Charles Piller

Well, I mean, I guess I would just say I'm not, first of all, I'm not an expert in all drug development. But one thing that I've observed in working on this book is that there are some difficulties that FDA faces right now, contradictions that they face that I'm very sympathetic about. So on the one hand, particularly for diseases for which there are not good remedies, Alzheimer's among them,

Well, I mean, I guess I would just say I'm not, first of all, I'm not an expert in all drug development. But one thing that I've observed in working on this book is that there are some difficulties that FDA faces right now, contradictions that they face that I'm very sympathetic about. So on the one hand, particularly for diseases for which there are not good remedies, Alzheimer's among them,

Well, I mean, I guess I would just say I'm not, first of all, I'm not an expert in all drug development. But one thing that I've observed in working on this book is that there are some difficulties that FDA faces right now, contradictions that they face that I'm very sympathetic about. So on the one hand, particularly for diseases for which there are not good remedies, Alzheimer's among them,

And for rare diseases, there is enormous pressure on the agency to fast-track drugs, to wave them through, even though the results might be ambiguous, even though the results might be even not so great, because people who are in a desperate situation desperately want those drug approvals.

And for rare diseases, there is enormous pressure on the agency to fast-track drugs, to wave them through, even though the results might be ambiguous, even though the results might be even not so great, because people who are in a desperate situation desperately want those drug approvals.

And for rare diseases, there is enormous pressure on the agency to fast-track drugs, to wave them through, even though the results might be ambiguous, even though the results might be even not so great, because people who are in a desperate situation desperately want those drug approvals.

And the agency is then blamed if they hold things up for what many people would say are perfectly understandable, scientifically sound thinking by their analysts. So what I feel very concerned about is that the pressure is sometimes going to result in drugs being approved that are not just not very effective, but could also be harmful.

And the agency is then blamed if they hold things up for what many people would say are perfectly understandable, scientifically sound thinking by their analysts. So what I feel very concerned about is that the pressure is sometimes going to result in drugs being approved that are not just not very effective, but could also be harmful.

And the agency is then blamed if they hold things up for what many people would say are perfectly understandable, scientifically sound thinking by their analysts. So what I feel very concerned about is that the pressure is sometimes going to result in drugs being approved that are not just not very effective, but could also be harmful.

And the effects haven't been fully felt in the clinical trials that led up to their approval.

And the effects haven't been fully felt in the clinical trials that led up to their approval.

And the effects haven't been fully felt in the clinical trials that led up to their approval.

Is there a world where, and again, I don't consider myself an expert in this space, but I'm curious, based on your observations, if it would be valuable to create a new track for the FDA for medications?

Is there a world where, and again, I don't consider myself an expert in this space, but I'm curious, based on your observations, if it would be valuable to create a new track for the FDA for medications?

Is there a world where, and again, I don't consider myself an expert in this space, but I'm curious, based on your observations, if it would be valuable to create a new track for the FDA for medications?

where there are exemptions made for people who have terminal illnesses and they could be given an exemption to take a medicine where we know it's very dangerous, it's experimental, but because they have no other option, they may get an exemption to use a drug. Can there be some kind of research exemption track created for conditions like this?

where there are exemptions made for people who have terminal illnesses and they could be given an exemption to take a medicine where we know it's very dangerous, it's experimental, but because they have no other option, they may get an exemption to use a drug. Can there be some kind of research exemption track created for conditions like this?

where there are exemptions made for people who have terminal illnesses and they could be given an exemption to take a medicine where we know it's very dangerous, it's experimental, but because they have no other option, they may get an exemption to use a drug. Can there be some kind of research exemption track created for conditions like this?

you know, I'm going to pass on this one. I just feel like it's a little outside my area of expertise. Because I'm just trying to think from a rational standpoint of how to get around this issue that the FDA- Yeah, there's already, I do know there are already exemptions that the agency has the ability to grant exemptions.

you know, I'm going to pass on this one. I just feel like it's a little outside my area of expertise. Because I'm just trying to think from a rational standpoint of how to get around this issue that the FDA- Yeah, there's already, I do know there are already exemptions that the agency has the ability to grant exemptions.