FDA: Is there something rotten here?

would need to change to practice what they preach. I'm your host time onto you, and I've spent over a decade helping organizations define what they stand for, their purpose and then help them to use that purpose to drive transformation throughout their business. Unfortunately, at a lot of institution today, there's still a pretty wide gap between word. Indeed, that gap has a name, bullshit. But, and this is important,

we believe that bullshit is a treatable condition. So when our bullshit detector lights up, we're going to explore everything the organization should do to fix it. There was a time in the not too distant past when cocaine was marketed to children and literal snake oil was sold as medicine, a time when sawdust was put into food as filler, and when rats were ground up with the beef, and

it was all perfectly legal. Food and drugs were sold in a completely unregulated market until President Theodore Roosevelt signed into law the Food and Drugs Act of nine six, giving the executive branch the power to regulate food and drugs and thus creating what we now call the f d A. Today, the Food and Drug Administration has an expansive jurisdiction regulating things raging from microwave ovens to cat

nip to ibuprofen and beyond, way beyond chew. On this the FDA regulates twenty cents of every dollar that you spend to cover such a broad water front. They employ eighteen thousand people that work across several inter agencies, including the Center for Drugs, Biologics, Devices, Veterinary Medicine, Food Safety

and Nutrition, and tobacco. Their formal purposes a few paragraphs long, but on the homepage of their website they have a phrase that nicely captures the spirit of it, and it really Today, as in the past, the FDA strives above all else to safeguard the health and well being of the American people. That is a monumentally important purpose, one in which the stakes for all of us are high. However, if you've been listening to the news lately, it seems like the f d A is falling pretty short of

living up to it. Speaking about the epidemic of youth use of e cigarettes, it retrospects the FDA should have acted center nationwide of baby formula stock is gone. Part of the blame for a lot of these shortages rest at the feet of the f d A. The FDA first approved OxyContin. Since then, more than five hundred thousand

people have died from opioid related overdoses. We've actually encountered the FDA twice before, first when discussing their role regulating Jewel, and again while researching Perdue Pharma for a potential episode.

The FDA was certainly a character in the first Jewel episode, but when we checked in on Jewel again this season, it was clear that the f d A shared a lot more of the blame for the damage caused by Jewels unregulated product, and so we decided to aim our BS detectors directly at the f d A. Starting with picking up the strange case of Big Tobacco, Vaping and Jewel. Okay, folks, I am very excited to introduce Lauren Etter for her second time on the show. Lauren, thank you for being

here and welcome back to calling Bullshit. Thanks for having me tie great to be here. Lauren is the author of the Devil's playbook, Big Tobacco, Jewel and the Addiction of a New Generation. But before we continued the conversation with Lauren, let's catch you up on the escalating story of the regulator and the company with a b S

roundtable recap. Okay, So, Jewel Labs launched its Jewel E cigarettes as a smoking cessation device in it was actually effective and had the potential to help smokers get off cigarettes. But Jewel was funded by venture capitalists with a growth at all costs mindset, which led them to target kids, the demographic most susceptible to picking up a smoking habit, thus sparking a new youth nicotine epidemic total BS. But

at the time the cigarettes were totally unregulated. Finally, in the FDA began regulating the cigarettes as tobacco products and requiring manufacturers to submit applications to be on the market. And guess what, Jewel Labs didn't get around to submitting their application to the FDA until July, all while they were still selling Jewel more bs. You would think the story ends here, but it doesn't. It then took the FDA two more years to review Jewels application, all the

while jewels are still being sold. Finally, in June of twenty two, the f D announcer decision to deny Jewel Labs application, essentially banning the e cigarette. Their reasoning Jewel did not provide enough scientific data to show that their products were not harmful. Not surprisingly, Jewel Labs immediately sued and within a few days was granted an emergency stay, allowing them to keep their products on the market. And now the FDA has walked back their decision and it's

currently re reviewing the application, leaving Jewel. You guessed it still on the market, and that you're round. I think we have different internet connections and that's your round table recap. The FDA website says, today, as in the past, the FDA strives above all else to safeguard the health and well being of the American people. So first, I just wanted to ask you, how do you think they're doing

at meeting their mission or achieving their purpose? I would say just in general that with tobacco, for many years, until the early two thousands, the agency didn't have any jurisdiction over the tobacco industry. It was a completely unregulated market. And it was only after the Master Settlement Agreement and after the tobacco companies has gotten crushed in that whole ordeal. When you know, for years Congress tried to figure out how to regulate tobacco. The Supreme Court even at one

point said they didn't have jurisdiction. So this has been an issue like where should the tobacco industry sit doesn't make sense for the f d A to regulate this industry, But for years there's industry was totally unregulated. So I think that there's a lot of questions worthy of tasking about the f d A and certainly about their role in the regulation of tobacco. You may remember that we

we score organizations on their level of BS. Would you be comfortable giving the f d A a score even as it relates to the Jewel situation of zero to in terms of gaps between word indeed. So if you look at what the agency is doing in the top back the overall kind of tobacco space and their efforts to implement a harm reduction framework, they're actually making strides.

My issue is, I don't feel like the FDA has enough resources to police the kind of illicit sale of the product to keep it out of the hands of the youth. They're just a very underfunded agency, especially the tobacco products. And so if you're looking at the twin problems of adult smoking and youth nicotine addiction, I feel like they they are focusing quite a bit on the adult smoking issue and then the youth nicotine addiction issue.

I don't know if I have enough confidence that they're going to be able to ultimately keep this highly addictive product out of the hands of kids, which is ultimately the goal to stop a new generation from becoming addicted. So can I give them a score? Um? I just don't know if I feel comfortable settling on a on a number, Yeah, that's okay, but it's it's definitely not

the best number. Zero right there bumbling their way through this, and let's just say, with the best of intention, right, they have failed to protect America's youth so far from vaping, which is, at the end of the day, an extremely efficient delivery system for what ought to be a controlled substance in my view, right, But the FDA is constantly barraged with this flood of new products, and they're constantly on their heels responding to these like rapidly innovating markets.

