Here’s an interesting article, and about one third of the way down, it shows a slide from an FDA presentation about what is required to obtain an Emergency Use Authorization (EUA) for a new drug or vaccine.
The interesting point is the one at the bottom – to obtain an EUA, there must not be any adequate, approved, and existing alternative. The entire narrated presentation can be seen in context on this YouTube video, and the discussion of this slide starts at about the 10 minute 35 second point.
The presenter makes two points. The first is the self-evident point that EUA is only granted where there are no existing alternatives. The second point is that it is much easier to give an EUA to an existing off-the-shelf treatment that has a known demonstrated safety protocol than it is to give an EUA to an entire new drug or vaccine.
This raises two questions.
First, why has’t an EUA been given to ivermectin? By the FDA’s own standard, it is sufficient to merely show that a drug “may be effective” and also to show that the drug is safe – as the presenter explains, the safer the drug, the lower the standard of proven benefit that is needed to qualify for an EUA. Whatever you think about the Nobel-prize winning drug, IVM, you’ll probably agree that it is definitely safe, based on the millions/billions of doses given over decades of use, and you’ll hopefully also agree, at the very least, that there might be some evidence of it providing some level of positive effect and benefit to Covid sufferers. So – why no EUA for IVM?
The second question, and possibly the answer to the first question, is whether or not there was pressure not to recognize ivermectin and hydroxychloroquine as existing alternatives to the vaccines, meaning the vaccines could not be fast tracked to an EUA. The EUAs were announced starting in December, full final approval for the Pfizer vaccine has not yet happened (but might on Monday). So there were seven months of lead-time at risk.
This is of course nothing more than speculation, because we’ll never know for sure. But I’ve been searching for any type of credible explanation for the irrationality of the experts who pretend that these two cures don’t exist. Here’s the latest example of an irrational expert – a man who describes himself as “Microbiologist, biochemist & molecular geneticist by training. COO for a medical education provider”. In a lengthy series of tweets, this person says :
There are no study results showing any clear benefit to using Ivermectin against covid19. As scientists we remain open minded, and trials are underway. No health agency in the world is advising the use of Ivermectin. Even if we find it has efficacy, the dosage and formulation of what is currently available is geared to parasitic infections, and could be highly toxic to people if they take the drug. It’s not a miracle cure, it has shown limited impact and no trial results yet show convincing data that supports its use against COVID-19.
Let’s look at his several statements :
No study results showing any clear benefit to using ivermectin against Covid19 : In truth, there are 112 studies, nearly all of which show clear benefit, and 70 of which are peer reviewed. That’s an extraordinary, even overwhelming, number of studies and results.
As scientists we remain open minded : Not evidenced in his comments so far!
No health agency in the world is advising the use of ivermectin : Totally wrong, as shown on this website.
Dosage and formulation of what is currently available is geared to parasitic infections and could be highly toxic to people if they take the drug : Wrong in two respects. First, if it is safe to take ivermectin at a particular level, it is always safe to take ivermectin at that level, whether for parasites or for Covid or for nothing at all. Secondly, the studies to date, encompassing over 26,000 patients, have included testing at different levels to determine efficacy and safety.
It has shown limited impact : An 86% reduction in people getting infected if they take ivermectin as a prophylaxis – on a par with vaccine effectiveness; a 61% – 75% improvement if taken as an early treatment, and a 30% – 43% improvement if taken as a late treatment. Those are not limited impacts, They are transformational.
No trial results yet show convincing data : Restating his earlier claim, already rebutted above.
Everything he said about ivermectin is spectacularly wrong. And he is not the only one. Plus, like a snowball rolling downhill, his “voice” – even though comically incorrect – will now be used to “prove” and “support” other naysayers, and so on and so on.
To put this all in context, currently we are expected to think it is acceptable and normal that if we get a Covid infection, we do nothing and hope for the best, and only go to a hospital (if we can find space in one, because they’re filling again) if we’re seriously unwell. That is neither acceptable nor normal. Imagine if we were told to do the same thing with a urinary infection. An infected toe. Earache. And so on.
Seychelles has moved to the top of the minor country list. Within a week or two, it will have passed the point of having 20% of its entire population infected with Covid.
In the major list, the US opens up the gap between it and the third place country, but it will be a very long time before the US finally reaches the Czech Republic (assuming it ever does). The UK moved up a place.
Making up for its rise in the case list, the UK dropped off the death list, being replaced by Mexico.
