0:02

Welcome back to Behind the Bastards,

0:04

the only podcast with more worms

0:07

than the average bottle of milk in

0:10

a century ago. Tougs of

0:12

worms and filled with them.

0:14

Love your new tagline. It's great, thank

0:17

you, thank you. It's

0:20

We're gonna move on from discussing

0:22

horrible old timey foods before there

0:24

were any kind of laws about what you could do with foods. But

0:26

I just came across an article in the Guardian.

0:29

Uh, you know there's that truck convoy trying

0:31

to do with January six in Canada all

0:34

about next week. Yeah, there's an article in

0:36

the Guardian called Canada trucker's vaccine

0:38

protests spirals into calls to repeal

0:40

all public health rules. My

0:45

favorite, my favorite response on

0:47

Twitter is someone who's posted a picture of a

0:49

sign outside of a swimming pool that says person

0:52

is currently having active diarrhea or who

0:54

have had active diarrhea within the previous fourteen

0:56

days shall not be allowed to enter the pool water. And

0:58

he's just responded, He's just most of that and said

1:00

in all caps, oh, captain, my captain.

1:07

This concludes the part of the episode where I read to

1:09

you from Twitter, mad, what

1:12

you you got a podcast compare yourself

1:14

a gun but yourself a gun past.

1:18

It's uh. You know, this is what separates

1:21

us from any other TV rewatch podcast

1:23

as uh I do a parody song every

1:25

week that does the synopsis of the episode.

1:28

Is it good kind of tow? People

1:31

like it? Oh? No, do I do it? Yes?

1:33

Insistently? U what

1:36

a plug? Everyone loves that hot

1:39

damn Matt.

1:42

Now now that we have really we've

1:44

laid the groundwork here, it is time to

1:47

move on to the true bastard of our

1:49

episode, the f d A. We've

1:51

had it's it's it's Anakin Skywalker

1:53

phase here and now we're about it's about to go

1:55

full Vader, right, That's

1:57

that's today's story. Pub

2:00

poisoned back in the food Yeah,

2:02

actually, yes, that is

2:04

a part of what's happening in this period. Um,

2:07

of course, it is much bigger than that. We're actually going to focus

2:09

a bit more in the pharmaceutical industry today. There's a

2:11

lot to say about food though. So we

2:13

ended last episode with the creation of

2:16

the f d A in nineteen thirty eight, after eight

2:18

years after the death of Harley Whitley. Harvey

2:20

Whitley, he dies in nineteen thirty

2:23

uh. And the FDA was initially taxpayer

2:25

funded. Right again, so all of its money

2:27

at first comes from the American people because

2:29

its job is to be a watchdog

2:32

for the American people and to make sure they're eating.

2:34

That's changed. Oh, yes, that's

2:37

a big part of our story today, Matt. So

2:39

at first it is taxpayer funded,

2:41

and as a taxpayer funded organization,

2:44

it experiences a titanic success

2:46

very early on. When we've actually discussed

2:49

previously on the show. In the

2:51

late nineteen fifties, the grun in Tall Corporation

2:53

of Germany, which was a pharmaceutical concern

2:56

staffed mainly by Nazis, tried

2:58

to get approval to sell their blockbust a new

3:00

sleeping pill, philidamide, which may have initially

3:02

been tested on concentration camp inmates

3:04

in the United States now for

3:07

the person and it was like some other company that was trying

3:09

to sell the product for gruden Tal

3:11

was buying and wanted to sell in the U S. Whatever, Like you know,

3:14

corporations work. But this company

3:16

that wants to sell palidamide in the U s as a sleeping

3:18

pill, UH, has to go to the FDA

3:20

to get approval, right, and the person they come

3:23

before is Francis Oldham

3:25

Kelsey. Now Francis Kelsey had

3:27

earned a PhD the same year the FDA

3:29

was founded, and she had been hired in nineteen

3:31

sixty after six years of teaching pharmacology

3:34

at the University of South Dakota. Um

3:36

So, her job, she's one of the people who's supposed to evaluate

3:39

new medical sins and substances and decide

3:41

whether or not they get FDA approval. One

3:43

of her very first assignments for the FDA

3:46

was the litamide and her job is essentially

3:48

to review the evidence of drug safety provided

3:50

by the manufacturer, because that's what that

3:52

nineteen thirty eight law, in the nineteen o six law

3:54

had gradually established that if you want

3:56

to sell a medicine, you have to prove it works

3:58

and that it doesn't kill people, or at least it doesn't kill

4:01

too many people, right, any kind of effect.

4:04

Yeah, you have two shows. You have to prove

4:06

it alike, be worth it, you know. Um

4:09

So, it's her job to review all of that evidence. Now,

4:11

Solidamite is at this point in use in like forty

4:14

six nations around the world, including most of Europe.

4:16

But Dr Kelsey thought their data was shipped.

4:19

She actually looks at the evidence they have that this stuff

4:21

is safe, and she's like, because one of the big things they're

4:23

selling this as is it's like this is finally a

4:25

safe sleeping pill for pregnant women, right,

4:28

and they're they're saying that based on nothing,

4:30

and in fact, a lot of the data they have suggests that, like,

4:32

no, it's actually like it's fine for women who

4:35

are nursing. They do show that that, like,

4:37

it's probably okay for women who are nursing to have

4:39

it, but there's there's evidence that it's

4:41

really bad for pregnant women. Um, and

4:43

there's really tried

4:45

out and Nazi concentration camps.

4:47

Well, that is debatable. We talked

4:49

about this in the episode. Yeah, there's a lot

4:52

of evidence that suggests that it's not ironclad.

4:54

So I don't want to be like saying, but there

4:56

is some evidence that's because they were they were Nazi

4:59

doctors who were in concentration camps are

5:01

the people who are doing all of the medical testing for Grooon

5:03

at all, and there's evidence that they just like took

5:05

this drug they've been testing in camps and

5:07

like tried to launder its. Robert,

5:10

I'm not about nuance. We're gonna call it

5:12

anti semitic ambient and

5:14

anti semitic ambient. That's right. So

5:16

anti semitic ambient is in use all over the world.

5:19

Um. But Francis Kelsey is like, I don't give a shit

5:21

about what the rest of the world says. This data

5:23

doesn't convince me, and it's my job to

5:25

say whether or not this ship is safe, So I don't

5:27

give you approval. UM.

5:30

So she turns them down, and then they try

5:32

to pressure her boss, and her boss

5:34

backs her to the hilt. Her boss is like,

5:36

no, Frances is fucking great scientist,

5:38

and she's right about this, and we're not gonna fucking

5:41

self phillidamite in the United States, and

5:43

the litamite has never approved for use on a

5:45

wide scale in the U S. There's a couple of like

5:47

trials and stuff. A handful

5:49

of Americans do take it um, but

5:52

nothing like what happens in Europe, where millions

5:54

of people take the litamide. Roughly

5:56

one year after she turns down philidamide,

5:59

scientists and Urbany and Australia

6:01

proved that the litamide caused a whole host

6:03

of debilitating birth defects. Babies were

6:05

being born without lungs or with their arms coming

6:07

directly out of their shoulders and like no actual

6:09

like like foe arms and ship. You can find

6:12

pictures if you want. Tens of thousands

6:14

of children are disabled, hundreds of thousands

6:16

of children that are disabled, Tens of thousands are killed as a

6:18

result of the litamide. Um, but none

6:20

of those are in the US, thanks to Dr

6:22

Kelsey and the f d A. This is a huge

6:25

success. Is exactly what it's there for, right,

6:27

that's for this is a bullet proof

6:29

vest stopping a bullet from entering your body.

6:32

This is like exactly why we

6:34

have this thing in proof that it is worth every goddamn

6:36

penny. Um. And Americans at

6:38

the time recognize that they have dodged a huge

6:40

bullet. H The ship that happens

6:43

with the litamide inspires the passage

6:45

of the nineteen sixty two Drug Amendments.

6:49

This bill is why ads for new medicines

6:51

always end with like forty seconds of a dude

6:53

talking very fast about the side effects experience.

6:56

Like that's that's where that starts, like being mandatory,

6:59

right, um, And there's a bunch of other good

7:01

stuff and it including it forces a comprehensive

7:03

reclassification of all available

7:05

drugs based on whether or not they actually do anything.

7:07

So there were all this medicine that was like grandfathered

7:10

in when the FDA gets created, and they're right, well,

7:12

actually, why the funk are we doing that? We should make sure

7:14

this stuff all works. You know, I don't

7:16

care we got tested.

7:19

I understand that dark defeats

7:21

the bright, but we gotta test it. I'm

7:23

not a big law fan, but the nineteen sixty two

7:25

drug ammendments are pretty comprehensively,

7:28

like a good, good, good call,

7:30

you know. Um So, the f D a

7:33

huge fucking hit at this point, right,

7:35

Like, that's that's I mean, that's worth all

7:37

the money we'd spent on it forever if they just

7:39

stopped the litamide. And obviously there's other ship

7:41

they're stopping their ship they're making safer.

