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This is On Point. I'm Debra Becker, in for Meghna Chakrabarty. How do you know if a prescription drug you're taking is safe and if it's effective? There are regulations designed to make sure that medications are safe, and those rules have improved over the years. About 100 years ago, you could put almost anything into a bottle, call it medicine, and sell it.
That included the over-the-counter sale of heroin. Heroin was advertised as a less addictive and more powerful painkiller than morphine and a more effective cough suppressant. This made the new drug very desirable, as chronic coughing from pneumonia and tuberculosis affected millions. That's a video from the Federal Drug Enforcement Agency Museum. It explains that in 1898, Bayer and company, the German pharmaceutical giant,
sold heroin in a bottle, and it was widely popular. But soon doctors and pharmacists started to notice that patients required larger and larger doses and were becoming increasingly dependent on the drug.
It soon became clear that this wonder drug was actually more addictive than morphine. And by 1913, Bayer stopped producing it. In the midst of this was the creation of the FDA, the Federal Food and Drug Administration. Congress passed the Pure Food and Drug Act because of the outrage over misbranded food and drugs.
Under this new federal agency, drugs in the U.S. had to be monitored and tested before they were sold, and that was something that never happened before. Our next guest argues that one of the best-kept secrets in health care today is that the FDA's evaluation of drug evidence has deteriorated.
Dr. Jerry Avorn is with us. His new book is titled Rethinking Medications, Truth, Power, and the Drugs You Take. He's a professor of medicine at Harvard Medical School. Welcome, Dr. Avorn, to On Point. Thank you, Debra. So let's start a little bit with this.
the history of the FDA. Before we get to FDA standards and whether or not they've weakened over the years and, of course, the cost of drugs, let's have a little context here. The common assumption is that, well, the FDA tests and regulates these things, but that's not necessarily true, right? Dr.
That's right. They certainly do not test in the sense of determining whether drugs work or not. They have, over the decades, delegated that activity pretty much to the manufacturers of the drugs, who for the most part set up the studies, run the studies, pay for the studies,
until not long ago, owned the findings to do with what they wanted. Right. But before we get to how it's been perhaps delegated to drug manufacturers, why was it even assumed that this was necessary, that we needed this federal agency to oversee at least? Well, it happened in increments. The first step, as you mentioned, was when it
dawned on people during the progressive era of the first decade of the 20th century, 19-oh-something, that maybe it's not a great idea for there to be medicines sold with no prescription. There really weren't prescriptions in those days anyway that contained unstated amounts of opioids or alcohol or cocaine or any number of things, and you couldn't even tell what it was.
when you bought the bottle. So the idea was in 1906, at least say what is in the bottle, which was seen as a radical step forward, but obviously an important one. And that was it. Just say what's in the bottle. Exactly right. But then there were changes though, right? They did become more complex. Those seem to be, based on reading your book, probably
prompted by crises with particular drugs. So let's talk about some of the big ones and what happened in terms of improving drug regulation. What would you say was the next biggest one after, say, the 1910s, 1906, when we got the Food and Drug Administration? What was sort of the next big crisis that folks said, "Oh, we need to strengthen these rules even further to make sure that we have a better regulatory agency and that people are safe?" Exactly. Well, that would have been in 1938,
when in the absence of any requirement that the drugs cannot be poisonous, a chemist put in to a medication that was an antimicrobial called sulfanilamide, one of the early ones, a substance which we know now as antifreeze. And it seemed to him that that would be a good way to dissolve the sulfanilamide and it would have a pleasant taste and kids would take it
when their doctor told them to. This was cough suppressant. Cough suppressant. No, it was supposedly an anti-infective. Oh, I see. And the problem was that it was poisonous, but there was no law saying your medicine can't be poisonous. And so that in 1938, 100...
kids died. So did the chemist who came up with this idea who actually killed himself because he was crushed by what he had done. And somebody said, wouldn't it be a good idea for us to have the government require that medicines not be poisonous? And so in 1938, we got that modification to the old 1906 law. Yeah. Well, it seems like that took a while. A lot of things that seem obvious to us now were seen as dramatic advances in the day.
Right, right. And then the 60s, of course, we had thalidomide, which some people may remember. We may not remember the 30s and what happened, but the 60s, and we're getting there. We're getting closer. So in the 60s, we had thalidomide. Why don't you tell our listeners, remind us all of what happened then and what we saw in response to drug regulation? Sure. So all through the 1940s and the 1950s, there still was not a requirement that a drug had to actually work. It just, you had to say what was in the container and it had to not be poisonous.
And Senator Estes Kefauver, a liberal Democrat, said we ought to have better regulation and
So that companies should have to show their drugs work before they can be sold as prescription medicines. And there was a lot of backlash and saying that's going to be crippling the pharmaceutical industry, that's violating patients' civil liberties. And there was a lot of pushback until the thalidomide disaster, which, as many listeners will know, there was a medication heavily promoted in Europe and Japan and many countries around the world, but not here.