In the activity last week table, the US moves up one place. The UK cases rose by 14%, while elsewhere in Europe, Germany was up 57%, Switzerland 52%, and Austria 38%. At the other end, Spain was down 38%, and France dropped 10%. Europe as a whole saw a 1% rise.
Canada continued to report strong growth in cases (27%), but its actual case numbers remains very low, even after several weeks of strong growth (442 cases per million in the last week). Mexico dropped a slight 2%, and the world as a whole saw a 4% drop in cases.
Top Case Rates Minor (population under 10 million) Countries (cases per million)
|Rank||One Week Ago||Today|
|1||Andorra (192,807)||Seychelles (195,778)|
|2||Seychelles (190,803)||Andorra (193,628)|
|4||Gibraltar (154,751)||Gibraltar (156,977)|
|10||Aruba (124,448)||French Polynesia (128,633)|
Top Case Rates Major (population over 10 million) Countries (cases per million)
|Rank||One Week Ago||Today|
|1||Czech Republic (156,200)||Czech Republic (156,315)|
|2||USA (112,453)||USA (115,677)|
|3||Argentina (111,358)||Argentina (112,416)|
|12||UK (91,783)||Colombia (94,942)|
Top Death Rate Major Countries (deaths per million)
|Rank||One Week Ago||Today|
|1||Peru (5,893)||Peru (5,906)|
|2||Czech Republic (2,830)||Czech Republic (2,831)|
|8||Poland (1,992)||Poland (1,993)|
|9||UK (1,918)||Mexico (1,940)|
|10||USA (1,914)||USA (1,936)|
Top Rates in New Cases Reported in the Last Week (new cases per million) for Countries over one million population
|Rank||One Week Ago||Today|
|1||Georgia 8,457||Georgia 8,332|
|2||Botswana 5,898||Cuba 5,798|
|8||UK 2,909||UK 3,309|
|10||Mongolia||USA 3,000 (est)|
|11||USA 2631 (est)||Iran|
|12||France 2,535||Kazakhstan 2,609|
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Items below include the reason why at-home instant Covid test kits are hard to find, the US is terrified of Canada, does the FDA have a double standard with vaccines, a possible change to vaccine administration that might greatly boost their effectiveness but which is being ignored in the US, the country with the most people vaccinated is not the one you’d guess, stats on returning to the office and future travel plans, and NYC celebrates recovering from the virus, even while suffering a nine-times increase in virus cases over the last two months.
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3 thoughts on “Covid-19 Diary : Sunday 22 August, 2021”
When an MP in New Zealand questioned why the government made it illegal to buy self-test kits from overseas, he was bombarded with abusive tweets because, according to the twitterati, those kits were ‘not accurate enough’. Indeed, as you say, we are our own greatest enemy.
I had a look at the Twitter thread you wrote about above…remarkably it’s getting hundreds of likes and almost no replies (let alone negative ones) at all….Wow, just wow.
The accuracy issue is an interesting one, but it is only part of the equation.
There are really three things to consider with a Covid test :
(1) How soon after a person becomes infected will the test detect the infection
(2) How soon after the test is administered will the results be available
(3) The “accuracy” – the false negatives and false positives
and possibly a fourth consideration
(4) The cost and ease of administration
Even if we ignore the valid concerns about the accuracy of PCR testing as an alternate to these rapid antigen type tests, PCR testing also fails in terms of the cost/ease of administration and the speed of results. I know this from a very personal perspective – when my daughter thought she might have Covid, her mother first took her to a public test site and got a PCR test, but was told the results would not be available for at least a day (things are not as efficient here as in NZ). So I went out and bought an at-home test and had results in minutes.
The response to the concern about accuracy is to get two antigen tests (at a cost of about US$20) and test twice, with some moderate time interval between them. That is a perfectly acceptable solution.
Modelling studies have shown that the ability to test regularly with a less accurate test actually gives better outbreak control than testing infrequently with a more accurate test.
So I’m all in favor of the at-home antigen testing. I know if I have a scare, the last thing in the world I want to do is waste half a day going to find a public test site somewhere, waiting in line, etc, then waiting another day or more to get the result. I’ll simply reach up in my medicine cupboard, break open an at-home test, and within minutes have a high-probability result, and if I need further confirmation/reassurance, repeat it again the next day.
you make excellent points. Maybe you should return to NZ and run for parliament 🙂