That makes it very difficult for them to contain this, again, highly addictive product that's being sold at seven elevens, and you know corner stores around the country that not all of them have the greatest I D checking abilities. So I admit it's a very difficult task for them to do. I think it should be one of the most important tasks that they undertake, and I know that they're taking

it seriously. I'm just concerned that they might not have enough resources to adequately keep these highly addictive products out of the hands of young people. Is the FDA's lack of resources the reason they fumbled through regulating e cigarettes and jewel in particular. Lauren thinks so, or at least she thinks it's a significant part of it, and although she deferred on giving them a B S score, she does believe the FDA is making strides, no doubt, it

is an incredibly challenging undertaking. But if your purpose is to safeguard the health of the American people and a new generation gets addicted to nicotine on your watch, it's definitely a harbinger of bullshit. But maybe the Center for Tobacco Products is an outlier considering the FDA covers so much ground, I'm going to reserve judgment and see what's cooking at their second biggest interagency, the Center of Food

Safety and Applied Nutrition. With food specific we're trying to do a little more because we don't want to just make food safe. We want to give consumers information that helped them to choose a healthier diet. Richard Williams worked at the FDA for nearly three decades, and he left the Center for Food Safety and Applied Nutrition with a bad taste in his mouth. I think the big thing was as I approached the end of my twenty seven years, it occurred to me in all those years is that

most of what we had done had not succeeded. And so the more I thought about it, the more I thought, well, what actually happened? What went wrong? And I thought maybe if I could write a book about it, we can start changing things and and actually solving things for consumers. Richard's book Fixing Food and f D A Insider Unravels the myth and the Solutions, is an eye opening account of his tenure at the organization, beginning when he was hired as their very first economic analyst. You can blame

it on President Carter. President Carter was the first one who said we need some economic thinking in these particularly social regulations. More and more presidents begin insisting that we do these things and that we take take them into account so we can make better decisions. Let's talk about your job and some of the eye opening parts of your book, because you, it sounds like, walked into that job with the best of intention. You wanted to help

the I achieve its mission of making people safer. One of the first assignments that you had was to do a cost benefit analysis on lead acetate in men's hair dye. I wondered if you would tell us that story. Sure, that was the first one just assigned to me. All I had to go by was the executive order and what I knew from from being an economist. So I jumped into it and found out that this was basically the thing that you put in your hair, and over

time it takes the great away. Richard wanted to know of using lead acetate could cause skin cancer, and after a deep dive into the toxicology, he found that the risk was near zero, thus there was no benefit to banning the drug. There was, however, a high cost to taking it off the market. It was the only product of its kind available, so without it, gray haired men would have no alternative, I mean, other than living with the fact that their hair was great. I turned into

my analysis. We didn't think a thing about it until a couple of weeks later a young woman had come down from the center director's office and she said, this is great. Now we need you to do the other one. And I said, what other one? She said, well, you said that benefits were lower than the cost and if we decide not to do anything about let acitate that will work. But we want you to do one that shows the exact opposite, that the benefits succeed the costs,

that it does costs cancer. And I'm like, well, no, that wouldn't be honest. I'm not going to do that. And she said, you don't understand. This is an order, you know, from the sixth floor. And I said, no, I'm not going to do that. I didn't hear anything

more about it. A few weeks later, I was in our first my first training class where I was getting my introduction to FDA, and the deputy Center director was in there, and at lunch, I went up and I said, you know, a funny thing happened to me, and I explained the situation, and he said that order came from me, and you're going to do it or you're going to be fired. And I said something really stupid. I just made this up on the spot. I said, I'm not

an economic prostitute. And he said, then you were fired and you are going to be leaving this agency. And so I went back to my office. I'm like, should I start packing up my stuff? I didn't know. And then nothing ever happened. He apparently decided it would be a bad idea to fire over that kind of thing. But that was just the first time I was threatened with being fired. I mean, good on you that you did not gave to that pressure. But it sounds like

that this was not an isolated occurrence. Were there other instances where you were asked to essentially compromise your integrity for twenty seven years. There were other instances. Was it was it never stopped. That is incomprehensible to me, and it's terrible. And so, for the first time in my life, decided to become political with a small p like a bureaucrat politician operator, which you have. Yeah, sadly, Well, so let's let's follow that threat a little bit, because I

assume that, let's assume the best of people. Assume that people who were feeling the pressure above you in the organization, we're feeling it from other entities. You know, in your book, you go into the FDA spending a lot of energy responding to influence from just an incredible variety of stakeholders. There's you know, the executive branch, there's Congress, there's courts, there's press, private industry, activists, academics. Can you help us

understand the FDA's relationship with some of those stakeholders? Sure, I mean, you know, first of all, you have to start understanding one thing. FDA has been around since nineteen o six, and they have continued to accumulate literally power such that one off there said that in the twentieth century, there was no regulatory agency in the world that was more powerful than f DA, and that's because they're very

good at what they do. So if you think about it, they work for the president, and the presidents are supposed to oversee them, but every president, Republican and Democrat, has said it's nearly impossible to control the administrative state. That is, all the agencies that they oversee. There are hundreds of thousands of employees. They all have their own little agendas, and it's very, very difficult for the presidents to do anything. Um So that's a problem. Congress they just don't oversee FDA.

They're afraid of f d A and um so there's not a lot of oversight. They're interesting, Why is Congress afraid of the f d A. Well, FDA has very complex issues, very hard for Congress. People are really busy, you know, with lots and lots of things, mostly getting reelected and raising money. They don't have a lot of time, and their stats aren't very good at overseeing these complex issues.

I get it, but it means that FDA is kind of more free to do what they want, so they hold Congress at bay the courts have up until recently and generally will give them deference to how they interpret their statutes. Then they have other people, academics they generally give grants to that kind of buys them off. And then when they go into Congress to ask, you know, which they do every year, for more money, they actually have large food firms going and testifying and saying, yeah,

FDA should get more money. There's a reason for that. Large firms usually get regulations that are easy for them to comply with but hard for small firms, so it puts their small competitors at a disadvantage. I want to go into that issue a little bit later, the issue of big companies versus small companies, because that that feels like an important topic. But before we go there, let's talk about one other constituency, consumers and where they rank

in that higher are key. I think consumers and small businesses both are at the bottom. When I first came into f d A, you know, I truly believe in what we're trying to do. I thought these are important issues, and over time I found out well, initially when I got there, I was told this that this actually happened with the let acetate rule. I said, this rule won't do anything. Why are we doing it? And my boss at the time said, Richard, we don't have to solve problems.