For pregnant women in particular, there was a sedative and an anti-nauseant. And they applied for marketing permission in the U.S. And there was a new doc at the FDA named Frances Kelsey. And she said, I don't see evidence that this is safe.
And the pushback was don't be a pointy-headed government bureaucrat slowing everything down. Just approve the damn drug and let Americans have access to it so that they don't have their freedom impaired. And she said, no, I want evidence that it's safe. It turns out as this debate was going on and the industry was saying you're just taking too long to approve our drug, it turned out that no, it wasn't safe. It caused problems.
Fetal damage in utero such that kids were born instead of with normal limbs with little flipper-like appendages in their arms and legs and a lot of other internal derangements. And suddenly it was realized, well, there wasn't safety data. It was widely used around the world but not in the U.S.
Thanks to Dr. Kelsey's keeping it off the market here, saving thousands of potential families from the tragedy of having their kids have a bad birth defect. And that gave rise to the approval of this almost dead-in-the-water legislation from Senator Kefauver that the FDA has the right to demand that a company show that its drug is safe and effective before it can be sold. And we were the first country in the world to do that in 1962. Wow.
But, you know, that argument that if we wait too long for the science to tell us that something is safe and effective, then we could be losing lots of lives. And so how long is too long and how do we do that? And that really affected a lot of things and came about in the 80s when we were talking about AIDS medications, right? So then we jumped to the 80s and now we're hearing...
You know, we can't wait that long. We need these lifesaving drugs on the market right now, right? Exactly. And that was a big crisis at the height of the AIDS epidemic in the late 1980s. And a number of AIDS activists went to the FDA's headquarters and poured red liquid all over the floor saying that, you know,
Which in those days, people thought, you know, you could catch AIDS by contact with infected blood. And nobody was quite sure if it was infected blood or just red paint. But it freaked out the FDA bureaucrats. And they came to understand that maybe, as you just said, Debra, you can wait too long.
And we certainly never want to do that. We never want to have a situation where the FDA or a doctor for that matter says, "Well, we don't have perfect evidence. Let's not use the drug." Because as you pointed out, you could have people not get the benefits. So it's always a delicate balance between how long is too long a wait and how quick is too fast.
And so this leads us rapidly to the present because in 1992, at the height of the AIDS epidemic, the idea was brought to the FDA, which they accepted, which made a lot of sense. Let's have a new fast track called accelerated approval for a drug that looks like it could be promising. We may not have the luxury of waiting a year or two to do all the randomized trials we'd like because people are literally dying there.
before our very eyes of AIDS, and this also applied to some cancers. And so this very plausible idea was put forward and adopted that if a drug looks promising and maybe it makes a lab test look better, maybe it changes the number of AIDS virus in your blood, but you haven't got the one-year follow-up, let's approve it and ask the company to do follow-up studies to see if it really works as well as we hope it does. But in the meantime, you've got it out there and people can take it.
And that was a great idea in 1992, and it's really been abused to bits in the decades since then. Abused to bits how? Well, it turns out that once you have a well-intentioned exception like that,
I don't want to say the whole pharmaceutical industry, but some pharmaceutical companies figure out, oh, okay, so if the rule is we just need to have a little change in a lab test that looks interesting and promising, and then we can get the drug approved, let's do that. And we'll get it approved. We can charge full price for it. And then...
part of that social contract that went back to the 1992 era was, we'll approve your drug quick, says FDA, but company, you have to then do a follow-up study to show that it really works. The company's really
really ran right through that provision quickly about we've got a lab test that's a little better, approve our drug under accelerated approval. But many of them did not get around to doing their part of the social contract, which is completing the follow-up studies needed to show that it actually helps patients.
Was there any timeline? Like, didn't you have to complete those studies in a certain amount of time? Well, that's another way in which I think the FDA has really fallen asleep with the switch. There's nothing in the law about the timeline. It was left to FDA's discretion. And so in one of the most egregious examples of just a few years ago, this Alzheimer's drug, Aduhelm, which did not work, it was sort of retroactively approved through this accelerated approval pathway by the FDA commissioner.
against the advice of all of her scientists and outside advisors. And it turns out that not only did it not work, but the FDA itself gave the company nine years to do the follow-up study, which would have been useless because nine years later, it almost doesn't matter what they found.
Let's talk a little bit more about adjuvam after a break, because I think it's a really interesting example of what we're talking about here, which is the U.S. medication market, from how drugs are approved to how they're kept safe and how they're priced. I'm Deborah Becker. This is On Point.
