Speaker 1: Overall, the FDA has had a number of spectacular hits
Speaker 1: and pretty notable failures, and it is worth asking how
Speaker 1: good of a job is the agency doing and are
Speaker 1: they living up to their mandate to protect the public health.
Speaker 1: My boss at the time said Richard, we don't have
Speaker 1: to solve problems. All we have to do is appear
Speaker 1: to solve problems. Welcome to Calling Bullshit, the podcast about
Speaker 1: purpose washing, the gap between what an organization says they
Speaker 1: stand for and what they actually do and what they
Speaker 1: would need to change to practice what they preach. I'm
Speaker 1: your host time onto you, and I've spent over a
Speaker 1: decade helping organizations define what they stand for, their purpose
Speaker 1: and then help them to use that purpose to drive
Speaker 1: transformation throughout their business. Unfortunately, at a lot of institution today,
Speaker 1: there's still a pretty wide gap between word. Indeed, that
Speaker 1: gap has a name, bullshit. But, and this is important,
Speaker 1: we believe that bullshit is a treatable condition. So when
Speaker 1: our bullshit detector lights up, we're going to explore everything
Speaker 1: the organization should do to fix it. There was a
Speaker 1: time in the not too distant past when cocaine was
Speaker 1: marketed to children and literal snake oil was sold as medicine,
Speaker 1: a time when sawdust was put into food as filler,
Speaker 1: and when rats were ground up with the beef, and
Speaker 1: it was all perfectly legal. Food and drugs were sold
Speaker 1: in a completely unregulated market until President Theodore Roosevelt signed
Speaker 1: into law the Food and Drugs Act of nine six,
Speaker 1: giving the executive branch the power to regulate food and
Speaker 1: drugs and thus creating what we now call the f
Speaker 1: d A. Today, the Food and Drug Administration has an
Speaker 1: expansive jurisdiction regulating things raging from microwave ovens to cat
Speaker 1: nip to ibuprofen and beyond, way beyond chew. On this
Speaker 1: the FDA regulates twenty cents of every dollar that you
Speaker 1: spend to cover such a broad water front. They employ
Speaker 1: eighteen thousand people that work across several inter agencies, including
Speaker 1: the Center for Drugs, Biologics, Devices, Veterinary Medicine, Food Safety
Speaker 1: and Nutrition, and tobacco. Their formal purposes a few paragraphs long,
Speaker 1: but on the homepage of their website they have a
Speaker 1: phrase that nicely captures the spirit of it, and it
Speaker 1: really Today, as in the past, the FDA strives above
Speaker 1: all else to safeguard the health and well being of
Speaker 1: the American people. That is a monumentally important purpose, one
Speaker 1: in which the stakes for all of us are high. However,
Speaker 1: if you've been listening to the news lately, it seems
Speaker 1: like the f d A is falling pretty short of
Speaker 1: living up to it. Speaking about the epidemic of youth
Speaker 1: use of e cigarettes, it retrospects the FDA should have
Speaker 1: acted center nationwide of baby formula stock is gone. Part
Speaker 1: of the blame for a lot of these shortages rest
Speaker 1: at the feet of the f d A. The FDA
Speaker 1: first approved OxyContin. Since then, more than five hundred thousand
Speaker 1: people have died from opioid related overdoses. We've actually encountered
Speaker 1: the FDA twice before, first when discussing their role regulating Jewel,
Speaker 1: and again while researching Perdue Pharma for a potential episode.
Speaker 1: The FDA was certainly a character in the first Jewel episode,
Speaker 1: but when we checked in on Jewel again this season,
Speaker 1: it was clear that the f d A shared a
Speaker 1: lot more of the blame for the damage caused by
Speaker 1: Jewels unregulated product, and so we decided to aim our
Speaker 1: BS detectors directly at the f d A. Starting with
Speaker 1: picking up the strange case of Big Tobacco, Vaping and Jewel. Okay, folks,
Speaker 1: I am very excited to introduce Lauren Etter for her
Speaker 1: second time on the show. Lauren, thank you for being
Speaker 1: here and welcome back to calling Bullshit. Thanks for having
Speaker 1: me tie great to be here. Lauren is the author
Speaker 1: of the Devil's playbook, Big Tobacco, Jewel and the Addiction
Speaker 1: of a New Generation. But before we continued the conversation
Speaker 1: with Lauren, let's catch you up on the escalating story
Speaker 1: of the regulator and the company with a b S
Speaker 1: roundtable recap. Okay, So, Jewel Labs launched its Jewel E
Speaker 1: cigarettes as a smoking cessation device in it was actually
Speaker 1: effective and had the potential to help smokers get off cigarettes.
Speaker 1: But Jewel was funded by venture capitalists with a growth
Speaker 1: at all costs mindset, which led them to target kids,
Speaker 1: the demographic most susceptible to picking up a smoking habit,
Speaker 1: thus sparking a new youth nicotine epidemic total BS. But
Speaker 1: at the time the cigarettes were totally unregulated. Finally, in
Speaker 1: the FDA began regulating the cigarettes as tobacco products and
Speaker 1: requiring manufacturers to submit applications to be on the market.
Speaker 1: And guess what, Jewel Labs didn't get around to submitting
Speaker 1: their application to the FDA until July, all while they
Speaker 1: were still selling Jewel more bs. You would think the
Speaker 1: story ends here, but it doesn't. It then took the
Speaker 1: FDA two more years to review Jewels application, all the
Speaker 1: while jewels are still being sold. Finally, in June of
Speaker 1: twenty two, the f D announcer decision to deny Jewel
Speaker 1: Labs application, essentially banning the e cigarette. Their reasoning Jewel
Speaker 1: did not provide enough scientific data to show that their
Speaker 1: products were not harmful. Not surprisingly, Jewel Labs immediately sued
Speaker 1: and within a few days was granted an emergency stay,
Speaker 1: allowing them to keep their products on the market. And
Speaker 1: now the FDA has walked back their decision and it's
Speaker 1: currently re reviewing the application, leaving Jewel. You guessed it
Speaker 1: still on the market, and that you're round. I think
Speaker 1: we have different internet connections and that's your round table recap.
Speaker 1: The FDA website says, today, as in the past, the
Speaker 1: FDA strives above all else to safeguard the health and
Speaker 1: well being of the American people. So first, I just
Speaker 1: wanted to ask you, how do you think they're doing
Speaker 1: at meeting their mission or achieving their purpose? I would
Speaker 1: say just in general that with tobacco, for many years,
Speaker 1: until the early two thousands, the agency didn't have any
Speaker 1: jurisdiction over the tobacco industry. It was a completely unregulated market.
Speaker 1: And it was only after the Master Settlement Agreement and
Speaker 1: after the tobacco companies has gotten crushed in that whole ordeal.
Speaker 1: When you know, for years Congress tried to figure out
Speaker 1: how to regulate tobacco. The Supreme Court even at one
Speaker 1: point said they didn't have jurisdiction. So this has been
Speaker 1: an issue like where should the tobacco industry sit doesn't
Speaker 1: make sense for the f d A to regulate this industry,
Speaker 1: But for years there's industry was totally unregulated. So I
Speaker 1: think that there's a lot of questions worthy of tasking
Speaker 1: about the f d A and certainly about their role
Speaker 1: in the regulation of tobacco. You may remember that we
Speaker 1: we score organizations on their level of BS. Would you
Speaker 1: be comfortable giving the f d A a score even
Speaker 1: as it relates to the Jewel situation of zero to
Speaker 1: in terms of gaps between word indeed. So if you
Speaker 1: look at what the agency is doing in the top
Speaker 1: back the overall kind of tobacco space and their efforts
Speaker 1: to implement a harm reduction framework, they're actually making strides.
Speaker 1: My issue is, I don't feel like the FDA has
Speaker 1: enough resources to police the kind of illicit sale of
Speaker 1: the product to keep it out of the hands of
Speaker 1: the youth. They're just a very underfunded agency, especially the
Speaker 1: tobacco products. And so if you're looking at the twin
Speaker 1: problems of adult smoking and youth nicotine addiction, I feel
Speaker 1: like they they are focusing quite a bit on the
Speaker 1: adult smoking issue and then the youth nicotine addiction issue.
Speaker 1: I don't know if I have enough confidence that they're
Speaker 1: going to be able to ultimately keep this highly addictive
Speaker 1: product out of the hands of kids, which is ultimately
Speaker 1: the goal to stop a new generation from becoming addicted.
Speaker 1: So can I give them a score? Um? I just
Speaker 1: don't know if I feel comfortable settling on a on
Speaker 1: a number, Yeah, that's okay, but it's it's definitely not
Speaker 1: the best number. Zero right there bumbling their way through this,
Speaker 1: and let's just say, with the best of intention, right,
Speaker 1: they have failed to protect America's youth so far from vaping,
Speaker 1: which is, at the end of the day, an extremely
Speaker 1: efficient delivery system for what ought to be a controlled
Speaker 1: substance in my view, right, But the FDA is constantly
Speaker 1: barraged with this flood of new products, and they're constantly
Speaker 1: on their heels responding to these like rapidly innovating markets.
Speaker 1: That makes it very difficult for them to contain this, again,
Speaker 1: highly addictive product that's being sold at seven elevens, and
Speaker 1: you know corner stores around the country that not all
Speaker 1: of them have the greatest I D checking abilities. So
Speaker 1: I admit it's a very difficult task for them to do.