All we have to do is appear to solve problems. We have to do something about it. And that never left me, and I noticed more and more that was the case once we passed the regulation. No matter what the regulation did, it didn't matter. It looked like we had addressed the problem. And that and that leaves consumers and public health in in in last place, if you will,

what a mess. Okay, So let's talk about some of the you know, in your view, the biggest and most dangerous problems that face consumers today that the FDA is responsible for. And we can live within the domain of food, but feel free also to talk about stuff outside of food. Yeah. Well, I do think it's obesity. I think that is probably the number one and it's going to get worse. You know, there was a harvest study that projected that by the end of this decade, which is only eight years away,

half of this country will be obese. Um FDA plays a role in that with food labeling. Food labeling has not worked, It's not going to work. It's really not

going to be the answer. Putting calories on foods hasn't really changed anyone's behavior as far as we can tell, sticking with obesity, and I don't think you you made this connection overtly in the book, But one of the impressions that I've gotten both from you know what we've learned from your book and also other research that we've done, is that intended or not, the combination of the industrialized food system where people eat a diet and combine that

with a for profit healthcare system that then profits from the multiple diseases that result from things like obesity is kind of the perfect dystopian partnership. What do you think about that first? And and do you think the FDA has played a role in that. I don't personally think that is the exact issue. I think it is an issue. I think certainly food companies, like every other company in

this country, are there to make a profit. The problem is we have no idea what a healthy diet looks like because nutrition science is the worst science that we have, and so we've got people out there hawking books, you know, on diets, something say well, you gotta have a high carb diet, and so you have to have a low carb diet, high fat diet, low fat diet, on and

on and on. And the truth of the matter is one we don't know, and to what we're beginning to find out is that one diet probably isn't right for everyone. Different people with different genetic backgrounds, different underlying health conditions probably need different diets. So I think, in my mind a bigger problem and this is why basically companies can sell whatever they want. It's because we just don't know enough yet because the science is so bad. Well that

that that's a good point. I think to pivot to another aspect that you touch on in your book. You believe that entrepreneurs are solving many problems that the FDA can't or won't. Can you talk more about that. FDA has recently announced they're going to start looking at technologies. So the first thing that they're gonna do, and this is gonna be tremendously helpful if we can get it done, is using blockchain, the same thing that you use for cryptocurrency,

in order to start recalling things faster. For example, this technology could in theory, reduce the time it takes to trace the origin of a contaminated food upbreak from two weeks into two seconds. So that does several things. One, if you can trace sinks back very quickly, you can find out what the root caused us in others, what actually went wrong that caused this problem. More importantly, it

gets bad products off the market more quickly. And it also doesn't basically indict everybody right yes, which sort of leads to something that you've entered at already in this interview, which is that the playing field is not necessarily level between small companies and big companies. Can you talk more about that? So there's a law on the regulatary flexibility

access we have to take into account. You know what the impacts these things are on small producers, and if we can to give them some kind of relief, And given the fact that the benefits birth that great, I said, well, at least let's examp some of these small firms and make the requirements easier on them. We didn't do that. Of course, all the large firms didn't want to give small firms a break. But as they say, it's an

unlevel playing field. They have much more influence over FDA, and this is true in any regulatory agency than the small firms do. So the small firms get driven out of business, and I think it's a shame that we have two different laws that are supposed to protect small firms and we're still not doing enough for them. One of the other topics that you you touch on, and that that I've encountered in other environments is the topic

of conflict of interest. One of the things that I just have a hard time getting over is government employees leaving the FDA and going to work for the corporations that they're trying to regulate. And you give a very poignant example of a person who wrote a regulation just so that they could jump out and get a job consulting on that same regulation to help corporations figure out how to wend their way through it. Is that common. It's hard for me to know. I don't have data

on how common is. I certainly saw it often enough. The law allows it. What they do say is that it has to be a number of years before you can come back and lobby the f DAY for that industry. But you can go out and work for them. You can tell them how to comply, and you can make money. I could be wrong, about this, But I think a lot of people feel, you know what, I work in a quote unquote low wage government job. I should be allowed to go out and make money like everybody else.

I sort of served my country in this job, and I have some sympathy for that. But again, like you say, it seems to be something wrong if you can be a part of writing a rule and then you know, right it in such a way that you can go out and profit from it. Yeah. I mean this is a really hard question, so I don't expect an answer, honestly, But how do you solve that problem? You know, it's just a great question. I wish I did know, But I'm pretty sure it's not the worst problem. F d A.

What's the worst problem? The fact that they're not solving any problems, the fact that decades and decades go by, uh there, their budget keeps going up, they get more people, people believe in them, they believe that they're keeping us safe, and that it just keeps going like that. And the fact that you can go to Congress every single year

and say we've got to do something. One out of six people in this country getting sick from food poisoning every year for thirty or forty years you're saying the same thing. Congress goes, oh my god, that's terrible, we got to give you more money. Well, no, sooner or later you gotta start saying, Okay, you gotta do something different. So, just to be fair, are there any big winds that you would point two times that the f d A

has gotten it really right? Oh? Absolutely, And first of all, let me say, a lot of it is the system. It's not the people. There are a lot of great people that work for FDA. They're very smart, they're very dedicated, they believe in it, but unfortunately they they they've run out of ideas. But one thing I think where we got it right was transfatty acids. This was a case where an initially we were just going to ask firms

if they wanted to voluntarily label it. Trans fatty acids are worse for you than than saturated fats, so that was the bottom line. We really needed to do something, so we kind of went round and round. There's a long story about it, but we ended up with mandatory labeling and companies sort of got the message and they began pulling trans fatty acids because they're added to most foods, so if they're added, that means you can easily take them out as opposed to saturated fat, which is just

a part of the food. So they started take them out and then eventually adding them has become illegal. I think that's probably one of the best things that we did. Is there anything that I haven't asked you about that you think people should know about the f d A. I do think right now with the Commissioner saying our food safety system is broken with what has been happening with infant formula, which f d A incidentally played a

huge role in why that happened. For forty years they've been telling firms who want to come and start making infant formulated, said no, they've kept it at six firms new kidding. So they created essentially the monopoly that then right hurt the hurt the whole countactly exactly. So when you had one manufacturer drop out, of course there's a huge problem. So with with these problems coming up, I think the curtain has fallen down and we see what's

