FDA: Is there something rotten here?

The Food and Drug Administration has expansive jurisdiction. On their website, they say “The FDA strives above all else to safeguard the health and wellbeing of the American people." 

Given what we learn in this episode we’d say that’s highly questionable. 

Join us as we break down the alarming story of the FDA with a 27-year veteran of the FDA, Dr. Richard Williams, author and journalist Lauren Etter, physician and professor Dr. Gail Van Norman, and conflict of interest professor Genevieve P. Kanter.  

See omnystudio.com/listener for privacy information.

Episode Transcript

Speaker 1 (00:05):
Overall, the FDA has had a number of spectacular hits
and pretty notable failures, and it is worth asking how
good of a job is the agency doing and are
they living up to their mandate to protect the public health.
My boss at the time said Richard, we don't have
to solve problems. All we have to do is appear
to solve problems. Welcome to Calling Bullshit, the podcast about

(00:34):
purpose washing, the gap between what an organization says they
stand for and what they actually do and what they
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

(00:54):
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

(01:16):
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,

(01:39):
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,

(02:02):
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

(02:26):
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

(02:47):
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

(03:08):
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

(03:28):
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

(03:50):
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,

(04:10):
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,

(04:39):
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

(05:01):
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.

(05:22):
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

(05:45):
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

(06:07):
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,

(06:28):
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.

(06:50):
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,

(07:13):
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

(07:35):
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

(07:57):
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

(08:19):
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

(08:42):
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.

(09:04):
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

(09:29):
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

(09:53):
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

(10:15):
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

(10:36):
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

(11:01):
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

(11:23):
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

(11:45):
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,

(12:06):
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

(12:28):
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

(12:49):
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.

(13:11):
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

(13:32):
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

(13:54):
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

(14:14):
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,

(14:36):
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,

(14:58):
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

(15:19):
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

(15:40):
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

(16:03):
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,

(16:24):
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,

(16:48):
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,

(17:11):
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.

(17:32):
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,

(17:55):
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

(18:17):
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

(18:38):
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

(18:58):
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

(19:20):
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

(19:44):
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,

(20:07):
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

(20:29):
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,

(20:52):
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

(21:16):
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

(21:37):
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

(21:58):
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

(22:19):
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

(22:39):
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,

(23:05):
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,

(23:27):
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

(23:47):
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

(24:10):
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

(24:32):
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.

(24:55):
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

(25:16):
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

(25:39):
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,

(25:59):
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

(26:21):
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,

(26:41):
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

(27:03):
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,

(27:23):
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.

(27:44):
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

(28:06):
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

(28:28):
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,

(28:50):
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,

(29:11):
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

(29:32):
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,

(29:58):
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

(30:20):
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

(30:41):
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

(31:01):
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,

(31:22):
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,

(31:51):
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.

(32:15):
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,

(32:39):
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

(33:00):
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,

(33:20):
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

(33:43):
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

(34:06):
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.

(34:27):
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

(34:48):
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

(35:14):
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.

(35:35):
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

(35:57):
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

(36:17):
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

(36:41):
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

(37:05):
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

(37:26):
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

(37:49):
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

(38:11):
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

(38:32):
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

(38:54):
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,

(39:17):
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

(39:40):
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

(40:04):
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

(40:24):
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

(40:46):
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,

(41:07):
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

(41:27):
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,

(41:48):
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

(42:10):
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

(42:32):
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

(42:52):
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,

(43:16):
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,

(43:39):
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

(44:01):
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

(44:26):
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

(44:48):
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

(45:13):
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

(45:34):
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

(45:58):
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

(46:18):
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

(46:41):
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.

(47:04):
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

(47:27):
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

(47:47):
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.

(48:10):
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

(48:32):
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

(48:54):
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.

(49:17):
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

(49:42):
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

(50:04):
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

(50:29):
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

(50:52):
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

(51:14):
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,

(51:40):
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.

(52:14):
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.

(52:35):
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

(52:58):
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,

(53:18):
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

(53:40):
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,

(54:04):
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

(54:25):
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

(54:46):
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

(55:09):
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

(55:31):
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

(55:54):
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

(56:16):
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,

(56:37):
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

(57:00):
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

(57:21):
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.

(57:44):
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

(58:07):
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,

(58:30):
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

(58:52):
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

(59:13):
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

(59:36):
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

(59:57):
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,

(01:00:17):
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

(01:00:38):
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.

(01:01:02):
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

(01:01:23):
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

(01:01:44):
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

(01:02:06):
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

(01:02:28):
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

(01:02:48):
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.

(01:03:10):
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

(01:03:32):
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

(01:03:53):
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

(01:04:15):
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

(01:04:35):
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.

(01:04:55):
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

(01:05:16):
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

(01:05:36):
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

(01:05:58):
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

(01:06:20):
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.

(01:06:40):
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

(01:07:03):
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

(01:07:26):
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

(01:07:47):
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

(01:08:10):
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

(01:08:32):
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

(01:08:53):
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

(01:09:15):
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

(01:09:39):
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

(01:10:00):
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.

(01:10:22):
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,

(01:10:43):
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

(01:11:03):
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

(01:11:24):
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

(01:11:45):
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

(01:12:09):
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

(01:12:31):
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

(01:12:54):
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

(01:13:17):
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

(01:13:40):
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.

(01:14:05):
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

(01:14:26):
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

(01:14:48):
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

(01:15:12):
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?

(01:15:34):
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

(01:15:56):
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

(01:16:19):
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

(01:16:41):
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