7:43

There's stuff that they're you know, medications

7:45

that they're limiting the scope of that too many people

7:47

don't take them. The FDA is doing fucking

7:50

gang busters, and it's it's first few

7:52

decades in existence. Um

7:54

So, that's dope as hell. And President Kennedy even

7:56

gives the agency a shout out in nineteen sixty

7:59

two shortly but or being gunned down by Bernard

8:01

Montgomery Sanders. And it's worth

8:03

noting that this massively but

8:08

I mean, okay, look, there is the theory that Orenthal

8:10

James Simpson, who was a young adult

8:12

at this period of time, may have taken part

8:15

in the assassination of John

8:17

Fitzgerald Kennedy. He was a very fast

8:19

runner. I believe that he may have been

8:21

providing the ammunition to Bernie Sanders.

8:24

Um, there's no way to know that he wasn't you

8:26

know. That's why

8:29

proved me wrong. Yeah, what are you gonna do? Show

8:31

me that Bernie Sanders and O J and

8:33

the Juice didn't collaborate together

8:35

to assassinate John Fitzgerald

8:38

Kennedy. Prove it. I hope that we all did

8:40

a headshake in Unison

8:42

when that happened. So

8:46

it's worth noting that this, uh, this,

8:48

this massive early dub for the

8:50

f d A was due in part to the agency's

8:53

independence in large part. Really like the fact

8:55

that this this is there's no ties to

8:57

anybody but the U. S. Taxpayer. That is the

8:59

only response posibility the f d A has.

9:01

There's a shipload of money to be made in approving

9:04

like philidamide right, Like they

9:06

could have been like that, Like that company would

9:08

have made millions before they realized that it

9:10

was harming babies at a scale

9:12

almost inconceivable. But the only

9:15

FDA doesn't give a shit about anybody's profits.

9:17

All they care about his safety. And Dr

9:20

Kelsey looked at the data and was like, no, funk, this ship

9:22

responsible only to the taxpayers, because

9:25

that's what government is supposed

9:27

to do. Well, that's not how the FDA works

9:29

anymore. Um. And to explain

9:31

why things changed, I'm going to read a quote

9:33

by a write up from Michael White of the University

9:36

of Connecticut School of Pharmacy. Quote.

9:39

The first US case of HIV induced

9:42

AIDS occurred in nineteen eighty one. It was rapidly

9:44

spreading, with devastating complications like

9:46

blindness, dementias, severe respiratory diseases,

9:48

and rare cancers. Well known sports

9:50

stars and celebrities died of AIDS related complications.

9:53

AIDS activists were incensed about long delays

9:55

and getting experimental HIV drugs studied

9:57

and approved by the f d A. In nineteen

10:00

nine two, in response to intense pressure, Congress

10:02

passed the Prescription Drug User Fee

10:04

Act. It was signed into law by President

10:07

George H. W. Bush. With

10:09

the Act, the FDA moved from a fully

10:11

taxpayer funded entity to one funded through

10:13

tax dollars and new prescription

10:16

drug user fees. Manufacturers

10:18

pay these fees when submitting applications to

10:20

the FDA for drug review, and annual

10:22

user fees based on the number of approved drugs

10:25

they have on the market. Now

10:27

surface level go back in time. Number

10:29

one. This is in response to a real problem,

10:32

right, the and this we saw this with like COVID.

10:34

Right, sometimes you can't afford

10:37

to take as much time, you know,

10:39

testing ship because there's a real immediate

10:42

fucking plague and you might just need to like

10:44

throw some ship out there. And maybe there will be some side effects

10:47

with the boosters and ship I. You know, some

10:49

people like there are some side effects and ship um

10:51

that we probably would have caught and maybe even minimized

10:54

if we had not been dealing with a global

10:56

play, right, Like you gotta fucking get shipped out. You

10:58

know, that's a reasonable problem.

11:00

The way they one of

11:02

the ways they deal with this is that like they

11:04

make this partially funded by

11:07

the pharmaceutical drug companies, and

11:09

they allow ways for the FDA to expedite

11:12

um pharmaceutical drug approvals. And

11:14

this is where all the problems start to come in. Right,

11:17

But you have to note that it does kind of sound surface

11:19

level reasonable to a lot of people. And

11:21

this is kind of the way a lot of the government works really.

11:24

Right, you go to the d m V. You have to pay fees

11:26

to apply for stuff, right to get like register a

11:28

car, get a license. Why wouldn't big

11:30

pharmaceutical companies have to pay the FDA

11:32

for drug review and other stuff? You know, you can make

11:34

a case to most people on both sides of the political

11:36

spectrum that this is a reasonable idea,

11:39

right um. And obviously

11:41

the reason why you don't do that for the

11:43

f d A is because it might lead to a situation

11:46

wherein those companies are all paying the FDA

11:48

for the FDA to exist. And when the

11:50

people funding your organization are the folks

11:52

with a vested interest in you saying yes to their

11:55

drugs, well, that can cause some problems.

11:57

You are no longer the independent organization

11:59

that stopped philetamide from hitting the streets.

12:01

You know it was there

12:03

was a short sighted move on that law. You

12:05

know, I got where they were coming from

12:07

But uh, it sounds

12:10

bad. You get why people could be convinced that

12:12

this was a good idea because it sounds

12:14

like a tax. It sounds like, Oh, all we're

12:16

doing is like making you

12:18

know, you're you're still going to get the money from the taxpayers,

12:21

but you're also we're gonna a tax these companies

12:23

for you even applying. And it's like it

12:27

is tying these salaries of

12:30

uh, the of

12:32

of the people who work for the FDA to

12:34

the pharmaceutical industry. You know, that's

12:37

that's what it's doing, and that's not great,

12:40

you know. Um So,

12:42

over the years, new fees were introduced

12:44

for the approval of generic drugs, over the

12:46

counter drugs, biosimilar drugs, animal

12:48

medications, as well as medical devices.

12:51

The FDA develops a complex system

12:53

of waivers, refunds, and exemptions dependent

12:55

on the category of drug and the total number of drugs

12:57

the manufacturer had approved. A LABYRINTHI

13:00

an expensive bureaucracy developed, and the

13:02

proceeds from this bureaucracy grew to account

13:04

for forty of the f d a's five

13:06

point nine billion dollar budget. But

13:09

wait, there's more. Sixty

13:12

five percent of the funding for human drug regulation

13:14

comes directly from user fees submitted

13:17

by pharmaceutical companies. Now this

13:19

has had some positive outcomes because

13:21

their funding comes from these fees. The FDA

13:23

has gotten a lot faster at responding to

13:25

manufacturers about what they need in their applications.

13:28

The whole process of getting new medicines approved

13:30

has gotten a lot speedier. Seven

13:32

it took twenty nine months to get FDA approval

13:35

or denial. By fourteen, it took

13:37

thirteen months. By two eighteen,

13:39

it was down to ten months. President Trump

13:41

personally promised to streamline the process by which

13:44

drugs were approved, and his administration seems

13:46

to have delivered in this respect. Now that

13:49

can be good, as we've seen in the COVID

13:51

responses. Sometimes you need stuff approved

13:54

very rapidly, but usually

13:56

you don't. One of

13:58

the things that these changes have done is they've led to an increase

14:01

from thirty eight percent to sixty one in

14:03

the number of first time approvals on new drug

14:05

applications in diseases where there are a

14:07

few existing medications and even more

14:10

streamlined approval process means that eight

14:12

nine percent of applications get approved the first

14:14

time, often and under eight months. This

14:16

is all coincided with a huge surge

14:18

in the number of new drug applications because

14:20

you can get them said yes a lot quicker and get him out there

14:22

and start making fucking money. So that is

14:25

impressive if you don't account

14:27

for the fact that an awful lot of these new drugs getting

14:29

expedited approvals are fucking horrible. And

14:31

I'm gonna quote from Michael White from the University

14:33

of Connecticut here. While

14:35

the number and speed of drug approvals have been increasing

14:38

over time, so have the number of drugs that end up

14:40

having serious safety issues coming to light after

14:42

FDA approval, and one assessment, investigators

14:45

looked at the number of newly approved medications

14:47

that were subsequently removed from the market or

14:49

had to include a new black box warning over

14:51

sixteen years from the year of approval. These

14:54

black box warnings are the highest level of safety

14:56

alert that the FDA can employ, warning

14:58

users that are very serious verse event could

15:00

occur before the user fee was approved

15:03

of medications were removed or had new black box

15:05

warnings as compared to twenty seven percent

15:07

afterwards. Now that jump alone

15:10

is not great, right, but it's also like, you

15:12

know, six percent, that's not the

15:14

worst thing in the world, But when you really

15:17

dig into the data, it's it sounds a lot worse

15:19

than that. Actually, matt um, it

15:21

does. It does. And I'm gonna quote now from a write up

15:23

I found by CNN, about a third

15:25

of the drugs the FDA approved between two thousand

15:27

and one and two thousand ten were involved in some kind of

15:29

safety event after reaching the market, According to

15:31

a study published in Tuesday in the Journal of America

15:34

the American Medical Association. The authors

15:36

found that in that time, two and twenty two novel

15:38

therapeutics were approved, and there were a hundred and

15:40

twenty three post market safety events involving

15:43

seventy one products that required FDA action.

