Silicon Valley's longevity drug obsession is facing its first real reality check

[Endymio]

I chose your first example and assumed you followed suit on the others

I did: all three were correct, and each and all disprove your statement. Why are you so stubbornly refusing to admit a simple error?

I'm here to argue for one thing: following the scientific method which I have done from the start.

No. You claimed that observational studies -- which formulate a hypothesis then test it against observations -- isn't "science", and that that "the only way to prove" a drug's effects are through double-blind random trials.

LOL @ your claim of 7 participants at the end of your third consecutive post there. You invented a strawman and knocked it down. Wow, Bravo.

Eh? I've known clinical trials with as few as five participants. Did you really believe all trials have thousands?

 

[TempleOrion]

Don't hold your breath. Speaking from personal experience, Endy tends to treat scientific research as if it were a fill-in-the-blanks exercise where the blanks are filled in with his/her own conclusions even if researchers never said anything, in publishing their research, that supported making those conclusions.

I'd hunt down a TS discussion in the General forum between it and I if I had more time to waste.

Twisted logic indeed.

Absolutely. He's beyond any known or forthcoming therapy, just like his idol, the Mango Messiah...

 

[Lew Zealand]

I did: all three were correct, and each and all disprove your statement. Why are you so stubbornly refusing to admit a simple error?

You do not understand the difference between a Biotech company and a techbro. The difference is in expertise as the techbro has little to none in the field he is trying to push his "new idea" in, and a Biotech company is founded and run by scientists in the field of their research with the intent to develop or invest in Biotech. What is so difficult to understand about that?

No. You claimed that observational studies -- which formulate a hypothesis then test it against observations -- isn't "science", and that that "the only way to prove" a drug's effects are through double-blind random trials.


Eh? I've known clinical trials with as few as five participants. Did you really believe all trials have thousands?

Again a lack of understanding. Different Phases of medical trials are defined by how many participants are in them. Phase I is defined by very few people (like 5!), Phase II is defined by having a larger sample but generally below statistical relevance. Phase III is defined by having enough people to be statistically relevant.

Willful ignorance will never be a benefit to anyone.

 

[Endymio]

...the techbro has little to none in the field he is trying to push his "new idea" in, and a Biotech company is founded and run by scientists in the field of their research with the intent to develop or invest in Biotech. What is so difficult to understand about that?

That's Olympic-grade goalpost shifting there, Lew. Look-- if you refuse to admit your error, just try this excuse instead: "when I posted 'tech bros don't fund trials', I actually meant 'tech bros don't themselves personally conduct accurate scientific research', but my AI voice assistant translated it improperly".

Different Phases of medical trials are defined by how many participants are in them. Phase I is defined by very few people (like 5!), Phase II is defined by having a larger sample but generally below statistical relevance. Phase III is defined by having enough people to be statistically relevant.

Oops again. You're confusing the legal requirements of an FDA trial with the scientific method in general. Nor does it refute my point: an observational study can (and often does) produce safety and efficacy data better than a randomized clinical trial. The ONLY reason the FDA mandates RCTs in the first 3 phases is that they can provide the required significance level with a smaller number of participants...thus exposing fewer people to potential side-effects.

Finally (yes, even more errors!) Phase III trials do not have a defined minimum number of participants; the FDA has approved them for very rare diseases with as few as 10 or 20 participants, and under their expanded access program, they've even allowed Phase III approval with just one single participant ... so-called "N-of-One" trials. So much for your "strawman" claim.

By the way, the term of art is statistical significance, not relevance.

 

[Lew Zealand]

That's Olympic-grade goalpost shifting there, Lew. Look-- if you refuse to admit your error, just try this excuse instead: "when I posted 'tech bros don't fund trials', I actually meant 'tech bros don't themselves personally conduct accurate scientific research', but my AI voice assistant translated it improperly".

LOL, no. I explained it and you don't accept it, instead preferring once again to play your game of imagining what I should say. Why do you like to play that game so much?

Oops again. You're confusing the legal requirements of an FDA trial with the scientific method in general. Nor does it refute my point: an observational study can (and often does) produce safety and efficacy data better than a randomized clinical trial. The ONLY reason the FDA mandates RCTs in the first 3 phases is that they can provide the required significance level with a smaller number of participants...thus exposing fewer people to potential side-effects.

Finally (yes, even more errors!) Phase III trials do not have a defined minimum number of participants; the FDA has approved them for very rare diseases with as few as 10 or 20 participants, and under their expanded access program, they've even allowed Phase III approval with just one single participant ... so-called "N-of-One" trials. So much for your "strawman" claim.

By the way, the term of art is statistical significance, not relevance.

This has devolved into semantics and edge cases now? What point are you trying to make? There will always be edge cases where you can't get enough people for a rare disease but that doesn't violate the principle of Phase III (which expands the Phase II pool to more people, that is one of the reasons for it vs. Phase II). You don't get to skip it and just go "observational is good enough". You take as many people as you can get.

My focus (as stated many times) is that scientific trials for anything that can be double-blinded and controlled (like drugs) need to be done this way in order to prove cause and effect. That's it, pretty simple. If you don't do this then you're just guessing and hoping, which makes a poor basis for developing a new treatment or principle. Sometimes you're screwed with fewer numbers in your tests than you'd like but that doesn't mean "fall back to observational."

Observational studies are great but do not prove cause and effect scientifically, which you do not seem to care about. What treatments or principles have been developed observationally when double-blinded controlled studies could have been done but weren't?

 

[Endymio]

LOL, no. I explained it and you don't accept it, instead preferring once again to play your game of imagining what I should say. Why do you like to play that game so much?

LOL, no, Lew. Your words were clear: "Tech bros don't fund RCTs". Why not simply admit the error and move on?

What point are you trying to make? There will always be edge cases where you can't get enough people for a rare disease but that doesn't violate the principle of Phase III (which expands the Phase II pool to more people

I don't know how much clearer I can explain it. Your claim was that "the only way" one can prove a drug works is via an RCT. This couldn't possibly be more wrong.

My focus (as stated many times) is that scientific trials for anything that can be double-blinded and controlled (like drugs) need to be done this way in order to prove cause and effect. That's it, pretty simple.

And it's just as simply false. Proof comes from statistically significant observations. That is in fact the very reason it's called "significance". Have you never taken even one class on statistics?

The FDA demands RCT trials not because "that's the way science works", but because an RCT will (potentially) achieve statistical significance with less participants. But all that matters is the degree of significance. That's it.

Observational studies are great but do not prove cause and effect scientifically

Honestly, this is getting ludicrous. As just one of 2500+ examples from modern pharmacology, thalidomide was "proven safe" by random controlled FDA trials. Those turned out to be wrong. It was the observational study -- performed later on a larger population -- that proved the case-effect relationship that the drug causes birth defects.