Jerry Avorn, MD
speaker
49 appearances
1 recordings
1 series
first heard May 2025
last heard May 2025
Jerry Avorn, MD’s voice in public audio — every appearance, attributed to the second.
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Appearances
Many people, including a lot of doctors, think that the FDA tests drugs. It doesn't. It doesn't test any drugs. It relies on studies that are submitted to it. Often the manufacturer will set up those studies in a way that will put the drug in the most favorable light.
Sure. I think anybody that takes a medication has a number of questions that either they wonder about or they ought to wonder about. One is, does it work and how do we know if it works? The second is, is it safe and how do we know that? What side effects might it cause? The third is, why does it cost what it costs and can I get it for less money?
And then there's a whole host of related questions about what are we doing as a nation to try to make sure that we get it right on those issues of does it work? Is it safe? And is this the right price for it?
Great question, Mike. And in fact, we do need to wonder about all of those things for a couple of reasons. One is we doctors do the very best we can, but we can only work with the information that is out there and available to us. And for that, we rely on the FDA to tell us whether a drug is effective and safe.
many people including a lot of doctors think that the fda tests drugs it doesn't it doesn't test any drugs to see if they are effective it relies on studies that are submitted to it usually from the manufacturer and one of the more surprising issues is that often the manufacturer will set up those studies in a way that will put the drug in the most favorable light
even if it actually turns out not to help people. And we can't blame the physician on the front lines for that because all we can do is rely on the decisions made by the FDA.
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.
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.
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
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.
and then we'll ask the company to do better studies later and that's where that alzheimer's drug aduhelm came from the fda said no evidence that this clearly helps patients with alzheimer's disease to have any better memory but it makes your brain amyloid levels seem a little lower so let's approve it
and then they did not get around to making the company do follow-up studies and as a result we have this drug that the initial list price was 56 000 a year it can cause brain swelling and hemorrhage and stroke um so you know no drug is going to be without side effects but you're willing to accept them if somebody has shown that the drug really works.
But if nobody's shown the drug works, and we know it causes side effects like brain swelling and bleeding, and it costs $56,000 a patient, that was probably one of the clearest examples of how we should not have approved that drug. And sure enough, later on, the drug needed to be pulled because after many years, it became clear that it was not only not helpful, but it was dangerous. So
You know, given that we've got such wonderful drugs out there, we just need to do what FDA was assigned to do and has drifted away from over the years.
Right. And we shouldn't have to rely on, well, the drug's been around for many, many years before I'll take it, because frankly, the American public deserves to get access to drugs and not just make sure that it's been a decade and no one died from it, so I'll take it. I think the answer, and there are some very hopeful answers to these questions.
It's not like we all need to throw up our hands and say, you know, I'm scared of drugs. Drugs are great. I love drugs. they are some of the best and most useful things we can do for our patients.
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