15:45

Manufacturers needed to add sixty one boxed

15:48

warnings also commonly called a black box warning

15:50

to call attention to serious risks. In fifty

15:52

nine cases, some communication had to warn

15:54

the users about a product safety. Three therapeutics

15:57

were withdrawn from the market. Now,

16:00

remember how I said that the FDA expedites

16:02

approval requests for drugs to treat illnesses

16:04

where there aren't a lot of existing treatments. That's

16:07

good again, if there's like a plague or something

16:09

that you need to get out quick, but it also means

16:11

there's an extra financial incentive for a pharmaceutical

16:13

corporation to get a medicine approved to treat

16:16

an illness that doesn't have a lot of medicines for

16:18

it. This includes all of

16:20

the mental illnesses, right, yeah,

16:22

really shortage of medicines because maybe in a

16:24

lot of cases medicines don't help that much. With a lot of

16:26

studies, we're fighting not not to be against medications.

16:29

A lot of great medications out there, but there's a

16:31

lot of fucking problems with mental health medications,

16:33

and it's very fucking easy to get an approval

16:36

for a mental health medication. Um.

16:39

And that for a while, mental

16:41

health medication was just doing electricity

16:43

on your brain. So you know, at

16:46

this point, if it's in pillform, people are like, yeah,

16:48

proven you don't you would think

16:50

that it wasn't worse now, but

16:53

in some ways it is. Um

16:57

so that a m A journal report noted that

16:59

drugs used for mental illness had a higher number

17:01

of events UM like negative

17:03

health and safety events. And most of these drugs,

17:06

and most of accelerated drugs are approved

17:08

on trials with fewer than a thousand patients. Because

17:10

the bar is lower, they don't need to show that it works

17:13

on many people. If you can jig a trial with a

17:15

hundred people with a thousand people and

17:17

show that it works like five people or whatnot,

17:19

you can fucking get approval and

17:22

expedited as well. Yeah, yeah,

17:24

you can get it done really quickly. And there's a good

17:26

book. We're not going to get into it much because I'm kind

17:28

of focusing on the FDA. There's a whole book

17:30

written about all of the different

17:33

ways in which the the

17:35

medical testing industry, like the industry

17:37

that is designed to determine whether or not

17:39

drugs work, is heavily compromised

17:42

because most of those studies are funded

17:44

by the pharmaceutical companies. There's all sorts of

17:46

ways they funk with the data. A lot

17:48

of those scientists wind up getting like cushy

17:50

jobs afterwards and stuff with these companies.

17:52

There's all sorts of ways like that's a big part of how

17:54

a lot of very like negative

17:56

like that's how they That's how a lot of like negative

17:59

aspects of different foods like sodas

18:01

and ship get hidden for so long. Because

18:04

you can kind of have a study of five

18:06

people that you control, and you can make it kind of say

18:08

whatever you want. The book is called

18:10

Unsavory Truth, How Food Companies skew

18:13

the science of what we eat, and it includes a lot of detail

18:15

on the pharmaceutical industry to It's by

18:17

a woman named Mary and Nestleie no relation to

18:19

the candy people. Um

18:21

again, we're not really going to get into that, but

18:25

yeah, I I should, you know, I should read one

18:27

quote from this about the way

18:29

in which industry funded research favors

18:31

the sponsors commercial interests. So

18:33

I'm gonna read a quote from that book here. Sheldon

18:36

Crimsky, a Toughs University professor who studies

18:38

industry manipulation of science, dates the discovery

18:40

of this funding effect to the mid nineteen eighties,

18:42

when social scientists realized that if they knew

18:44

who paid for a study, they could predict its

18:47

results. One funding effect investigation

18:49

from the late nineteen nineties looked at studies on the safety

18:51

of calcium channel blockers for reducing blood

18:53

pressure. Nearly all authors nineties percent

18:56

who concluded that the drugs were effective, reported

18:58

financial ties to their manufactures. Only

19:00

thirty seven percent of authors who doubted the effectiveness

19:03

had such ties, and two thousand three a systemic

19:05

review of more than one thousand biomedical research

19:08

studies came to a similar conclusion. Investigators

19:10

with industry affiliations were nearly four times

19:12

more likely to come up with pro industry conclusions

19:15

than those without such ties. See,

19:17

that's why we don't trust doctors.

19:20

If you want to know why they're there's a reason

19:22

people are so distrustful about like the vaccines

19:25

in the medical industry. Like they should be distrustful,

19:28

just not in this specific case. Really, yeah,

19:31

I mean, it's just it sucks because it's like every

19:34

time I hear an anti vaxer talk, I'm always

19:36

like, there's part of me that

19:39

understands exactly where you're coming

19:41

from, minus the part where

19:43

you're completely ignoring all subsequent

19:46

data as to the efficacy of these

19:48

like vaccines. But it's like I get it because

19:50

like, yeah, nine out of ten doctors

19:53

think that this drug is good. Also, nine

19:55

out of ten doctors are paid for by the company

19:57

that makes this drug. It's just yeah,

20:00

maybe a better solution would be to tax all

20:02

of the billionaires until they're not billionaires, to

20:04

dissolve all pharmaceutical corporations, and

20:07

to take all of their patents and property and

20:09

money and put it in a trust run or

20:11

administered by, you know, an agency

20:14

made up of scientists who are purely

20:17

paid and supported by the taxpayer, whose

20:19

job is to make pharmaceutical

20:22

stuff happen. Maybe just

20:26

off the topic I did I I I've actually

20:28

invented a whole system. Um it's called

20:30

Marxist uh Robertism.

20:33

Yeah, that's that's that's very heavily based

20:35

on what I what I another

20:37

word, I invented socialism. Yeah.

20:42

Yeah, I'm the first person to figure this out.

20:44

I have a lot of great ideas. We're

20:47

going to freeze a lot of seeds to see if

20:49

it makes them cold tolerant, a lot of cool stuff.

20:52

Try that out. Try that yeah.

20:59

So uh yeah,

21:02

one area where all of this ship.

21:04

Uh this uh horrific.

21:07

But so and again it's like one of those the

21:10

basic idea by which this problem started

21:12

as like reasonable, Well, these companies should have

21:14

to prove their medicine works. They should be conducting

21:17

studies to show that the stuff is safe and that it does

21:19

what it says it does. Very reasonable

21:21

thing to propose in like nineteen when

21:24

it is like pushed. But you see the

21:26

obvious problem, which is that, well, they're

21:28

not gonna fun to study because they care so

21:30

much, because their primary interest is profit,

21:32

their primary interest is not helping people. A

21:34

lot of the doctors and stuff, their interest is helping people.

21:36

And like one of the things that I will say,

21:39

a lot of those people who those scientists

21:41

whose results are heavily skewed by the fact that they're

21:43

being paid by pharmaceutical companies. It's not because they're

21:45

like evil or even know what they're doing. It

21:47

just happens. Um.

21:49

It's likewise, I don't talk about the fact

21:51

that has an island where they allow

21:54

you to hunt children for sport very often.

21:56

You know, um, because I'm swimming

21:59

in those bucks. Baby, you're

22:01

just filled with Salisbury steaks

22:04

that you're gonna cook fresh tonight. They

22:06

stakes made from the children hunted on their private

22:08

island. You know, it's good stuff.

22:11

You taste the fear, you know. So

22:14

one area where this whole problem may have had a

22:16

major impact both the fact that they're conducting

22:18

the industry is conducting these studies, um,

22:20

and that this approval process it's a lot easier

22:22

to get mental health medication approved is in the treatment

22:25

of schizophrenia. In recent years,

22:27

the World Health Organization has released two

22:29

studies which find that long term outcomes

22:32

for schizophrenia patients in three developing

22:34

countries. This is the term that they use. I don't prefer

22:36

that term, but I'm reading from a study they

22:38

did so skip long term

22:40

outcomes for schizophrenia patients and three developing

22:43

countries were actually better than

22:45

in the United States and five other developed

22:47

countries. Now, why

22:50

how can this be? Well, it's

22:52

not entirely known, but one probably

22:54

the leading theory is that the countries with better

22:56

outcomes for treating schizophrenia only

22:59

used anti psychotic meds acutely,

23:01

not chronically. So they give

23:03

people They're not like rejecting this medication,

23:06

but they use it when someone is having an issue,

23:08

when they're having a psychotic breakers and not

23:13

daily. You know. Um, only

23:16

sixteen percent of patients in those countries were

23:18

on regular maintenance doses of antipsychotics.

