"themanwithsauce - has as many vehicles as job titles" (themanwithsauce)
06/05/2020 at 12:31 • Filed to: None
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"themanwithsauce - has as many vehicles as job titles" (themanwithsauce)
06/05/2020 at 12:31 • Filed to: None | 6
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!!! UNKNOWN CONTENT TYPE !!!
A few of my friends/colleagues have been working on an antibody treatment with a bunch of other labs for everything from getting microbe to produce the antibodies to making a stabilized solution so they can package this treatment into doses and whatnot. With everything going on this week, it got a bit buried that Co vid-19 is still a thing, but work on cures/vaccines has also not ceased. And this is a definitive turning of the corner - no “this might help” or “this might be a sign”. A straightforward “This is a treatment and it works like this:”.
Th is article does a good job outlining some of the timeline of the project and how it all came together , but for a short tl;dr - Th ey have already begun testing a few variations in NY hospitals to treat patients who are suffering from Covid. At the same time, Eli Lilly has already been manufacturing batches of this treatment so that if/when it gets approval, they have inventory ready to go. Expected full approval and rollout is early autumn at the latest. Wo uldn’t be surprised if initial results cause some larger spread “testing” in hotspots to start knocking down infection numbers.
Hearing from friends about the results coming together has been very uplifting in the past few weeks so I figured I’d share it now that the press releases have been hitting national news. This isn’t a vaccine, and is more of a temporary solution, but it also has an immediate effect and can go a long way towards protecting healthcare workers, and for an immunocompromised person or the elderly, it might be their only defense if vaccines won’t be effective for them.
davesaddiction @ opposite-lock.com
> themanwithsauce - has as many vehicles as job titles
06/05/2020 at 12:52 |
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Thanks for sharing!
ttyymmnn
> themanwithsauce - has as many vehicles as job titles
06/05/2020 at 12:56 |
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I’ll be interested to see how all of this effort on COVID will be spun off into different viral illnesses.
DipodomysDeserti
> themanwithsauce - has as many vehicles as job titles
06/05/2020 at 13:47 |
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A word of warning from Peter Salk.
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themanwithsauce - has as many vehicles as job titles
> DipodomysDeserti
06/05/2020 at 14:00 |
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Agreed that there shouldn’t be a patent on the vaccine. But from the sounds of things, officials have been quick to respond. There’s a quote in the article where one of the scientists said that responses for information or resources from government officials that usually took weeks or months were often getting same day approval.
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DipodomysDeserti
> themanwithsauce - has as many vehicles as job titles
06/05/2020 at 14:08 |
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You’re a chemist, you know hiw hard chemistry is, not to mention biochemistry. We fuck up simple stuff like morning sickness meds. I don’t trust government officials to keep us safe. The current system ensures lots of eyes get to see data, and that helps ensure safety. We’ve removed most of those safeguards.
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themanwithsauce - has as many vehicles as job titles
> DipodomysDeserti
06/05/2020 at 14:37 |
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I’d argue the opposite - the quick hype around using other medicines as a stopgap solution was far more dangerous and without safeguards or oversight than this. I’m aware this is, strictly speaking, less safe than if we weren’t under duress of a pandemic. I’m also well aware of how seriously the EPA and FDA take their jobs when it comes to consumer product safety. It’s fine to remain skeptical about this, but also fine to be excited as we await trial results. A lot of people have been working on this for a while and results have been shared around the world in these labs. There’s probably close to a million man-hours behind this, if not more, due to how many people have been looking into it.
It’s also funny you mentioned the morning sickness meds and that you don’t trust government officials since, I’m pretty sure you’re referring to Th alidomide. In the US, we didn’t get “thalidomide babies” due to the FDA themselves - they held it up until more data was present. And the whole problem with thalidomide was in the manufacturing process. Once that was corrected, it became one of the most important medicines in the WORLD. I’m pretty sure the lessons learned by the FDA back then are being applied here.
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DipodomysDeserti
> themanwithsauce - has as many vehicles as job titles
06/05/2020 at 14:50 |
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Not getting thalidomide babies in the US was the point I was trying to make. You seem to think our normal safety measures are being followed. They are not. Getting excited about anything that’s been tested for less than a year is a good indication that people are tjinking straight.
Biology takes time and we are trying to rush out drugs.
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themanwithsauce - has as many vehicles as job titles
> DipodomysDeserti
06/05/2020 at 15:12 |
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Time, in and of itself, doesn’t make a product safer though. I guess that’s where we disagree. It didn’t take the FDA long to say “You have not satisfied our requirements for data, so we do not approve of this”. And from where I stand, and what I have gone through in dealing with the EPA and FDA, they have their own stringent requirements and expectations for claims. EIther you meet them, or you do not. “Time spent thinking about this” isn’t a scientific measure of effectiveness.
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DipodomysDeserti
> themanwithsauce - has as many vehicles as job titles
06/05/2020 at 15:35 |
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“ Time, in and of itself, doesn’t make a product safer though. I guess that’s where we disagree.”
From a biological perspective, it most certainly does. You can literally just expose toxins to microbes and they’ll eventually adapt to them. That’s like high school level biology. However, I’m not saying you use time to just sit on your ass, that’s moronic. It takes time to evaluate how biological systems will react to things. There’s no substitute. Unlike in chemistry, systems in biology adapt.
For whatever reason, you seem to think the FDA is following their normal protocols. They are not, that’s why we’re testing six month old products on humans (if you’ve ever studied anything related to toxicology, you’d know that’s insane).
As a environmental resource management grad student, I find it pretty hilarious that you think the EPA is stringent. I managed a print shop for a decade, and they’re a joke. If you’re wver in AZ I can take you on a tour of all the abandoned uranium tailing piles all over my state (there’s around 1,500). The EPA has cleaned up two or three.
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themanwithsauce - has as many vehicles as job titles
> DipodomysDeserti
06/05/2020 at 17:28 |
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“For whatever reason, you seem to think the FDA is following their normal protocols. They are not, that’s why we’re testing six month old products on humans (if you’ve ever studied anything related to toxicology, you’d know that’s insane).”
That’s not what I’m saying at all. I’m aware there are changes being made. My communications with those who have been making this stuff have revealed that they basically got a free pass to the front of the line when it came to validations and access to independent testing labs. Also, tests which would normally be done in a sequence were done concurrently rather than a stage gate “You must have passed 1, 2, and 3 before test 4" kind of stuff. I’m also aware that certain shelf-life claims are unavailable since there is a bit of a time crunch. So they might have a very narrow use-by window until those tests can be passed.
So to a
ddress the biological side of this - yes, systems can change, evolve, and adapt. I have no doubt that the batches of this treatment being mad
e today, if approved for rollout, will have to undergo some more last minute tests to prove that, yes they are still effective before being approved to
. And since this pandemic is still ongoing, there is race against the evolution of the virus itself. This treatment might not be effective a year from now. Which could render all of that work moot. I think they are trying to find out where they can optimize the approval process without cutting necessary tests and valdation steps.
As for the EPA/FDA stringency, I was literally filling out some paperwork for our products to submit to the EPA today. We got notifications that some cleaning companies had been making false kill claims about Covid-19 and were assessed fines and restrictions. I don’t know why a lack of tailings being cleaned up means the EPA isn’t stringent, but in my industry, they’re still taking this seriously. I see no reason to think the FDA isn’t either.
And I *did* take a toxicology class, thank you very much.