going on behind the curtain. Yeah, it couldn't have a better time to start thinking about doing things in new way and actually trying to solve problems than just appear to be doing that something. So I'm hoping now is the time. That's a nice note to wrap up on. So let's just say that you're the FDA commissioner for a day, or a month, or a year, for whatever

period of time is necessary to make real change. What would you do to help the f d A achieve its stated mission, which, as it says on the website, it says as in the past, the FDA strives above all else to safeguard the health and well being of the American people. What's the one thing you would change about the FDA to help them achieve that goal. I would, I would retask them. I would say, look, we're not going to pass all these regulations. Let's start looking at

these new technologies. If we think they're not completely safe, that they need some sort of adjustment, let's focus on those, let's promote them. I'll just give you quickly a list of things. Precision fermentation, genetic engineering, three D printers are coming along, consumer nutrition devices. They're going to have to go through the medical device basically preapproval thing. We've got

to get those through faster. Those are gonna help consumers eat better, nanopackaging, where we have smart packaging consumers when their food is becoming spoiled. All of these things, I would say, let's start looking there. That's the future. Those are the solutions. Let's start looking at real solutions and stop trying to pass these regulations. They were fine a hundred years ago, they're not fine now, so I would

retask them. I love that, Okay, Richard. On this show, we have a tool that we call the b S scale that we used to measure the gap between word and deed. And our scale goes from zero to one, zero being the best zero bs and a hundred being the worst total BS. So what score would you give the f D A Well, mostly I'm qualified to talk about the food's part the FDA, so I'll just focus on them on that scale, because you know, they say that they're protecting consumers. They say all these things, and

they're not doing it. I would give them about a seventy five. So it's of what they do in foods is bullshit. Okay, room for improvement, all right, Richard, thank you so much for being here today. This was a great conversation, and I also want to thank you for writing this book and doing the work that you're doing post your time at the FDA. It's incredibly important and we thank you for it. Well, thank you again for having me on. It's been great. Well, that's interesting, if

not totally disconcerting. Earlier in the episode, Lauren Adder posited that the FDA had fallen short due to a lack of resources, but Richard, a former FDA employee, says that the organization floundered in spite of a consistently increasing budget. If there was a harbinger of bullshit before, there now seems to be a flashing neon arrow. But to be fair, we've yet to explore the biggest inter agency. Buckle up, folks, because next we're looking into the f d a's Center

of Drug Evaluation and Research. Right after this. Okay, folks, it is my great pleasure to introduce Dr Gail Van Norman to the show. Gail, welcome to Calling Bullshit. Well, thank you, Ti, it's a pleasure to be here. Gail is a clinician and professor at the University of Washington. She writes and teaches about the medical research process, everything from the FDA to commercialization to how animal testing works.

So the reason that we're doing this episode on calling BS is that the f d A has come up a couple of times on this show, and our research left me with the impression that the f d A sometimes gets things very right and sometimes it gets things very wrong. Would you agree with that? I would. I think the the FDA operates under constraints that are imperfect, and even the best of organizations tasked with such a

complex mission are going to have misses and hits. Over All, the FDA has had a number of spectacular hits and pretty notable failures. Yeah, so let's let's get into some of those, because I'd love to have you start out providing, you know, an example or two of times when the FDA has truly lived up to their mission and really gotten it right. Okay, Well, let's start with the lidamide because it's a sort of a classic historical example of what can go right and wrong with medical research, as

well as what happens at the FDA. Phillidamide was an anti nausea drug introduced in Germany in the nineteen fifties, and it was considered one of the safest consumer drugs ever to hit the market because it was so safe practitioners really picked out its use in pregnancy because nausea during pregnancy is not only a misery to women, it can be dangerous to the health of the mother and the fetus in utero, and so having something that controls

nausea and vomiting is very important. The drug had been tested in animals prior to human tests that had been tested, and I believe the number is something like fifty or a hundred different species of animals, including rats and mice and dogs and cats and armadillos and ferrets and rabbits. It was considered such a safe drug that it was not required that you have a prescription to use it. Uh. The drug manufacturer gave it away free to its factory

workers pregnant factory workers to use during pregnancy. Wanting to expand the market into the US, the manufacturer submitted the drug for review with the f d A. The committee reviewing Philidamie was headed by Francis Oldham Kelsey, who just so happened to be the first woman to hold the position. She later joked that they gave her what they thought would be the easiest one they could possibly give and whether they did that because she was a woman or

she was new. We'll just leave to speculation. Anyway, she read the data and something about it didn't ring true with her. She didn't like it, and she said, I'm not going to approve this. I'm gonna stop you, and I want to see a few more studies. And just a few months later, on Christmas Day, in the first baby was born in Germany without years, a little baby girl. And that was followed by over ten thousand cases of severely deformed infants that were born and probably twenty cases

of in utero deaths. And the US saw exactly seventeen cases of thelidamid deformities, presumably in the children of mothers who brought the drug in from out of country. We were saved that plague because we never approved the drug in the United States for that use. I mean that Actually, I had a galvanic response to that story, like it makes the hair on the back of my next stand up to make me think how close we came to a total unmitigated disaster. You know, yeah, it really is true.

And let's let's talk about COVID also, because that's fresh in everyone's mind, and that's clearly a case where you know, I mean it seemingly the normal process takes forever, and it just it feels like COVID vaccines just magically appeared. How did that happen? It was very incredible, right. Yeah.

I'm thinking to myself two and a half years ago when COVID hit and I have in my distant medical background, I have a background in immunology, and I remember people coming and asking me, well, how long will it take for us to have a vaccine? And the average time to get a vaccine created for a new disease is fifteen years, So it's it was like, so right away what was happening was the the government was saying We'll have a vaccine for you in a year, and I

was going, not, on your life, you won't. It's just not trying to happen. No chance. But of course there was a chance due to several important factors all occurring simultaneously. First, the US government created a public private partnership offering ten billion dollars to pharmaceutical companies to start immediately making and

testing vaccines. Second, the mRNA vaccine had become available. This new technology created a way for the body to show effecsimile of the virus to itself, making testing on humans much easier. And finally, the Century Cures Act allowed for emergency authorization and the quick release of the vaccines. All those things came together. It's just amazing. Yeah, it is amazing. So the litamide and covid vaccines y f d A truly, and they do so many more things right as well.