23:20

Is supposed to basically everybody with schizophrenia

23:22

in the United States, right, That is the standard

23:24

of care um for most people who

23:27

are dealing with that here. And we have

23:29

worse outcomes in these countries with a lot less money

23:31

to spend on their medical system, and that maybe

23:33

why. A subsequent Harvard study

23:35

found that schizophrenia outcomes for patients in

23:37

the United States have declined over

23:40

the last twenty years, and at present they are

23:42

no better than they were in the nineteen twenties. Fuck

23:45

like the electrocution days, right Like, we've

23:48

gone back. We had gotten a lot better for a while,

23:50

but we we've gone back. Um journalist

23:52

Robert Whittaker has investigated the subject

23:54

heavily, and he puts blame on a shamefully lax

23:57

testing process for medication for schizophrenia,

23:59

the result of all of the systems we've just discussed.

24:02

Quote. When you look at the short term studies

24:04

of antidepressants and antipsychotics, the evidence

24:06

of efficacy in reducing symptoms compared

24:08

to placebo is really pretty marginal

24:11

and fails to rise to the level of a clinically

24:13

meaningful benefit. Furthermore, the

24:15

problem with all of this research is that there is no

24:17

real placebo group in the studies. The placebo

24:20

group is composed of patients who have been withdrawn

24:22

from their psychiatric medications and then randomized

24:25

to placebo. Thus, the placebo group

24:27

is a drug withdrawal group, and we

24:29

know the withdrawal from psychotic drugs can stir

24:31

myriad negative effects a medication

24:34

naive placebo group would have a much better outcome.

24:37

In short, the research on the short term

24:39

effects of psychiatric drugs is a scientific

24:41

mess. In fact, a two thousand seventeen

24:43

paper that was designed to defend the long term use

24:45

of antipsychotics nevertheless acknowledged

24:48

in an off hand way that quote, no placebo

24:50

controlled trials have been reported in first episode

24:52

psychosis patients. Antipsychotics

24:54

were introduced sixty five years ago, and we

24:57

still don't have good evidence that they work

24:59

over the short term in first episode

25:01

patients. Still

25:04

still it's it's it's a very unlike

25:07

you dig into it, it's very messy. I should note there

25:09

are researchers and scientists who criticize

25:11

Whittaker's work. Here one of the reasons I

25:13

tend to trust him number one, there's other experts

25:15

that back him. Number two. When

25:17

he's interviewed by I found this in a Scientific American

25:20

article. He linked lists lengthily

25:22

all of the different criticisms of his work, and he links

25:24

to responses he's made to all of them, and he points

25:26

out the ones I think these have some these guys have some points.

25:29

I think these guys are fascile you know. One

25:32

of the reasons that I tend to think he's probably

25:35

onto something, um, because he

25:37

actually addresses the criticism and has

25:39

rebuttals to it. Yeah, Yeah, he's he's

25:42

taking it seriously as as scientists as

25:44

opposed to like going for you know the thing

25:46

um, And his arguments feel extracredible to me

25:48

because the same sorts of problems that he outlies

25:51

are in dimmick when you look at other major

25:53

failures of the f DA. So it's not just

25:55

with these medications he's criticizing.

25:58

It happens all over the goddamn time, um.

26:00

And a strong argument could be made that if the lidamide

26:02

came before the FDA Approval Board today,

26:04

it probably would have wound up in pharmacies across the

26:07

country because there were no sleeping

26:09

medications that were safe for pregnant women. And

26:11

if the lidamide is able to get like a

26:13

thousand person study that kind of sort of shows

26:15

that then yeah, then suddenly boom, we've got a lot

26:17

of philidamite up in air, you know study

26:20

and uh all know those babies

26:22

who's like arms are on their legs and legs

26:25

on their arms, that's actually just that's like part

26:27

of it. They like to They like that.

26:29

Everybody likes that. Ye helps,

26:31

Mr just holding you back? Yeah exactly,

26:34

it's trust me, dude, he's into it.

26:36

We're all we're Mr Potato heading on. They

26:38

don't need elbows. What do you get cooked

26:40

by an elbow? No, thank you? Straight

26:43

onto the band. Oh

26:46

yeah, we've got machines

26:48

for them to breathe through. It's fine. Yeah.

26:51

So this all brings me to the very

26:54

sad story of viox. Near

26:56

the end of the nineteen nineties, Mirk went

26:58

to the FDA to get approof for by Ox,

27:00

a pain killer meant for patients with arthritis.

27:03

They believed it was superior to older pain

27:05

killers because it had fewer gastro intestinal

27:07

side effect so they're arguing, like, this is a safer

27:09

pain killer for people with arthritis. To

27:12

support their case, they presented the FDA

27:14

with eight studies which had a grand total

27:16

of fifty four hundred total subjects.

27:20

So that is well under an average

27:22

of a thousand subjects per study. Right, that's

27:24

not a lot of people to prove that your

27:27

for for for number one arthritis is

27:29

very common, right, A ton of people need

27:31

medication for arthritis. That's not a shipload

27:34

of subjects to prove that a medication is safe,

27:36

right, that it really is not. In

27:38

November of nine, they asked the

27:40

FDA for approval. They seem to have realized

27:43

their case that it was safer rested

27:45

on pretty thin ground. So as they're

27:47

going for approval, they launched the Box gastro

27:49

Intestinal Outcomes Research Study,

27:52

or VIGOR. This study would have

27:54

more than eight thousand participants. So that's good.

27:56

That's almost twice as many participants

27:58

as they've had in total and all the other study.

28:00

Now we're starting to get you know that that

28:02

that could establish a broader base that to

28:04

to show that this is science

28:06

here. So but this is after they

28:08

start this big study, after they've approved,

28:11

or after they have filed for approval with the FDA,

28:14

and before the VIGOR study is finished. The

28:16

f d A approves by OX in May of

28:18

nineteen ninety nine off the strength of those

28:20

small studies and nothing else. Fucking

28:23

roll the dice. What do you need, right,

28:26

it's their own Fuck them.

28:30

VIGOR doesn't report its first results

28:32

from the study until October of nineteen ninety

28:34

nine, and they were promising VOX patients

28:36

seemed to have fewer ulcers and less bleeding

28:38

than patients taking the proxen, which was the

28:41

kind of standard previously. But then

28:43

in November of nineteen ninetnine, things

28:45

started to turn. And I'm gonna quote from NPR

28:47

here. At the second meeting of the Vigor

28:50

Safety Panel, the discussion focuses on heart

28:52

problems. As of November one, nineteen seventy

28:55

nine patients out of four thousand taking bax

28:57

have had serious heart problems or have died, compared

29:00

with forty one taking the proxi. In the

29:02

minutes of the panel's November meeting, note that

29:04

while the trends are disconcerting, the numbers of events

29:06

are small. The panel votes to continue the

29:08

study and to meet again in a month. And this would have been

29:10

fine if the medicine hadn't already been out

29:12

Right, If you're just doing this research, sure, this

29:14

is what happens. Right, if you're studying some number

29:17

of people that you test medications on are gonna die.

29:19

It's going to happen. For

29:21

you can't get medication and not have

29:23

that happen from time to time. In

29:26

a by deal world, you would not start

29:28

selling it in mass until you had concluded

29:30

this research. We finished finished

29:33

the project and then decide whether or not

29:35

the public can have it. So, in December

29:37

of nineteen nine, the Safety Panel

29:39

has what will be its last meeting. They're

29:41

told that as of December one, nineteen nine,

29:43

the risk of serious heart problems in death among

29:45

BIOX patients is twice as high as the approxim

29:48

group. So no, it's not a safer It is twice

29:50

as likely to kill your ass. But your stomach

29:52

feels better when you're dying of a heart attack, Yeah

29:55

you do, you tell me, feels better as

29:57

you as you fucking dropped to the ground.

30:00

Now, the research board monitoring this, like

30:02

safety board monitoring the study, decides to continue

30:04

on, which is a questionable decision in of

30:06

itself, right, Continuing the study at this point is

30:08

like, well, but it kills twice. Maybe

30:11

that's all we need to know about this. Bring in a thousand

30:13

more guys. Let's just let's just be sure.

