[FRIAM] FW: Covid-Lancet-PART-2 (002).doc

Frank Wimberly wimberly3 at gmail.com
Sat May 8 13:17:46 EDT 2021


"I couldn't get two minutes into their chatter before I fled to google."

I did like, "Your confirmation bias is not my pronlem."

---
Frank C. Wimberly
140 Calle Ojo Feliz,
Santa Fe, NM 87505

505 670-9918
Santa Fe, NM

On Sat, May 8, 2021, 10:45 AM Roger Critchlow <rec at elf.org> wrote:

> Sirry, I couldn't get two minutes into their chatter before I fled to
> google.
>
> https://www.nature.com/articles/nrd.2017.243.pdf is a Nature Review
> article on mRNA vaccines from 2018, so a snapshot of a technology prior to
> covid-19.
>
> The mRNAs are synthesized in vitro using phage RNA polymerase,
> ribonucleotides, and template DNA, products purified using high performance
> liquid chromatography or something similar to remove double stranded RNA,
> and packaged into lipid balls.  The Moderna specifies modified nucleosides,
> meaning not the common RNA bases, which reduces immune response to the RNA
> itself.   The Pfizer-BioNTech didn't specify.
>
> (Apparently there are mRNA treatments which package viral RNA amplifier
> enzymes on the mRNA, not relevant to these vaccines, though.)
>
> Note that "2 days to vaccine" is comparing the final step in vaccine
> manufacture.  There are months or years of work before that step to develop
> the virology, molecular biology, immunology, mRNA and protein engineering
> to the point where you have a template DNA for any vaccine.  And some of
> those precursor steps will involve filtering out mRNAs that don't
> transcribe well and protein fragments that don't fold well or fail to have
> the desired antigenicity, steps which might not be necessary if you were
> developing a vaccine with another technology.
>
> -- rec --
>
>
> On Sat, May 8, 2021 at 9:08 AM Pieter Steenekamp <
> pieters at randcontrols.co.za> wrote:
>
>> There is a story about a frog and a scorpion trapped on an island that's
>> going to explode or something and they both will die unless they get off
>> the island. The frog got ready to swim to safety and the scorpion asked him
>> for a lift. After the scorpion promised that he's not going to kill the
>> frog, the frog conceded to give him a lift. Half way towards safety the
>> scorpion stung the frog and both were about to die. Just before he died the
>> frog asked the scorpion why he did that. His answer was, it's in my nature
>> to kill frogs.
>>
>> Although I promised not to stir, it's in my nature to do so, so here we
>> go again. I know many of you are probably against the Intellectual Dark Web
>> (IDW), so a reference to a card carrying member Bret Weinstein is probably
>> stirring?
>>
>> My knowledge of biology is very poor, but I found the discussion by Bret
>> Weinstain and his wife Heather Heying on mRNA vaccination technology very
>> informing for a lay person like me:
>>
>> https://www.youtube.com/watch?v=ifPjaVL_1yw&t=3s
>>
>> If you can for a moment ignore their political views and listen to their
>> explanation of mRNA you might just find it very informative.
>>
>>
>>
>> On Sat, 8 May 2021 at 12:25, David Eric Smith <desmith at santafe.edu>
>> wrote:
>>
>>> Hi Pieter,
>>>
>>> Yes, as I also said in the earlier post.  From what we can tell so far,
>>> these mRNA/lipid vaccines look like a technology that really matters.
>>>
>>> Earlier in 2020, I wasn’t paying close attention to the technology
>>> (attention in other areas, and I didn’t know that there was a big
>>> technology deal in the offing).  A colleague who works in academic/research
>>> partnerships, and is a close associate of my boss at the time (a microbial
>>> molecular biologist), was emphasizing that this is a big deal.  That was
>>> what got me to start paying attention.