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Stick around until the end of this podcast for a field trip to the Basketball Hall of Fame in Springfield, Massachusetts. We were talking before about this idea of accelerated approval and how it seemed like, and it was a good idea at the time of the AIDS crisis, to say, well, if it looks promising and it's making a lab test a little better, let's let it out there and then the companies will do follow-up research. And
Adjuhelm really represented kind of the bottom of the barrel in the evolution or de-evolution of that concept in which the company that made it, which is a local Boston Cambridge company, Biogen, spent – and you got to feel sorry for them. They spent many tens or hundreds of millions of dollars to study this drug.
The idea was that it would lower amyloid levels in your brain and that was the cause they felt of Alzheimer's. And so this would be a way of making people with Alzheimer's either better or not deteriorate as much. And they did some very difficult, expensive randomized control trials.
And their statisticians came back and said, "Sorry, folks. The drug doesn't work." And they declared the drug essentially dead. And then in a remarkable sort of resurrection of a dead drug, the company got together with the FDA, had some probably back channel meetings that weren't supposed to happen, collaborated with some FDA people on, "Isn't there some way we can look at the data to show that maybe it does work?"
And there's this old saying in clinical trials research is if you torture drugs enough, you can make them say anything. And so what happened was somehow the FDA and the manufacturer, Biogen, agreed that there were promising findings. They ran them by the FDA's own internal scientists and by an advisory committee of outside scientists and published
They all said, "No, this does not show the drug works. This is not a good drug. It should not be approved." And then Dr. Janet Woodcock, who is the head of the FDA division responsible for making that decision, retroactively decided that, well, we're not going to use the criterion of does it make patients any better or even slow deterioration. We're going to focus on this accelerated approval measure of does it change your amyloid levels in your brain?
And she determined after the fact, which was never the design for the accelerated approval process, that, yeah, we're going to look at that other measure, declare that it works, and approve the drug. And this was so egregious a decision that three members of the advisory committee, including my colleague Aaron Kesselheim in our division at Harvard and the Brigham and Women's Hospital, resigned from the advisory committee saying, why are you even having outside scientists advise you if you're just going to ride roughshod over our decision? So the drug...
was sort of unilaterally approved by the FDA. And then the company said, we're going to charge $56,000 a year. And the FDA compounded their mistake and said, this should be used on everybody with Alzheimer's, not just the early Alzheimer's people in whom it was studied. And it went down in history as one of the dumbest decisions FDA has ever made. Oof.
You know, I do want to just bring up a point that we heard regarding the FDA. And this is back in 2023. We had Eva Temkin here on the show who worked at the FDA for about eight years. She left in 2021. And she said, you know, the FDA has a lot of
Right. A lot of work to do, a lot of drugs to approve. And it's really trying to carefully do this as much as possible. And you mentioned like the test for Aduhelm and things like that and looking at just markers for different diseases. And I think
Her argument essentially is that there are a lot of factors that the FDA needs to look at for a lot of different drugs and a lot of different pharmaceutical companies, and they try to do the best they can. Let's listen to what she told us back in March of 2023. Everything from cancer drugs to acne drugs to immunotherapies that have the potential to have some sort of negative impact on
on pregnancy or otherwise, right? Almost all drugs have the potential for toxicity. That is why FDA does this careful balancing between risks and benefits. And I don't think we want to be in a position where drugs
can't be developed or become too costly to develop or shouldn't be made available to patients because there might be some potential toxicity that arises. Rather, I think where the benefits outweigh the risks and
And that has been determined by appropriate scientific expertise. That's sort of where we need to be. So, Dr. Avorn, I wonder, what do you say to those comments? That really there's a balancing act here that the FDA needs to do to try to get drugs to market and still make sure they're safe for most people, right? There may be problems for some, right? Absolutely. It is always a balancing act. And I think we need to point out that there are some fantastically smart, effective scientists at FDA who
And they do this work really very capably and very carefully. And there is, as Dr. Temkin said, a ton of data to go through. So I don't disagree with anything she said. I think she was right on the mark.
But her comments actually in 2025 raise two points. One is how many of those very effective, smart, hardworking FDA scientists have been let go in the recent purge of the Department of Health and Human Services because this does take a ton of work by very smart people who normally do a very good job. And I should point out that without you, Helen, the FDA staffers and scientists did a great job. It was Dr. Woodcock as one of the senior leaders who
who reversed all their decisions. This was not any sort of FDA scientist problem. It was a leadership problem. But the other point that comes up is, as Dr. Temkin said, you need a lot of people working very hard on a lot of fronts to get this right.
Going back decades, ironically, to 1992, the FDA said to Congress, we don't have enough scientists to be able to do the careful job of the sort that was just described. We need more people. And the 90s were a period of we want government to be as small as possible. We don't want all these bureaucrats hanging out and ruining everything. And Congress said, no, FDA, you cannot have the staff you want working.
In March is the pharmaceutical industry in 1992 and says, oh, don't worry, we'll take care of that. We'll pay the staff of the FDA to review our drugs.
