Dr. Marty Makary

And so we're going to be rolling out a new pathway for drugs, which is a pathway based on a plausible mechanism. If there's a rare condition or a condition that's incurable, that affects a small number of people, we may be approving drugs based on a plausible mechanism on sort of a conditional basis. What does that mean? Put that in normal speak.

Let's say there's a condition that affects 75 people in the world and there's a new treatment that makes sense physiologically. The mechanism is scientifically plausible that this treatment would help these individuals. No one's forcing these medications on these individuals.

Let's say there's a condition that affects 75 people in the world and there's a new treatment that makes sense physiologically. The mechanism is scientifically plausible that this treatment would help these individuals. No one's forcing these medications on these individuals.

Let's say there's a condition that affects 75 people in the world and there's a new treatment that makes sense physiologically. The mechanism is scientifically plausible that this treatment would help these individuals. No one's forcing these medications on these individuals.

If they want to try these new medications, even though we don't have a randomized controlled trial because it's not feasible, we will allow that and at the same time monitor everybody who gets it so that we can make inferences as soon as the data speaks with a signal in the data. Wow.

If they want to try these new medications, even though we don't have a randomized controlled trial because it's not feasible, we will allow that and at the same time monitor everybody who gets it so that we can make inferences as soon as the data speaks with a signal in the data. Wow.

If they want to try these new medications, even though we don't have a randomized controlled trial because it's not feasible, we will allow that and at the same time monitor everybody who gets it so that we can make inferences as soon as the data speaks with a signal in the data. Wow.

There's been, look, let's be honest, there's been an epidemic of distrust, and part of it is warranted. And when you don't want to look at complications, the complication rate looks lower than it really is, and it makes products look safer than they really are. And so in the case of VAERS, you have something that could suggest It's a screening tool. It could suggest that there's an issue.

There's been, look, let's be honest, there's been an epidemic of distrust, and part of it is warranted. And when you don't want to look at complications, the complication rate looks lower than it really is, and it makes products look safer than they really are. And so in the case of VAERS, you have something that could suggest It's a screening tool. It could suggest that there's an issue.

There's been, look, let's be honest, there's been an epidemic of distrust, and part of it is warranted. And when you don't want to look at complications, the complication rate looks lower than it really is, and it makes products look safer than they really are. And so in the case of VAERS, you have something that could suggest It's a screening tool. It could suggest that there's an issue.

But you have to do a rigorous evaluation. If you don't follow up with a rigorous evaluation, that screening tool is not very useful.

But you have to do a rigorous evaluation. If you don't follow up with a rigorous evaluation, that screening tool is not very useful.

But you have to do a rigorous evaluation. If you don't follow up with a rigorous evaluation, that screening tool is not very useful.

Exactly.

Exactly.

Exactly.

We're gonna know, we're gonna do intense comprehensive research and that's why if we have massive electronic health record data, which we now have through something called the Health Information Exchange, we can have researchers go into there and look at real world complication rates. So we're not relying on self-reported data from which you can make no inferences about rates.

We're gonna know, we're gonna do intense comprehensive research and that's why if we have massive electronic health record data, which we now have through something called the Health Information Exchange, we can have researchers go into there and look at real world complication rates. So we're not relying on self-reported data from which you can make no inferences about rates.

We're gonna know, we're gonna do intense comprehensive research and that's why if we have massive electronic health record data, which we now have through something called the Health Information Exchange, we can have researchers go into there and look at real world complication rates. So we're not relying on self-reported data from which you can make no inferences about rates.

That's just a basic scientific methodologic principle. When you have a couple people saying, hey, I had this or I had this, you can't infer what the rate is, that is, the frequency per unit time. But when you have comprehensive data, which we only have now because of cloud storage ability, we couldn't do this 10 years ago, we have now tremendous big data where we can go in there and look at