>>>
>>> I believe the following thing is correct to say, but it is outside my
>>> daily work (though bread and butter for a lab I work in, so I should know
>>> it), and I could be wrong:  I think custom RNA production these days is
>>> done by chemical assembly, and doesn’t require a living cell for
>>> manufacture (which always used to be the case).  If that is correct, then
>>> _all_ components of the new vaccine are chemical.  One of the slowest and
>>> hardest to scale of bio-based vaccines is the gene editing and growth of
>>> the cells or viruses or whatever.  To eliminate that step and move to an
>>> all-chemical platform changes both the cost and the timescale of
>>> production.
>>>
>>> I believe that is also why monoclonal antibodies are slow and
>>> expensive.  They are proteins, and we have no other ways to manufacture
>>> proteins at scale.  In labs, custom RNAs are a commodity item; proteins are
>>> still expensive.
>>>
>>> Two weeks ago, I was in a conversation with two younger colleagues who
>>> work full-time in cancer biology, where the problem is that even if a known
>>> mutation is the source of the problem, there is no direct way to eliminate
>>> the cells with that mutation; you always end up doing something at the
>>> phenotype level that misses some of what you are after and causes a lot of
>>> collateral damage.  I was asking them whether there were important
>>> techniques in view for using CRISPR on these delivery vehicles to get
>>> directly at the relevant mutations.  Their opinions is, not anywhere close
>>> anytime soon, because there are too many other difficulties that just
>>> having a delivery system will not address.  But given the nature of
>>> technology and technologists, I feel certain those pursuing this area are
>>> looking at it as a general-purpose platform, and not one defined by its
>>> introductory role in vaccines.
>>>
>>> I don’t have a context-free desire either to pursue or to avoid any of
>>> this, but I would like to be able to understand what exists and what is
>>> possible, not only decades after it has become common.
>>>
>>> We’ll see what happens.
>>>
>>> Take care,
>>>
>>> Eric
>>>
>>>
>>>
>>> On May 8, 2021, at 6:56 PM, Pieter Steenekamp <
>>> pieters at randcontrols.co.za> wrote:
>>>
>>> Eric,
>>>
>>> Thanks very much for this reply, I really appreciate it.
>>>
>>> To be honest, I admit I was probably a bit *naughty* in referencing
>>> Reason in my comment about the mRNA technology. I could just as well have
>>> summarised the technology and my enthusiasm for the potential benefit for
>>> humanity in having this to fight viruses in future, without referencing
>>> Reason. If my son in law was part of the discussion he would have done what
>>> he often does when I do something like this - he would have handed me a
>>> spoon, indicating that I'm just stirring.
>>>
>>> To emphasise the key point I wanted to make, I'm quoting your
>>> description of mRNA vaccinations:
>>> " *they seem likely be even safer with fewer side effects than viral
>>> vectors, as well as better for boosters, faster roll-out, greater
>>> mass-production scale, etc.*"
>>>
>>> So, on my original key point you and I seem to be in some sort of
>>> agreement.
>>>
>>> (Note to self: be more careful to use the spoon in future)
>>>
>>> Pieter
>>>
>>> On Sat, 8 May 2021 at 09:50, David Eric Smith <desmith at santafe.edu>
>>> wrote:
>>>
>>>> Pieter, hi and thank you,
>>>>
>>>> Yes, very good.
>>>>
>>>> Let me respond to your root post here, in parallel with whatever other
>>>> branches may have grown from it.  I want to note that the points in Glen’s
>>>> first reply to the same post speak well for the things that animate me, and
>>>> are better worded than mine.  So I won’t recap them, but want to
>>>> acknowledge and share endorsement of them.
