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Craig Kelly has been saying this for months, but I thought it was worth a simple summary of the current situation with regard to the use of Ivermectin to prevent/treat the Wuhan Flu.
The Australian Department of Health website advises:
There is currently insufficient evidence to support the safe and effective use of ivermectin, doxycycline and zinc (either separately, or in combination) for the prevention or treatment of COVID-19. More robust, well-designed clinical trials are needed before they could be considered an appropriate treatment option.
The National COVID-19 Clinical Evidence Taskforce, consisting of a large group of clinical experts, is continuously updating treatment recommendations based on the best available evidence. They have not made any recommendations for the use of ivermectin, doxycycline or zinc outside of properly conducted clinical trials with appropriate ethical approval.
Furthermore, there is insufficient data to recommend neither for nor against the use of zinc for the prevention or treatment of COVID-19.
That entry is dated 1 June 2021.
The US FDA says (my emphasis):
COVID-19. We’ve been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it’s perhaps not surprising that some consumers are looking at unconventional treatments, not approved or authorized by the Food and Drug Administration (FDA).
Though this is understandable, please beware. The FDA’s job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use, and then to decide whether or not to approve it. Using any treatment for COVID-19 that’s not approved or authorized by the FDA, unless part of a clinical trial, can cause serious harm.
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.
Here’s What You Need to Know about Ivermectin
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.
If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed.
Never use medications intended for animals on yourself. Ivermectin preparations for animals are very different from those approved for humans.
What is Ivermectin and How is it Used?
Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical (on the skin) forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea.
Some forms of ivermectin are used in animals to prevent heartworm disease and certain internal and external parasites. It’s important to note that these products are different from the ones for people, and safe when used as prescribed for animals, only.
When Can Taking Ivermectin Be Unsafe?
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. Taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too.
There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin. That is wrong.
Even the levels of ivermectin for approved uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.
Ivermectin Products for Animals Are Different from Ivermectin Products for People
For one thing, animal drugs are often highly concentrated because they are used for large animals like horses and cows, which can weigh a lot more than we do—a ton or more. Such high doses can be highly toxic in humans.
Moreover, FDA reviews drugs not just for safety and effectiveness of the active ingredients, but also for the inactive ingredients. Many inactive ingredients found in animal products aren’t evaluated for use in people. Or they are included in much greater quantity than those used in people. In some cases, we don’t know how those inactive ingredients will affect how ivermectin is absorbed in the human body.
Meanwhile, effective ways to limit the spread of COVID-19 continue to be to wear your mask, stay at least 6 feet from others who don’t live with you, wash hands frequently, and avoid crowds.
The above, largely strawman, diatribe is dated May 3, 2021. Doctors advocating the use of Ivermectin, and those conducting clinical trials (none of which are detailed in either government website), are not suggesting that people should self-medicate, that they should binge on the stuff or that they should take versions designed for horses.
I don’t know how many clinical trials are currently underway (Craig Kelly says many) but the US National Institutes of Health National Library of Medicine has an article detailing the results of a number of successful trials. The summary of that article is:
To date, the efficacy of ivermectin in COVID-19 has been supported by the following:
Since 2012, multiple in vitro studies have demonstrated that Ivermectin inhibits the replication of many viruses, including influenza, Zika, Dengue, and others.
Ivermectin inhibits SARS-CoV-2 replication and binding to host tissue through several observed and proposed mechanisms.
Ivermectin has potent anti-inflammatory properties with in vitro data demonstrating profound inhibition of both cytokine production and transcription of nuclear factor-κB (NF-κB), the most potent mediator of inflammation.
Ivermectin significantly diminishes viral load and protects against organ damage in multiple animal models when infected with SARS-CoV-2 or similar coronaviruses.
Ivermectin prevents transmission and development of COVID-19 disease in those exposed to infected patients.
Ivermectin hastens recovery and prevents deterioration in patients with mild to moderate disease treated early after symptoms.
Ivermectin hastens recovery and avoidance of ICU admission and death in hospitalized patients.
Ivermectin reduces mortality in critically ill patients with COVID-19.
Ivermectin leads to temporally associated reductions in case fatality rates in regions after ivermectin distribution campaigns.
The safety, availability, and cost of ivermectin are nearly unparalleled given its low incidence of important drug interactions along with only mild and rare side effects observed in almost 40 years of use and billions of doses administered.
The World Health Organization has long included ivermectin on its “List of Essential Medicines.”
A summary of the statistically significant results from the above controlled trials are as follows:
Controlled trials in the prophylaxis of COVID-19 (8 studies)
All 8 available controlled trial results show statistically significant reductions in transmission.
Three RCTs with large statistically significant reductions in transmission rates, N = 774 patients.
Five OCTs with large statistically significant reductions in transmission rates, N = 2052 patients.
