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).
5 replies
0 recast
0 reaction
🪷
@pdr
What compelling arguments have you found that Operation Warp Speed will be found to have been a massive mistake?
1 reply
0 recast
0 reaction
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.
1 reply
0 recast
0 reaction
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.
1 reply
0 recast
0 reaction
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.
1 reply
0 recast
0 reaction
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”.
2 replies
0 recast
0 reaction