Speaker 1: I think it should be one of the most important
Speaker 1: tasks that they undertake, and I know that they're taking
Speaker 1: it seriously. I'm just concerned that they might not have
Speaker 1: enough resources to adequately keep these highly addictive products out
Speaker 1: of the hands of young people. Is the FDA's lack
Speaker 1: of resources the reason they fumbled through regulating e cigarettes
Speaker 1: and jewel in particular. Lauren thinks so, or at least
Speaker 1: she thinks it's a significant part of it, and although
Speaker 1: she deferred on giving them a B S score, she
Speaker 1: does believe the FDA is making strides, no doubt, it
Speaker 1: is an incredibly challenging undertaking. But if your purpose is
Speaker 1: to safeguard the health of the American people and a
Speaker 1: new generation gets addicted to nicotine on your watch, it's
Speaker 1: definitely a harbinger of bullshit. But maybe the Center for
Speaker 1: Tobacco Products is an outlier considering the FDA covers so
Speaker 1: much ground, I'm going to reserve judgment and see what's
Speaker 1: cooking at their second biggest interagency, the Center of Food
Speaker 1: Safety and Applied Nutrition. With food specific we're trying to
Speaker 1: do a little more because we don't want to just
Speaker 1: make food safe. We want to give consumers information that
Speaker 1: helped them to choose a healthier diet. Richard Williams worked
Speaker 1: at the FDA for nearly three decades, and he left
Speaker 1: the Center for Food Safety and Applied Nutrition with a
Speaker 1: bad taste in his mouth. I think the big thing
Speaker 1: was as I approached the end of my twenty seven years,
Speaker 1: it occurred to me in all those years is that
Speaker 1: most of what we had done had not succeeded. And
Speaker 1: so the more I thought about it, the more I thought, well,
Speaker 1: what actually happened? What went wrong? And I thought maybe
Speaker 1: if I could write a book about it, we can
Speaker 1: start changing things and and actually solving things for consumers.
Speaker 1: Richard's book Fixing Food and f D A Insider Unravels
Speaker 1: the myth and the Solutions, is an eye opening account
Speaker 1: of his tenure at the organization, beginning when he was
Speaker 1: hired as their very first economic analyst. You can blame
Speaker 1: it on President Carter. President Carter was the first one
Speaker 1: who said we need some economic thinking in these particularly
Speaker 1: social regulations. More and more presidents begin insisting that we
Speaker 1: do these things and that we take take them into
Speaker 1: account so we can make better decisions. Let's talk about
Speaker 1: your job and some of the eye opening parts of
Speaker 1: your book, because you, it sounds like, walked into that
Speaker 1: job with the best of intention. You wanted to help
Speaker 1: the I achieve its mission of making people safer. One
Speaker 1: of the first assignments that you had was to do
Speaker 1: a cost benefit analysis on lead acetate in men's hair dye.
Speaker 1: I wondered if you would tell us that story. Sure,
Speaker 1: that was the first one just assigned to me. All
Speaker 1: I had to go by was the executive order and
Speaker 1: what I knew from from being an economist. So I
Speaker 1: jumped into it and found out that this was basically
Speaker 1: the thing that you put in your hair, and over
Speaker 1: time it takes the great away. Richard wanted to know
Speaker 1: of using lead acetate could cause skin cancer, and after
Speaker 1: a deep dive into the toxicology, he found that the
Speaker 1: risk was near zero, thus there was no benefit to
Speaker 1: banning the drug. There was, however, a high cost to
Speaker 1: taking it off the market. It was the only product
Speaker 1: of its kind available, so without it, gray haired men
Speaker 1: would have no alternative, I mean, other than living with
Speaker 1: the fact that their hair was great. I turned into
Speaker 1: my analysis. We didn't think a thing about it until
Speaker 1: a couple of weeks later a young woman had come
Speaker 1: down from the center director's office and she said, this
Speaker 1: is great. Now we need you to do the other one.
Speaker 1: And I said, what other one? She said, well, you
Speaker 1: said that benefits were lower than the cost and if
Speaker 1: we decide not to do anything about let acitate that
Speaker 1: will work. But we want you to do one that
Speaker 1: shows the exact opposite, that the benefits succeed the costs,
Speaker 1: that it does costs cancer. And I'm like, well, no,
Speaker 1: that wouldn't be honest. I'm not going to do that.
Speaker 1: And she said, you don't understand. This is an order,
Speaker 1: you know, from the sixth floor. And I said, no,
Speaker 1: I'm not going to do that. I didn't hear anything
Speaker 1: more about it. A few weeks later, I was in
Speaker 1: our first my first training class where I was getting
Speaker 1: my introduction to FDA, and the deputy Center director was
Speaker 1: in there, and at lunch, I went up and I said,
Speaker 1: you know, a funny thing happened to me, and I
Speaker 1: explained the situation, and he said that order came from me,
Speaker 1: and you're going to do it or you're going to
Speaker 1: be fired. And I said something really stupid. I just
Speaker 1: made this up on the spot. I said, I'm not
Speaker 1: an economic prostitute. And he said, then you were fired
Speaker 1: and you are going to be leaving this agency. And
Speaker 1: so I went back to my office. I'm like, should
Speaker 1: I start packing up my stuff? I didn't know. And
Speaker 1: then nothing ever happened. He apparently decided it would be
Speaker 1: a bad idea to fire over that kind of thing.
Speaker 1: But that was just the first time I was threatened
Speaker 1: with being fired. I mean, good on you that you
Speaker 1: did not gave to that pressure. But it sounds like
Speaker 1: that this was not an isolated occurrence. Were there other
Speaker 1: instances where you were asked to essentially compromise your integrity
Speaker 1: for twenty seven years. There were other instances. Was it
Speaker 1: was it never stopped. That is incomprehensible to me, and
Speaker 1: it's terrible. And so, for the first time in my life,
Speaker 1: decided to become political with a small p like a
Speaker 1: bureaucrat politician operator, which you have. Yeah, sadly, Well, so
Speaker 1: let's let's follow that threat a little bit, because I
Speaker 1: assume that, let's assume the best of people. Assume that
Speaker 1: people who were feeling the pressure above you in the organization,
Speaker 1: we're feeling it from other entities. You know, in your book,
Speaker 1: you go into the FDA spending a lot of energy
Speaker 1: responding to influence from just an incredible variety of stakeholders.
Speaker 1: There's you know, the executive branch, there's Congress, there's courts,
Speaker 1: there's press, private industry, activists, academics. Can you help us
Speaker 1: understand the FDA's relationship with some of those stakeholders? Sure,
Speaker 1: I mean, you know, first of all, you have to
Speaker 1: start understanding one thing. FDA has been around since nineteen
Speaker 1: o six, and they have continued to accumulate literally power
Speaker 1: such that one off there said that in the twentieth century,
Speaker 1: there was no regulatory agency in the world that was
Speaker 1: more powerful than f DA, and that's because they're very
Speaker 1: good at what they do. So if you think about it,
Speaker 1: they work for the president, and the presidents are supposed
Speaker 1: to oversee them, but every president, Republican and Democrat, has
Speaker 1: said it's nearly impossible to control the administrative state. That is,
Speaker 1: all the agencies that they oversee. There are hundreds of
Speaker 1: thousands of employees. They all have their own little agendas,
Speaker 1: and it's very, very difficult for the presidents to do anything.
Speaker 1: Um So that's a problem. Congress they just don't oversee FDA.
Speaker 1: They're afraid of f d A and um so there's
Speaker 1: not a lot of oversight. They're interesting, Why is Congress
Speaker 1: afraid of the f d A. Well, FDA has very
Speaker 1: complex issues, very hard for Congress. People are really busy,
Speaker 1: you know, with lots and lots of things, mostly getting
Speaker 1: reelected and raising money. They don't have a lot of time,
Speaker 1: and their stats aren't very good at overseeing these complex issues.
Speaker 1: I get it, but it means that FDA is kind
Speaker 1: of more free to do what they want, so they
Speaker 1: hold Congress at bay the courts have up until recently
Speaker 1: and generally will give them deference to how they interpret
Speaker 1: their statutes. Then they have other people, academics they generally
Speaker 1: give grants to that kind of buys them off. And
Speaker 1: then when they go into Congress to ask, you know,
Speaker 1: which they do every year, for more money, they actually
Speaker 1: have large food firms going and testifying and saying, yeah,
Speaker 1: FDA should get more money. There's a reason for that.
Speaker 1: Large firms usually get regulations that are easy for them
Speaker 1: to comply with but hard for small firms, so it
Speaker 1: puts their small competitors at a disadvantage. I want to
Speaker 1: go into that issue a little bit later, the issue
Speaker 1: of big companies versus small companies, because that that feels
Speaker 1: like an important topic. But before we go there, let's
Speaker 1: talk about one other constituency, consumers and where they rank
Speaker 1: in that higher are key. I think consumers and small
Speaker 1: businesses both are at the bottom. When I first came
Speaker 1: into f d A, you know, I truly believe in
Speaker 1: what we're trying to do. I thought these are important issues,
Speaker 1: and over time I found out well, initially when I
Speaker 1: got there, I was told this that this actually happened
Speaker 1: with the let acetate rule. I said, this rule won't
Speaker 1: do anything. Why are we doing it? And my boss
Speaker 1: at the time said, Richard, we don't have to solve problems.