And they came up with this idea, actually it was kind of homegrown here in Massachusetts that Senator Kennedy was a big supporter of, called the user fee. And the idea was what could possibly go wrong if you just have the companies that are having their drugs evaluated paying the salary of the FDA staffers who are evaluating their product?
And we are now at the point where half of the salary dollars that FDA uses to pay its scientists come from the drug industry through those user fees. And that can't be a good way of getting enough manpower or person power at FDA. Too much conflict of interest, you would argue. You said it. I mean, how would we feel if there was a court case that we were involved in and we found out that one of the litigants was actually paying half the judge's salary? We would not feel very comfortable with that. So let's talk about why it's so expensive.
Right? We have the most expensive drug prices in the world. Some folks say it's because we have this long-involved regulatory process that you're saying really is mainly funded by the pharmaceutical company and also is shorter than a lot of us thought. So how much, let's start with just how much does regulation and regulatory control contribute to that cost? Are they related in some other way that we're not thinking about here?
Yeah, hardly at all. And that's kind of a canard that the drug industry has used over the years. Drugs are so expensive because we have to do all these darn tests and the FDA takes so long. The FDA is the fastest or one of the very fastest regulatory bodies in the world when it comes to reviewing drugs.
When they have a priority drug review, they can do it in six months. We saw that with the COVID vaccine, they did it in even less time. They are very fast and they cannot be blamed for the fact that drugs are so expensive. We got to look elsewhere for that. Okay. So we did hear from big pharma executives before Congress last year about why prescription drug costs are so high.
One of the folks who testified, Robert Davis, the CEO of Merck and Company, said to senators that one of the main reasons that drugs cost so much is because of research and development or R&D costs. Let's listen to a clip we have from that hearing. We know 90 percent of all drugs we will bring into the clinic fail.
The reality is the drugs that make it have to fund that failure. In the case of Merck, it's just interesting, I think, to point out since 2014, majority have not returned their cost of R&D. So it means that when you do get the rare drug that succeeds, it has to help cover that.
So, Dr. Averin, what do you say to pharmaceutical executives like Mr. Davis who say, you know what, we have to make a huge investment here in research and development. Where are we supposed to pay for that unless we have high drug prices to support our research into perhaps making new innovative medications? Right. It certainly is fair that when a drug company comes up with an important discovery, they should be richly rewarded for it.
in dollar terms, certainly, and that those profits ought to also cover all the false
starts that they had, and I totally understand that and agree with that. However, what industry spokesmen often don't mention is that a ton of the most expensive early-stage research is funded by the public through the NIH. And Dr. Kesselheim and I and our team over at Harvard Med School in the Brigham have looked at the grants, the papers, the patents, and so forth, and shown that for an awful lot of drugs...
The taxpayer did a lot of the heavy lifting in funding that early research and is never compensated by virtue of a break on the price of that drug. Taxpayer meaning you're talking about National Institutes of Health grant fund. Explain what that is to folks who don't know.
And the industry is very good at painting a rather simple and not always accurate picture that new drugs come from their white-coated scientists working through the night in drug company labs and discovering drugs. And, you know, they do work very hard and they are very smart people and they do spend money on these things. But they somehow leave out the fact that their starting point is a –
discovery or set of discoveries that have often been funded by the public through the National Institutes of Health that has led right up to the door of the new drug. And, you know, in most other industries, early stage investors get a big chunk of the resulting profits because they go in at the riskiest time. We have a situation with medications where the public who really are the early stage investors through the NIH
not only doesn't get a break, doesn't even get a piece of the action, and then we have set up laws so that the company then gets to say, we now own this molecule. And unique in all the world, we allow companies to set the price of their products at whatever level they want. And that's true. They can set it. But there's a time limit as to how long it can be at the high price. Well, Deborah, there used to be. And what I mean by that is that, yes, there are patents. And, you know, patents, this is our...
250th anniversary of the country, we're thinking about our origins. In the Constitution, there's a law there as part of the Constitution that says we will have patents to protect inventors so that they can reap a rich reward from their discoveries and then it will come to an end and then everybody owns it. And again, this is kind of the social contract issue that we've enforced the first part of the social contract, that is if you have a molecule that you own, you can patent it for X years.
What the founding fathers never anticipated is that companies would spend a ton on very savvy, clever patent lawyers and then develop what we call thickets of patents around the drug. So if you think about inhalers for COPD or asthma, our colleague Will Feldman has done a lot of good work on this. The companies don't just patent the
the drug and many of those drugs are so old they're off patent. Think of the EpiPen or other things where we have old drugs but they patent the device, they patent aspects of the device like the strap on the inhaler, the counter on the inhaler and somehow FDA gets led down the garden path and they say, "Oh well, you can't have a generic because not only do they patent the inhaler but they also patented the strap and the method of getting the drug into the patient's lungs and so forth."
some of which might be advances and some of which are just silly. And that makes these drugs unaffordable because they're still under patent many years beyond when they should have had those patents expire. So does the FDA or any agency say, you know, no, Dr. Avorn, that pill is not a million dollars. The market won't support it. We're not allowing you to do that. Nope. Nobody does that. The one time that happened, which I think was a very encouraging development,
and it brings us back to the Alzheimer's drug, Aduhelm, was FDA did this ridiculous after the fact. Well, it makes the lab test better. It doesn't help patients. You've got your approval.