>>>>
>>>> On May 7, 2021, at 9:35 PM, Pieter Steenekamp <
>>>> pieters at randcontrols.co.za> wrote:
>>>>
>>>> So please help me, I don't understand how you get from, I quote from
>>>> the transcript  (my underlining) :
>>>> *"Safe and effective COVID-19 vaccines were produced far faster than
>>>> any expert expected. Yet almost all of the time that it took to bring the
>>>> vaccines to market was due to safety testing and other governmental
>>>> mandates that could have been sped up without endangering anyone. By
>>>> January 13, 2020—only two days after the Chinese researchers shared the
>>>> genetic sequence of the COVID-19 virus and before most Americans had heard
>>>> of the disease—the biotech company Moderna had devised the formula for its
>>>> vaccine. BioNTech launched its COVID-19 vaccine program in January and had
>>>> partnered with Pfizer to manufacture it by mid-March of last year. The
>>>> first volunteer was injected with Moderna's vaccine on March 16, 2020, yet
>>>> it was only approved by the FDA last December 17th, a week after Pfizer's
>>>> vaccine met the agency's approval. Had the agency been faster off the mark
>>>> and used human-challenge trials and other innovative testing techniques,
>>>> the vaccines could have been brought to market months earlier with no
>>>> compromise in safety. That would have conceivably saved hundreds of
>>>> thousands of lives globally*.*"*
>>>>
>>>> to your comment? I quote from your email (my underlining):
>>>>
>>>> *But of course the article puts up the mRNA vaccines as evidence of
>>>> how, because the agencies got out of the way (is implied), BioNTech and
>>>> Moderna had vaccines in a few days.  That is deliberate BS, and I doubt the
>>>> writer is such an idiot that he doesn’t know it. *
>>>>
>>>>
>>>> So very good.  I took hours thisAM writing a bunch of awful stuff,
>>>> feeling stupider and stupider for having written a screed instead of a good
>>>> argument yesterday, and realized I have to re-examine what I am responding
>>>> to.
>>>>
>>>> I think my objection is to a salience structure of the article that I
>>>> think grossly miss-apportions credit and fault, in a way that is not only
>>>> unfair but that supports an anti-public and anti-institutional point of
>>>> view that is harmful in many cases where it succeeds.  So let me list for
>>>> you what I experience as the salience structure, and what I would replace
>>>> it with that I think would be more fair and also a better foundation for
>>>> decisions.  I am not complaining about any of Gillespie’s facts.  Those he
>>>> quotes that I know are consistent with what I understand from other
>>>> sources, and I don’t doubt the veracity of those I didn’t know in detail.
>>>>
>>>> So here’s what I read in the paragraph you quote above:
>>>>
>>>> *. Natural timescales for production, accomplished by Companies, were
>>>> very fast.
>>>> **. What Government provided was a vastly longer and unnecessary gap,
>>>> which didn’t have a good reason to exist.
>>>> (Then, to adduce evidence)
>>>> 1. Companies invented formula for vaccines (only the mRNA ones
>>>> mentioned): pertinent timescale was 2 days.
>>>> 2. Company partnered with other Company for production, Company
>>>> produced a first human-injectable product; pertinent timescale was a bit
>>>> under 2 months.
>>>> 3. Government, Regulator, with Mandates, stepped in and 9 months were
>>>> spent needlessly
>>>> 4. Because of those 9 lost months (or some unspecified subset of them),
>>>> some hundreds of thousands of people died needlessly.
>>>>
>>>> Here’s how I would have written a salience analysis for the first part
>>>> — I will come back a bit later to the last two points, both their substance
>>>> and how Gillespie renders them.
>>>>
>>>> -2. Government funds mRNA uptake and expression research, but just
>>>> barely and precariously.  Academic labs keep getting shut down, and their
>>>> directors go to Companies, where that work is not in the portfolio.
>>>> Somehow, remarkably, it does get pushed through to a working system; the
>>>> outcome could easily have been quite different; pertinent timescale: 30
>>>> years, during which much of the cost and all of the long-horizon risk is
>>>> carried in the public sector.  (Could be, however, that Company grants do
>>>> contribute at places, and perhaps fill in key steps that happen to fall on
>>>> the timelines they can support.  If so, note it.)