Speaker 1: All we have to do is appear to solve problems.
Speaker 1: We have to do something about it. And that never
Speaker 1: left me, and I noticed more and more that was
Speaker 1: the case once we passed the regulation. No matter what
Speaker 1: the regulation did, it didn't matter. It looked like we
Speaker 1: had addressed the problem. And that and that leaves consumers
Speaker 1: and public health in in in last place, if you will,
Speaker 1: what a mess. Okay, So let's talk about some of
Speaker 1: the you know, in your view, the biggest and most
Speaker 1: dangerous problems that face consumers today that the FDA is
Speaker 1: responsible for. And we can live within the domain of food,
Speaker 1: but feel free also to talk about stuff outside of food. Yeah. Well,
Speaker 1: I do think it's obesity. I think that is probably
Speaker 1: the number one and it's going to get worse. You know,
Speaker 1: there was a harvest study that projected that by the
Speaker 1: end of this decade, which is only eight years away,
Speaker 1: half of this country will be obese. Um FDA plays
Speaker 1: a role in that with food labeling. Food labeling has
Speaker 1: not worked, It's not going to work. It's really not
Speaker 1: going to be the answer. Putting calories on foods hasn't
Speaker 1: really changed anyone's behavior as far as we can tell,
Speaker 1: sticking with obesity, and I don't think you you made
Speaker 1: this connection overtly in the book, But one of the
Speaker 1: impressions that I've gotten both from you know what we've
Speaker 1: learned from your book and also other research that we've done,
Speaker 1: is that intended or not, the combination of the industrialized
Speaker 1: food system where people eat a diet and combine that
Speaker 1: with a for profit healthcare system that then profits from
Speaker 1: the multiple diseases that result from things like obesity is
Speaker 1: kind of the perfect dystopian partnership. What do you think
Speaker 1: about that first? And and do you think the FDA
Speaker 1: has played a role in that. I don't personally think
Speaker 1: that is the exact issue. I think it is an issue.
Speaker 1: I think certainly food companies, like every other company in
Speaker 1: this country, are there to make a profit. The problem
Speaker 1: is we have no idea what a healthy diet looks
Speaker 1: like because nutrition science is the worst science that we have,
Speaker 1: and so we've got people out there hawking books, you know,
Speaker 1: on diets, something say well, you gotta have a high
Speaker 1: carb diet, and so you have to have a low
Speaker 1: carb diet, high fat diet, low fat diet, on and
Speaker 1: on and on. And the truth of the matter is
Speaker 1: one we don't know, and to what we're beginning to
Speaker 1: find out is that one diet probably isn't right for everyone.
Speaker 1: Different people with different genetic backgrounds, different underlying health conditions
Speaker 1: probably need different diets. So I think, in my mind
Speaker 1: a bigger problem and this is why basically companies can
Speaker 1: sell whatever they want. It's because we just don't know
Speaker 1: enough yet because the science is so bad. Well that
Speaker 1: that that's a good point. I think to pivot to
Speaker 1: another aspect that you touch on in your book. You
Speaker 1: believe that entrepreneurs are solving many problems that the FDA
Speaker 1: can't or won't. Can you talk more about that. FDA
Speaker 1: has recently announced they're going to start looking at technologies.
Speaker 1: So the first thing that they're gonna do, and this
Speaker 1: is gonna be tremendously helpful if we can get it done,
Speaker 1: is using blockchain, the same thing that you use for cryptocurrency,
Speaker 1: in order to start recalling things faster. For example, this
Speaker 1: technology could in theory, reduce the time it takes to
Speaker 1: trace the origin of a contaminated food upbreak from two
Speaker 1: weeks into two seconds. So that does several things. One,
Speaker 1: if you can trace sinks back very quickly, you can
Speaker 1: find out what the root caused us in others, what
Speaker 1: actually went wrong that caused this problem. More importantly, it
Speaker 1: gets bad products off the market more quickly. And it
Speaker 1: also doesn't basically indict everybody right yes, which sort of
Speaker 1: leads to something that you've entered at already in this interview,
Speaker 1: which is that the playing field is not necessarily level
Speaker 1: between small companies and big companies. Can you talk more
Speaker 1: about that? So there's a law on the regulatary flexibility
Speaker 1: access we have to take into account. You know what
Speaker 1: the impacts these things are on small producers, and if
Speaker 1: we can to give them some kind of relief, And
Speaker 1: given the fact that the benefits birth that great, I said, well,
Speaker 1: at least let's examp some of these small firms and
Speaker 1: make the requirements easier on them. We didn't do that.
Speaker 1: Of course, all the large firms didn't want to give
Speaker 1: small firms a break. But as they say, it's an
Speaker 1: unlevel playing field. They have much more influence over FDA,
Speaker 1: and this is true in any regulatory agency than the
Speaker 1: small firms do. So the small firms get driven out
Speaker 1: of business, and I think it's a shame that we
Speaker 1: have two different laws that are supposed to protect small
Speaker 1: firms and we're still not doing enough for them. One
Speaker 1: of the other topics that you you touch on, and
Speaker 1: that that I've encountered in other environments is the topic
Speaker 1: of conflict of interest. One of the things that I
Speaker 1: just have a hard time getting over is government employees
Speaker 1: leaving the FDA and going to work for the corporations
Speaker 1: that they're trying to regulate. And you give a very
Speaker 1: poignant example of a person who wrote a regulation just
Speaker 1: so that they could jump out and get a job
Speaker 1: consulting on that same regulation to help corporations figure out
Speaker 1: how to wend their way through it. Is that common.
Speaker 1: It's hard for me to know. I don't have data
Speaker 1: on how common is. I certainly saw it often enough.
Speaker 1: The law allows it. What they do say is that
Speaker 1: it has to be a number of years before you
Speaker 1: can come back and lobby the f DAY for that industry.
Speaker 1: But you can go out and work for them. You
Speaker 1: can tell them how to comply, and you can make money.
Speaker 1: I could be wrong, about this, But I think a
Speaker 1: lot of people feel, you know what, I work in
Speaker 1: a quote unquote low wage government job. I should be
Speaker 1: allowed to go out and make money like everybody else.
Speaker 1: I sort of served my country in this job, and
Speaker 1: I have some sympathy for that. But again, like you say,
Speaker 1: it seems to be something wrong if you can be
Speaker 1: a part of writing a rule and then you know,
Speaker 1: right it in such a way that you can go
Speaker 1: out and profit from it. Yeah. I mean this is
Speaker 1: a really hard question, so I don't expect an answer, honestly,
Speaker 1: But how do you solve that problem? You know, it's
Speaker 1: just a great question. I wish I did know, But
Speaker 1: I'm pretty sure it's not the worst problem. F d A.
Speaker 1: What's the worst problem? The fact that they're not solving
Speaker 1: any problems, the fact that decades and decades go by,
Speaker 1: uh there, their budget keeps going up, they get more people,
Speaker 1: people believe in them, they believe that they're keeping us safe,
Speaker 1: and that it just keeps going like that. And the
Speaker 1: fact that you can go to Congress every single year
Speaker 1: and say we've got to do something. One out of
Speaker 1: six people in this country getting sick from food poisoning
Speaker 1: every year for thirty or forty years you're saying the
Speaker 1: same thing. Congress goes, oh my god, that's terrible, we
Speaker 1: got to give you more money. Well, no, sooner or
Speaker 1: later you gotta start saying, Okay, you gotta do something different. So,
Speaker 1: just to be fair, are there any big winds that
Speaker 1: you would point two times that the f d A
Speaker 1: has gotten it really right? Oh? Absolutely, And first of all,
Speaker 1: let me say, a lot of it is the system.
Speaker 1: It's not the people. There are a lot of great
Speaker 1: people that work for FDA. They're very smart, they're very dedicated,
Speaker 1: they believe in it, but unfortunately they they they've run
Speaker 1: out of ideas. But one thing I think where we
Speaker 1: got it right was transfatty acids. This was a case
Speaker 1: where an initially we were just going to ask firms
Speaker 1: if they wanted to voluntarily label it. Trans fatty acids
Speaker 1: are worse for you than than saturated fats, so that
Speaker 1: was the bottom line. We really needed to do something,
Speaker 1: so we kind of went round and round. There's a
Speaker 1: long story about it, but we ended up with mandatory
Speaker 1: labeling and companies sort of got the message and they
Speaker 1: began pulling trans fatty acids because they're added to most foods,
Speaker 1: so if they're added, that means you can easily take
Speaker 1: them out as opposed to saturated fat, which is just
Speaker 1: a part of the food. So they started take them
Speaker 1: out and then eventually adding them has become illegal. I
Speaker 1: think that's probably one of the best things that we did.
Speaker 1: Is there anything that I haven't asked you about that
Speaker 1: you think people should know about the f d A.