Those are just a couple of examples. But let's let's pivot to where they get it wrong. For for me, because we did the research we did, Purdue Pharma comes to mind and the OxyContin crisis. So the thing that that shocked me about the Purdue situation and I did not I did not understand this prior to doing this research. But there are people at the FDA who have to write the language that goes on warning labels on drugs, and there are different kinds of warning labels. And the

big thing in in news world OxyContin was addictiveness. Any opioid heretofore had been deemed to be addictive and had to carry a label that said it was addictive and would be prescribed in that same way. I e very sparingly, and Purdue figured out a way to get the warning label written in such a way as to avoid any language of addiction, so that more doctors would be inclined

to write prescriptions for it. And my understanding of this story is that the person who wrote the language actually hold up in a hotel room with the executives from Purdue and they all crafted that language together. And so this gets to a larger issue obviously, which is sort of the revolving door or the I would say, fraught relationship between giant for profit industries and low paid government workers.

And further, to sort of add insult entry, once the language had been crafted, once OxyContin was approved and being sold across the world, that person left the f d A and took a job at Purdue Pharma, you know, kind of closing the circle as it were. And you know, that story really disturbed me. It outraged me, honestly, and I would love to hear your take on that and

how widespread a problem like that really is. I think what you're getting at is a real problem in that there is a variously porous interface between the kinds of researchers who work within within the f d A and those that work in commercial industry, and so people do switch teams and that's perfectly legal right now, is it not?

Oh sure? I mean the current Commissioner of the FDA, Robert Coliff, was an executive for or I can't remember the name of the research company that's a subsidiary of Alphabet anyway, he made two point seven million dollars a year in salary and he used that And I'm not criticizing him. I don't make it make it sound like it was nefarious. That was actually a selling point for his appointment as the Commissioner to the FDA because he knew the ins and outs of commercial research companies. So

you can make an argument that it's helpful. And by the way, his salary there right now is now three dollars, which is considerably less. And he put in a lot of agreements to say he would not participate in owning, selling talking to you know, he self restricted to say, I'm going to make sure you know that who I work for, you know who my boss is. But other

people have not been quite so clear about it. And so you have somebody who works on an FDA committee and they have a drug presented to them, and the people who are presenting the drug whisper in their ears Wow, we really think your help has been really valuable, and we'd like to get think about coming on as a researcher or a head of marketing in our company. And they offer you a two and a half million dollar raise, it can be a little hard to turn it turned down.

And so there are connections which between the FDA and the commercial world, which if properly aligned, are helpful because it can give the FDA insights as to what the company is doing, but if they're not properly aligned, can lead to conflicts of interest into the detriment of the safety and health of the American public. Right. So, the FDA is a government organization with a mission to protect us all from the effects, intended or not of private

for profit interests. So, so let's talk a little bit about money. How does how does the FDA receive its funding? Well, the FDA used to be back in the nineteen twenties, it was all government funded. It just came out of the General Treasury Fund for the FDA. Now, about forty five percent of the FDA's funds come from something called user fees and application fees that are paid by the

drug companies to get their drugs reviewed. When that was first proposed, there was a lot of concern that this would create a conflict of interest for the FDA because a lot of their funding would come from the very people they're trying to regulate. But it became so popular because those user fees were enacted because the FDA was

woefully short staffed. Congress enacted this as a way specifically for the FDA to hire the people that needed to do the work, and it led to a big reduction in through put times and it accomplished exactly what was supposed to do. So it's still popular to this day. And how much do you think the f d A is affected by lobbying, either by big drug companies lobbying on the health to change laws and regulations, or patient advocacy groups lobbying to influence the way the organization is

is funded or regulated itself. Well, both affect the f d A. I mean, it's not immune to them. The FDA acts is funded, as I mentioned, from congressional funding, and Congress is affected very heavily by patient advocacy. You get patient advocacy groups getting Congress to write both good and cockamami laws all the time. With regard to health and so the f d A is not immune from

those effects. The other thing I would say that there's no it's hard to say that there's a direct effect, like you know, Glaxo smith Klein plays their two million dollar drug fee and that makes the FDA prove the drug. That doesn't happen. But the other kind of effect is hard to regulate against. The individual who sits in an influential part of a committee who then is favorably impressed by a drug company about their drug in various ways

and advocates for it. Those do happen, and individuals that sit on these committees can make big differences in what the FDA decides to do. One of the things that is just true is that our health care system is run largely as a for profit enterprise. And is that part of the problem here, oh sure? Or is that the whole problem here? That that might even be the

whole problem for all we know. I mean, I suppose there are good aspects commercialization, because it does, in an ideal world, promote competition and innovation, but it also promotes manipulation and profit taking, and neither of those serve patients at all. They serve the companies that make the drugs, and they're talking about well, that's right. I mean we're not just talking about the company making a profit. We're

talking about unimaginable amounts of money. We're talking about a drug generating a hundred billion dollars in profits, a hundred billion dollars. So this is money that will buy anybody's soul, right, maybe even mine? I don't think so, but you never know. Well, and know, like, it's an interesting question to ask yourself, right, is like what's my number? But in the current system, the consequences for breaking the law often take the form

of fines. But with profits of that size, you know, would it be fair to say the fines are just a cost of doing business? Oh? Absolutely, it's it's amazing. I mean, what you see in the media, what the American public sees is the sacklers paid what was it billion dollars? Well, weighed against what did they make. Even if it's a hundred over a hundred billion, it's less than of their whole profit margin. And remember it's not just the profit, it's not just the actual dollars that

go in the bank. It's how much their stock is worth. Right, So if you're making a hundred billion dollars in profits, your stock becomes worth a huge amount more. And these companies are run by individuals who have heavy stock interests, who may have individual conflicts of interest with doing the right thing, and more and more, we're talking about dollar amounts that seem insurmountable in their ability to bribe and attract people into behaviors that we would hope we wouldn't

see in this industry. Right And and you know, just to contrast that, to make this really clear, how much money would a typical f D A employee take home, if there is such a thing, And how much can we contrast that with an average pharma executive even just roughly? Uh? Well, I I the farmer executives take home millions of dollars. The average FDA salaries a hundred and ten thousand dollars a year, and their top executive makes three dollars a year.

