Jerry Avorn, MD
Appearances
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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?
Something You Should Know
The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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?
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
Something You Should Know
The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
Something You Should Know
The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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
Something You Should Know
The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
I think we just need to hold the FDA to the standard that it was really expected to meet back in 1962 when its legislation was established, that it needs to make sure the manufacturer showed the drug is safe and effective before approving it. And one of the maybe scarier points is that because FDA has gotten lax on that and has accepted changes in lab tests,
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And then as a marker for approving a drug, even though it doesn't show that it helps patients. And I think even worse, FDA has then failed to follow up on requiring that the companies do the follow-up studies that the law requires them to, which of course the companies are happy to forget doing if they have a drug that may not pass those tests and they can leave it on the market.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
charge full freight for it, and then it may be years before we find out that it really doesn't help people. So I think all we need to really expect is that the FDA will do its job better than it has been doing, and that companies essentially have their feet held to the fire and be told, look, you can charge a lot for this drug, and if it's a great drug, that's okay, and we'll pay for it.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
But you can't not study it adequately and then not do the follow-up studies that the law requires you to do and expect that somebody is going to come up with either $50,000 or in some cases $300,000 a year, as we see in the drugs for muscular dystrophy, for drugs that have not been shown to help.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
So I think one of the things that I, when I teach doctors, I urge my colleagues to do is just because it's new and shiny and there's a tremendous sales pitch that you're presented, you know, maybe over a delicious dinner at the best restaurants in town. I think all of us as doctors ought to have a, just a high level of,
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
wanting to see more about the evidence and that doesn't mean that every doctor needs to study every drug but to not assume that if it's new and it's expensive and it's fda approved it's got to be better than what we've already got sometimes it is and we need to be very open to that but sometimes it isn't and you know you can just turn on the tv and see all the different psoriasis and eczema
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
drugs that are so lavishly advertised. And frankly, a lot of them are not a lot better than the older ones that we have that are way cheaper. So I think doctors and patients alike need to basically have a high level of scrutiny about how do we know it's better. And doctors can ask that of the sales reps that come to visit them from the companies.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And I think patients can also ask their doctors, first of all, you should ask, what is this going to cost me? Because we've got an awful lot of prescribing that We, as doctors, do. We have no way of knowing what it's going to cost the patient.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And I've often had patients, I write them a script that looks like a good drug for them, and then they go to the drugstore and they find out what it's going to cost, even if they have health insurance and they can't afford it. So I think there is a responsibility of us doctors to learn more about what things cost.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And for patients, when you're with a doctor, I think it's perfectly fair to say, is there a related drug that is going to be more affordable and work just as well? And any doctor worth his or her salt ought to be willing to answer that question.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
They do not volunteer it because that's not a selling point. They are trained heavily on what are the selling points and affordability is usually not a selling point. And I don't see sales reps anymore because it is not easy. way to learn about drugs. But when I used to, and if I would ask that question, they would say, Dr. Avorn, I'm just here to tell you about the new product.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
I don't get into pricing. But what you can do is there's a couple of apps that are out there that people can look up and find out what is this drug going to cost. Doctors can look it up. Patients can look it up.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And to see if there's maybe another drug that works as well and is going to end up being much more affordable because one in five Americans cannot afford the drugs that we doctors prescribe for them. So something is wrong if we make a careful prescribing decision, the patient gets to the drugstore and then they can't buy what we prescribe because it's too expensive.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
Absolutely.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
Yeah, I think that is exactly, and I think you said it perfectly, that if we have a system in which any drug can show, all it really has to show is that it's better than placebo or better than nothing. That is the legal standard that unless it's a condition where you've got a treatment, you know, like HIV or cancer, where you have a drug you know works,
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
You can't test your new drug against just a sugar pill. But for a condition like eczema, which is not going to kill anybody, or psoriasis, it is okay. I mean, it's allowed by the law to test the drug against nothing. And the legal standard is that if you're a drug company and you can show your new drug works better than a placebo, the FDA is kind of legally obliged to approve it.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And that is problem one. Problem two is that the company then gets to decide what it wants to charge for it, and it can charge whatever in the world it wants to charge.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
They would say we are under a ton of political pressure to not make enemies in high places. And this is the case for both the Democrats and the Republicans. This is an equal opportunity problem we've got. Most people don't know that about half of the salary that FDA pays to the doctors and other scientists who review the drugs that it's evaluating are actually paid by the drug industry.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And that... has a long history where the congress has not given fda enough money and that was before the current cutbacks hasn't got given fda enough money to hire enough people to review the drugs and back in 1992 the drug industry came along and said well That's a problem for us, too, because we want our drugs approved quickly. Why don't you let us pay something that's known as user fees?
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And we will simply pay the FDA a huge amount of money for each drug that it reviews. And that's how you can meet salary for your scientists to review the drugs.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
know for me that makes about as much sense as saying well you know the court system is kind of strained so why don't we let all the plaintiffs attorneys or the defendants attorneys pay the judges because that way we'll have enough judges i think you know if the judge is getting paid by one side in the courtroom we all know where that can lead but unfortunately that's the system we've sort of backed into with these user fees that now comprise as i said about 50 of fda salaries
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
in its drug approval branch. So one thing I would say to the hypothetical person at the FDA is we need to figure out a way that you can actually get enough money from Congress that you can pay your own staff and not rely on user fees from the drug makers that you're supposed to regulate to be able to meet payroll.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
Actually, Mike, I don't see it that way at all. I do think of it, although it shouldn't be sort of nasty with people kind of pounding the table, but I think in a very kind of quiet and careful way, a lot of science is sort of adversarial in the sense that you're describing it. And that is, I think the assumption needs to be that when a new drug comes to the FDA,
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
There's no assumption that it works. There's no assumption that it doesn't work. I think one needs to just say, I don't know if this is a good drug. I don't know if it's a bad drug. I just want to look at all the evidence and let the people who are bringing it forward give me their best shot.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
And I, as an FDA reviewer, for example, if I worked at the FDA, I'm going to basically say, that may or may not be true. I want you to convince me. I think that's a very healthy, scientific, gentle way to proceed without any assumptions being made one way or the other. And that's probably the best way to do science.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
The way now is that the industry has gotten an enormous amount of influence about these decisions. And the FDA is under a lot of pressure to basically please the industry because that is the side their bread is buttered on. And the industry is always complaining that, oh, FDA is keeping these great drugs away from the American people because they're so sluggish and obstinate.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
In fact, when we and others have looked at the data, the FDA is about as fast an approval agency as any in the world. Traditionally, the FDA has been able to turn around a decision within six months of getting, you know, terabytes of data that it reviews very carefully. And I don't think you'd want them to do it too much faster.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
Again, I certainly don't want to leave listeners with the sense that most drugs on the market are unsafe or don't work. You know, most drugs on the market are safe and do work. And I guess I just would love it if we could be more scientific about getting it right nearly all the time instead of most of the time.
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The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
Thanks, Mike. I've really enjoyed talking with you, and thanks for having me.
Something You Should Know
The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?
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.