Speaker 1: I do think right now with the Commissioner saying our
Speaker 1: food safety system is broken with what has been happening
Speaker 1: with infant formula, which f d A incidentally played a
Speaker 1: huge role in why that happened. For forty years they've
Speaker 1: been telling firms who want to come and start making
Speaker 1: infant formulated, said no, they've kept it at six firms
Speaker 1: new kidding. So they created essentially the monopoly that then
Speaker 1: right hurt the hurt the whole countactly exactly. So when
Speaker 1: you had one manufacturer drop out, of course there's a
Speaker 1: huge problem. So with with these problems coming up, I
Speaker 1: think the curtain has fallen down and we see what's
Speaker 1: going on behind the curtain. Yeah, it couldn't have a
Speaker 1: better time to start thinking about doing things in new
Speaker 1: way and actually trying to solve problems than just appear
Speaker 1: to be doing that something. So I'm hoping now is
Speaker 1: the time. That's a nice note to wrap up on.
Speaker 1: So let's just say that you're the FDA commissioner for
Speaker 1: a day, or a month, or a year, for whatever
Speaker 1: period of time is necessary to make real change. What
Speaker 1: would you do to help the f d A achieve
Speaker 1: its stated mission, which, as it says on the website,
Speaker 1: it says as in the past, the FDA strives above
Speaker 1: all else to safeguard the health and well being of
Speaker 1: the American people. What's the one thing you would change
Speaker 1: about the FDA to help them achieve that goal. I would,
Speaker 1: I would retask them. I would say, look, we're not
Speaker 1: going to pass all these regulations. Let's start looking at
Speaker 1: these new technologies. If we think they're not completely safe,
Speaker 1: that they need some sort of adjustment, let's focus on those,
Speaker 1: let's promote them. I'll just give you quickly a list
Speaker 1: of things. Precision fermentation, genetic engineering, three D printers are
Speaker 1: coming along, consumer nutrition devices. They're going to have to
Speaker 1: go through the medical device basically preapproval thing. We've got
Speaker 1: to get those through faster. Those are gonna help consumers
Speaker 1: eat better, nanopackaging, where we have smart packaging consumers when
Speaker 1: their food is becoming spoiled. All of these things, I
Speaker 1: would say, let's start looking there. That's the future. Those
Speaker 1: are the solutions. Let's start looking at real solutions and
Speaker 1: stop trying to pass these regulations. They were fine a
Speaker 1: hundred years ago, they're not fine now, so I would
Speaker 1: retask them. I love that, Okay, Richard. On this show,
Speaker 1: we have a tool that we call the b S
Speaker 1: scale that we used to measure the gap between word
Speaker 1: and deed. And our scale goes from zero to one,
Speaker 1: zero being the best zero bs and a hundred being
Speaker 1: the worst total BS. So what score would you give
Speaker 1: the f D A Well, mostly I'm qualified to talk
Speaker 1: about the food's part the FDA, so I'll just focus
Speaker 1: on them on that scale, because you know, they say
Speaker 1: that they're protecting consumers. They say all these things, and
Speaker 1: they're not doing it. I would give them about a
Speaker 1: seventy five. So it's of what they do in foods
Speaker 1: is bullshit. Okay, room for improvement, all right, Richard, thank
Speaker 1: you so much for being here today. This was a
Speaker 1: great conversation, and I also want to thank you for
Speaker 1: writing this book and doing the work that you're doing
Speaker 1: post your time at the FDA. It's incredibly important and
Speaker 1: we thank you for it. Well, thank you again for
Speaker 1: having me on. It's been great. Well, that's interesting, if
Speaker 1: not totally disconcerting. Earlier in the episode, Lauren Adder posited
Speaker 1: that the FDA had fallen short due to a lack
Speaker 1: of resources, but Richard, a former FDA employee, says that
Speaker 1: the organization floundered in spite of a consistently increasing budget.
Speaker 1: If there was a harbinger of bullshit before, there now
Speaker 1: seems to be a flashing neon arrow. But to be fair,
Speaker 1: we've yet to explore the biggest inter agency. Buckle up, folks,
Speaker 1: because next we're looking into the f d a's Center
Speaker 1: of Drug Evaluation and Research. Right after this. Okay, folks,
Speaker 1: it is my great pleasure to introduce Dr Gail Van
Speaker 1: Norman to the show. Gail, welcome to Calling Bullshit. Well,
Speaker 1: thank you, Ti, it's a pleasure to be here. Gail
Speaker 1: is a clinician and professor at the University of Washington.
Speaker 1: She writes and teaches about the medical research process, everything
Speaker 1: from the FDA to commercialization to how animal testing works.
Speaker 1: So the reason that we're doing this episode on calling
Speaker 1: BS is that the f d A has come up
Speaker 1: a couple of times on this show, and our research
Speaker 1: left me with the impression that the f d A
Speaker 1: sometimes gets things very right and sometimes it gets things
Speaker 1: very wrong. Would you agree with that? I would. I
Speaker 1: think the the FDA operates under constraints that are imperfect,
Speaker 1: and even the best of organizations tasked with such a
Speaker 1: complex mission are going to have misses and hits. Over All,
Speaker 1: the FDA has had a number of spectacular hits and
Speaker 1: pretty notable failures. Yeah, so let's let's get into some
Speaker 1: of those, because I'd love to have you start out providing,
Speaker 1: you know, an example or two of times when the
Speaker 1: FDA has truly lived up to their mission and really
Speaker 1: gotten it right. Okay, Well, let's start with the lidamide
Speaker 1: because it's a sort of a classic historical example of
Speaker 1: what can go right and wrong with medical research, as
Speaker 1: well as what happens at the FDA. Phillidamide was an
Speaker 1: anti nausea drug introduced in Germany in the nineteen fifties,
Speaker 1: and it was considered one of the safest consumer drugs
Speaker 1: ever to hit the market because it was so safe
Speaker 1: practitioners really picked out its use in pregnancy because nausea
Speaker 1: during pregnancy is not only a misery to women, it
Speaker 1: can be dangerous to the health of the mother and
Speaker 1: the fetus in utero, and so having something that controls
Speaker 1: nausea and vomiting is very important. The drug had been
Speaker 1: tested in animals prior to human tests that had been tested,
Speaker 1: and I believe the number is something like fifty or
Speaker 1: a hundred different species of animals, including rats and mice
Speaker 1: and dogs and cats and armadillos and ferrets and rabbits.
Speaker 1: It was considered such a safe drug that it was
Speaker 1: not required that you have a prescription to use it. Uh.
Speaker 1: The drug manufacturer gave it away free to its factory
Speaker 1: workers pregnant factory workers to use during pregnancy. Wanting to
Speaker 1: expand the market into the US, the manufacturer submitted the
Speaker 1: drug for review with the f d A. The committee
Speaker 1: reviewing Philidamie was headed by Francis Oldham Kelsey, who just
Speaker 1: so happened to be the first woman to hold the position.
Speaker 1: She later joked that they gave her what they thought
Speaker 1: would be the easiest one they could possibly give and
Speaker 1: whether they did that because she was a woman or
Speaker 1: she was new. We'll just leave to speculation. Anyway, she
Speaker 1: read the data and something about it didn't ring true
Speaker 1: with her. She didn't like it, and she said, I'm
Speaker 1: not going to approve this. I'm gonna stop you, and
Speaker 1: I want to see a few more studies. And just
Speaker 1: a few months later, on Christmas Day, in the first
Speaker 1: baby was born in Germany without years, a little baby girl.
Speaker 1: And that was followed by over ten thousand cases of
Speaker 1: severely deformed infants that were born and probably twenty cases
Speaker 1: of in utero deaths. And the US saw exactly seventeen
Speaker 1: cases of thelidamid deformities, presumably in the children of mothers
Speaker 1: who brought the drug in from out of country. We
Speaker 1: were saved that plague because we never approved the drug
Speaker 1: in the United States for that use. I mean that Actually,
Speaker 1: I had a galvanic response to that story, like it
Speaker 1: makes the hair on the back of my next stand
Speaker 1: up to make me think how close we came to
Speaker 1: a total unmitigated disaster. You know, yeah, it really is true.
Speaker 1: And let's let's talk about COVID also, because that's fresh
Speaker 1: in everyone's mind, and that's clearly a case where you know,
Speaker 1: I mean it seemingly the normal process takes forever, and
Speaker 1: it just it feels like COVID vaccines just magically appeared.
Speaker 1: How did that happen? It was very incredible, right. Yeah.
Speaker 1: I'm thinking to myself two and a half years ago
Speaker 1: when COVID hit and I have in my distant medical background,
Speaker 1: I have a background in immunology, and I remember people
Speaker 1: coming and asking me, well, how long will it take
Speaker 1: for us to have a vaccine? And the average time
Speaker 1: to get a vaccine created for a new disease is
Speaker 1: fifteen years, So it's it was like, so right away
Speaker 1: what was happening was the the government was saying We'll
Speaker 1: have a vaccine for you in a year, and I
Speaker 1: was going, not, on your life, you won't. It's just
Speaker 1: not trying to happen. No chance. But of course there
Speaker 1: was a chance due to several important factors all occurring simultaneously. First,
Speaker 1: the US government created a public private partnership offering ten
Speaker 1: billion dollars to pharmaceutical companies to start immediately making and
Speaker 1: testing vaccines. Second, the mRNA vaccine had become available. This
Speaker 1: new technology created a way for the body to show
Speaker 1: effecsimile of the virus to itself, making testing on humans
Speaker 1: much easier. And finally, the Century Cures Act allowed for
Speaker 1: emergency authorization and the quick release of the vaccines. All
Speaker 1: those things came together. It's just amazing. Yeah, it is amazing.