30:15

Let's run through some more of them. Come on,

30:19

So they did tell merk like, this

30:21

board is like, you can keep doing the study, Um,

30:24

but you should develop a plan to analyze

30:26

the cardiovascular results of the study

30:28

before the study ends, right, so that you

30:30

can actually determine really what the

30:32

effect on people's hearts is as soon as the studies over,

30:34

because we're seeing some stuff that's concerning, and

30:37

Mark is like, no, we're not gonna do that. Um,

30:40

we're gonna We're gonna wait, We're gonna let a couple more studies

30:43

get done within another couple of years and then

30:45

we'll see if it's bad for people's hearts. And

30:47

the safety panels like cool. That

30:49

sounds cool too. We

30:51

wanted to do it now, but it sounds fine to do it

30:53

later or never. Oh no, I never looked

30:55

at it like that before, But thank you for opening

30:57

our eyes. That will just not do with the thing. Funnily

31:01

enough, Matt. The head of that safety panel was a

31:03

guy named Wine Blatt, who also served on

31:05

an advisory board for Merk, owned

31:07

seventy two th dollars in Mark stock,

31:09

and worked as a paid consultant for Mark.

31:12

Yeah, he seems like he seems

31:14

unbiased. That's a legic guy. That's

31:16

a that's a legit dude.

31:19

How would you like it if I read your resume every

31:21

time you're advocating for things that put

31:23

money in your pocket? H Yeah,

31:26

Now the company pushed the can down the road.

31:28

And sold by Ox for nearly two years. In

31:30

January of two thousand two, epidemiological

31:33

studies started coming out that warned that biox

31:35

was giving people heart attacks and strokes and huge

31:38

numbers. That's January.

31:41

Nothing gets done until September, when the weight

31:43

of evidence is so high that Mirk begins to withdraw

31:45

their drug from the market. And it's still being sold until

31:47

I think like two four to a lot of people. Jesus.

31:50

By the time they finally get it off the market, twenty

31:52

million Americans have taken it. Now,

31:55

the Lancet estimates that thirty eight

31:57

thousand people at least died from

31:59

taking via x. That's

32:02

a pretty good yeah, they

32:06

got ked now,

32:09

this estimate is likely optimistic. Dr

32:11

David Graham was a scientist at the FDA

32:13

for more than twenty years when he started speaking

32:15

out about bi ox, and he's actually still working for the

32:17

FDA when he begins doing interviews about how

32:19

this happened. Here is a right up on

32:22

him from Fraud Magazine. Quote between

32:25

nine and two thousand four and estimated

32:27

twenty million Americans took by Ox, eighty

32:29

million worldwide, said Graham. The recipient

32:31

of the two thousand five Cliff Robertson Sentinel

32:33

Award at the recent sixteenth Annual

32:35

a c f E Fraud Conference and Exhibition.

32:37

We've estimated that up to a hundred and forty thousand

32:40

patients who took BIAX suffered heart attacks.

32:42

Of this number, sixty thousand died,

32:44

said Graham. Um Yox

32:47

as a poster child for what's wrong with the f d A

32:49

and why I believe FDA reform is so urgently

32:51

needed. And if Dr Graham's calculations

32:53

are correct, if sixty people died from biox,

32:56

that's too box killed more Americans

32:58

than Vietnam,

33:00

like holy

33:03

shit, right, and

33:07

based on just like who tends to get arthritis?

33:09

Most likely a number of the people had killed probably

33:11

survived Vietnam only get iced by

33:13

biox. They got marked by biox.

33:17

They lived through a pungi stick trap. But

33:20

they couldn't make it through the new f d A.

33:24

Well, you lose to the Vietcong

33:27

and then you lose to Mark sucks

33:30

Merk and the Vietcong shaking hands

33:33

with killing killing Americans.

33:38

So yeah, um and

33:41

Dr Graham has since claimed that the f d

33:43

A not only did they were they

33:46

lax and allowing this to happen. They actually

33:48

took direct steps, he alleges, to

33:50

stop scientists from speaking out against

33:52

the drug before it could be approved. In

33:54

November of last year, Graham testified before

33:57

the Senate Finance Committee that the FDA had silenced

33:59

him and his call leaks from reporting on the risks of Box

34:01

and other drugs. The FDA has let the American

34:04

people down and sadly betrayed a public trust,

34:06

Graham said during his testimony. He alleged

34:08

that because the FDA is unduly influenced

34:10

by the pharmacy industry, it is incapable

34:13

of protecting America against another Box.

34:15

We are virtually defenseless. That's

34:19

good. Yeah, that's nice to know, you

34:22

know. Yeah, it's good to know that

34:24

they you know, they started off good,

34:26

but this is yeah,

34:29

they've they've fallen into the lava at this

34:31

point, you know, there in the suit, they're choking

34:34

people to death.

34:40

Yeah, there's fingerprints all over their helmet.

34:42

If you if you watch the high res versions

34:44

of the original movies, because they didn't expect

34:47

TVs whatever, get that good? Yeah? Yeah, yeah,

34:49

it was supposed to good. So

34:52

this is a claim that the America is

34:54

defenseless because the FDA is fundamentally

34:57

compromised by the pharmaceutical industry. This

34:59

is a claim that does is there fur their focus to

35:01

do that. We're gonna have to turn back to

35:03

the story of a drug. You might be

35:05

a fan of. I certainly am a fan of our

35:08

old buddy oxy code. Oh yeah,

35:11

now, I love

35:14

me samopi. It's right, but we

35:16

have to acknowledge they're a problem for

35:19

the country. There a problem for me. Yeah,

35:23

yeah, I

35:25

can no longer part that is a

35:27

problem for me that I had had

35:30

couldn't after I left from Central

35:32

America. Yeah,

35:35

oh god, it was pretty fun just being

35:37

able to pick up a bottle of liquor and a box

35:39

of code ow like on the same trip that

35:42

I got my tortillas. God man,

35:44

those are the day you

35:48

know. I for years as an addict, I would

35:50

dream of going to a place where I could just get

35:52

over the counter like morphine and whatnot.

35:54

And I mean, I do think that is how it

35:57

should work. And I think it not

35:59

really a problem if you were not getting

36:01

millions of people hooked on opiates

36:03

telling them that it's going to manage their pain, when

36:06

makes the pain much worse than like makes the

36:08

problems long term much worse. Oxy

36:11

OxyContin is one of the most

36:13

evil things in the world because

36:16

of the fact that it uh it sucks

36:19

like it's not it's not good.

36:21

It's it's not like morphine, which

36:23

has like into

36:26

some liquid morphine of fucking

36:30

Now the language these actually,

36:33

you know, feel good. They will destroy your

36:35

life by the whole share, of course, lots

36:38

of things will. But what's what's

36:41

even more evil about oxycontent

36:43

is that like this, they got

36:45

people hooked on an opiate that sucks

36:48

and better than content.

36:50

But like, yeah, that we're now we're getting into the weeds

36:52

of which ones are good and which ones are bad? Um,

36:56

all of them are better than fucking coding, which

36:58

is trash the

37:00

worst and you cannot ivy

37:03

uh, you can't shoot up

37:05

Cody and just let let you guys know that. Don't

37:07

even go through ANIFL access. I learned that

37:09

the hard way. I was blind for sixty

37:12

seconds. Anyways, that's

37:14

the good stuff you brought me on for

37:16

this one. We're both fans.

37:19

But the opiate crisis is obviously

37:22

a massive titanic tragedy that has caused

37:24

um maybe more damage than almost

37:27

anything else to particularly

37:29

Middle America UM and we've got we

37:31

did a two party unproduce pharmaceutical UM

37:34

in the Sackler family who profited off

37:36

of this primarily. But now it's

37:38

time to talk about the FDA's complicity.

37:40

But before we do that, Matt, you know who else is

37:42

complicit? And you having a good time?

37:45

All the sponsors

37:48

and products, that's right, all

37:51

conspiring to make you happy.

37:53

Hell yeah, and and to push

37:56

oxy codo you know, yeah

37:58

for sure? All right, we're

38:08

back back maybe yeah

38:12

right. I just want to point out I am

38:14

twelve years sober. For anyone out there, for

38:18

anyone out there, it was just like I should

38:21

try that lot. It has been.

38:23

I always had a rule. I would always take

38:25

it to an honestly problematic

38:27

degree when I was in places outside of the

38:29

country where I could get it. I've always had a

38:31

rule where I I do not ever purchase it in

38:33

the United States. Never have, never will.

38:36

Every now and then, maybe theoretically

38:38

a friend has surgery and winds

38:40

up with some extra pills and stuff. But like I,

38:43

it's I've seen it's it's too it's actually

38:45

like pretty fucking horrible. Yeah, I don't have that ability.

