Ed O'Shaughnessy pfp
Ed O'Shaughnessy
@eddieosh
I like a lot of what @balajis.eth (👋) 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
@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
@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
@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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@pdr
Thanks for your thoughtful response. From that perspective, would the best course of action have been continuing thorough mask wearing and other mitigation measures until the longitudinal studies are completed and widespread vaccination could be more scientifically considered?
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Ed O'Shaughnessy
@eddieosh
There are so many systemic issues to address now that I’d be foolish to think I’ve any great insight on what could/should have been done. My position is that we need to rely on empirical scientific processes & uphold high standards of ethics & integrity. This would include complete openness & transparency of the da
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Ed O'Shaughnessy
@eddieosh
Complex adaptive systems (e.g. the human body, society, institutions, etc) are not deterministic, we can’t control them like a room theromostat, hence we must learn our way forward, testing hypotheses & adjusting as we gain a better understanding of the system. When the data is hidden/corrupted/ignored we stop learni
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