Speaker 1: So the litamide and covid vaccines y f d A truly,
Speaker 1: and they do so many more things right as well.
Speaker 1: Those are just a couple of examples. But let's let's
Speaker 1: pivot to where they get it wrong. For for me,
Speaker 1: because we did the research we did, Purdue Pharma comes
Speaker 1: to mind and the OxyContin crisis. So the thing that
Speaker 1: that shocked me about the Purdue situation and I did
Speaker 1: not I did not understand this prior to doing this research.
Speaker 1: But there are people at the FDA who have to
Speaker 1: write the language that goes on warning labels on drugs,
Speaker 1: and there are different kinds of warning labels. And the
Speaker 1: big thing in in news world OxyContin was addictiveness. Any
Speaker 1: opioid heretofore had been deemed to be addictive and had
Speaker 1: to carry a label that said it was addictive and
Speaker 1: would be prescribed in that same way. I e very sparingly,
Speaker 1: and Purdue figured out a way to get the warning
Speaker 1: label written in such a way as to avoid any
Speaker 1: language of addiction, so that more doctors would be inclined
Speaker 1: to write prescriptions for it. And my understanding of this
Speaker 1: story is that the person who wrote the language actually
Speaker 1: hold up in a hotel room with the executives from
Speaker 1: Purdue and they all crafted that language together. And so
Speaker 1: this gets to a larger issue obviously, which is sort
Speaker 1: of the revolving door or the I would say, fraught
Speaker 1: relationship between giant for profit industries and low paid government workers.
Speaker 1: And further, to sort of add insult entry, once the
Speaker 1: language had been crafted, once OxyContin was approved and being
Speaker 1: sold across the world, that person left the f d
Speaker 1: A and took a job at Purdue Pharma, you know,
Speaker 1: kind of closing the circle as it were. And you know,
Speaker 1: that story really disturbed me. It outraged me, honestly, and
Speaker 1: I would love to hear your take on that and
Speaker 1: how widespread a problem like that really is. I think
Speaker 1: what you're getting at is a real problem in that
Speaker 1: there is a variously porous interface between the kinds of
Speaker 1: researchers who work within within the f d A and
Speaker 1: those that work in commercial industry, and so people do
Speaker 1: switch teams and that's perfectly legal right now, is it not?
Speaker 1: Oh sure? I mean the current Commissioner of the FDA,
Speaker 1: Robert Coliff, was an executive for or I can't remember
Speaker 1: the name of the research company that's a subsidiary of
Speaker 1: Alphabet anyway, he made two point seven million dollars a
Speaker 1: year in salary and he used that And I'm not
Speaker 1: criticizing him. I don't make it make it sound like
Speaker 1: it was nefarious. That was actually a selling point for
Speaker 1: his appointment as the Commissioner to the FDA because he
Speaker 1: knew the ins and outs of commercial research companies. So
Speaker 1: you can make an argument that it's helpful. And by
Speaker 1: the way, his salary there right now is now three dollars,
Speaker 1: which is considerably less. And he put in a lot
Speaker 1: of agreements to say he would not participate in owning,
Speaker 1: selling talking to you know, he self restricted to say,
Speaker 1: I'm going to make sure you know that who I
Speaker 1: work for, you know who my boss is. But other
Speaker 1: people have not been quite so clear about it. And
Speaker 1: so you have somebody who works on an FDA committee
Speaker 1: and they have a drug presented to them, and the
Speaker 1: people who are presenting the drug whisper in their ears Wow,
Speaker 1: we really think your help has been really valuable, and
Speaker 1: we'd like to get think about coming on as a
Speaker 1: researcher or a head of marketing in our company. And
Speaker 1: they offer you a two and a half million dollar raise,
Speaker 1: it can be a little hard to turn it turned down.
Speaker 1: And so there are connections which between the FDA and
Speaker 1: the commercial world, which if properly aligned, are helpful because
Speaker 1: it can give the FDA insights as to what the
Speaker 1: company is doing, but if they're not properly aligned, can
Speaker 1: lead to conflicts of interest into the detriment of the
Speaker 1: safety and health of the American public. Right. So, the
Speaker 1: FDA is a government organization with a mission to protect
Speaker 1: us all from the effects, intended or not of private
Speaker 1: for profit interests. So, so let's talk a little bit
Speaker 1: about money. How does how does the FDA receive its funding? Well,
Speaker 1: the FDA used to be back in the nineteen twenties,
Speaker 1: it was all government funded. It just came out of
Speaker 1: the General Treasury Fund for the FDA. Now, about forty
Speaker 1: five percent of the FDA's funds come from something called
Speaker 1: user fees and application fees that are paid by the
Speaker 1: drug companies to get their drugs reviewed. When that was
Speaker 1: first proposed, there was a lot of concern that this
Speaker 1: would create a conflict of interest for the FDA because
Speaker 1: a lot of their funding would come from the very
Speaker 1: people they're trying to regulate. But it became so popular
Speaker 1: because those user fees were enacted because the FDA was
Speaker 1: woefully short staffed. Congress enacted this as a way specifically
Speaker 1: for the FDA to hire the people that needed to
Speaker 1: do the work, and it led to a big reduction
Speaker 1: in through put times and it accomplished exactly what was
Speaker 1: supposed to do. So it's still popular to this day.
Speaker 1: And how much do you think the f d A
Speaker 1: is affected by lobbying, either by big drug companies lobbying
Speaker 1: on the health to change laws and regulations, or patient
Speaker 1: advocacy groups lobbying to influence the way the organization is
Speaker 1: is funded or regulated itself. Well, both affect the f
Speaker 1: d A. I mean, it's not immune to them. The
Speaker 1: FDA acts is funded, as I mentioned, from congressional funding,
Speaker 1: and Congress is affected very heavily by patient advocacy. You
Speaker 1: get patient advocacy groups getting Congress to write both good
Speaker 1: and cockamami laws all the time. With regard to health
Speaker 1: and so the f d A is not immune from
Speaker 1: those effects. The other thing I would say that there's
Speaker 1: no it's hard to say that there's a direct effect,
Speaker 1: like you know, Glaxo smith Klein plays their two million
Speaker 1: dollar drug fee and that makes the FDA prove the drug.
Speaker 1: That doesn't happen. But the other kind of effect is
Speaker 1: hard to regulate against. The individual who sits in an
Speaker 1: influential part of a committee who then is favorably impressed
Speaker 1: by a drug company about their drug in various ways
Speaker 1: and advocates for it. Those do happen, and individuals that
Speaker 1: sit on these committees can make big differences in what
Speaker 1: the FDA decides to do. One of the things that
Speaker 1: is just true is that our health care system is
Speaker 1: run largely as a for profit enterprise. And is that
Speaker 1: part of the problem here, oh sure? Or is that
Speaker 1: the whole problem here? That that might even be the
Speaker 1: whole problem for all we know. I mean, I suppose
Speaker 1: there are good aspects commercialization, because it does, in an
Speaker 1: ideal world, promote competition and innovation, but it also promotes
Speaker 1: manipulation and profit taking, and neither of those serve patients
Speaker 1: at all. They serve the companies that make the drugs,
Speaker 1: and they're talking about well, that's right. I mean we're
Speaker 1: not just talking about the company making a profit. We're
Speaker 1: talking about unimaginable amounts of money. We're talking about a
Speaker 1: drug generating a hundred billion dollars in profits, a hundred
Speaker 1: billion dollars. So this is money that will buy anybody's soul, right,
Speaker 1: maybe even mine? I don't think so, but you never know. Well,
Speaker 1: and know, like, it's an interesting question to ask yourself, right,
Speaker 1: is like what's my number? But in the current system,
Speaker 1: the consequences for breaking the law often take the form
Speaker 1: of fines. But with profits of that size, you know,
Speaker 1: would it be fair to say the fines are just
Speaker 1: a cost of doing business? Oh? Absolutely, it's it's amazing.
Speaker 1: I mean, what you see in the media, what the
Speaker 1: American public sees is the sacklers paid what was it
Speaker 1: billion dollars? Well, weighed against what did they make. Even
Speaker 1: if it's a hundred over a hundred billion, it's less
Speaker 1: than of their whole profit margin. And remember it's not
Speaker 1: just the profit, it's not just the actual dollars that
Speaker 1: go in the bank. It's how much their stock is worth. Right,
Speaker 1: So if you're making a hundred billion dollars in profits,
Speaker 1: your stock becomes worth a huge amount more. And these
Speaker 1: companies are run by individuals who have heavy stock interests,
Speaker 1: who may have individual conflicts of interest with doing the
Speaker 1: right thing, and more and more, we're talking about dollar
Speaker 1: amounts that seem insurmountable in their ability to bribe and
Speaker 1: attract people into behaviors that we would hope we wouldn't
Speaker 1: see in this industry. Right And and you know, just
Speaker 1: to contrast that, to make this really clear, how much
Speaker 1: money would a typical f D A employee take home,
Speaker 1: if there is such a thing, And how much can
Speaker 1: we contrast that with an average pharma executive even just roughly? Uh? Well,
Speaker 1: I I the farmer executives take home millions of dollars.
Speaker 1: The average FDA salaries a hundred and ten thousand dollars
Speaker 1: a year, and their top executive makes three dollars a year.