Controlled trials in the treatment of COVID-19 (19 studies):
♦Five RCTs with statistically significant impacts in time to recovery or hospital length of stay.
♦One RCT with a near statistically significant decrease in time to recovery, P = 0.07, N = 130.
♦One RCT with a large, statistically significant reduction in the rate of deterioration or hospitalization, N = 363.
♦Two RCTs with a statistically significant decrease in viral load, days of anosmia, and cough, N = 85.
♦Three RCTs with large, statistically significant reductions in mortality (N = 695).
♦One RCT with a near statistically significant reduction in mortality, P = 0.052 (N = 140).
♦Three OCTs with large, statistically significant reductions in mortality (N = 1688).
In addition to the trials, there are reports of actual widespread clinical usage in India and other parts of the world.
So why do the US and Australian governments continue to ignore what should be very welcome news? Let me quote Dr Jay Bhattacharya, a Stanford trained economist and physician:
The NIH exists to solve market failure’, however, the agency ‘has made comparatively little effort to catalyze randomized evaluations of off-patent drugs from Covid 19 therapeutics’, but ‘has devoted considerable resources to aid the Covid-19 vaccination randomized trial studies.
Argentinian doctor Hector Carvallo, the lead researcher in one preventive study – a study that resulted in all 788 people who received Ivermectin remaining uninfected, as opposed to 50 per cent of the control group who did – believes that ‘by now half of Argentina is using Ivermectin’. He says that his team faced pressure from ‘many doctors who worked for the pharmaceutical industry, because this was a very, very cheap treatment’.
That is one reason but, here in Australia, I believe there is another.
We are told that the vaccines will not prevent you from catching or spreading the disease but that they will prevent you from getting seriously ill. That’s good enough for me but not everyone is convinced. Government is desperate to get everyone vaccinated, despite the sluggish roll-out and the contrary and conflicting edicts and opinions from chief medical officers. And this has been exacerbated by “vaccination resistance” engendered by the news of blood clots and mixed messaging from the government. This leaves the government with the choice of forcing people to have a vaccine many don’t want, thus infringing on some very basic human rights, or allowing them to take a chance and refuse the vaccine and be it on their own head. In the latter case it would be a totalitarian state that denied those people an effective treatment. The knowledge that an effective treatment was available, would certainly inhibit the purported aim of getting 80 per cent of people vaccinated. To avoid this complication, I suspect the authorities are professional incurious about Ivermectin, which they are content to leave on the back burner.
Back in April 2020, researchers from Monash University’s Biomedicine Discovery Institute (BDI) with the Peter Doherty Institute of Infection and Immunity at Royal Melbourne Hospital recently published the results of a study revealing that Ivermectin, an approved anti-parasitic drug available worldwide, may actually treat against SARS-CoV-2 when applied to an infected cell culture. They also suggested Ivermectin be seriously investigated for possible use in humans.
The announcement that this research would be undertaken in Australia was covered on the Bolt Report. My impression then was that the research would involve clinical trials on humans, but I may be misremembering. As far as I’m aware, despite the recommendation from this trial, nothing further has been done in this country in over 12 months. And one wonders why the research team confined themselves to in vitro research in the first place, which, according to the NIH report above had shown promising results as early as 2012. Much must already have been known at this level. This is particularly odd, since the impetus for the trial initially came from representations by Dr Tomas Barody, who had already demonstrated the effectiveness of Ivermectin on human patients. I smell a large, laboratory rat.
And one final thought. Now that we have a number of vaccines, principally thanks to President Trump and his Operation Warp Speed, it is much easier for governments to sideline the Ivermectin treatment. But, given that development of a vaccine for a coronavirus was highly problematical – never having been done before nor in such haste – why was an effective treatment not fast-tracked as well? In April 2020, we had no guarantee a vaccine would be available by the end of the year and all the pundits were saying it would take at least 18 months.
Furthermore, according to Rebecca Weisser speaking to Alan Jones on Wednesday night, the incidence of adverse reactions to these vaccines – including fatalities – is considerably higher than we have been led to believe. This, we can safely assume, is because their development was fast-tracked and interim approval for emergency use was given in advance of full clinical trials. All of which suggests they should only be given to the most-at-risk group. Which, in turn, adds even more weight to the case for an effective prophylaxis and/or treatment viz ivermectin or hydroxychloroquine.
And now the big question: How many people died (or will die) that need not have, due to this politicised, mercenary and cavalier approach to public health? And who will pay?
Q: “How many people died (or will die) that need not have, due to this politicised, mercenary and cavalier approach to public health? And who will pay?”
.
A: Don’t know the answer to the first part, but I’m 99% sure that those responsible for the deaths will not be the ones who pay, which leaves the ones whom the dead leave behind paying, in the sense of suffering needlessly.