So it's considerably less than anything the commercial environment could offer, right. Yeah, And it just seems like there's a massive incentive for these big companies to try to figure out how to gain the system in one way or another. Well, I think it's not just there's this incentive. There's virtually no disincentive to do it, because if you're that rich, you can just pay the fine and move on, doesn't doesn't matter. You actually factor that into the cost of developing the drug,

the cost of putting the drug out there. Yeah, well that's terrifying. So, Gail, another way to look at our show is fundamentally it's about trust, and it's just incredibly important that we trust institutions like the f d A literally lives around the line. And honestly, I can understand in someone who has lost trust in politicians today or in big pharma, or even in the f d A. You know, this is the same institution that approved oxy. So what are some things that you think the FDA

should do to try to rebuild trust with people. I think, first of all, we need to start with Congress and say, who do we have in Congress sitting on the committees that give the FDA it's marching orders. Frankly, I can't.

I can't tell you who those people are. I should be able to, but I can't right now, and do I trust them, particularly when I well know that many of our congressional representatives are, for lack of a better word ignorance of science and how it works and don't care to learn it, and the hander to sort of the conspiracy theorists who want to think that we're all out to get them. So I think we need to look at that and ask should there be special or

qualifications for people who determine how this agency works. I think overall the agency does a remarkable job given the mission that it has and the number of opportunities for failure that it has, how relatively few it really has experienced.

I think we need to look at how we can reduce conflicts of interest that we've talked about within the agency so that we don't have people who are pretending to serve the FDA but are really serving a commercial interest or serving themselves so that they can position themselves for for a well paying job with the commercial companies. I think that would be helpful. And I think we need to have real penalties for pharmaceutical companies that openly

commit criminal acts. This is in the criminal Code now produted things that were criminal, and that perhaps money is not the price those people should be paying that people people there should be real prison time assigned when those sorts of things happen because as a CEO who knows that their signature on a piece of paper might put them in jail one day, may think twice before signing it and may have better oversight. Yeah, okay, alright, Gail,

this is really my last question on this show. We have a tool called the b S scale, and the b S scale goes from zero to one, zero being the best score meaning zero bs one being the worst total bs. So on that scale, what score would you give the f d A in achieving its stated mission? I would give it a really good score. I think that to do it's the complicated job it does, to do it with the high degree of success, and it's had in protecting the American public for nearly two hundred

years now. I think that they deserve a score of and that they've done really, really well. Gail, I want to thank you for being with us today. Thanks for calling bullshit well, thank you for having me. It's been fun. It really has been folks. It is time to make the call. The f d A is a complicated institution

with huge responsibilities. We couldn't possibly cover the entirety of what they do in a single episode, but with the help of our three experts, we're still able to get enough insight to answer the fundamental question, does the f d A strive above all else to safeguard the health of the American people. Although they've had some notable successes, we're calling bullshit on the f d A, But as always,

we're not here to just curse the darkness. When we come back, we'll speak with an expert in f d A conflicts of interest to see if we can light a few candles in the halls of this bureaucratic beheemoth. My name is Genevieve Cantor. I am an assistant professor at the Proman School of Medicine at the University of Pennsylvania. I'm trained as an economist and I study regulation of biomedical technologies, the f d A, and conflicts of interest.

Thank you for being here and welcome to calling bullshit. Thanks happy to be here. What we're here to do is talk about ideas for helping the f d A better live their purpose. And before we get into those ideas, I don't do this in every show, but but I wanted to actually say something to our listeners because I've been feeling some of this stuff myself as I prepped for this episode. It's really easy, and I would say even understandable, when faced with a problem as complex as

the FDA to basically just shrug and give up. And it's it's easy to just declare that the problem is impossible and to kind of move on. And I want to ask our listeners to suspend their disbelief for this section, because we really do want to explore actions that the FDA or the executive branch to whom the FDA reports could actually enact to help the f d A build better trust with people and really deliver on the promise

of keeping all of us safer. It's such an important purpose, and I really believe we need to take an optimistic point of view here because giving up on it is unthinkable. Sorry, I had to get that off my chest initially. So let's get into some ideas. Genevieve, I'm gonna ask you

to go first. In two minutes, can you tell us the one thing that you would do to change the f So, if I were emperor of the United States, the one thing I would do is to replace our current approval process with a system where the firms are given conditional approval of their products and they have to seek renewal of approval every say, ten years. So in the current system, a firm applies for approval of a product and receives that approval until basically the end of

time or the sun burns itself out or something. So with this ten year sort of renewable approval, you could incentivize the monitoring of how well drugs are working, because that will be required to get your renewal for the approval.

You incentivize the monitoring of how safe drugs are because again that's part of the renewal process that will allow us the government to pull drugs off the market that turn out to be not effective or that turned out to be unsafe, because sometimes you don't see a lot of safety events in the small clinical trial populations and you only see them in the broader population. I love that idea. That is an incredibly smart idea. Not surprisingly, you are the experts, so well done. I think that's

a fantastic idea. Will we will return to that, I'm sure throughout the conversation. So here's my idea. The f d A is much more important to all of us than is currently reflected in the salaries of the people who work there. Their job is literally to to save lives,

to protect us from harm. But there's a pretty massive salary gap between the average f d A worker in the average pharmat exact or food company exact, which has resulted in this revolving door where regulators from the FDA moved to higher paying jobs at food and drug companies. And I think that the knowledge that that reward is there waiting for them if they play ball while they're at the f d A has the effect of creating

huge conflicts of interest. And so my idea is to change the FDA through compensation reform, pay salaries competitive with the private sector, because right now the FDA is kind of a drab government bureaucracy and it attracts people who are up for working in that kind of job. Closing the salary gap would begin to level the playing field. When you know you pay people more money, you attract better people, and their job is so incredibly important that

that would be better for all of us. So salary reform is the idea I want to put on the table. But let's some we can we can get back to that. I want to I want to talk more about your idea, because I think it's so smart because when things and and a lot goes right at the FDA, right, but but when things go wrong, it's not often on day one you don't know that a problem is a problem right out of the gate. And yet once something is approved, it's been released into the wild and you almost can't