Speaker 1: So it's considerably less than anything the commercial environment could offer, right. Yeah,
Speaker 1: And it just seems like there's a massive incentive for
Speaker 1: these big companies to try to figure out how to
Speaker 1: gain the system in one way or another. Well, I
Speaker 1: think it's not just there's this incentive. There's virtually no
Speaker 1: disincentive to do it, because if you're that rich, you
Speaker 1: can just pay the fine and move on, doesn't doesn't matter.
Speaker 1: You actually factor that into the cost of developing the drug,
Speaker 1: the cost of putting the drug out there. Yeah, well
Speaker 1: that's terrifying. So, Gail, another way to look at our
Speaker 1: show is fundamentally it's about trust, and it's just incredibly
Speaker 1: important that we trust institutions like the f d A
Speaker 1: literally lives around the line. And honestly, I can understand
Speaker 1: in someone who has lost trust in politicians today or
Speaker 1: in big pharma, or even in the f d A.
Speaker 1: You know, this is the same institution that approved oxy.
Speaker 1: So what are some things that you think the FDA
Speaker 1: should do to try to rebuild trust with people. I think,
Speaker 1: first of all, we need to start with Congress and say,
Speaker 1: who do we have in Congress sitting on the committees
Speaker 1: that give the FDA it's marching orders. Frankly, I can't.
Speaker 1: I can't tell you who those people are. I should
Speaker 1: be able to, but I can't right now, and do
Speaker 1: I trust them, particularly when I well know that many
Speaker 1: of our congressional representatives are, for lack of a better
Speaker 1: word ignorance of science and how it works and don't
Speaker 1: care to learn it, and the hander to sort of
Speaker 1: the conspiracy theorists who want to think that we're all
Speaker 1: out to get them. So I think we need to
Speaker 1: look at that and ask should there be special or
Speaker 1: qualifications for people who determine how this agency works. I
Speaker 1: think overall the agency does a remarkable job given the
Speaker 1: mission that it has and the number of opportunities for
Speaker 1: failure that it has, how relatively few it really has experienced.
Speaker 1: I think we need to look at how we can
Speaker 1: reduce conflicts of interest that we've talked about within the
Speaker 1: agency so that we don't have people who are pretending
Speaker 1: to serve the FDA but are really serving a commercial
Speaker 1: interest or serving themselves so that they can position themselves
Speaker 1: for for a well paying job with the commercial companies.
Speaker 1: I think that would be helpful. And I think we
Speaker 1: need to have real penalties for pharmaceutical companies that openly
Speaker 1: commit criminal acts. This is in the criminal Code now
Speaker 1: produted things that were criminal, and that perhaps money is
Speaker 1: not the price those people should be paying that people
Speaker 1: people there should be real prison time assigned when those
Speaker 1: sorts of things happen because as a CEO who knows
Speaker 1: that their signature on a piece of paper might put
Speaker 1: them in jail one day, may think twice before signing
Speaker 1: it and may have better oversight. Yeah, okay, alright, Gail,
Speaker 1: this is really my last question on this show. We
Speaker 1: have a tool called the b S scale, and the
Speaker 1: b S scale goes from zero to one, zero being
Speaker 1: the best score meaning zero bs one being the worst
Speaker 1: total bs. So on that scale, what score would you
Speaker 1: give the f d A in achieving its stated mission?
Speaker 1: I would give it a really good score. I think
Speaker 1: that to do it's the complicated job it does, to
Speaker 1: do it with the high degree of success, and it's
Speaker 1: had in protecting the American public for nearly two hundred
Speaker 1: years now. I think that they deserve a score of
Speaker 1: and that they've done really, really well. Gail, I want
Speaker 1: to thank you for being with us today. Thanks for
Speaker 1: calling bullshit well, thank you for having me. It's been fun.
Speaker 1: It really has been folks. It is time to make
Speaker 1: the call. The f d A is a complicated institution
Speaker 1: with huge responsibilities. We couldn't possibly cover the entirety of
Speaker 1: what they do in a single episode, but with the
Speaker 1: help of our three experts, we're still able to get
Speaker 1: enough insight to answer the fundamental question, does the f
Speaker 1: d A strive above all else to safeguard the health
Speaker 1: of the American people. Although they've had some notable successes,
Speaker 1: we're calling bullshit on the f d A, But as always,
Speaker 1: we're not here to just curse the darkness. When we
Speaker 1: come back, we'll speak with an expert in f d
Speaker 1: A conflicts of interest to see if we can light
Speaker 1: a few candles in the halls of this bureaucratic beheemoth.
Speaker 1: My name is Genevieve Cantor. I am an assistant professor
Speaker 1: at the Proman School of Medicine at the University of Pennsylvania.
Speaker 1: I'm trained as an economist and I study regulation of
Speaker 1: biomedical technologies, the f d A, and conflicts of interest.
Speaker 1: Thank you for being here and welcome to calling bullshit.
Speaker 1: Thanks happy to be here. What we're here to do
Speaker 1: is talk about ideas for helping the f d A
Speaker 1: better live their purpose. And before we get into those ideas,
Speaker 1: I don't do this in every show, but but I
Speaker 1: wanted to actually say something to our listeners because I've
Speaker 1: been feeling some of this stuff myself as I prepped
Speaker 1: for this episode. It's really easy, and I would say
Speaker 1: even understandable, when faced with a problem as complex as
Speaker 1: the FDA to basically just shrug and give up. And
Speaker 1: it's it's easy to just declare that the problem is
Speaker 1: impossible and to kind of move on. And I want
Speaker 1: to ask our listeners to suspend their disbelief for this section,
Speaker 1: because we really do want to explore actions that the
Speaker 1: FDA or the executive branch to whom the FDA reports
Speaker 1: could actually enact to help the f d A build
Speaker 1: better trust with people and really deliver on the promise
Speaker 1: of keeping all of us safer. It's such an important purpose,
Speaker 1: and I really believe we need to take an optimistic
Speaker 1: point of view here because giving up on it is unthinkable. Sorry,
Speaker 1: I had to get that off my chest initially. So
Speaker 1: let's get into some ideas. Genevieve, I'm gonna ask you
Speaker 1: to go first. In two minutes, can you tell us
Speaker 1: the one thing that you would do to change the
Speaker 1: f So, if I were emperor of the United States,
Speaker 1: the one thing I would do is to replace our
Speaker 1: current approval process with a system where the firms are
Speaker 1: given conditional approval of their products and they have to
Speaker 1: seek renewal of approval every say, ten years. So in
Speaker 1: the current system, a firm applies for approval of a
Speaker 1: product and receives that approval until basically the end of
Speaker 1: time or the sun burns itself out or something. So
Speaker 1: with this ten year sort of renewable approval, you could
Speaker 1: incentivize the monitoring of how well drugs are working, because
Speaker 1: that will be required to get your renewal for the approval.
Speaker 1: You incentivize the monitoring of how safe drugs are because
Speaker 1: again that's part of the renewal process that will allow
Speaker 1: us the government to pull drugs off the market that
Speaker 1: turn out to be not effective or that turned out
Speaker 1: to be unsafe, because sometimes you don't see a lot
Speaker 1: of safety events in the small clinical trial populations and
Speaker 1: you only see them in the broader population. I love
Speaker 1: that idea. That is an incredibly smart idea. Not surprisingly,
Speaker 1: you are the experts, so well done. I think that's
Speaker 1: a fantastic idea. Will we will return to that, I'm
Speaker 1: sure throughout the conversation. So here's my idea. The f
Speaker 1: d A is much more important to all of us
Speaker 1: than is currently reflected in the salaries of the people
Speaker 1: who work there. Their job is literally to to save lives,
Speaker 1: to protect us from harm. But there's a pretty massive
Speaker 1: salary gap between the average f d A worker in
Speaker 1: the average pharmat exact or food company exact, which has
Speaker 1: resulted in this revolving door where regulators from the FDA
Speaker 1: moved to higher paying jobs at food and drug companies.
Speaker 1: And I think that the knowledge that that reward is
Speaker 1: there waiting for them if they play ball while they're
Speaker 1: at the f d A has the effect of creating
Speaker 1: huge conflicts of interest. And so my idea is to
Speaker 1: change the FDA through compensation reform, pay salaries competitive with
Speaker 1: the private sector, because right now the FDA is kind
Speaker 1: of a drab government bureaucracy and it attracts people who
Speaker 1: are up for working in that kind of job. Closing
Speaker 1: the salary gap would begin to level the playing field.
Speaker 1: When you know you pay people more money, you attract
Speaker 1: better people, and their job is so incredibly important that
Speaker 1: that would be better for all of us. So salary
Speaker 1: reform is the idea I want to put on the table.
Speaker 1: But let's some we can we can get back to that.
Speaker 1: I want to I want to talk more about your idea,
Speaker 1: because I think it's so smart because when things and
Speaker 1: and a lot goes right at the FDA, right, but
Speaker 1: but when things go wrong, it's not often on day
Speaker 1: one you don't know that a problem is a problem
Speaker 1: right out of the gate. And yet once something is approved,
Speaker 1: it's been released into the wild and you almost can't
Speaker 1: get it back in the current system. And so that
Speaker 1: I think that would you know, really increase people's safety.
