Jerry Avorn, MD

Over the years, FDA has gotten way too loosey-goosey about accepting data that are presented to it by a manufacturer, even when that data does not demonstrate, as it really ought to legally, that the drug is indeed safe and effective.

Right. And that is exactly not a good way for a doctor or for a patient to determine if a drug works, because the experience of any one doctor is not going to be enough to reveal whether a particular drug is effective. And it's certainly not going to be able to reveal whether that drug works better than another drug that I might have prescribed for that patient.

Right. And that is exactly not a good way for a doctor or for a patient to determine if a drug works, because the experience of any one doctor is not going to be enough to reveal whether a particular drug is effective. And it's certainly not going to be able to reveal whether that drug works better than another drug that I might have prescribed for that patient.

Right. And that is exactly not a good way for a doctor or for a patient to determine if a drug works, because the experience of any one doctor is not going to be enough to reveal whether a particular drug is effective. And it's certainly not going to be able to reveal whether that drug works better than another drug that I might have prescribed for that patient.

Really, the only way we can know that is by well-designed, well-conducted studies of hundreds or thousands of patients where all those issues are looked at carefully.

Really, the only way we can know that is by well-designed, well-conducted studies of hundreds or thousands of patients where all those issues are looked at carefully.

Really, the only way we can know that is by well-designed, well-conducted studies of hundreds or thousands of patients where all those issues are looked at carefully.

I think probably okay is a good term to think of because I think what Americans deserve is not probably okay. I think we deserve to know that even though every patient is different and you can never tell 100% of the time how something's going to work, we do rely a little bit more on probably okay than we ought to.

I think probably okay is a good term to think of because I think what Americans deserve is not probably okay. I think we deserve to know that even though every patient is different and you can never tell 100% of the time how something's going to work, we do rely a little bit more on probably okay than we ought to.

I think probably okay is a good term to think of because I think what Americans deserve is not probably okay. I think we deserve to know that even though every patient is different and you can never tell 100% of the time how something's going to work, we do rely a little bit more on probably okay than we ought to.

So for example, the drug that was in the headlines a number of years ago for Alzheimer's called Aduhelm. And it's part of this larger problem that

So for example, the drug that was in the headlines a number of years ago for Alzheimer's called Aduhelm. And it's part of this larger problem that

So for example, the drug that was in the headlines a number of years ago for Alzheimer's called Aduhelm. And it's part of this larger problem that

going back to the aids epidemic in the 1980s the fda was trying to get drugs out there approved as quick as possible for obvious reasons people were dying every single day and there's nothing good to treat them so they created this thing called the accelerated approval pathway which made a lot of sense at the time and it said even if a company has a drug that may or may not work if it looks like it maybe makes a lab test look better

going back to the aids epidemic in the 1980s the fda was trying to get drugs out there approved as quick as possible for obvious reasons people were dying every single day and there's nothing good to treat them so they created this thing called the accelerated approval pathway which made a lot of sense at the time and it said even if a company has a drug that may or may not work if it looks like it maybe makes a lab test look better

going back to the aids epidemic in the 1980s the fda was trying to get drugs out there approved as quick as possible for obvious reasons people were dying every single day and there's nothing good to treat them so they created this thing called the accelerated approval pathway which made a lot of sense at the time and it said even if a company has a drug that may or may not work if it looks like it maybe makes a lab test look better

Let's approve it, get it out there, and then make the company do a study afterwards to see if it really works. And that way you won't have AIDS patients or cancer patients feeling like there was a drug that could have helped me, but the FDA took so long to study it that, you know, I died or my friend or my mother or father died before the drug was made available.

Let's approve it, get it out there, and then make the company do a study afterwards to see if it really works. And that way you won't have AIDS patients or cancer patients feeling like there was a drug that could have helped me, but the FDA took so long to study it that, you know, I died or my friend or my mother or father died before the drug was made available.

Let's approve it, get it out there, and then make the company do a study afterwards to see if it really works. And that way you won't have AIDS patients or cancer patients feeling like there was a drug that could have helped me, but the FDA took so long to study it that, you know, I died or my friend or my mother or father died before the drug was made available.

So that made sense back in the 80s and the 90s. The problem is that has grown into a loophole big enough to drive a Brinks truck through. And what I mean by that is that the FDA has gotten way too comfortable with the idea of saying, well, nobody really showed this drug helps patients, but it makes a lab test look better. So let's just let everyone have it.