Dr. Marty Makary

We discovered Vioxx killed maybe 38,000 plus Americans years after it was approved. We discovered a million Americans died of opioids and overdoses. over a decade after the OxyContin label was given, why weren't we monitoring in real time people who were getting it immediately after approval? In part, the answer to that question is we couldn't do it. We didn't have the data.

We discovered Vioxx killed maybe 38,000 plus Americans years after it was approved. We discovered a million Americans died of opioids and overdoses. over a decade after the OxyContin label was given, why weren't we monitoring in real time people who were getting it immediately after approval? In part, the answer to that question is we couldn't do it. We didn't have the data.

We discovered Vioxx killed maybe 38,000 plus Americans years after it was approved. We discovered a million Americans died of opioids and overdoses. over a decade after the OxyContin label was given, why weren't we monitoring in real time people who were getting it immediately after approval? In part, the answer to that question is we couldn't do it. We didn't have the data.

It was too sophisticated. You'd have to have everybody registered in a study. Now we have giant big data from electronic health records nationally. Now we can have our researchers and universities go in there And look at everyone who's taken a new medication, match to somebody who's similar who is not taking that medication. And look at the adverse event rate and ask, is it working?

It was too sophisticated. You'd have to have everybody registered in a study. Now we have giant big data from electronic health records nationally. Now we can have our researchers and universities go in there And look at everyone who's taken a new medication, match to somebody who's similar who is not taking that medication. And look at the adverse event rate and ask, is it working?

It was too sophisticated. You'd have to have everybody registered in a study. Now we have giant big data from electronic health records nationally. Now we can have our researchers and universities go in there And look at everyone who's taken a new medication, match to somebody who's similar who is not taking that medication. And look at the adverse event rate and ask, is it working?

Is there a safety signal? When you don't do that, people get suspicious. And they are suspicious about the cozy relationship sometimes that results in approvals. And they're also suspicious when they hear stories and they don't have hard data. You don't have great rates about certain complications when you just have self-reported data. Self-reported data is terrible data.

Is there a safety signal? When you don't do that, people get suspicious. And they are suspicious about the cozy relationship sometimes that results in approvals. And they're also suspicious when they hear stories and they don't have hard data. You don't have great rates about certain complications when you just have self-reported data. Self-reported data is terrible data.

Is there a safety signal? When you don't do that, people get suspicious. And they are suspicious about the cozy relationship sometimes that results in approvals. And they're also suspicious when they hear stories and they don't have hard data. You don't have great rates about certain complications when you just have self-reported data. Self-reported data is terrible data.

That's right. And in the void of good scientific data, every opinion fills that void. So we can do a better job. And if we have good post-approval monitoring of drugs and devices, then we can also tell companies, hey, instead of doing two randomized control trials to get your drug on the market,

That's right. And in the void of good scientific data, every opinion fills that void. So we can do a better job. And if we have good post-approval monitoring of drugs and devices, then we can also tell companies, hey, instead of doing two randomized control trials to get your drug on the market,

That's right. And in the void of good scientific data, every opinion fills that void. So we can do a better job. And if we have good post-approval monitoring of drugs and devices, then we can also tell companies, hey, instead of doing two randomized control trials to get your drug on the market,

How about one, and we'll take a close look in the post-approval monitoring, how the drug is doing in real time immediately after it's approved. And that's particularly important when you're talking about rare diseases. When you talk about a genetic issue that affects 52 kids in the world, and that's a real thing. There is a condition that affects 15 kids. That's also a real thing.

How about one, and we'll take a close look in the post-approval monitoring, how the drug is doing in real time immediately after it's approved. And that's particularly important when you're talking about rare diseases. When you talk about a genetic issue that affects 52 kids in the world, and that's a real thing. There is a condition that affects 15 kids. That's also a real thing.

How about one, and we'll take a close look in the post-approval monitoring, how the drug is doing in real time immediately after it's approved. And that's particularly important when you're talking about rare diseases. When you talk about a genetic issue that affects 52 kids in the world, and that's a real thing. There is a condition that affects 15 kids. That's also a real thing.

You can't expect the companies to do a randomized control trial. You'll kill innovation. You'll kill investment in those innovative ideas. You've got to say... Hey, this is a very difficult condition. It's incurable. It's fatal. It's a permanent disability. We're going to customize the approval process to the condition.

You can't expect the companies to do a randomized control trial. You'll kill innovation. You'll kill investment in those innovative ideas. You've got to say... Hey, this is a very difficult condition. It's incurable. It's fatal. It's a permanent disability. We're going to customize the approval process to the condition.

You can't expect the companies to do a randomized control trial. You'll kill innovation. You'll kill investment in those innovative ideas. You've got to say... Hey, this is a very difficult condition. It's incurable. It's fatal. It's a permanent disability. We're going to customize the approval process to the condition.

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.

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.