Speaker 1: What barriers do you think we would encounter if we
Speaker 1: decided to try to actually enact that today? Who would
Speaker 1: have an issue with that idea? Probably the same parties
Speaker 1: that have blocked a lot of reforms in this space,
Speaker 1: the pharmaceutical companies. I suspect that some of the arguments
Speaker 1: that would be presented might be that it would be
Speaker 1: even more costly and time consuming for firms than the
Speaker 1: existing approval processes. Uh IN might delay access to some products,
Speaker 1: But overall, broadly speaking, it's not politically feasible because the
Speaker 1: drug companies would intensely oppose this kind of conditional approval.
Speaker 1: And when they oppose that kind of thing, how does
Speaker 1: what form does that opposition take? So every five years
Speaker 1: there is legislation related to authorizing the budget for the
Speaker 1: f D a um. In fact, there's actually currently the
Speaker 1: re authorization happening this year and we expect to see
Speaker 1: it past at the end of this summer actually, And
Speaker 1: so usually it's through you know, lobbying legislators as to
Speaker 1: the features that might go into this reauthorization package. So if,
Speaker 1: for example, if it were to be introduced in one
Speaker 1: of these five year reauthorization bill's armor as well as
Speaker 1: individual pharmaceutical lobbyists would oppose the inclusion of such a conditionality,
Speaker 1: and the lobbyists are there to threaten by removing financial
Speaker 1: support from Congress. That's right through you know, campaign contributions.
Speaker 1: M hmm. Yeah. That sort of leads us to a
Speaker 1: discussion around conflict of interest in general. So so I
Speaker 1: want to I want to go there, But before we
Speaker 1: go there more deeply, what do you think of the
Speaker 1: idea that I put on on the table, This idea
Speaker 1: of like leveling the playing field from a salary standpoint,
Speaker 1: Does that make any sense? I'd like it, And I
Speaker 1: think you've tackled head on one of the issues with
Speaker 1: the approval process at the FDA, which is they do
Speaker 1: lose a lot of very good people because the pharmaceutical
Speaker 1: companies are able to entice government workers who have a
Speaker 1: lot of experience and knowledge. Away, I do see some
Speaker 1: constraints while we're on the topic of you know, pluses
Speaker 1: and minuses. One might be that these are civil servants,
Speaker 1: and so what you describe is just a generic problem
Speaker 1: among the civil service. So are there some rules related
Speaker 1: to parity relating you know, GS scales and so on
Speaker 1: that you would have to consider. I see, just the
Speaker 1: way government workers are compensated has to be essentially universal
Speaker 1: there or standardized. Yet in some way. A second issue
Speaker 1: is just where that money would come from, because the
Speaker 1: central source of conflicts actually, even with funding the f
Speaker 1: d A is user fees, so basically requiring pharmaceutical companies
Speaker 1: to pony up you know, hundreds of thousands of dollars
Speaker 1: to finance the review process. Now it's not earmarks, so
Speaker 1: that if visor submits a you know, drug for review,
Speaker 1: that you know, people will necessarily favor the approval of
Speaker 1: that drug. But financially the f d A and its
Speaker 1: operations are funded in large part by pharmaceutical companies through
Speaker 1: these user fees. I would consider that attacks in a
Speaker 1: way of getting your product to market, and I think
Speaker 1: that that makes sense. I mean, I do realize it
Speaker 1: gives them a voice in the world of money and politics,
Speaker 1: and so raising those fees probably would be unpopular with them.
Speaker 1: I want to continue to talk about different conflicts of interest.
Speaker 1: You wrote a chapter in a book called Conflicts of
Speaker 1: Interest in FDA Advisory Committee that was eye opening for me.
Speaker 1: Can you first just explain what an advisory committee is
Speaker 1: and how that actually works. Sure, when a drug comes
Speaker 1: up for approval, the f d A, you know, has
Speaker 1: the final say, but oftentimes it doesn't have the internal
Speaker 1: expertise or perhaps even the person hours to commit to
Speaker 1: doing a full review of a particular drug, or you know,
Speaker 1: the evidence is complicated and it needs external advice. So
Speaker 1: frequently it convenes these advisory committees to review the application
Speaker 1: for a particular drug. The people on these advisory committees
Speaker 1: are not formally employees or full time employees of the
Speaker 1: f d A. They are external experts. They're sitting at universities,
Speaker 1: research institutes, think tanks, and they are physicians, researchers, some statisticians.
Speaker 1: But one of the important things about this is if
Speaker 1: you work for the government, there very clear ethics rules
Speaker 1: regarding your financial ties to industry. Um, if you were
Speaker 1: working at a university and then you get called on
Speaker 1: to be on these advisory committees, you know, these people
Speaker 1: sitting at universities have relationships with drug companies, They are
Speaker 1: consultants for them, they have their research funded by them.
Speaker 1: And so one of the things I looked at was
Speaker 1: whether the financial ties of these external experts who are
Speaker 1: called upon to advise whether a drug should be approved
Speaker 1: or not. Whether the financial ties of these experts had
Speaker 1: to drug companies was associated with whether they voted for
Speaker 1: approval of the drug or not, and how open they
Speaker 1: were to approval of the drug. Right, And it sounded
Speaker 1: to me like you had a specific hypothesis going into
Speaker 1: the work, which actually you even you were surprised by
Speaker 1: the results. Is that right? Yeah? So, I mean conventional wisdom,
Speaker 1: certainly in the ethics literature on conflicts of interest, which is,
Speaker 1: if you have, you know, when tied to industry, you know,
Speaker 1: that's not good. But if you have multiple ties, that's
Speaker 1: even more not good. That's like really really bad, yes, exactly.
Speaker 1: And then so we found two things. One was it
Speaker 1: turned out that when we compared how these experts voted,
Speaker 1: and we compared people who had one financial tie to
Speaker 1: those who had no financial ties. We actually found that
Speaker 1: people with a single financial tie to a company were
Speaker 1: more likely to vote in favor of the product sponsored
Speaker 1: by that company than people who had no financial ties.
Speaker 1: So there did to seem to be some bias, but
Speaker 1: it was only if you had a single financial tie
Speaker 1: to a company. In contrast, people who had a lot
Speaker 1: of financial ties, So people who had ties to murt
Speaker 1: Fiser lots of companies did not appear to vote any
Speaker 1: differently on average than people who had no financial ties.
Speaker 1: People with a lot of ties did not appear to
Speaker 1: be biased in how they voted, and so we talk
Speaker 1: a little bit about why that might be the case.
Speaker 1: One you know, hypothesis that makes sense to me is that,
Speaker 1: you know, a lot of times when people have a
Speaker 1: lot of financial ties, it's because they're really really good
Speaker 1: at what they do, and so a lot of companies
Speaker 1: want a piece of their brain. Um, it's not so
Speaker 1: they're not hiring these people so they could be hired
Speaker 1: guns to say what the company wants them to say.
Speaker 1: They're hiring these people because they're just really good at
Speaker 1: advising them. Yes, some of it is just they literally
Speaker 1: want great advice from smart people. But we did find
Speaker 1: some bias. I mean, I think the other thing that
Speaker 1: came out in the paper was that, you know, the
Speaker 1: type of conflict matters. So that hypothesis that I presented earlier,
Speaker 1: one tie is bad, many ties worse. It's sort of
Speaker 1: a the simplistic rule of film we had that doesn't
Speaker 1: acknowledge the fact that different kinds of ties matter for influence.
Speaker 1: And so the other thing we found was that it
Speaker 1: did not seem, for example, that experts who had ties
Speaker 1: through research funding so their research was funded by the
Speaker 1: drug company, were biased. But the kind of financial ties
Speaker 1: that really mattered were either you were you had an
Speaker 1: ownership stake in the company, you had some kind of
Speaker 1: stock in the company, which makes sense, and also a
Speaker 1: very strong effect came from whether you were on an
Speaker 1: advisory board for the company. Lots of times you may
Speaker 1: be on the board and you have a fiduciary responsibility
Speaker 1: for the company to act in uh interest right exactly. Yeah,
Speaker 1: that's a clear conflict like that that seems like that
Speaker 1: should be illegal. I mean, a lot of this should
Speaker 1: be illegal. To be honest, you would think it would,
Speaker 1: and if you read the rules, people who do have
Speaker 1: that kind of financial interest should not be participating in
Speaker 1: the advisory committees. But there is also a process that
Speaker 1: allows the FDA to make exceptions, and many times they
Speaker 1: make exceptions. And so you have people with these kinds
Speaker 1: of financial ties on these advisor committees, but things that
Speaker 1: don't matter, consulting research, you know, other kinds of ties
Speaker 1: don't matter. So I guess the paper was really advocating
Speaker 1: for more subtle policy related to conflicts of interests. Yeah,
Speaker 1: more disclosure, right, I mean, it seems like that should
Speaker 1: be fair if the FDA is tasked with, as it
Speaker 1: says on the website, above all else, safeguarding the health
Speaker 1: and well being of the American people. If that truly
Speaker 1: is above all else, then you know, you should have
Speaker 1: to disclose all of your financial ties. And it should
Speaker 1: be acknowledged that there are financial ties that are okay.
Speaker 1: In other words, if you're just being paid as an
Speaker 1: advisor for a company, and that's you being paid for
Speaker 1: your professional expertise, and that's fine. If you own a
Speaker 1: piece or you're on the on the board of one
Speaker 1: of the companies that's in question, that would disqualify you.
