Vinay Prasad

Prasad argues that labeling AI clinical studies as 'phase 1' is nonsensical since patients already widely use AI.

But if I put on my common sense hat, I would argue that it's not a phase 1 study. Phase one studies are nonsensical in this context. Patients are already using AI to navigate their questions and understanding on medicine and every other topic under the sun.

Prasad criticizes studies where doctors grade answers from multiple AI models, noting models change before publication, making results uninformative.

Why are we asking questions to three different AI machines and then having random doctors grade the results? By the time that paper is published, the AIS are all different. What does that answer exactly?

Prasad says that if AI is claimed to improve patient outcomes, it should be tested in randomized trials comparing usual care with AI integration.

Instead, many believe that AI improves patient outcomes. In that case, you should do… spoilers to follow… drum roll please.. a randomized study. It turns out it's simple. You randomize people to doing things the way you're currently doing them, or to integrate the AI.

Prasad urges AI trials to use patient-relevant endpoints like hospital length of stay or 30-day mortality rather than surveys.

Here's the tricky part: you measure something that actually matters to patients. You measure their length of stay in the hospital, or their 30-day mortality.

Prasad warns that no randomized outcome trials of hospital AI exist yet, even as AI is being pushed into clinical workflows.

But we don't have those studies. I’ve yet to see a single one. In the meantime, AI is the cow. Someone's pushing it wherever we walk.

Prasad partly agrees with Amodei that the FDA struggles to regulate fast-moving medical AI, and thinks regulating all digital health AI is not the agency's best role.

I see kernels of truth in what he's saying, but maybe I don't go all the way he goes. Where I see the big core truth is the FDA tries to regulate AI itself, medical AI. You wear a watch that's supposed to give you information and the FDA wants to do a lot of that regulation. That's a very tough thing to regulate, because this technology is changing so much faster than our ability to judge it.

Prasad says pharma should invest in AI for clinical trials but is less optimistic than Amodei about AI in molecule discovery and basic science.

If I was a pharmaceutical firm, I would definitely invest in AI. There's so many things around running clinical trials that we can do better with AI, help us run them cheaper and faster and more efficiently. But when it comes to molecule discovery and basic science, I'm not as optimistic as Dario for a couple of reasons.

Prasad argues AI drug discovery is limited by unreliable biology literature and by human validation bottlenecks, not by a shortage of ideas.

One, a lot of the information that is fed into models about cancer biology is basically as close to fraudulent research as you can imagine. If you train AI on garbage, what can it learn? The second challenge is AI will be happy to give you hypotheses to study, but you'll still need to run it with a few people to validate those hypotheses. I suspect the limiting reactant is not coming up with ideas; we have more ideas than we can study with people.

Prasad says the FDA changed only marginally during his tenure and the system remains largely the same.

Maybe we changed 4 percent, 2 percent of the FDA. The FDA is an 18,000-person agency. There's tens of thousands of people still there. But the system is largely the same as it's always been.

Prasad doubts real public health reform is possible and expects the field to splinter.

But I don't think a real reform is possible. I suspect it'll splinter into different public health groups.

Prasad says early-stage research regulation in the US is heavy and often poorly fit for small companies and rare diseases.

During my time at the FDA, I was often sympathetic to the people who work at companies who told me about the hurdles they were forced to jump through. The regulation in this early side of research is tremendous in the United States. A lot of it is well-intentioned, but not all of it is fit for purpose.

Prasad says his FDA experience made him more libertarian and skeptical of one-size-fits-all safety and efficacy standards.

The idea that a single monolithic government agency in the suburbs of D.C. can set that bar for every single person in America, that to me is a tougher pill to swallow now.