A happy, healthy and safe Thanksgiving to all
celebrating today.
In the stock casinos, rising mania, fuelled by expectations
of a Biden Boom from more “free” money.
“It’s true that stock prices are quite expensive but markets are finding
fewer and fewer reasons to sell them. In this environment, you can’t make
profits by selling. The only question to ask is what assets you should buy.”
My thoughts, buy gold and silver
on every major sell off.
In the real world, SARS-CoV-2
infections are soaring again, the general public is running out of money, governments
are running out of room to increase “free money” for all, and winter is just
about to start in the northern hemisphere.
You can fool some of the people some of the time -- and that's
enough to make a decent living.
W. C. Fields.
Asian shares advance as vaccine,
recovery hopes triumph soft U.S. data
November
26, 2020
he makers of a third coronavirus vaccine announced
positive results in clinical trials on Monday, setting off yet another
round of excited news reports. This one, produced by a partnership between a
University of Oxford research institute, its spinout company Vaccitech,
and the pharmaceutical company AstraZeneca, does not need to be stored at
freezing temperatures and would be cheaper and easier to produce than the
high-efficacy vaccines produced by BioNTech-Pfizer and Moderna. Indeed,
according to an initial
write-up in TheNew York Times, Oxford-AstraZeneca’s is
“expected to be relied upon heavily across the globe, to help curb a pandemic
that has killed more than 1.3 million people.”
Sounds like great news, right? Monday’s press release from
AstraZeneca presents “convincing
evidence that [the vaccine] works,” said Science. But not everyone
has been convinced. The price of AstraZeneca’s shares actually
dropped on the news, and an analysis from an investment bank concluded, “We
believe that this product will never be licensed in the US.” Over at STAT
News, Anthony
Fauci cautioned that we’ll need to see more data before coming to a
conclusion. The skeptics have strong reasons to be concerned: This week’s “promising”
results are nothing like the others
that we’ve been hearing about in November—and the claims that have been drawn
from them are based on very shaky science.
The problems start with the fact that Monday’s announcement
did not present results from a single, large-scale, Phase
3 clinical trial, as was the case for earlier bulletins about the
BNT-Pfizer and Moderna vaccines. Instead, Oxford-AstraZeneca’s data came out of
two separate studies: one in the UK that began
in May, and another in Brazil, which got started at
the end of June. These two studies were substantially different from one
another: They didn’t have standardized dosing schemes across the trials, for
one thing, nor did they provide the same “control” injections to volunteers who
were not getting the experimental Covid vaccine. The fact that they may have
had to combine data from two trials in order to get a strong enough result
raises the first red flag.
Consider that leading vaccine makers—including
AstraZeneca—issued a scientific-rigor-and-integrity
pledge back in September, in which they promised to submit their products for
approval or emergency use authorization only “after demonstrating safety and
efficacy through a Phase 3 clinical study that is designed and conducted to
meet requirements of expert regulatory authorities such as FDA.” Note the
wording here: These companies did not suggest that they might claim to have
demonstrated efficacy through multiple, distinct clinical studies, combined
together to get enough data. They said they would use a Phase 3
study—as in, one big one. Yet AstraZeneca has already applied on the
basis of this data for approval in
Canada, and has plans to do the same in Britain, Europe and Brazil. The
company also says it will use the data to apply for emergency use authorization
in
the US.
The Food
and Drug Administration’s guidance for Covid-19 vaccines does allow for
emergency use authorization based on interim analyses, but the same document
says this must be supported by a minimum level of vaccine efficacy “for a
placebo-controlled efficacy trial.” Again: it refers to a trial. That
is exactly what BNT-Pfizer and Moderna did. Both released the FDA-approved
blueprints for their trials—called trial protocols—weeks ahead of time, with
details of the calculations and statistical rules that they’d use to determine
when to perform an interim analysis and how much certainty could be attached to
those results. When BNT-Pfizer’s discussions with the FDA led to changes in
this plan, BNT-Pfizer explained why, and released an updated protocol. That’s
scientific rigor, and it matters a lot. When a vaccine-maker specifies the
rules of the game before the results start coming in, we can check their work
and be confident in what they tell us at the end. We can make sure they haven’t
cherry-picked the data.
Following the markets on both sides of the Atlantic since 1968. A dinosaur, who evolved with the financial system as it was perverted from capitalism to banksterism after the great Nixonian error of abandoning the dollar's link to gold instead of simply revaluing gold. Our money is too important to be left to probity challenged central banksters and crooked politicians.
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