get it back in the current system. And so that I think that would you know, really increase people's safety. What barriers do you think we would encounter if we decided to try to actually enact that today? Who would have an issue with that idea? Probably the same parties that have blocked a lot of reforms in this space, the pharmaceutical companies. I suspect that some of the arguments that would be presented might be that it would be even more costly and time consuming for firms than the

existing approval processes. Uh IN might delay access to some products, But overall, broadly speaking, it's not politically feasible because the drug companies would intensely oppose this kind of conditional approval. And when they oppose that kind of thing, how does what form does that opposition take? So every five years there is legislation related to authorizing the budget for the

f D a um. In fact, there's actually currently the re authorization happening this year and we expect to see it past at the end of this summer actually, And so usually it's through you know, lobbying legislators as to

the features that might go into this reauthorization package. So if, for example, if it were to be introduced in one of these five year reauthorization bill's armor as well as individual pharmaceutical lobbyists would oppose the inclusion of such a conditionality, and the lobbyists are there to threaten by removing financial support from Congress. That's right through you know, campaign contributions. M hmm. Yeah. That sort of leads us to a

discussion around conflict of interest in general. So so I want to I want to go there, But before we go there more deeply, what do you think of the idea that I put on on the table, This idea of like leveling the playing field from a salary standpoint,

Does that make any sense? I'd like it, And I think you've tackled head on one of the issues with the approval process at the FDA, which is they do lose a lot of very good people because the pharmaceutical companies are able to entice government workers who have a lot of experience and knowledge. Away, I do see some constraints while we're on the topic of you know, pluses and minuses. One might be that these are civil servants, and so what you describe is just a generic problem

among the civil service. So are there some rules related to parity relating you know, GS scales and so on that you would have to consider. I see, just the way government workers are compensated has to be essentially universal

there or standardized. Yet in some way. A second issue is just where that money would come from, because the central source of conflicts actually, even with funding the f d A is user fees, so basically requiring pharmaceutical companies to pony up you know, hundreds of thousands of dollars to finance the review process. Now it's not earmarks, so that if visor submits a you know, drug for review, that you know, people will necessarily favor the approval of

that drug. But financially the f d A and its operations are funded in large part by pharmaceutical companies through these user fees. I would consider that attacks in a way of getting your product to market, and I think that that makes sense. I mean, I do realize it gives them a voice in the world of money and politics, and so raising those fees probably would be unpopular with them. I want to continue to talk about different conflicts of interest.

You wrote a chapter in a book called Conflicts of Interest in FDA Advisory Committee that was eye opening for me. Can you first just explain what an advisory committee is and how that actually works. Sure, when a drug comes up for approval, the f d A, you know, has the final say, but oftentimes it doesn't have the internal expertise or perhaps even the person hours to commit to doing a full review of a particular drug, or you know,

the evidence is complicated and it needs external advice. So frequently it convenes these advisory committees to review the application for a particular drug. The people on these advisory committees are not formally employees or full time employees of the f d A. They are external experts. They're sitting at universities, research institutes, think tanks, and they are physicians, researchers, some statisticians.

But one of the important things about this is if you work for the government, there very clear ethics rules regarding your financial ties to industry. Um, if you were working at a university and then you get called on to be on these advisory committees, you know, these people sitting at universities have relationships with drug companies, They are consultants for them, they have their research funded by them.

And so one of the things I looked at was whether the financial ties of these external experts who are called upon to advise whether a drug should be approved or not. Whether the financial ties of these experts had to drug companies was associated with whether they voted for approval of the drug or not, and how open they were to approval of the drug. Right, And it sounded to me like you had a specific hypothesis going into the work, which actually you even you were surprised by

the results. Is that right? Yeah? So, I mean conventional wisdom, certainly in the ethics literature on conflicts of interest, which is, if you have, you know, when tied to industry, you know, that's not good. But if you have multiple ties, that's even more not good. That's like really really bad, yes, exactly. And then so we found two things. One was it turned out that when we compared how these experts voted, and we compared people who had one financial tie to

those who had no financial ties. We actually found that people with a single financial tie to a company were more likely to vote in favor of the product sponsored by that company than people who had no financial ties. So there did to seem to be some bias, but it was only if you had a single financial tie

to a company. In contrast, people who had a lot of financial ties, So people who had ties to murt Fiser lots of companies did not appear to vote any differently on average than people who had no financial ties. People with a lot of ties did not appear to be biased in how they voted, and so we talk a little bit about why that might be the case.

One you know, hypothesis that makes sense to me is that, you know, a lot of times when people have a lot of financial ties, it's because they're really really good at what they do, and so a lot of companies want a piece of their brain. Um, it's not so they're not hiring these people so they could be hired guns to say what the company wants them to say. They're hiring these people because they're just really good at advising them. Yes, some of it is just they literally

want great advice from smart people. But we did find some bias. I mean, I think the other thing that came out in the paper was that, you know, the type of conflict matters. So that hypothesis that I presented earlier, one tie is bad, many ties worse. It's sort of a the simplistic rule of film we had that doesn't acknowledge the fact that different kinds of ties matter for influence.

And so the other thing we found was that it did not seem, for example, that experts who had ties through research funding so their research was funded by the drug company, were biased. But the kind of financial ties that really mattered were either you were you had an ownership stake in the company, you had some kind of stock in the company, which makes sense, and also a very strong effect came from whether you were on an

advisory board for the company. Lots of times you may be on the board and you have a fiduciary responsibility for the company to act in uh interest right exactly. Yeah, that's a clear conflict like that that seems like that should be illegal. I mean, a lot of this should be illegal. To be honest, you would think it would, and if you read the rules, people who do have that kind of financial interest should not be participating in

the advisory committees. But there is also a process that allows the FDA to make exceptions, and many times they make exceptions. And so you have people with these kinds of financial ties on these advisor committees, but things that don't matter, consulting research, you know, other kinds of ties don't matter. So I guess the paper was really advocating

for more subtle policy related to conflicts of interests. Yeah, more disclosure, right, I mean, it seems like that should be fair if the FDA is tasked with, as it says on the website, above all else, safeguarding the health and well being of the American people. If that truly is above all else, then you know, you should have to disclose all of your financial ties. And it should be acknowledged that there are financial ties that are okay.