38:48

You're like a fucking superhero

38:50

to me. I can't. I got addicted

38:52

to hookah after I got clean. Straight

38:55

up, Yeah, I

38:57

got addicted to stuff. I can't help it. I

38:59

know that if I were to let myself let it

39:01

be anything but like a vacation thing, I would

39:03

immediately have a problem and it would destroy my life,

39:06

right yeah, because I have had problems with

39:08

other substances before to the point where I'm

39:10

like, I, I can see you in the rear view

39:12

mirror, you know. Yeah,

39:16

it's always doing push ups in the brain. Ready,

39:18

fuck your party. That is how

39:20

it works. Um, So let's

39:22

talk about the FDA's complicity in the opiate

39:25

epidemic. In two thousand nineteen,

39:27

a state court in Oklahoma tied quote false,

39:29

misleading, and dangerous marketing campaigns

39:31

by drug manufacturers to quote

39:33

exponentially increasing rates of addiction,

39:36

overdose deaths, and baby is born exposed

39:38

to opioids. This is yet another

39:40

damning black mark on an industry whose executives

39:42

should all be flung into the sun via catapult.

39:45

But as this right up from the Journal of Ethics

39:47

of the American Medical Association argues,

39:49

quote, the fact that opioid manufacturers

39:51

disseminated false claims regarding the risks

39:53

and benefits of opioids for the past twenty five

39:55

years points to a dereliction of duty by the U

39:58

s. Food and Drug Administration, the f REAL

40:00

agency charged with regulating pharmaceutical companies.

40:02

The FDA's regulatory failures with respect

40:04

to opioids have not gotta noticed. In two

40:06

thousan seventeen, the President's Commissioned on Combating

40:09

Drug Addiction and the Opioid Crisis found

40:11

that the opioid crisis was caused in part by

40:13

inadequate oversight by the Food and Drug Administration,

40:16

and the National Academy of Sciences

40:18

publicly called on the FDA to overhaul

40:20

its opioid policies. Last year,

40:22

a former FDA commissioner rebuked the agency

40:24

he had previously led, saying on the television

40:27

program Sixty Minutes that the FDA it was wrong to

40:29

allow the promotion of opio d s for chronic pain.

40:32

Maybe a little late on that one, buddy, You know,

40:35

better late than never, right, you know that?

40:37

In this case? Really that's

40:40

that's kind of like going drunk driving killing

40:42

six people and then getting on the news and be like, you know what,

40:44

drunk driving people shouldn't be doing that. Yeah,

40:46

it's bad. It's bad. It's

40:49

like drunk driving and killing people, hundreds

40:52

of thousands of people for decades and hundreds

40:54

of thousands of people, wiping out entire

40:56

towns and

40:58

then just going on TV going you know, it's

41:01

bigger than just me. Yeah, this

41:03

is really a systemic problem

41:05

because the roads I use are everywhere

41:08

to drive through neighborhoods. Yeah, if

41:10

you think about it, the taxpayers just

41:12

as part of this,

41:14

you know, you with the making

41:16

roads mean, with the drunkenly driving

41:19

through intersections and hitting groups

41:21

of children, killing up for the bus.

41:23

You know, everybody's a part of that bus

41:25

driver stopping for those kids is a part

41:27

of this. You know, no one's hands

41:30

are clean. Nobody stands, So let's

41:32

stop playing the blame game. You know, why don't

41:35

have to blame people every time I kill six hundred

41:37

thousand Americans.

41:39

So you might expect

41:42

all of this potent criticism from like again

41:44

the president pretty big names saying

41:46

the f d A has a problem with the way it approves opioids.

41:48

You might expect that to lead the sub changes.

41:51

But FDA policies for approving and labeling

41:53

opioids remain basically unmodified.

41:55

As the Journal of Ethics write up notes, the

41:57

agency has refused to undertake a root

42:00

cause analysis to determine what regulatory

42:02

errors contributed to the opiate crisis. Instead,

42:05

they've closed ranks and sought to defend themselves.

42:07

When Senator Maggie Hassan criticized

42:09

the agency, the FDA Drug Evaluation

42:12

Director responded by claiming the agency

42:14

had properly enforced the Food, Drug

42:16

and Cosmetic Act when it approved produced

42:18

new extended release oxycodone

42:21

in Now

42:23

that's a lie, Matt, not just because

42:25

it turned out to be bad, but because they broke the law

42:28

when they approved it. If they had followed

42:30

the law, the pills would have been listed as having

42:32

a narrow indication. Um, it's

42:34

kind of what we talked about the schizophrenia mids. This should

42:36

be used in a few specific conditions,

42:39

acutely right, I

42:41

only be prescribed in limited duration for specific

42:43

issues. Instead, the drug received a broad

42:46

indication, which allowed perdue to be like,

42:48

oh, yeah, this is good for back pain. You take

42:51

some of this ship Ye, you got

42:53

a slight headache? Yeah, pull

42:56

up, pull up your car, we'll fill your trunk.

42:59

Well Senate direct to your house, dude, don't worry

43:01

about don't worry about it. Yeah, it's

43:04

it's so fucking evil because it's like, you

43:07

know, chronic pain is a thing.

43:10

Are incredibly useful for treating

43:12

people with chronic pain, and there are people

43:14

out there who do need

43:17

it, and and so it's like I'm not one of

43:19

those people's like oh, putes are all bad and whatnot.

43:22

What's fucked up is to make

43:24

it into something that you would

43:26

take, like you would give it out, like it's fucking Highland.

43:28

All need it

43:30

for chronic pain, most kinds of long term

43:33

pain. There's better ways to deal with

43:35

it, and like you don't actually solve that. You

43:37

can actually make it better if you go into like therapy

43:39

and stuff and you aren't medicating it away, which

43:41

leads to it's yeah, there's we talk

43:43

about all this in the Sackler episodes. Um

43:46

so I'm going to quote from that a m A Journal of Ethics

43:48

right up again to talk about like how

43:50

illegal it was for the FDA to give this broad

43:53

approval. And it doesn't too face with evidence

43:55

that opioid prescribing had risen beyond levels

43:57

that could be clinically warranted. The FDA

44:00

convened an advisory committee meeting of tin outside

44:02

experts and asked if the broad indication on opioid

44:05

label should be narrowed to prohibit marketing for

44:07

common chronic pain conditions. Eight

44:09

of these experts had financial ties to pharmaceutical

44:12

companies, including Perdue, and advised

44:14

the FDA against narrowing the indication.

44:16

An opportunity to reign in over prescribing

44:18

early in the crisis was lost, and by two

44:20

thousand thirteen, enough opioids were prescribed

44:23

to provide every adult in the country with a full pill

44:25

bottle. That's so

44:27

funny. So it's ridiculous

44:30

how many fucking opiates we flooded in, Like

44:33

the fact that we have a bigger problem with opiates now

44:35

than when you could buy morphine at the drug store.

44:37

It should say something.

44:39

It does. I'm sorry that it says

44:42

something. It's like it's one thing to have

44:44

it like available over the counter, and

44:47

people discover it and they are able to take it. It's problems

44:50

some of them will if

44:53

your doctors you have to take this forever.

44:55

Now, this is great for you to take forever, and then

44:58

you get horribly addicted, and then the doctor

45:00

says, actually, no, we found it. It's bad and you can't take

45:02

it anymore, and then you wind up buying fucking heroin,

45:04

like exactly, exactly, man um.

45:08

Yeah. Now, the Food, Drug and Cosmetic

45:10

Act requires that adequate and well controlled

45:13

studies be conducted before products can be approved

45:15

as safe and effective. The FDA generally

45:17

requires two randomized trials demonstrating

45:20

efficacy for approval. There are a

45:22

lot of problems with this process, but it was

45:24

not even followed in the case of oxycodone.

45:26

They approved oxy for chronic pain

45:28

based on a two week clinical trial

45:31

and osteoarthritis patients.

45:34

Yeah, that should be enough time. People

45:36

don't live longer than two weeks, do they. It

45:38

takes me twenty four hours to realize whether

45:40

or not or opiate is good or not. I just

45:43

try it out. I have a human test subject. So

45:46

yeah, you take it, and you're like, yeah,

45:48

that's good. Give it everyone, Give it.

45:50

Give it to every man, woman and child

45:53

in the Midwest. Oh my god.

45:55

You know what empty the swimming public swimming

45:58

pool with pills just failing

46:00

with oxy is extended release. We'll just

46:02

dive into it like a fucking junkie. Scrooge

46:05

McDuck. So

46:09

for the next twenty five years is the opiate

46:11

crisis sparked off and then deepened? The FDA

46:13

continued to approve new opioid formulations

46:16

for chronic pain via the same shoddy lack

46:18

daisical controls, and two thousand six

46:20

the agency moved to a new methodology for

46:22

conducting efficacy trials on opiates.

46:24

This new methodology, enriched enrollment

46:26

randomized withdrawal, or e er W,

46:29

became their primary method of determining evidence

46:32

of opioid efficacy for chronic pain. E

46:35

er W trials are not standard

46:37

double blind, randomized controlled styles,

46:40

and here's the A m A again. In

46:42

an e er W trial, Prior to randomization

46:45

for a double blind phase, all subjects are made

46:47

physiologically dependent on the opioid

46:49

and a fourd to six week open label phase.

