto Martínez, Jesus A. Díazgranados, José M. Oñate, Hector Chavarriaga, Sócrates Herrera, Beatriz Parra, Gerardo Libreros, Roberto Jaramillo, Ana C. Avendaño, Dilian F. Toro, Miyerlandi Torres, Maria C. Lesmes, Carlos A. Rios and Isabella Caicedo, Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19 — A Randomized Clinical Trial, JAMA, doi:10.1001/jama.2021.3071 (04 March 2021)

Nevertheless, the paper's authors labeled this methodological mess, a "randomized clinical trial".

Societally speaking, the anti-ivermectin US charade reminds me of Big Brother's previous anti-hydroxychloroquine escapades. Those, even down to having quoted evidence from an obviously fraudulent 'study'. See here and (definitively) here.

The moral? — Corruption is American Government's core function

Way more than half a million COVID dead and still counting.

If this situation does not infuriate you — you are not paying knowledgeable attention to the stranglehold that Government and the Global Oligarchy have on our throats and thinking.

PeteFree.com

Food and Drug Administration — lazy, corrupt and incompetent — ivermectin, with an illustrating aside about fluvoxamine