In other words, if you're just being paid as an advisor for a company, and that's you being paid for your professional expertise, and that's fine. If you own a piece or you're on the on the board of one of the companies that's in question, that would disqualify you. And I don't understand why we can't enact rules like that. What would prevent us from from closing those loopholes? That's

a great question. The two arguments that I've seen presented are that we would no longer be able to find people qualified enough to be on our advisory committees if we just outright banned the participation of people with financial ties, because all the all the really smart people are already on the take, essentially like or you know, whereas my study indicated, you know a lot of people want want a piece of their brains, so it would be difficult.

And we can kind of see this because in the two thousands, the f d A in fact capped the exceptions that could be issued for people who had these kind of financial ties. Um So prior to this, the f d A issued just exceptions willy nilly and just basically said a lot of the apparently disqualifying financial interests did matter. In the two thousands, with one of the authorizations, the percentage of people who had these exceptions, and what you saw was of course a decline and people who

had these exceptions in these financial ties. But what you also saw was more positions on the advisory committees being vacant, a longer time it would take to convene these advisory committees because they would need to spend more time to find people who are not conflicted. Yeah right, Yeah, I want to delve a little bit more into this idea of trust, because ultimately the FDA's job is to make

us safe. And without guiding your answer at all, what needs to change so that we can trust the companies that are making our food and the companies that are making our drugs. What what about our system has to change to create more trust? I have to say I'm a little conflicted about this. I mean, the mission of the fd as pretty clear, you know, to ensure, among other things, to ensure the safety and efficacy of the

drugs that are marketed in the US. The mission the drug companies is not that it is to make money for their shareholders, and so, you know, I do wonder whether it's realistic um to expect organizations whose objective is profitmaking to not do what they can do to make profits.

But I like the way you framed it, because you framed it as a system, you know, not just the f d A. But I think the onus is on legislators policymakers to create rules that put guard rails on drug companies that still but that's still incentivize them to

do the right thing. I think, as as you you might have framed it, so things that minimize gaming, how clinical trials are run and analyze, things that incentivize the collection of data on effectiveness and safety, and start the things that we want, which is quality information on safety and effectiveness with things that drug companies want, which is

access to the market. Right, Okay, Genevieve, is there anything else that you think our our listeners should know about the f DA and things that either could or should change. I do think, you know, the problems we have with the f d A are structural. You know, there is that structural tension there about how can we get how can the agency have independence be based on the science, but you know, still have a commissioner that is serving

at the pledgure of the president. The other structural tension and we see this, you know in our discussion as well, is you know, you can have an agency that approves drugs almost too fast, so they proved drugs that don't work, or you have safety issues, but you've increase access to the drug. But that's opposed to well that you know, the alternative is to have an agency that approves things too slowly, which is their drugs that it's preventing from being out on the market that people need to get

access to. Right, we do need to have information systems that adapt an approval system that is adaptive in the same way that you know, all other systems in the world that we live in, you know, adapt to new information. And so hopefully that proposal and yours as well sort of adapts to you know, what we know and we can make better decisions that way. Okay, So last question

on this podcast. We have a tool that we call the BS index, and the BS index measures the gap between word indeed, and it goes from zero to a hundred. Zero is the best score, So zero b s a hundred is the worst score total BS. And so the f d A today says that it strives above all else to safeguard the health and well being of the

American people. What's or would you give the f d A. So I would say that my determined of the BA scores based on two main things that I think caused me to be worried about the f D A one is the degree of industry influence that leads it to diverge from its mission, as well as the degree to which it's vulnerable to political influence, you know, from the executive branch. Overall, I think the structure of the organization gives us generally reasonably high quality decisions. I would give

it a forty five. Okay, that was great. Thank you so much for being here today, Jenny. I really appreciate it. Thank you for inviting me and having us think together about this issue. It was I really really had a great time. Thank you. All Right, folks, it's time for the FDA to get their fish'll b s score. Somehow feels appropriate that I try to get a little scientific with this one. So if I were to average our

guest scores, the final score would be a forty eight. However, that still feels low to me, especially given Richard's account of basically being told to deliver the results his boss is wanted or risk losing his job at the agency. That's just plain scary. So I'm going to give the FDA a fifty five. I hope that acknowledges some of the agency's big winds over the years, but leaves plenty

of room for some much needed improvement. And f d A Commissioner Robert Caliph, if you ever want to come on the show to discuss anything we've touched on today, please know that you have an open invitation. And if you're starting a purpose led business or thinking about beginning the journey of transformation to become one, here are three things you can take away from today's episod D One.

Becoming purpose led is a big responsibility. It means that you're dedicating yourself to managing better outcomes for all of your stakeholders. That includes customers, employees, the community you do business in, and the planet. If all companies did that, we wouldn't need the f d A. The FDA only exists because the motivation to manage for maximum profitability is so powerful in our culture. The companies will knowingly sell

products and services that damage people and the planet. Purpose Led companies win the trust of all their stakeholders by being transparent, by taking on problems they discover, and by solving them. They tend to do the right thing, even if it costs the money. Two. Once you know your purpose, take action against it. Since on. Fortunately, we do need the FDA to protect us from companies who would do us harm. The FDA needs to do a better job

of that. The action idea that Genevieve brought today sticks with me. Any approval of any product is only conditional and time based and must be re reviewed once it's been in the market and we can all see the effects that it's actually having. That one change would help the f d A better live their purpose. What are the actions that you're taking to better live yours? Three? Simple is better. The f d A story is enormously complex because they cover such a broad waterfront and have

so many stakeholders with so many different agendas. Define a simple reason why your company exists. Choose clarity and specificity over fluff. Solve a real problem, Do the right thing by your stakeholders, and keep doing that until you win. And if this episode made it through your approval process, subscribe to the Calling Bullshit podcast on the I Heart Radio app Apple Podcasts, where wherever you listen to people speaking to your ears and friends. I'd like to ask

for your help. If you enjoy the Calling Bullshit podcast, please take a second to rate and review us on Apple podcasts or on your preferred platform. Thanks to our guests Lauren Edtter, Richard Williams, Gail Van Norman, and Genevieve Cantor. Learn more about them and get links to their work in our show notes, and many thanks to our production team Hannah bial, Amanda Ginsburg, d s Moss, Hailey, Pascalites, Parker Silzer, and Basil Soaper. Calling Bullshit was created by

co Collective and it's hosted by me Ti Monting. You thanks for listening. Four