>>>> -1. Government (Obama admin) seeds startup in thermostable lipid
>>>> delivery systems for mRNA; pertinent timescale is 5-10 years.  (I don’t
>>>> know BioNTech’s history or who funded it, if it was Company funded as a
>>>> venture, that matters and should be noted.  If public, then that.)  There
>>>> are no products in either country, because the disease targets turn out to
>>>> have either low enough severity and sales potential, or small enough
>>>> coverage that it requires too-large clinical trials to get statistics, for
>>>> any Company to be willing to foot that bill for an unproven technology.
>>>> 0. Technology sits around and skowly gets more mature, but has no
>>>> clinical trial testing history beyond basic safety of the delivery system.
>>>> 1. mRNA vaccine Companies are finally able to pull the trigger on the
>>>> gun that has been sitting loaded for years, and provide a formula in a
>>>> couple of days.  EXCELLENT — CREDIT TO ALL INVOLVED.  Standard
>>>> technologies, like adenovirus technologies (I think not mentioned in this
>>>> article), were already ready and are fairly quick, though less so because
>>>> of the inherent limits of the technology.  STILL EXCELLENT.
>>>> 2. Companies partnered with other Companies for production (GREAT —
>>>> JUST WHAT THEY ARE SET UP TO DO).  Some important Government regulatory
>>>> protocols that normally are serialized get parallelized because of the
>>>> singular circumstances.  Potential testing timeline is shortened from
>>>> typical 3-5 years to potentially less than 1 year if we get lucky.  (We
>>>> should come back to why they are normally serial, and whether even in light
>>>> of what we have learned, they would be reset that way anyway because it
>>>> costs less and is acceptable for many routine procedures.  If not, and we
>>>> want to go parallel, then that’s a great prod to innovation prompted by
>>>> this pandemic.). In any case, first human clinical trial; pertinent
>>>> timescale: a bit less than 2 months.
>>>> ...
>>>> etc.
>>>>
>>>> So, the way I responded yesterday, which you quote, is both needlessly
>>>> rude and also unclear; thank you for pushing back.  Let me be careful in
>>>> the next, and reply to your exact words:
>>>>
>>>> Do I miss something? I don't read in the transcript that they said or
>>>> implied that BioNTech and Moderna had vaccines in a few days?
>>>>
>>>>
>>>> I wasn’t attributing that as a Gillespie claim; I was taking that as a
>>>> factually roughly-correct description of what really happened.  It is
>>>> probably right that the “design of the formula” isn’t the same as “having
>>>> the first vaccines”.  However, RNA manufacturing is an off-the-shelf
>>>> technology, which both these companies almost-certainly have in-house and
>>>> don’t even need to go across town to get.  Since the lipid delivery
>>>> platforms are their product, the transition from sequence design to first
>>>> injectable droplets was probably very fast; an assembly of components
>>>> already on hand in their own shop.  If they do get their RNA from a
>>>> foundry, for a high-priority project they could probably get it made in a
>>>> day, across town or via airmail.  It probably took a bit longer to get
>>>> enough production to run a clinical trial — that could have been weeks or
>>>> even a month or more — but that is production scale-up and consistency
>>>> checking, all exacting but established Pharma technical stuff.
>>>>
>>>> Maybe I'm such an idiot that I don't see it?
>>>>
>>>>
>>>> What I was saying here was the I don’t think Gillespie is at all an
>>>> idiot.  Therefore I expect he understands well that the rapid delivery of
>>>> the first mRNA vaccines (specifically) was putting the cherry on top of a
>>>> sundae that had been a long time in the making, with the biggest foundation
>>>> being public, and essential but timescale- and risk-limited roles for
>>>> companies in partnership.  My objection was the salience one above, putting
>>>> up short timescales for that turnaround as if they were the natural
>>>> timescales of the process, mentioning them only in association with
>>>> Companies, which then only Big Regulatory Government with its Mandates came
>>>> in and broke down.