The Medicare program, whose job ought to be just paying for drugs and has virtually always gone with FDA's decision on whether if a drug's approved, Medicare would pay for it. For one of the only times in history when Medicare was asked to pay for this enormously expensive drug, that didn't really work. They put their foot down and they said, you know, FDA, you may have approved this drug, but we're not going to pay for it, which was seen as
a watershed moment. Many countries have this division of labor between approving the drug and then what will it cost and who's going to pay for it. We tend to have automatic payment of anything FDA approves, Medicare and Medicaid pay for, no questions asked. Adjuhelm was the first time that Medicare said, this is going to bankrupt our system and therefore our enrollees, we're not covering it. And now that drug is essentially never used. Right. So that's really the way it was
The only way to stop an ineffective drug is to try to not have it in insurance coverage?
if it works. And by the way, a very important aspect of this is that legally, if a drug works better than a placebo, FDA is often required to approve it. They're not supposed to say how much better. They certainly can't say, is it worth the money? But if you bring in a drug that works better than nothing, and ironically, even if it works better than nothing in making a perhaps
meaningless change in a lab test, you've got an FDA-approved drug. Medicaid has got to pay for it. Medicare has got to pay for it. Most European countries don't do that. They will say, "Okay, it's approved. Now we're going to have a bunch of smart people without any conflicts of interest."
look at the drug and say, is this really addition we should pay more for? Or is it just the same old, same old and we're not going to pay any more than we are for the old stuff? I know in your book you mention, you cite a 2022 study, I believe it says that more than half of the prescription drugs in the U.S. have been approved on an expedited approval process.
Yeah, exactly right. Yes. Right. So what about other countries? Are they going through that quickly in European countries and other countries as well, or is it abnormally quick in the U.S.? The Europeans are more what I would call appropriately skeptical about some of these scammier drugs or on the patent side, some of the scammier patents.
And Dr. Kesselheim and his team have looked at that very carefully drug by drug. We are much more of a pushover country for the industry than our colleagues in the wealthy European countries are both on the patenting side and on the payment side. Okay.
Okay. So we're going to continue talking about that. And we also will hopefully have some optimism. Yes, we'll have optimism and answers. Optimism and answers. After a break, we're speaking with Dr. Jerry Avorn about the U.S. prescription drug market. I'm Debra Becker. This is On Point.
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One of the things that we've heard from some of the big drug companies is that, well, we offer assistance with copayments initially when a drug is really high-priced. And we do take steps to try to make sure that a drug is affordable because no matter how good it is, if patients can't get it, it doesn't really matter, right? So what about these steps that pharmaceutical companies take to help with drug costs? Is that hopeful? I think it's...
not heading us in the right direction. If we have a drug that is unaffordable, in a sense, bribing the patient with a coupon to take the heat off of them for their copay just leaves the other
perhaps 80% of the cost at the doorstep of their insurer, whether it is Medicare or a private health insurer. And in a way, it's an attempt to co-opt the patient's, you know, don't worry about that co-pay. Your insurer is going to make you pay. We'll take care of that. And then the lion's share of the insurance
of the payment is still at the doorstep of the insurer. And then you've got the patient, in a sense, acting like a sales rep going to the company and saying, I want you to cover this. It's not going to cost me anything, and you should pay for the rest. And insurers hate that for understandable reasons. So what do you think is a way that costs first could be contained? Before we get to some of the ideas about testing and safety of drugs in general, what
What about the cost? What can be done? As you mentioned earlier, there really is no limit, really, to what a drug company can seek to charge for its medicine. So what's the way to improve the way the system works now? And as we discussed earlier, we want to treat the companies fairly. We want to reward them when they come up with something really good.
We want to encourage that kind of investment and innovation. But we also don't want them to say, whatever we make, we're going to charge whatever we want, however good or not so great it may be. And there's a number of solutions, and it's really a matter of
the political will to implement them rather than inventing some new idea that no one has ever thought of before. And for one, we can kind of look to our colleagues, as I said before, in other parts of the world where there is a body of people who have no commercial ties to the industry, who are experts in their field, who look at a drug like...
any of the ones that we see advertised ad infinitum for psoriasis or eczema or Crohn's disease on the evening news programs. Many of them are very similar. Many of them are no better than the others. Many of them are no better than the so-called biosimilars, which are like the generics of their category. And yet, if you advertise them enough, you can get people to demand it from their doctor, which is much less sensible than saying, let's bring together a bunch of really expert doctors
Gastroenterologists, if it's for Crohn's disease, dermatologists, if it's for eczema or psoriasis, have them look at all the studies of these drugs and decide which ones are really better and worth paying more for and which are not. Lots of countries do that, maybe because they have a unified system of the government paying for drugs for everybody.