Speaker 1: And I don't understand why we can't enact rules like that.
Speaker 1: What would prevent us from from closing those loopholes? That's
Speaker 1: a great question. The two arguments that I've seen presented
Speaker 1: are that we would no longer be able to find
Speaker 1: people qualified enough to be on our advisory committees if
Speaker 1: we just outright banned the participation of people with financial ties,
Speaker 1: because all the all the really smart people are already
Speaker 1: on the take, essentially like or you know, whereas my
Speaker 1: study indicated, you know a lot of people want want
Speaker 1: a piece of their brains, so it would be difficult.
Speaker 1: And we can kind of see this because in the
Speaker 1: two thousands, the f d A in fact capped the
Speaker 1: exceptions that could be issued for people who had these
Speaker 1: kind of financial ties. Um So prior to this, the
Speaker 1: f d A issued just exceptions willy nilly and just
Speaker 1: basically said a lot of the apparently disqualifying financial interests
Speaker 1: did matter. In the two thousands, with one of the authorizations,
Speaker 1: the percentage of people who had these exceptions, and what
Speaker 1: you saw was of course a decline and people who
Speaker 1: had these exceptions in these financial ties. But what you
Speaker 1: also saw was more positions on the advisory committees being vacant,
Speaker 1: a longer time it would take to convene these advisory
Speaker 1: committees because they would need to spend more time to
Speaker 1: find people who are not conflicted. Yeah right, Yeah, I
Speaker 1: want to delve a little bit more into this idea
Speaker 1: of trust, because ultimately the FDA's job is to make
Speaker 1: us safe. And without guiding your answer at all, what
Speaker 1: needs to change so that we can trust the companies
Speaker 1: that are making our food and the companies that are
Speaker 1: making our drugs. What what about our system has to
Speaker 1: change to create more trust? I have to say I'm
Speaker 1: a little conflicted about this. I mean, the mission of
Speaker 1: the fd as pretty clear, you know, to ensure, among
Speaker 1: other things, to ensure the safety and efficacy of the
Speaker 1: drugs that are marketed in the US. The mission the
Speaker 1: drug companies is not that it is to make money
Speaker 1: for their shareholders, and so, you know, I do wonder
Speaker 1: whether it's realistic um to expect organizations whose objective is
Speaker 1: profitmaking to not do what they can do to make profits.
Speaker 1: But I like the way you framed it, because you
Speaker 1: framed it as a system, you know, not just the
Speaker 1: f d A. But I think the onus is on
Speaker 1: legislators policymakers to create rules that put guard rails on
Speaker 1: drug companies that still but that's still incentivize them to
Speaker 1: do the right thing. I think, as as you you
Speaker 1: might have framed it, so things that minimize gaming, how
Speaker 1: clinical trials are run and analyze, things that incentivize the
Speaker 1: collection of data on effectiveness and safety, and start the
Speaker 1: things that we want, which is quality information on safety
Speaker 1: and effectiveness with things that drug companies want, which is
Speaker 1: access to the market. Right, Okay, Genevieve, is there anything
Speaker 1: else that you think our our listeners should know about
Speaker 1: the f DA and things that either could or should change.
Speaker 1: I do think, you know, the problems we have with
Speaker 1: the f d A are structural. You know, there is
Speaker 1: that structural tension there about how can we get how
Speaker 1: can the agency have independence be based on the science,
Speaker 1: but you know, still have a commissioner that is serving
Speaker 1: at the pledgure of the president. The other structural tension
Speaker 1: and we see this, you know in our discussion as well,
Speaker 1: is you know, you can have an agency that approves
Speaker 1: drugs almost too fast, so they proved drugs that don't work,
Speaker 1: or you have safety issues, but you've increase access to
Speaker 1: the drug. But that's opposed to well that you know,
Speaker 1: the alternative is to have an agency that approves things
Speaker 1: too slowly, which is their drugs that it's preventing from
Speaker 1: being out on the market that people need to get
Speaker 1: access to. Right, we do need to have information systems
Speaker 1: that adapt an approval system that is adaptive in the
Speaker 1: same way that you know, all other systems in the
Speaker 1: world that we live in, you know, adapt to new information.
Speaker 1: And so hopefully that proposal and yours as well sort
Speaker 1: of adapts to you know, what we know and we
Speaker 1: can make better decisions that way. Okay, So last question
Speaker 1: on this podcast. We have a tool that we call
Speaker 1: the BS index, and the BS index measures the gap
Speaker 1: between word indeed, and it goes from zero to a hundred.
Speaker 1: Zero is the best score, So zero b s a
Speaker 1: hundred is the worst score total BS. And so the
Speaker 1: f d A today says that it strives above all
Speaker 1: else to safeguard the health and well being of the
Speaker 1: American people. What's or would you give the f d A.
Speaker 1: So I would say that my determined of the BA
Speaker 1: scores based on two main things that I think caused
Speaker 1: me to be worried about the f D A one
Speaker 1: is the degree of industry influence that leads it to
Speaker 1: diverge from its mission, as well as the degree to
Speaker 1: which it's vulnerable to political influence, you know, from the
Speaker 1: executive branch. Overall, I think the structure of the organization
Speaker 1: gives us generally reasonably high quality decisions. I would give
Speaker 1: it a forty five. Okay, that was great. Thank you
Speaker 1: so much for being here today, Jenny. I really appreciate it.
Speaker 1: Thank you for inviting me and having us think together
Speaker 1: about this issue. It was I really really had a
Speaker 1: great time. Thank you. All Right, folks, it's time for
Speaker 1: the FDA to get their fish'll b s score. Somehow
Speaker 1: feels appropriate that I try to get a little scientific
Speaker 1: with this one. So if I were to average our
Speaker 1: guest scores, the final score would be a forty eight. However,
Speaker 1: that still feels low to me, especially given Richard's account
Speaker 1: of basically being told to deliver the results his boss
Speaker 1: is wanted or risk losing his job at the agency.
Speaker 1: That's just plain scary. So I'm going to give the
Speaker 1: FDA a fifty five. I hope that acknowledges some of
Speaker 1: the agency's big winds over the years, but leaves plenty
Speaker 1: of room for some much needed improvement. And f d
Speaker 1: A Commissioner Robert Caliph, if you ever want to come
Speaker 1: on the show to discuss anything we've touched on today,
Speaker 1: please know that you have an open invitation. And if
Speaker 1: you're starting a purpose led business or thinking about beginning
Speaker 1: the journey of transformation to become one, here are three
Speaker 1: things you can take away from today's episod D One.
Speaker 1: Becoming purpose led is a big responsibility. It means that
Speaker 1: you're dedicating yourself to managing better outcomes for all of
Speaker 1: your stakeholders. That includes customers, employees, the community you do
Speaker 1: business in, and the planet. If all companies did that,
Speaker 1: we wouldn't need the f d A. The FDA only
Speaker 1: exists because the motivation to manage for maximum profitability is
Speaker 1: so powerful in our culture. The companies will knowingly sell
Speaker 1: products and services that damage people and the planet. Purpose
Speaker 1: Led companies win the trust of all their stakeholders by
Speaker 1: being transparent, by taking on problems they discover, and by
Speaker 1: solving them. They tend to do the right thing, even
Speaker 1: if it costs the money. Two. Once you know your purpose,
Speaker 1: take action against it. Since on. Fortunately, we do need
Speaker 1: the FDA to protect us from companies who would do
Speaker 1: us harm. The FDA needs to do a better job
Speaker 1: of that. The action idea that Genevieve brought today sticks
Speaker 1: with me. Any approval of any product is only conditional
Speaker 1: and time based and must be re reviewed once it's
Speaker 1: been in the market and we can all see the
Speaker 1: effects that it's actually having. That one change would help
Speaker 1: the f d A better live their purpose. What are
Speaker 1: the actions that you're taking to better live yours? Three?
Speaker 1: Simple is better. The f d A story is enormously
Speaker 1: complex because they cover such a broad waterfront and have
Speaker 1: so many stakeholders with so many different agendas. Define a
Speaker 1: simple reason why your company exists. Choose clarity and specificity
Speaker 1: over fluff. Solve a real problem, Do the right thing
Speaker 1: by your stakeholders, and keep doing that until you win.
Speaker 1: And if this episode made it through your approval process,
Speaker 1: subscribe to the Calling Bullshit podcast on the I Heart
Speaker 1: Radio app Apple Podcasts, where wherever you listen to people
Speaker 1: speaking to your ears and friends. I'd like to ask
Speaker 1: for your help. If you enjoy the Calling Bullshit podcast,
Speaker 1: please take a second to rate and review us on
Speaker 1: Apple podcasts or on your preferred platform. Thanks to our
Speaker 1: guests Lauren Edtter, Richard Williams, Gail Van Norman, and Genevieve Cantor.
Speaker 1: Learn more about them and get links to their work
Speaker 1: in our show notes, and many thanks to our production
Speaker 1: team Hannah bial, Amanda Ginsburg, d s Moss, Hailey, Pascalites,
Speaker 1: Parker Silzer, and Basil Soaper. Calling Bullshit was created by
Speaker 1: co Collective and it's hosted by me Ti Monting. You
Speaker 1: thanks for listening. Four