>>>>
>>>> If he had talked _only_ about the adenovirus vaccines, already
>>>> established in company production lines, rolled out unusually quickly (to
>>>> their credit, in just the way he says generally), and with a history of
>>>> clinical trial evaluation of essentially the same technology, then his
>>>> discussion of regulatory roles would have indeed focused on the only
>>>> remaining discretionary variable in affecting the time of the public
>>>> availability.  Everything else was more or less constrained.  Only
>>>> mentioning the adeno vaccines would have been a lot less compelling
>>>> rhetorically, though, since J&J is a minor player in the US, Astra not yet
>>>> at all (in the US, unless it has been approved and I haven’t kept up), both
>>>> are slightly less-flashy by the efficacy numbers, may have more limited
>>>> scope for use in boosters if there is immune response against the viral
>>>> vectors that disables the delivery system in second doses before it can
>>>> deposits its payload, and also have rare inflammatory side-effects that
>>>> have been enough to give them some negative PR (though do not change the
>>>> fact that they are excellent vaccines).
>>>>
>>>> Yet I think the only companies he mentions are the mRNA ones, for which
>>>> the turnaround timescales are shortest and most impressive, and seem by
>>>> comparison to make the Government Regulatory timescale look most
>>>> blameworthy.  That is what I felt is disingenuous.  If you are going to use
>>>> those as the standard for government responsiveness, why not mention that
>>>> the most impressive timescale is that they exist at all, and which actor
>>>> ultimately made the difference between now and never?
>>>>
>>>>
>>>> But let me let that part go.  You may still find my objection unjust as
>>>> well as inept.
>>>>
>>>>
>>>> I do want to respond to the points 3 and 4 above, though, because they
>>>> are part of a tone that undoubtedly was what I was ranting against.  The
>>>> specific sentences are:
>>>> "Had the agency been faster off the mark and used human-challenge
>>>> trials and other innovative testing techniques, the vaccines could have
>>>> been brought to market months earlier with no compromise in safety. That
>>>> would have conceivably saved hundreds of thousands of lives globally”
>>>>
>>>> I want to flag where I think this is specifically manipulative, and
>>>> suggest what I think would be a more correct and productive framing.
>>>>
>>>> Those two sentences are an assertion about constraint and causation,
>>>> meaning that removal of a constraint would have caused a better outcome. Of
>>>> course, they are not literally an “assertion", since everything is framed
>>>> in conjectures or conditionals.  That’s how lawyers and debaters talk.  But
>>>> with a clear intent to have the reader conclude what they only express as
>>>> conditional.
>>>>
>>>> Let me give an ad absurdum for why I say it is a bogus assertion of
>>>> causation.  Not that the ad absurdum is a great literal model of the
>>>> Gillespie language, but so I can be unambiguous about the structure of the
>>>> argument I want to flag.  Here:
>>>> 1. This pig doesn’t have feathers.
>>>> 2. Feathers have all these important functional roles in flight.
>>>> 3. If this pig had features, he could fly.
>>>> Why is that a bad argument?  After all, each of the first two points is
>>>> incontestably true.  It is a bad argument because there is a complicated
>>>> multi-factor relation behind any “true” concept of cause.  The above not
>>>> only leaves out things, it does so in a way that is designed to distort.
>>>> There are probably many reasons this pig (and others) don’t fly.  For
>>>> instance, maybe they just don’t want to.  A careful man might worry that,
>>>> even if the pig had feathers, he still wouldn’t want to, which would keep
>>>> us from concluding he “could fly”.
>>>>
>>>> So, if the FDA approvers had been faster off the mark “could” the
>>>> vaccines have been brought to market faster?  (Btw, great language; keeps
>>>> our minds in the right frame: they are not “made available to people”; they
>>>> are “brought to market”.)  “Would” they then have saved hundreds of
>>>> thousand of lives _worldwide_?
>>>>
>>>> So let’s go through some context-seeking questions.
