Ed O'Shaughnessy pfp
Ed O'Shaughnessy
@eddieosh
I like a lot of what @balajis.eth (đź‘‹) says on the network state but I think he's very wrong on circumventing FDA regs for covid treatments. There are very significant reasons why clinical trials should take as long as they do (and why Op Warp Speed will be found to have been a massive mistake).
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@pdr
What compelling arguments have you found that Operation Warp Speed will be found to have been a massive mistake?
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Ed O'Shaughnessy pfp
Ed O'Shaughnessy
@eddieosh
I should state my creds first, 10yrs in pharma/biotech delivering R&D and manufacturing projects for Pfizer, AZ, GSK, Novartis, Dupont, and various cellular therapy companies in US, UK, EU and AU. They all spent an enormous amount of time, effort and money on very extensive clinical trials to prove safety and efficacy.
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Ed O'Shaughnessy pfp
Ed O'Shaughnessy
@eddieosh
The clinical trials phased process has been developed over decades to gather the empirical data in a rigorous and repeatable way needed to establish the veracity of a drug's effectiveness. The process phases have evolved in rigour as problems were encountered and resolved ("form follows failure"), e.g. thalidomide.
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Ed O'Shaughnessy pfp
Ed O'Shaughnessy
@eddieosh
All the people I worked with were extremely professional and conscientious, they knew that to do it right takes time and great care, i.e. you can't and shouldn't cut corners. To have adequate proof that a drug is fit to market requires longitudinal studies that run for years and use randomised control trials.
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Ed O'Shaughnessy
@eddieosh
FDA is the gatekeeper for v/high standards. But when the Pfizer phase3 trial was declared a win after only 90 days & the control group was negated, my alarm bells went off. This was unprecedented & no sound evidence was presented that warranted breaking thru the gates & tearing up the “Chesterton's Fences”.
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Ghees
@gheescaster
Interesting. That happened two years ago. Haven’t seen anything yet that would make me question that doing trials faster was a mistake? 1000s of papers have analyzed millions of people. I was against forced vaccine mandates but haven’t seen much against the vaccines
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Ed O'Shaughnessy pfp
Ed O'Shaughnessy
@eddieosh
Some interesting longitudinal studies are starting to be published. It's a complex multivariant problem space and will take a very long time to untangle and draw out useful insights and principles. One of the big challenges is access to clean data sets, which is inexcusable.
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Ghees
@gheescaster
Interesting - what do we know so far?
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Ed O'Shaughnessy pfp
Ed O'Shaughnessy
@eddieosh
Concerned about muddying the water with an endless stream of scientific papers as I believe that we should be focused on the integrity of the scientific methodologies used, but just to give an example of a signal that's appearing here's one that is addressing relative risks https://pubmed.ncbi.nlm.nih.gov/36176195/
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