I come back a week later to check my results. Of the 5 that got the vaccine, 3 lived but looked like shit and 2 died. I’ll pour out some for them later. Of the 5 that got the placebo (water) they all fucking ded! And that right there is why we don’t use placebo groups for god damn vaccines!
Oh you pour so eloquently in words what every person with half a brain was thinking! Thank you.
Can I just say I adore your salty fucking ass? 😆
Fucking thanks. You’re cool to
I believe the word you were looking for was “equipoise”
NIH coming to the rescue 😄
If it's Ebola, you'll pour the ones that died out later.
This is the best fucking explainer EVER.
How can I roll this up into one thread to post elsewhere???? This is gold.
There was a direct thread roll link made. It’s in the comments somewhere
TX. I'll look for it!
Lol - I saw an article that said "RFK JR wants to do studies on vaccines with a placebo group, here's a video on why that's a problem" and I was like, who has to watch a video to know that to test effectiveness of vaccines means you have to actually infect the control group with a deadly virus???
People who don't think about this stuff as often as us? Or ever?
As for people needing or wanting *videos* for stuff that is way more efficiently transmitted by text, that's something I feel like I will never personally understand, but just have to acknowledge at this point.
A lot of soft brained bitches, that who
The brain 🪱 really did a number, didn’t it?
But we DID placebo studies on measles and Covid vaccines! For measles, RFKjr and I were in the placebo group, and the mid-1960s showed what happened when you expose everybody without/with the 1st measles vax. For Covid, we just did community exposure. ourworldindata.org/grapher/meas...
And RFKjr did ANOTHER placebo test for measles using the MMR vaccine, in Samoa - it got similar results, showing that lots of people die if you don't vaccinate the population and then introduce measles (a traveler, in that case), compared to a very small number if you do.
We even have a rule about it! The name of which I cannot remember right now. But basically it says if there is a chance for harm to a test subject, you need to design your testing to prevent that shit, like death!
Equipoise
There have also been cases where placebo-controlled tests get shut down early because the results show the tested drug is so clearly effective that it would be unethical not to give it to the placebo group as well.
Correct! That’s a bit in the weeds for this discussion though. That’s the next discussion.
Equipoise? Great thread. Hope Saturday is more peaceful than Friday
That’s the right term
21 CFR 56.111 Criteria for IRB approval of research www.ecfr.gov/current/titl... Even before you get to IRB review, FDA can (should) reject an IND or IDE application if the proposed research will result in death, injury requiring hospitalization or congenital anomaly
I’ve been told we have too many regulations as it is so I’m sure just ignoring 21 CFR 56 or any myriad of others will be fine. 🙄
Unless some ignorant DOGE bro cuts it because it looked too burdensome. Even as it stands, it's remarkable how flexible an IRB can be in determining that risk to subjects are minimized and that risk is reasonable in relation to anticipated benefit.
So the next time your, I do my own research shithead says I don’t see anything wrong with what Lowly’s human car wants to do. Fucking punch them in the arm and ask if they want an aspirin or a skittle. Mother fucking dumb ass bitches!!!
Are you eligible to be Health Secretary?!
I so fucking am!
I mean, if RFK Jr is at the front of the line of those in said clinical trial for the ebola vaccine, followed by the rest of the administration...
I like it when you talk technical like that. 🤣🤣🤣🤣🤣🤣
This is, by far, the best thread I’ve had the pleasure of reading in I don’t even know how long.
God how I love you right now. Thinking about giving my next department talk the same way. #skittlebitches
Instead of slapping a "kick me" sign on his back put "my other car is an apple."
#SkittleBitches
💀
I will literally sign up for any demonstration, talk, or seminar @altfda.altgov.info is giving. This is how motherfucking science should be explained punk ass bitches1
A Ted talk would be EPIC!
I'll be the coffee barista for that shit, sign me up!
I’m 100% in!
#skittlebitches 🤣
Novavax: how do you measure efficacy of a vaccine when there's low levels of infection in the community? What if nobody in the placebo arm gets infected during the trial? You can't do a challenge study because there's no treatment for covid, unlike say, vivax malaria.
You can measure antibodies produced (and how long response lasts). It’s a common surrogate for efficacy.
Yes and then what would be the purpose of having a placebo arm, aside from political dumb stuff.
There’s no scientifically valid reason to do this, as far as I understand it. Placebo studies are useful in some cases (painkillers and antidepressants are great examples where there is a strong placebo effect), but that is not the case for infectious disease and vaccines.
It's my understanding as well. But if you listen to FDA commish, it's clear he doesn't like covid vaccines.
You can also do challenge studies using animals susceptible to disease. If you’re just tweaking something that already works (like flu or COVID vaccines), either approach is resource intensive for little new information.
Precisely. So why is FDA commish doubling down on demanding a new RCT from Novavax? We have an MOU with Health Canada, where Novavax is approved. The whole thing is nuts. Animal challenge studies got the anthrax vaccine approved IIRC.
I’m guessing (1) sow doubt with general public that testing isn’t being done in a scientifically valid way. People know about RCTs and placebos but not the more inside baseball details of trials and (2) generate datasets showing large numbers of side effects “vs placebo” that sound bad.
Read FDA commish. Also scroll down for other interviews. tinalexander.github.io/notes/2025/0...
And (3) slow down/make trials so expensive that vaccine R&D is no longer worth pursuing.
So literally all politics, but very costly in terms of advancing science and human life.
I glad you did a science for me
Sorry, but if they’re that dumb they’re just getting punched. They don’t deserve an aspirin or a skittle.
@unroll.skywriter.blue unroll
The thread as a shareable webpage: https://skywriter.blue/pages/did:plc:gytrxuwp7zpfeuk6u72brcga/post/3lo7cjqvvrc2j. Powered by @skywriter.blue
Equipoise
That’s fucking it!!! Thank you
I just learned that word this week, lol.
Known it for decades - Equipoise was the great-grandfather of that totally-gonna-win horse in "Fugue For Tinhorns" from Guys&Dolls :-)
Was that covered under ICH rules?
Sorta yes
I love when the FDA is unhinged. Best thread I’ve ever read. 👏🏻
Thank you for excellent explanation! I was LOL in my cube reading this. OMG🤣😂 #skittlebitches #mademyday