>>>> 1. [dumb and annoying: worldwide?]. FDA is a US agency.  How much do we
>>>> think that US FDA approval of vaccines made in the US could have saved
>>>> lives worldwide in 2020?  (Is Moderna even used outside the US?  Have any
>>>> vaccines originally bought by the US government from either Pfizer or
>>>> Moderna been distributed outside the US?)  Does Astra's use in any country
>>>> besides the US depend on US approval?  So the “worldwide” looks to me like
>>>> a red herring, put there to allow bigger numbers who “would conceivably
>>>> have” been saved, but not real.
>>>> 2. So let’s be a bit more conservative.  It could/would have saved how
>>>> many lives in the US then?  Hundreds of thousands?  That is a reasonable
>>>> number to have been saved.  Do we think vaccine approval on any achievable
>>>> timeframe is the major, or even an eligible, factor in their not having
>>>> been saved?
>>>>
>>>> In my email yesterday, I used the snarky language
>>>> “There was nothing else going on at the time?  Hmm, can’t recall.  Or
>>>> since?  Or still, even worse?”
>>>> Glen, in his reply late-night US, I think was reminded of BLM and other
>>>> social upheavals, perhaps by that comment.  Those are true and also
>>>> relevant, but had not been in my thought at the time of writing.  I was
>>>> referring, rather, to two HUGE things going on at the time:
>>>>
>>>> A. Almost every federal agency had had its chief offices staffed by
>>>> people who were either out of their depth or incompetent, or put there as
>>>> deliberate saboteurs.  I would class Redfield at CDC as out of his depth
>>>> and incompetent, but not a saboteur.  Azar was a kind of flatly-unqualified
>>>> lackey, though probably less than a pure saboteur.  Giroir may have been
>>>> tolerably competent, and in any case did some things okay.  I forget now
>>>> exactly what I thought of people like Stephen Hahn heading FDA at the time,
>>>> when news was more immediate.  We do have names of various others who were
>>>> harassing, interfering in, and distorting the output of, multiple officers
>>>> within CDC.  Again, I forget which people and which news articles, but all
>>>> that can be dug up.
>>>>
>>>> Anyway, to get to what matters:  I think it is fair to say that FDA and
>>>> CDC committed a couple of important errors early on (CDC in not allowing
>>>> tests to be used just bypassing a superficial third screen that wasn’t
>>>> essential, or accepting early German designs), FDA (maybe, though I want to
>>>> revisit their reasoning) in blocking universities or others from
>>>> participating on various things (was it testing?)
>>>>
>>>> Some of that could have been creeping incompetence within the agencies;
>>>> it’s fair to ask.  Maybe some of the choices were actually hard, given
>>>> standing rules and available information.  But I think it is sure that all
>>>> of them were operating crippled, internally disrupted, I believe on cut
>>>> funding and cut staffing in many cases, and certainly not by any means in
>>>> their best form.  We saw the same people, under good leadership, do much
>>>> better, for instance under Tom Frieden on the ebola response, so I think we
>>>> know they can.
>>>>
>>>> To criticize agencies while they are under attack by a government whose
>>>> goal is to make them fail so it can eliminate them — not mentioning that
>>>> any of that is going on — while suggesting that if they could be moved
>>>> aside either the same government would save lots of lives, or that the
>>>> lives would somehow get saved by other means not relying on the government
>>>> (a question on which we have good data from the current administration’s
>>>> role), was one thing I was calling a BS move.