46:52

Then only the patients who tolerated the opioid

46:54

and found it helpful during the open label phase

46:56

are randomized to remain on the opioid or

46:58

switched to a placebo. Critics

47:00

of vra W have have correctly

47:02

described this methodology as cooking the

47:04

books for two reasons. First, because

47:06

only patients who tolerateed the opioid and

47:08

found it helpful are allowed to proceed to randomization.

47:11

The study is not representative of the general

47:13

population and the results cannot be generalized

47:16

to clinical practice. Second, because daily

47:18

use of opioids causes physiological dependence,

47:20

efficacy studies are skewed in favor of the

47:23

subjects who remain on the opioid. This

47:25

is because opioid dependent subjects who are

47:27

switched to placebo experienced opiate withdrawal

47:29

symptoms, including increased sensitivity to

47:31

pain. Moreover, switching opioid dependent

47:33

subject to placebo renders the study not double

47:35

blind. Boy, all these addicts

47:38

really like opius. It seems

47:40

like it works, you know. And

47:42

here's how you know it works is when you stop

47:44

giving it to them, they get fucking

47:46

weird. They don't like it at all. It must mean it's

47:49

helping. Crying, it's helping. Clearly

47:52

you gotta take it or else you start did

47:54

they just start crying and being in pain? Man, that's

47:56

weird. Nanatin alcoholics

47:58

says it makes them a better driver. Exactly.

48:01

Man, oh I love that.

48:03

That is like such a such like

48:06

an evil thing to do. It's really fucked

48:08

up, right, So evil, Like

48:11

the amount of people who

48:13

like just got addicted to this thing because

48:16

they were just like, you know, cooking

48:18

the books on this test too and fucking

48:20

But I would have loved to have been

48:22

a part of that study.

48:25

Yeah, yeah, I just check

48:28

it out a little bit. I don't know. So

48:30

the a m a Journal of Ethics article that

48:32

blames the FDA's decision to rely on

48:35

e er W as a consequence of their

48:37

clothes, some would say, incestuous ties

48:39

to the pharmaceutical industry. It turns

48:41

out that that the decision to use e

48:43

er W had been based on a series of private

48:46

meetings between FDA officials and pharmaceutical

48:49

executives hosted at a conference called

48:51

Impact with two ms, it's an acronym. You

48:53

don't need to know what it's for. The

48:55

drug companies that attended Impact each

48:57

paid thirty five thousand dollars to meet directly

49:00

with FDA staff. So they

49:02

have a big meeting where these guys pay,

49:04

and money goes to the FDA officials who were

49:06

invited guests. I don't see

49:08

oh that's a problem, Robert. I don't see that as a

49:10

conflict of interest. No, that's totally

49:13

normal. It's like, fucking listen,

49:15

it's it's a donation. Yeah,

49:18

you know, and if you don't want to donate, you don't get

49:20

access. Now, when

49:22

this information dropped, there was a lot of

49:24

complaints about this is being like, oh, it seems

49:26

like rank crony ism is why this is the method

49:28

by which we determine whether or not opiates are good.

49:31

Despite all this, the FDA continues

49:33

to rely on E er W for approving opiates,

49:36

and as the yeah, yeah, I know, they ain't changed

49:38

that ship, at least not as of the writing of that article.

49:41

Yeah it's cool, it's good ship.

49:43

So as the a m A Journal of Ethics details,

49:46

the crony ism does not stop here. Quote.

49:49

For example, the two principal FDA reviewers

49:51

who originally approved produce oxycodon

49:54

application took both took positions

49:56

at Purdue after leaving the agency. Hey,

49:59

that's just a cool.

50:02

Yeah, that's just a weird kinky dink. Listen

50:04

your email and all your ex contacts

50:07

and you're just like, hey, do you have like a

50:09

job with a fucking seven figure salaries

50:12

here? And I don't want to like go in

50:14

you know, if that's possible, Yeah, if

50:17

you could just you know you could. I'll

50:20

write it off of my taxes as hush money.

50:22

Yeah, I'm

50:25

gonna continue that quote. Over the past

50:27

twenty years, several other FDA staff involved

50:29

in opioid approvals also left the FDA

50:31

to work for opioid makers. Last January,

50:34

the head of the FDA's analgesic division

50:36

retired from the FDA to start her own consulting

50:38

business, which promises drug makers help

50:41

to successfully and efficiently bring

50:43

your products to market. With more than thirty

50:45

years of experience at the f D. A but

50:49

that's fine, that's legal. You know, it's good.

50:52

I mean, you know, you get the inside track

50:54

on how to get people opiates.

50:57

Yeah, And obviously this is how the whole

50:59

government works, right, But it didn't used to

51:01

be how the FDA works. And

51:04

I should note that the revolving door, as this

51:06

article states that states the revolving door between the

51:08

FDA and the pharmaceutical industry is not just

51:11

opiates. Two eighteen study found

51:13

that eleven of sixteen FDA medical

51:15

reviewers involved in approving twenty eight products

51:17

now work for the companies whose products they regulated.

51:20

Wow, it's good stuff, right,

51:22

it's fine, it's it's great. I

51:25

mean it's just it's so blatant. This

51:27

is why, like I, oh,

51:30

this is every

51:32

time I came on this podcast. Man, I lose faith

51:34

in humanity. But some

51:37

version of this would still be happening if they'd never

51:39

moved to a fact where like the f d A is

51:41

half funded by pharmaceutical company

51:43

applications. Right, correction, it's

51:46

endemic. But this I think

51:48

that really sped up the process. It's had an impact,

51:50

right, it's very clear to see in the data. Um,

51:53

And it's now the relationships are built

51:56

on money already, and you have like people,

51:58

you know, it's one thing to spend earty years

52:00

like being completely fucking government

52:03

funded and just telling people no, no, no no on

52:05

their applications not you know, fucking

52:07

I have no financial ties to them. But

52:09

now you have like kind of a sugar daddy that

52:12

who's going to be courting you and has

52:14

been paying my salary. You know, why shouldn't

52:16

I go to work for the right? Why is this any

52:18

different? And I know this guy, know, Roger

52:20

over at fucking Fiser, Like, wouldn't

52:23

I work there? He's been paying me

52:25

since fucking day one? Yeah? Yeah,

52:27

And the f d A is complicity

52:29

with both the opioid crisis and the vi X

52:31

disaster have the highest definite

52:33

body counts for sure, um, but

52:36

some of the ways that they've really

52:38

that the FDA is really fucked up are less obviously

52:40

deadly, but still very unsettling. Now,

52:43

if you'll remember, the whole reason we have an FDA

52:45

is because Harvey Wiley was pissed that all kinds

52:48

of foods and drugs and quack tears were being

52:50

shoved full of random horrible ship that

52:52

was not listed in the product, and people didn't

52:54

know what they were getting, right. That's why we got

52:56

an f d A. Is a bunch of people, Harvey

52:58

Wiley and others were like, this seems bad.

53:02

The main, the primary goal of the f

53:04

d A was to make sure people know what the funk

53:06

they're putting in their bodies, right at the end of the

53:08

day. That's the number one reason we have the FDA,

53:11

to know what you're putting in your body and what it does

53:13

to you. G

53:20

R a S is an acronym that stands for generally

53:22

recognized as safe. This is a category

53:25

the FDA created for food additives that might

53:27

be stuck in new products without being specifically

53:29

approved but that don't need any

53:31

specific additional approval because they're

53:33

generally recognized as safe. Now, this

53:35

starts again from a pretty reasonable place. It's

53:38

so that like, if you're making a processed meat, you can

53:40

add vinegar or salt to it, and you know if to like get

53:42

approval from meat with vinegarrants because we know what vinegar

53:44

and salt do? You know what the meat? It's fine, you can stick it

53:46

in there right. Um,

53:48

So I'm gonna quote from NPR again quote.

