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Posted
53 minutes ago, High Plains Drifter said:

 

like bus routes?

 

but less socialism and public funds to grift to something else 

 

Posted
On 5/9/2025 at 6:32 PM, Brisketexan said:

"The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process."

 

You know.....tasks like verifying the accuracy and sourcing of data, shit like that.

Maybe AI will be better at statistical analysis than the frustrated scientist lifers at FDA so Phase II and III clinical trials could require fewer subjects or shorter time points, thus less expense and time to market.

Posted
9 minutes ago, Murfdogg21 said:

Maybe AI will be better at statistical analysis than the frustrated scientist lifers at FDA so Phase II and III clinical trials could require fewer subjects or shorter time points, thus less expense and time to market.

 

Jennifer Lawrence Reaction GIF

 

And they'll still at least double the price.

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Posted
17 minutes ago, Murfdogg21 said:

Maybe AI will be better at statistical analysis than the frustrated scientist lifers at FDA so Phase II and III clinical trials could require fewer subjects or shorter time points, thus less expense and time to market.

How that will work...

Pharmaceutical executive, who likely also happens to be embedded in the current presidential administration: "We ran our new drug, HelpsIngrownToenailsButMakesYourDickFallOff, through an AI trial, and it came out just fine and practically no imaginary test subject's dick fell off.  You can trust us, and our AI engine, the Aways-Approve-o-Max 5000."

Posted
3 minutes ago, Brisketexan said:

How that will work...

Pharmaceutical executive, who likely also happens to be embedded in the current presidential administration: "We ran our new drug, HelpsIngrownToenailsButMakesYourDickFallOff, through an AI trial, and it came out just fine and practically no imaginary test subject's dick fell off.  You can trust us, and our AI engine, the Aways-Approve-o-Max 5000."

I believe I understand your viewpoint on most issues in 2025. I've shared on other FDA and UHC related threads that I have a good deal of experience getting medical devices cleared by FDA. It is very frustrating and not efficient. A typical FDA review panel assigned to a new product submission is composed of a manager (usually 5-10 years experience but looking to escape to pharma/med device as a VP of Regulatory), a couple senior reviewers (30-65 yo lifers that got hired by FDA out of school and never left for whatever reason), and a couple junior scientists (the new hires with <5 years experience). Rarely do any of them have industry experience or perspective. They lean hard on testing precedent when it's outdated, but also apply new (more difficult to pass) standards on new products. What's worse is they keep products on the market that were previously approved under old standards and permit companies with old products to piggy back approvals of their products under the old standards. The FDA reviewers consider themselves thoughtful scientists, and often ask for additional studies, experiments, and data that are irrelevant to the product approval or indicated uses. In almost every product submission, there has been a negotiation on sample size and time duration because the FDA has no concern over a product's need on the market or the R&D expenses required for their additional asks. Brisket and thunderlounge took my post as naively supporting big pharma, when the current system favors big pharma over the startups and small companies.

Posted
18 minutes ago, Murfdogg21 said:

I believe I understand your viewpoint on most issues in 2025. I've shared on other FDA and UHC related threads that I have a good deal of experience getting medical devices cleared by FDA. It is very frustrating and not efficient. A typical FDA review panel assigned to a new product submission is composed of a manager (usually 5-10 years experience but looking to escape to pharma/med device as a VP of Regulatory), a couple senior reviewers (30-65 yo lifers that got hired by FDA out of school and never left for whatever reason), and a couple junior scientists (the new hires with <5 years experience). Rarely do any of them have industry experience or perspective. They lean hard on testing precedent when it's outdated, but also apply new (more difficult to pass) standards on new products. What's worse is they keep products on the market that were previously approved under old standards and permit companies with old products to piggy back approvals of their products under the old standards. The FDA reviewers consider themselves thoughtful scientists, and often ask for additional studies, experiments, and data that are irrelevant to the product approval or indicated uses. In almost every product submission, there has been a negotiation on sample size and time duration because the FDA has no concern over a product's need on the market or the R&D expenses required for their additional asks. Brisket and thunderlounge took my post as naively supporting big pharma, when the current system favors big pharma over the startups and small companies.

I believe you - truly, I do.  I have navigated more than a few inefficient/ineffective bureaucratic systems in my day (for myself and for clients).

My stand here is a direct one, and is consistent with one I took long ago in opposing a light rail proposal in Austin that would have (and eventually did) put the program under CapMetro's control: I don't oppose the concept, and agree there is a need for (better transit operations, a better system at FDA, what have you)....I just oppose 100% any plan to put these people in charge of doing it.

Any actions taken by this regime in this field will serve one purpose, and one purpose only: faster and easier funneling of dollars to billionaires.  And the other side of that coin is just as true: that will always come at the expense of everyone else, including smaller enterprises, consumer/patient safety, and the like.

You know it's true.  Any "improvement" will be incidental, confined to small parts of the process, and will be dwarfed by the bigger mission of "complete regulatory capture performed on behalf of the oligarchs who own the regime."

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Posted
1 hour ago, Brisketexan said:

How that will work...

Pharmaceutical executive, who likely also happens to be embedded in the current presidential administration: "We ran our new drug, HelpsIngrownToenailsButMakesYourDickFallOff, through an AI trial, and it came out just fine and practically no imaginary test subject's dick fell off.  You can trust us, and our AI engine, the Aways-Approve-o-Max 5000."

The best part is you then have ChatGPT just change all the zeroes to ones, and "wallah," I present to the C-suite the "UnitedHealth Never-Authorize-O-Min (-)5000."

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Posted

Maybe not an "Enshittening" but definitely something that felt weird:

Went for visit to optometrist, they do the pretest stuff with the assistant, then I go in the exam room and the doc patches in via zoom/teams/ or  cc program and conducts things.  I don't care because I just want my script, but it did surprise me.  Seems like it might help with true but minor medical issues as well, while also limiting docs' exposure to germs in a MD office.  I could also see it as a huge help on access for rural/ remote patients.

Posted
1 hour ago, Murfdogg21 said:

Maybe AI will be better at statistical analysis than the frustrated scientist lifers at FDA so Phase II and III clinical trials could require fewer subjects or shorter time points, thus less expense and time to market.

If it takes ana’s job away, I’ll consider it a win.

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