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|
I Am Not a Doctor, But….
I noticed that the almost-instant, low-cost, at-home Covid test kits have transitioned from being available in lots of different places to now being scarce and hard to obtain. I looked on Amazon and it no longer even shows them at all, not even on back-order.
There’s a reason for this. A surprising and frustrating one. The manufacturer destroyed what they thought would be no longer needed surpluses of inventory, believing that virus case numbers were dropping steadily all the way to zero. They had hoped to at least sell them internationally in other countries, but that proved to be impossible due to a mess of regulations.
They are now struggling to restart bulk production again. As I repeatedly observe, the biggest problem in our fight against the virus is not the virus, it is ourselves.
Talking about stunningly stupid decisions, in Canada, their level of Covid cases is currently seven times lower than our level here. To put that another way, if you met a Canadian, they are seven times less likely to be carrying the virus than if you met another American. But, the people in charge of protecting us have decided the risk is unacceptably high to allow Canadians into the country at present.
Actually, I’d rather surround myself with Canadians than with my friends and neighbors at present. The Canadians are seven times safer. They’re also massively braver – Canada is allowing Americans to enter their country, even while we refuse to allow them here.
I’ve commented above about how the official support for the vaccines may have encouraged a spurning of ivermectin and hydroxychloroquine. But as well as that, it is interesting to note there seem to be two different levels of love being given to vaccines.
At the one level, we see Pfizer and Moderna, who can apparently do no wrong. Most recently, there are suggestions the Moderna vaccine might cause a higher risk of heart inflammation. The FDA says it is reviewing the data.
But when there was a suggestion, a couple of months ago, that there might be a negative outcome from the Johnson & Johnson vaccine, the FDA made a big showy public ban on all J&J vaccinating for several days before it had reviewed the data and decided there was nothing to worry about (something that was essentially self-evident right from the get-go). The FDA said they did this to “boost confidence” in the vaccine approval process. But, quite the opposite occured. Public confidence in the J&J vaccine, which was always lower perhaps because it was “only” one shot instead of two (some people seem to think two must be twice as good as one) or because of lower levels of effectiveness by some measures, collapsed, and has never recovered, to the point that many places are no longer even bothering to stock it and offer it as an option.
That is a shame, because it seems the J&J vaccine might possibly be more long-lasting and effective than the two mRNA vaccines (Pfizer and Moderna).
As for the AstraZeneca vaccine, while it is true its testing protocols were a terrible mess, it has never even been submitted to the FDA for approval – my sense being that the AZ people were selling all the vaccine they could make, anyway, elsewhere in the world, and didn’t want to risk the embarrassment of the FDA turning it down. It is a similar type of vaccine to the J&J vaccine (an adenovirus vaccine) and it too has been shown to have long life.
Which leads me to my observation, not for the first time, that while the Pfizer and Moderna vaccines might have been better than nothing, I’m far from convinced they are the best, now that we have dozens of different vaccines either approved or nearing approval.
While I’ve been very critical of the Pfizer and Moderna (and AstraZeneca) vaccines, I’ve actually been surprisingly accepting of the (very limited) data presented by their manufacturers, and have accepted, pretty much without question, that their dosing guidelines have been optimized, both in terms of the strength of each dose, and the time between the two doses.
I did note the surprising accidental discovery in the AZ trials that an initial half-strength dose seemed to end up giving better protection than two full-strength doses, and wondered why that wasn’t acted on further. But I never really thought to question the recommendation from Pfizer that their two doses be four weeks apart, nor the recommendation from Moderna that their two doses be three weeks apart.
The main purpose of the second phase of the three phases of trials for a vaccine (or other drug) is to get the dosage right. The researchers experiment with different dosages to see which work better, so it is reasonable to expect that their ultimate recommendations are science based rather than created by rolling a pair of dice.
So I was dismissive of countries deciding to increase the gap between doses so they could give more first doses to people, albeit at the cost of giving them timely second doses. “Follow the science” seemed to be clearly indicated, and I also observed how the CDC, here in the US where we are not short of vaccine, continues to urge that we follow the timing guidelines between doses.
But it seems the timing between doses may be way too short, and much better protection might be gained by increasing the timing considerably. Here’s just one recent commentary on that, there have been other formal studies conducted as well.
If indeed a longer gap is better than the current 3 and 4 week gaps, shouldn’t the pharmaceutical companies know that too? Shouldn’t they be advising the FDA, and shouldn’t the FDA be updating their EUAs? It will be interesting to see what the full approvals state, if anything.
The downside to incorrect timing between doses, by the way, is of course major. It may help to explain why there have been so many vaccine breakthrough cases, and why we now need a booster shot after only eight months.
Timings And Numbers
Here’s an update on how well the world is doing when it comes to getting vaccinated. Canada is now leading the world, both in fully vaccinated people and in people partially and fully vaccinated.
Well done Canada. But how then to explain that in the last month, Canada’s new Covid case rate has increased six-fold?
Closings and Openings
This article has some interesting statistics on the percent of people back in offices around the world.
With timing rather reminiscent to President Biden’s July 4 Freedom from the virus Party, New York City held a concert to celebrate its recovery from the coronavirus today. Should we mention that New York is experiencing an average of over 4,500 new cases every day at present, a nine times increase in the last two months? That’s a very strange recovery.
This set of data views reporting on a survey about the impact of the virus on travel plans is a bit frustratingly vague in some respects, but still mildly interesting, particularly to see how evenly balanced the pro and anti groups are on issues like masks.
Please stay happy and healthy; all going well, I’ll be back again on Thursday.