We don't do that. We have a wonderful group here in Boston called ICER that does it on a kind of voluntary basis, but they're not wired into any payment mechanism. They just are a very respected group of people looking at these issues. But we ought to do that as part of our healthcare payment system and then let a great drug come in at a great price and let a
So-so drug, command a so-so price. As part of the FDA. Well, FDA does not want to have that responsibility. They're not staffed up for it. I think it ought to be a separate body. Let FDA look, as we heard from your earlier guest, at all the complicated issues about does it work, is it safe, and so forth. And then once that is determined, another body can say,
"Okay, and now let's decide what it's worth," exactly as the government does for almost everything else that it buys. It doesn't let Raytheon or Boeing say, "Here is what this new plane or missile system or whatever is going to cost."
and just say, "Okay, fine. Where should I send the check?" They do a little bit in negotiation and pushback. And certainly all of us in our households will look at what is this particular X cost, whether it is a laptop or an egg in the supermarket. You know, am I willing to pay that amount? Is it worth it to me?
We just leave out that step for drugs and we ought to do it, certainly at the level of the payor who are usually the government or insurance companies. And this is doable. It's hampered by the fact that the government –
and wait for this because it's unbelievable. The government has made it illegal to do cost-effectiveness analysis for any federal program where it can stop it. So because the industry does not... What would be the reasoning for that? Well, there is... The real reason is that the drug industry hates the idea. The proposed reason is that they claim that it will hurt...
minorities and the disabled and people with illnesses, that is a made-up reason. It is not going to hurt them. It's going to make the drugs they get affordable.
But that is out there. There is a law in place saying you're not allowed to use cost-effectiveness analysis in making drug decisions about payment. Well, I think that you can understand some of that, right? Because cost-effectiveness could then sort of get into, you know, whose idea of cost-effectiveness. And when you're talking about drugs, it can be very emotional and who determines when a drug is worth it or not, right? Correct. And we do need to take patients' voices into account. Mm-hmm.
And we do need to say, you know, somebody, let's say, who is in a wheelchair and they say, I'm able to get into and out of bed more easily. That ought to be a big plus for a drug that enables them to do that. And, you know, those of us who are not in wheelchairs should not poo-poo that. But people have developed mechanisms for doing this over decades. We know how to do that.
Well, I do wonder, you know, when we're talking about specific improvements and what you're saying in terms of the drug makers and what they're doing, any patient listening right now who might be prescribed a prescription drug or not,
might be saying, well, how do I know what to trust here? What do you tell to patients? How do I know that my doctor even knows, right, that I'm taking the right medication, that I'm being charged the right amount? I mean, what advice do you give to folks so they know if they're seeing all these ads which medication for Crohn's or another disorder is the one that they should be taking?
That is a key question, and let me just make it even more relevant. We doctors need help with that also. How are we supposed to know other than having the friendly sales rep come to our office and say, hey, this is the best drug ever?
And there's a whole section of the back of the book of what patients can do, what are some reliable resources they can turn to to get information about how their drug stacks up with other drugs, what questions to ask your doctor when you're being prescribed something. Because, you know, we doctors should not consider ourselves the
the only possible voice in the room when we write a prescription, I think it ought to be the case that a patient will say, how do I know if this is the right drug for me? Will I be able to... Is there a more affordable version? And there's that whole dialogue that I talk about in the end of the book about patients engaging with their doctors, but also...
Being careful to not use the phrase do your own research, which can lead us to all kinds of weird outcomes, but reliable sources patients can turn to to look at the options that are there prescribed. And then not always second guess the doctor, but at least come equipped with some questions to ask. And any doctor who says,
I don't want you to ask me any questions. That's a time, I think, to find another doctor. I think there are some doctors who say, I don't want you to ask me any questions. But there are also doctors who expect that the patients have done the research and then looked at some of these things at the same time. So there's a lot on the patient side.
Right, right.
when they're getting all kinds of different ideas from the internet and from TV and from their doctors to try to figure out what's best for them. Right. And Google can actually be a source of a lot of mischief because there's a lot of garbage on Google, too. And they may have thought that putting AI in will make it better and it can actually...