A very recent meta-analysis involving 15 trials in the American Journal of Therapeutics concluded “Moderate certainty evidence finds that large reductions in Covid-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally”. Yet our health authorities continue to claim there is insufficient evidence for its use, and despite vaccines being rushed into widespread use, we are encouraged to overlook risks that are becoming more accepted over time.
So, at the risk of labouring the point, at the beginning of a pandemic that was laying waste to much of the world, the Australian government put all its faith in an, at that stage, highly speculative vaccine. At that time, the strategy (now long lost in the mist of time) was to ‘flatten the curve’ which necessarily implies a need to treat patients. And yet they ignored a recommendation, from a highly respected research organization, to proceed to clinical trials of what had, even by then, been shown to be an effective treatment.
Covid-19 is a complex disease that requires early, multi-drug treatment. A number of protocols have been published by groups of practising physicians. The most advanced of these are those devised by the FLCCC Alliance (Front Line Covid-19 Critical Care Alliance – see their website).
All physicians advocating protocols using Ivermectin either alone as a prophylactic or in combination with other drugs, especially Fluvoxamine, stress the need for EARLY TREATMENT i.e. treatment should begin when symptoms appear. The first week is critical. Yet in many place those with the disease have been told to isolate at home and only come to hospital if they develop symptoms such as difficulty breathing or heart problems – but this is far too late according to the FLCCC Alliance.
There is a vast amount of information ‘out there’ about the use of Ivermectin for Covid-19. Governments are listening to epidemiologists and public health experts – often not very good ones, who are making irrational recommendations – when they should be listening to physicians who are actually treating patients.
Those advocating Ivermectin and HCQ have been stressing, since the beginning, that it must be used early and in conjunction with Zn and an antibiotic. That is as far as treatment is concerned, but it has also been shown to be effective as a prophylactic.
Yes, this disease is a hard one in many ways. How it is passed on, who catches it, what symptoms each infected person experiences, and when -there are a lot of uncertainties and unknowns.
But, let us be aware of the weaknesses, in terms of administrative ambiguities and unknowns in the public services generally when it comes to who has the responsibility to take charge of what tasks.
Examples: the VIC fires and the massive loss of life. And remember what happens when terrorists take hostages. And what happens when criminals/terrorists use cars/trucks to mow down civilians on Melbourne inner-city streets. And the NSW public service departments who did not know it was their responsibility to assess the staus of the virus infections on cruise ships in Sydney Harbour. And the officer in one of those departments who did not know how to read the reports drawn up by the ships’ doctors. -Very few people in the public sector, with nominal responsibility to keep civilians safe, seem to know who should do what.
Add to this the consequences of affirmation action -Identity instead of Competence all throughout the public services, incl in healthcare services.
Add to that the occupancy of some senior/critical public service healthcare roles persons of anti-Westernist/anti-free enterprise/ Big Statist disposition.
Then there’s the persons holding senior public service roles who are Peter Pan types for whom it’s all an adventure, a chance for celebrity. It is clear that these persons possess no real clue, no real interest, as to what constitutes technical competence or its significance in making things work properly, even in healthcare.
Add to these factors the use for security purposes companies of non-Western management and front-line staff all of zero technical competence -simply because, to marxist politicians and marxist public servants, non-white is better than say white ADF personnel.
With all of this, and its trust-destroying consequences, it no surprise at all that some civilians skirt lockdowns and/or do not believe the vax is any darn help. They are thinking: Why believe what the “authorities” say.
And beyond this current Chinese Plague, fewer and fewer Ordinary People trust the politicians and the public servants.
(Elsewhere, I see Turnbull is saying the vax roll-out is all a terrible mess -the worst “government” failure ever. But to me, Turnbull’s strange decisions re NBN and the subs, and his attempt to throw the 2016 election to the ALP-union-Green forces, all looked exceedingly bad.)
Commenting on a piece by Natasha Robinson, this comment was rejected by The Australian yesterday:
“As Professor Cheng says, medicine respects patient autonomy. The choice of the AstraZeneca vaccine is ultimately for a young person to make.” What about Ivermectin and Hydroxychloroquine?
You have more tenacity in this case than I do, POB. I’m 17 days clean and counting, and not missing my daily rejections.
There are so many threads to this issue it is difficult to pick them apart. One such thread is the politicization of social media caused by the indemnity provided by Section 230 of the US Communications Decency Act. This provides that an “interactive computer service” can’t be treated as the publisher or speaker of third-party content”. In other words social media is treated legally like a telephone line rather than like a newspaper publisher. A newspaper publisher is held responsible for content, but a social media company is not. This results in a situation where social media companies can censor that “telephone line”, that is manage content, without being held accountable.