>>>>
>>>>
>>>> B. In parallel with the undermining of institutional function
>>>> officially within the administration, there was an active and full-time
>>>> campaign to amplify conflict and dysfunction in the public.  It was in
>>>> place at a kind of baseline from the US right-wing media before the last
>>>> presidency started, added a whole new circus show starting with trump for
>>>> the first six months of 2020, and then propagated down through the whole
>>>> republican apparatus as the year went on, becoming even more fanatical and
>>>> destructive now that he is out of office.  We now have the vaccines and 30%
>>>> of the country won’t use them; I am comfortable suggesting that those
>>>>  people were the same in 2020 as they are in 2021.  Once masks were being
>>>> advocated (after the early-year mess about how to handle that, as we
>>>> discussed), during the long period when public health measures were _all_
>>>> we had under the best conceivable vaccine outcome, and when every country
>>>> in the Eastern Hemisphere was using them to good effect, we still had half
>>>> the country refusing to wear them, and all but a few right-wing politicians
>>>> pouring fuel on that fire as fast as they could carry it.  So it is not
>>>> idle of me to say that the political effort had a strong causal role in
>>>> what could or could not have been done, or what lives would have been saved
>>>> by vaccines “because" there weren’t other ways to save them before. and
>>>> “because” they would have been used afterward.
>>>>
>>>> Not only not admitting, but indeed choosing not to mention, the
>>>> constant and committed role of the political right in sowing confusion,
>>>> mistrust, belligerence, and sociopathic behavior as an important factor in
>>>> what could/would happen in the US, is what I call a second deliberate BS
>>>> move in the Gillespie presentation.
>>>>
>>>> (Note: I do understand that not every bad behavior in the US came from
>>>> right-wing political forces.  No country in the West did well, compared to
>>>> many in the East, presumably because the East had experienced SARS and MERS
>>>> and took these things seriously.  Likewise, we learned since that the trump
>>>> government didn’t have much of a plan for distribution in place beyond
>>>> shipments to states;  that, together with states limited by budget crises,
>>>> also affected availability post-approval.  So, many factors go into how
>>>> much difference in mortality really turned on some number of months’
>>>> difference in FDA approval time.)
>>>>
>>>>
>>>> Next, let’s come back to the wording “ with no compromise in safety.”.
>>>> That was my point in the Hippocratic oath.  I believe that is bogus several
>>>> ways.  Here again is the ad absurdum:  I ran across the highway and didn’t
>>>> get hit by a car, so clearly there wasn’t any risk in running across the
>>>> highway.   Nobody thinks that’s how risk assessment works, so insinuations
>>>> that because some particular thing is found ex post not to have gone wrong,
>>>> that shows that there would have been no compromise in not checking for it
>>>> ex ante, looks to me like deliberate distortion.  Please recall that when
>>>> the mRNA vaccines were first found to have 90-95% efficacy, people were
>>>> floored.  They were hoping to get above 50% for symptomatic disease.  If
>>>> the vaccines had been in that expected performance range, and human
>>>> challenge clinical trials had been done, how many people would have been
>>>> expected to get sick, possibly severely, possibly with long-term problems,
>>>> or possibly dying?  Some.  Not none.  If a human-challenge trial had been
>>>> designed to get comparable statistics to those delivered by the 66,000
>>>> people in the non-challenge clinical trials for Pfizer and Moderna taken
>>>> together, maybe quite a few.  Medical risk assessment is hard.  There are
>>>> lots of occasional but very consequential troubles that arise with such
>>>> mundane things as flu vaccines — cytokine storms and crippling
>>>> encephalitises, etc.  (I happen to know a woman, since deceased, who lived
>>>> for decades with brain damage from a flu vaccine that just happened to hit
>>>> her the wrong way.)  This is why approvers are careful.
>>>>
>>>> Yes, lots of people died in the months before a vaccine was available.
>>>> How do we assess that fact, when other public health measures that could
>>>> (as we know with certainty) have saved some of them were not used?