There's some examples in the book where it makes things much worse. So what I've done is listed a lot of sites that a patient can go to that are not commercial, that are scientifically appropriate, that are often in layman's language, that are useful resources for looking up their meds and then engaging in a conversation with the doctor. And we on...
in our own work have also set up a not-for-profit to teach doctors in a similar way so that they are not dependent on the sales reps. And we have a nonprofit called Alosa Health, named after the kind of fish that swim upstream, where we go out and just teach doctors about what you should know about drugs not sponsored by a drug company. Mm-hmm.
And before – I just want to make sure we get to this. Before we talk about some of the other kind of policy implications and certainly the current administration, what about supplements?
Can you tell folks, you know, we mentioned certainly over-the-counter sales in the beginning and how the FDA came about and what things weren't regulated. But what do we know? The supplement market in this country is enormous. It is. And I'm sure all of us not only are bombarded by prescription drug ads, but also by ads for all different kinds of supplements. What is the FDA's role there in overseeing what supplements are on the market?
Years ago, we had a very good FDA commissioner named David Kessler, and he said something very similar to what you just said. We have this unregulated, chaotic industry that they call themselves a supplement, and they don't have to show any evidence that they work properly.
And the TV ads are rife with them. You can't always tell it's a supplement because it looks like a prescription drug. But they do not need to demonstrate any effectiveness. And even the requirements of safety are limited. Kessler said FDA ought to regulate those. The supplements industry, which is a $50 billion a year industry, said no you don't. And they wrote legislation sponsored by Senator Orrin Hatch saying,
who represents a state with a lot of supplement companies in it. And they whipped out any control over the supplements industry from FDA's jurisdiction.
And poor Dr. Kessler really got the opposite of what he had hoped to achieve. And so now supplements have a life of their own. They do not need to show pretty much anything. Alert listeners might see the tiny letters that say on the bottom, these claims have not been reviewed by FDA. This product is not designed to diagnose or treat any condition, which contradicts everything above it. But that's their little get out of jail free phrase.
And that, you know, if you put that on the bottom of your ad, you can say pretty much whatever the hell you want. And there is no evidence behind it. And a lot of them about memory function, about weight loss are utterly useless and probably should be illegal if I ruled the world, which clearly I do not. But yet some doctors will still recommend the use of some supplements. Yeah, that's... Calcium, vitamin D, right? All of these things many doctors generally just recommend. Yeah, well, if they're cheap and...
totally safe. It's not a big deal like calcium. It's not necessary, but it's not going to kill anybody. But a lot of these other ones are really, you know, people think they're taking a medication for their memory.
for example. And then the bad that that does is not all the money they're wasting on this stuff that doesn't work, but maybe the alternative would be going to their doctor and maybe the doctor would find a treatable cause, like hypothyroidism or depression or some treatable form of vascular dementia that you could do something about. So they're bad beyond what they do in terms of side effects. They're bad because they divert people away from evidence-based medicine, which is
where we maybe can help people more. But it's a completely free zone for saying whatever you want and the law can't touch you.
Well, I do want to talk about the current administration and what we might expect in terms of, you know, drug pricing and drug regulation. You wrote this as President Trump was coming into office, right? And so some things you do talk about in the book in terms of the current administration. But I just want to take up tariffs because I think that's probably going to have a major effect on drugs because
So can you explain what you think might happen there in this new landscape? Sure. And this is very worrisome. And it appears that decisions are being made that are – he is contradicting himself from one day to the next. President Trump. President Trump. And it is not clear on what sort of rational basis these –
decisions that come and go are being made. But what is clear is that most of our medications are made in China or India. And if we slap an X percent tariff on everything coming in from those countries, and then if beyond that he has an additional set of tariffs on pharmaceuticals, that is going to rather quickly make people's medications way more expensive, but worse.
generic manufacturers that operate on really, really thin margins may well say, as they have in the past, "We were not making much profit off this drug in the first place. We just aren't going to make it anymore. And our shareholders want us to make things that we can make money off of. So go find your antibiotic or your cancer drug or whatever somewhere else. We're closing up shop." And that'll be devastating and pretty quick.
But what about the argument from the administration that perhaps these tariffs might help at least stop some of the importing of the precursors to fentanyl, right? So they're saying China is allowed to bring these into the country at huge volumes. There are no restrictions to go to Mexico. The cartels are then making fentanyl out of these precursors that China uses for prescription drugs. And now we have a fentanyl problem. So we need to do something. Right.
I get the feeling that that policy came from a focus group and not from any careful thinking about the problem. We've never done well in this country by trying to shut down supply instead of dealing with the underlying demand. You'd think we would have learned that 100 years ago with prohibition. You know, we did not fix...
by making alcohol illegal. And the height of absurdity was when an excuse for the tariffs imposed on Canada was to shut down the Canadian fentanyl. There's hardly any fentanyl coming from Canada. If we care about people who have substance abuse problems, and we should, we're...