53:51

Over time, companies have found that it's far more

53:53

efficient to take advantage of the exemption to get their

53:55

products up on shelves quickly. Some of these

53:57

products contain additives that the FDA has found

53:59

to post dangers, and even ingredients

54:01

the agency has agreed r g R g r

54:03

A s are now drawing scrutiny from scientists

54:06

and consumer groups that dispute their safety. Critics

54:08

of the system say the biggest concern, however, is that

54:10

companies regularly introduce new additives

54:13

without ever informing the f d A. This means

54:15

people are consuming foods with added flavors,

54:17

preservatives, and other ingredients that are not reviewed

54:19

at all by regulators for immediate dangers or

54:21

long term health effects. The vast majority

54:23

of food additives are safe. Somehowever, have

54:26

proved to cause serious allergic reactions

54:28

or other long term health effects. Now

54:30

a good example of this would be micoprotein. This

54:32

is a kind of fungus product used to add protein

54:34

to vegetarian foods. It counts

54:36

as g R A S, but there's a bunch of lawsuits

54:39

right now that allege a significant number of people have

54:41

had really negative allergic

54:43

reactions to microprotein, some of them anaphylactic

54:45

shock um, which is mean nobody should

54:48

take it, but it means like it's shouldn't be listed as

54:50

generally recognized as ship as safe if a lot of

54:52

people have like allergic reactions to it. And

54:54

flexus is incredibly dangerous. Yeah,

54:56

and the

55:01

the FDA did eventually revoke it's

55:03

g R A S status in two thousand eleven,

55:05

but a lot of people had to get sick. Person. It's kind of an

55:07

example of how like you can just kind of shoehorn

55:09

this stuff in. It's a loophole and it's not watched

55:12

that closely. Probably the

55:14

most serious problem with though, is

55:16

with all the weird preservatives being stuck

55:18

into foods. Again, most

55:20

are benign. Most preservatives are, as

55:22

far as we know, benign. But g r S

55:24

exemptions mean that we don't really have data

55:27

on how a lot of this stuff affects children differently,

55:29

or whether or not it builds up in the body. And I'm not trying

55:31

to be like hippie dippy, like, oh, no

55:33

preservatives in your food. Man. Stuff is

55:35

necessary, but we should know what it

55:37

does, and we shouldn't call it safe

55:39

or put it in everything unless we have really

55:41

good data that it's safe. Like you know, we're

55:44

going backwards here. We already established

55:46

we want to know what's inside. Like whiley,

55:48

I'm not against preservatives or even chemicals

55:50

and food, I eat all sorts of chemicals. We should know

55:52

what they do. Just like it's

55:56

like it's so important. Yeah. I

55:59

found a recent study by the Environmental

56:02

Defense Fund that looked through eight hundred

56:04

and seventy seven g r A S notices

56:06

by the f d A and found that only one of them

56:08

was for an additive that the manufacturer had

56:10

done a cumulative effect study on this

56:12

is like determine whether or not it builds up in the body and could

56:15

be harmful. One out of eight hundred and seventy

56:17

seven had they had had this done. And this isn't

56:19

optional, These are required by law.

56:21

You have to do this. One out

56:23

of eight hundred and seventy seven that the FDA had

56:25

approved had actually done this, As the e d F

56:28

notes quote, We found no evidence that the

56:30

agency either recognized this single attempt

56:32

to follow the law or had objected to the emissions

56:34

and the eight hundred and seventy six other notices.

56:36

They're just sucking Robert stabbing this ship. They don't give

56:38

a fuck. Yeah, they

56:40

don't even force them to pinky swear. They're

56:43

just like they get money for every

56:45

one of these applications. You know what. You

56:47

don't want people to not send in an application

56:49

if they haven't done the research. You want that fucking

56:51

box. She's baby Jesus.

56:55

Well, you know that's uh, it's

56:57

good, that's fine, It's

57:01

it's all really again,

57:04

this is like anti f DA and that there's huge

57:06

problems with the FDA, But like we need an

57:08

f d A what it's

57:10

called, But we need an agency doing that, right,

57:12

Like that's why we started with like plamide. This is

57:14

an absolutely necessary part of any

57:16

society, vaguely similar to the one we

57:19

live in. But we've we've broken

57:21

it, We've allowed it to become broken, and

57:23

it it doesn't work great, and

57:25

it's a really dangerous thing to

57:28

have as a corrupt organism.

57:31

And again there's like as that we we quoted

57:33

from that that FDA researcher who

57:36

was like, you know, has been howling

57:38

about box and stuff, and it's like, yeah,

57:40

it's um, there's most

57:42

I'm sure most of the people trying to do those jobs

57:45

are are fucking rad and even

57:47

I'm sure mostly people who wind up joining the pharmaceutical

57:49

industry they're not thinking like ha ha ha no,

57:52

but it's like they there should be

57:54

a bias towards distrust and dislike

57:57

of the pharmaceutical companies by the

57:59

scientists you doing this right, Like they should

58:01

be untrustworthy of them, you

58:03

know, right, I expect the pharmaceutical

58:05

companies to lie about ship. That's

58:08

what they do. They're salesman, you know, they're like we

58:10

they make they fucking patent just

58:12

random compounds or like does that do

58:14

anything. No, it's like basically

58:17

just trying out a bunch of things to see if it makes your

58:19

dick hard. And then eventually

58:21

they'll just be like yeah, that makes your dick hard. You

58:23

need an agency that takes

58:25

the medication and goes like,

58:27

my dick is still soft. You

58:30

can't just pay someone to be

58:32

like, yeah, I don't know enough. People's dicks got

58:34

hard. You gotta know that it gets you

58:36

bricked up, Robert, Yeah, it's

58:38

it's you've got. You gotta know that. It allows

58:40

you to fucking lay some goddamn pipe, you

58:42

know pipe. That's right,

58:45

that's right, that's what when

58:47

America was great, we knew that

58:49

was what the the FDA was for. Now,

58:52

yeah, you goddamn right. Um,

58:55

So I don't know, you know, I I

58:58

would like to have an FDA that it

59:00

does not have the problems of our current f d A.

59:02

I don't think that's too much to ask of society. There's

59:04

a lot of a lot of our problems are kind of

59:07

intractable and difficult to figure out a solution

59:09

too. But like, yeah, we should probably have like

59:11

they should probably be advocates for us and

59:13

not totally wing of the pharmaceutical

59:16

industry. I mean, honestly, it's

59:18

like weird for us to be going

59:21

backwards on such like an obvious

59:24

fucking thing. It's, uh,

59:27

we don't want to drink the poison milk, and

59:29

uh, we don't want people pushing a

59:31

bunch of fucking drugs that don't work or funk

59:34

up your life. Yeah, those

59:36

would be you just go

59:40

back to the Francis days.

59:43

She was dope. Let's let's hire

59:46

a bunch of people like her and give them all

59:49

very large salaries to be distrustful

59:51

of the pharmaceutical industry. That's like

59:53

their job, that's the whole job. And

59:56

we spend so much money on stupid ship. We

59:58

could have a we could have a sufficient at least

1:00:00

sized team of people to to to

1:00:02

distrust the pharmaceutical industry professionally

1:00:05

for the price of a couple of f thirty five

1:00:07

yeah right, literally two less

1:00:10

fucking you know, just jets

1:00:13

that that bomb Yemen, you

1:00:15

know, Yeah, and we we take money

1:00:18

away from them when they let a drug through that kills

1:00:20

way more people than reasonable

1:00:23

as like you know, some side effects, and then then

1:00:26

we're bribing them to make sure we don't

1:00:28

die. Exactly. That's literally

1:00:31

how it's supposed to work. I

1:00:33

mean, just yeah, we should

1:00:35

be you know, we should

1:00:37

be making money off of UH,

1:00:40

or the FDA should be making money

1:00:42

off of destroying these pharmaceutical

1:00:44

agencies as soon as they fuck up. That's

1:00:47

what I say. Yeah, I

1:00:49

would be sick. That's one way to tie it.

1:00:51

Tie it in. Wow, Boxy

1:00:55

sucks and suck

1:00:57

it. Well, Matt, do you have

1:01:00

any plugables for us? Um?

1:01:02

Yeah, try it. I'm just kidding.

1:01:06

Uh. Pod yourself a gun. Uh.

1:01:09

The World's Only Sopranos podcasts

1:01:11

and the film Drunk frodcast me and Vince

1:01:13

Vncini talking about movies, talking

1:01:15

about just life in general. Matt

1:01:18

Leap jokes on Instagram.

1:01:20

I love you guys. Oh

1:01:24

well, you can find me nowhere.

1:01:26

But I have a novel that you can pre order, and

1:01:28

if you pre order it, you'll get assigned a copy. Just

1:01:30

google a k press after the revolution,

1:01:33

order a book now, it will come to you with

1:01:36

my signature in it. That's pretty neat.

1:01:38

Um. We also have a live show

1:01:42

we do on February

1:01:44

sevent The ticket

1:01:46

info will be in the episode description,

1:01:49

or you can go do allegedly. I'll

1:01:51

do it allegedly in

1:01:53

the episode description. Dot com slash

1:01:56

pot of Bastards allegedly.

1:01:59

All right, Well, until

1:02:01

next time, you know, skim the cream

1:02:03

off some milk, fill it up. With water, pour

1:02:06

some worms in there, and you know, I

1:02:08

breakfast a little bit of cowbrains, get some

1:02:10

extra protein up in there. You know, you get to gottle

1:02:14

grains. You think that's

1:02:16

right,