>>>>
>>>> Glen did mention another thing, about trust in institutions, that is
>>>> dead center to this question.  If I wanted to do the unpleasant thing that
>>>> debaters do, I would trot out Media Trope #15 that is currently going
>>>> around every outlet:  Black Americans say they don’t want to get vaccinated
>>>> because they don’t trust the government because of the Tuskegee syphilis
>>>> trials.   Good reason, but of course it is embedded in a fabric of
>>>> institutional distrust that is a tilted playing field for _everything_ a
>>>> government agency has to do, with every constituency for one or another
>>>> reason.  And that is the center of the Hippocratic oath.  The reason
>>>> doctors won’t do things, even if the patients are desperate and would
>>>> approve them, is partly because doctors are trying to preserve medicine as
>>>> a practice that can be trusted.  One thing that did or didn’t go wrong in
>>>> one vaccine roll-out — called after the fact — is not the relevant context
>>>> for a decision structure.  One could go on and on about threads in that
>>>> fabric.  The awful Harvard psych experiments that get trotted out because
>>>> they were used on Ted Kaczynski, the LSD experiments on US servicemen, all
>>>> of anatomy that was written using data from Nazi doctor dissections, for
>>>> which reason it was withheld from use in medical schools for decades even
>>>> though ti was the most complete data available.  I don’t even know how much
>>>> else across countries and wars, because I am not informed on that topic.
>>>> All these together make up the decision context these agencies work under,
>>>> and I think to be fair one must grapple with the difficulties that result.
>>>>
>>>> That brings us back to whether the FDA approval timeline, which would
>>>> have been the major available expediting variable for the adeno vaccines
>>>> Gillespie doesn’t mention, really had the same relation to the mRNA
>>>> vaccines he does mention.  I don’t think it does.  Precisely because
>>>> nothing had been through full clinical trial, and because mRNA is a rather
>>>> different insertion than viral DNA, I think the standard for caution with
>>>> the mRNA vaccines had to be much higher.  We appear to have got very lucky
>>>> (on the shoulders of much good design), and they seem likely be even safer
>>>> with fewer side effects than viral vectors, as well as better for boosters,
>>>> faster roll-out, greater mass-production scale, etc.  But before 100M
>>>> people got vaccinated, that wasn’t known.
>>>>
>>>>
>>>> Anyway, I’ll stop.  I have probably driven you mad with tedium if you
>>>> have read this far.
>>>>
>>>> It’s shocking and appalling how much better a writer Gillespie is than
>>>> I am, isn’t it.
>>>>
>>>>
>>>> Eric
>>>>
>>>>
>>>>
>>>> - .... . -..-. . -. -.. -..-. .. ... -..-. .... . .-. .
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>>> - .... . -..-. . -. -.. -..-. .. ... -..-. .... . .-. .
>>> FRIAM Applied Complexity Group listserv
>>> Zoom Fridays 9:30a-12p Mtn GMT-6  bit.ly/virtualfriam
>>> un/subscribe
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>>> archives: http://friam.471366.n2.nabble.com/
>>>
>>>
>>> - .... . -..-. . -. -.. -..-. .. ... -..-. .... . .-. .
>>> FRIAM Applied Complexity Group listserv
>>> Zoom Fridays 9:30a-12p Mtn GMT-6  bit.ly/virtualfriam
>>> un/subscribe http://redfish.com/mailman/listinfo/friam_redfish.com
>>> FRIAM-COMIC http://friam-comic.blogspot.com/
>>> archives: http://friam.471366.n2.nabble.com/
>>>
>> - .... . -..-. . -. -.. -..-. .. ... -..-. .... . .-. .
>> FRIAM Applied Complexity Group listserv
>> Zoom Fridays 9:30a-12p Mtn GMT-6  bit.ly/virtualfriam
>> un/subscribe http://redfish.com/mailman/listinfo/friam_redfish.com
>> FRIAM-COMIC http://friam-comic.blogspot.com/
>> archives: http://friam.471366.n2.nabble.com/
>>
> - .... . -..-. . -. -.. -..-. .. ... -..-. .... . .-. .
> FRIAM Applied Complexity Group listserv
> Zoom Fridays 9:30a-12p Mtn GMT-6  bit.ly/virtualfriam
> un/subscribe http://redfish.com/mailman/listinfo/friam_redfish.com
> FRIAM-COMIC http://friam-comic.blogspot.com/
> archives: http://friam.471366.n2.nabble.com/
>
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