We got to help them get over their substance abuse problems, not reduce their access to something they're addicted to because it'll just get more expensive and they'll still try to get it. Okay. We promised hope. We've got about a minute left. Okay. And I do want to say we are talking about the new administration. And I wonder, you know, will we see something hopeful there? What about regulation and the FDA? Okay. Okay.
Today's Marathon Day in Boston, and I think of Rosie Ruiz. I don't know if that name rings a bell, but she was, in 1980, famous for having claimed that she ran the marathon, but actually came in at the finish line, collected her garland and her medal, and said, "I won the marathon, and I should be rewarded."
I think we don't want to do a Rosie Ruiz on drug development. We don't want to have companies coming in at the last minute and saying, "Give me my medal. I won the marathon," when in fact it was the public that paid for a lot of that development. And the company did something, but maybe they ran the last mile and a half, but that's not running the marathon. So we need to adjust our payment for who really took the burden of developing this drug.
and make our payments not whatever the traffic will bear, but based on how much research was put in and how good is this new product. All right. Dr. Jerry Aborn, professor of medicine at Harvard Medical School and author of the book Rethinking Medications. Thanks for being with us. Thank you very much, Debra. I'm Debra Becker. This is On Point.
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Rinse. Sign up now and get $20 off your first order at rinse.com. That's R-I-N-S-E dot com. Support for this podcast comes from It's Revolutionary, a podcast from Massachusetts 250. Listen on for the story of the revolution that is basketball. Yeah, go for it!
You're listening to It's Revolutionary, a podcast celebrating 250 years since the shot heard around the world was fired right here in Massachusetts. I'm Jay Feinstein. From revolution to revolution, we're exploring the people and places in Massachusetts that shape America. Today, we're in the birthplace of basketball, Springfield. Nice shot!
The game was founded at a YMCA in 1891 as a way of keeping kids busy during Massachusetts winters. Man, the game just took off right from there. I think within three, four years, the game was already being taught in different countries. Like, India is awesome. Alex Pedro is the curatorial assistant and historian at the Basketball Hall of Fame, which is just a few miles down the road from the original site that started it all.
He showed me around and he says he does that because he can't play for himself. I am terrible at basketball.
As I like to say, those who cannot do, teach. But he is pretty much the biggest basketball enthusiast I've ever met. You know, it's just so exciting because there's always constant action. There's excitement. You can see the emotion on the player's face. I feel like there's more of a personality. James Naismith was the physical education instructor who invented the sport. The original game had no dribbling, and players would shoot into peach baskets with enclosed bottoms.
Janitors had to fetch the ball every time a player made a basket. It was a slower game, but it was an exciting game from the start. When Naismith designed the game, I don't think he even knew. I mean, he knew it was going to be popular, but I don't think he knew it was going to be this popular, right? Like, he made a game...
so great for television. You know, you can see the players' face, you can see their emotion, you can see them getting hurt or seeing their agonizing pain or just at any given moment, anything can happen in a basketball game. It's just so exciting. You know, it's just no matter what, if there's a second on the clock, there's still a chance to win. ♪
But is excitement enough to make basketball revolutionary? At the very least, it inspired revolutionaries, like Lenny Wilkins, the first black player on his team. They wanted to use the game of basketball and say, hey, I belong here. It doesn't matter the color of my skin or my sexuality. It doesn't matter. Basketball is basketball. Or Georgian Wells, the first woman to dunk in a game. We see dunks and we still get excited because it's just...
such a raw athleticism, right? We're seeing somebody just jump in the air and do something so creative with their hand just to dunk the ball. It is really fun. But for the women's game, I feel like it's just showing that, hey, we're the same. We can do what you guys do. Or any of the number of Celtics hoop stars who have played right here in Massachusetts, featured in a new exhibit at the Hall of Fame called The Vault. So
So when you first walk in, you give you that feel of a bank vault, right? This is like a bank vault door. It's all secure. This is all items that have never been together in one place. So it's pretty remarkable. There we were looking at Bob Cousy's All-Star jersey.
John Havlicek's 25,000 point ball, Cedric Maxwell's MVP finals trophy, and more. The history is so rich with the Celtics. I mean, there's so much lore. There's so many stories, so many iconic moments. And personally, to see all these championship rings and to see the evolution of them over the years and to have them in one place...
Man, that's just special. But basketball isn't just a professional sport. I met up with James Gee, a coach at Springfield Central High School, who says he sees the tangible difference basketball makes in the lives of kids.
And perhaps there's nothing more revolutionary than that.
But for Alex, it's really the game's history that makes the sport special. From a game that started in Springfield, Massachusetts at a YMCA with just 18 kids in a class to now this global game where people want to come from Europe and Asia to play in the NBA or to play for their national team and to see it, it's just, that in itself is revolutionary.
It's Revolutionary is a podcast from MA250. For more stories, check out Massachusetts250.org or WBUR.org slash MA250. Oh my God, it's been a while. Told you, those who can't do, teach.