O’Sullivan’s Law states that any organization or enterprise that is not expressly right wing will become left wing over time, and so it has become with social media companies. Consequently social media companies now “manage” content in support of leftwing priorities. This will not change unless social media is treated legally the same a other media, or is forced to become like that telephone line, obliged to carry whatever content is input by the public.
Just as politics has struggled to come up with a consistent line on Covid (origin, treatment, vaccines etc.), so social media has struggled to keep up. As the origin story has evolved, the reaction has been to stick to a position until leftwing authority figures say otherwise. It is likely to be the same with vaccines and various other treatment options as well.
The indirect benefits of the published protocols for rational, early treatment of Covid-1919 with repurposed drugs including Ivermectin are these:
Gives GPs an effective first-line treatment to offer patients
Returns power to the people
Cures the pandemic of fear
Eliminates the need for tyrannical lockdowns, masks and other evidence-free interventions
Eviscerates the arguments for compulsory vaccination
Provides time for proper study of the adverse effects of the vaccines
Those benefits accrue in addition to the primary benefit of actually curing the sick.
Once again, the mainstream media by suppressing that which is widely known, act as gatekeepers, not so much for government policies who seem to be part of the same plot, but for Big Pharma. Why are governments and media working for Big Pharma? This is getting really quite sinister.
Unfortunately the sustained opposition to the use of repurposed drugs, which has been driven primarily by people with political and commercial interests wishing to promote mass vaccination, has been widely supported by prominent academic experts in evidence-based medicine and epidemiology. These include the brilliant opponent of lockdowns, and one of my personal pandemic heroes, John P. A. Ioannidis.
This is a very sad situation from an intellectual perspective. The argument against the FLCCC Alliance protocols is that, although they appear to work, and are endorsed by highly competent doctors who have successfully treated thousands of patients with them, their use is not supported by large randomised controlled trials (RCTs). But this argument should be rejected, for the following reasons.
While nobody will question the supremacy of RCTs in the modern hierarchy of evidence, the absence of RCTs (which can occur for a number of reasons) is not the same thing as an absence of good evidence. In fact no medical treatments in use up to and including the Second World War were supported with RCTs, the first of which was run in 1948. Yet most of the really valuable medicines in use today were in common use long before then. They include insulin and penicillin. If one goes back in time to the early nineteenth century, long before the era of the great modern medical miracles, one finds the discovery and widespread adoption of smallpox vaccination from the early 1800s. No RCTs.
Therefore there is a real need – rather than undermining the use of repurposed drugs, which is rarely supported by RCTs – to reformulate the concept of evidence currently dominant in the academic Evidence-Based Medicine (EBM) movement. In particular, the combination of well-documented, systematic practical experience (short of RCTs) with a rational mechanism of action should be considered good evidence in some circumstances.
Finally, let it be remembered that none of the non-pharmaceutical measures that have been extensively deployed on expert advice in this pandemic have been supported by RCTs, nor are they supported, in the main, by experts in EBM. Rather they have been justified – in spite of their known adverse effects – on the grounds of a public health ’emergency’. Similarly the vaccines, none of which have been tested according to accepted standards of evidence, have been rolled out to billions of people on the basis of ’emergency authorisation’. It is inconsistent to bless this type of activity in public health, and then turn round and prohibit the use of repurposed drugs, which (unlike the Covid vaccines) are already known to be safe, effective and harmless when taken under medical supervision.
Tsk, tsk, Mr O’Brein, “whose” is a personal pronoun and drugs are impersonal. The headline should have read “A drug, name of which must not be uttered”.
NFW, first, Peter didn’t write the headline. That was me, as it is with almost everything we publish. As to the grammar, I’m reminded of Orwell’s advice: don’t break the rules of grammar unless the result is ugly. In this instance, your suggested headline is something Quasimodo might have fathered. Beyond that, what people who don’t write headlines for a living seldom grasp is that the bloody thing has to fit the available space — in this instance, a per-line homepage character count over three decks of no more than 14 characters each.
Golly, but how I would have liked to have you suggesting headlines as a down-table sub. A stern talking-to and a bit of vigorous re-education would be in order, and I always enjoyed that. — RF
Stephen Due, thank you for your detailed explanation.
Further to Stephen Due’s contribution, the need for large scale RCTs in the case of Ivermectin and Hydroxychloroquine is mitigated not only by their demonstrated effectiveness but also by the fact that they have been used safely for other conditions for decades.
See also the website of the American Association of Physicians and Surgeons
https://aapsonline.org/
and the important site
https://c19protocols.com/
Apologies: that should be ‘Association of American Physicians and Surgeons’
I am waiting for the class action by relatives of the unnecessarily deceased. Having a treatment that was denied to the sick and suffering should be worth millions but of course the taxpayer will pay.