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Speaker 1: Welcome to Stuff you Should Know from House Stuff Works

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Speaker 1: dot com. Hey, and welcome to the podcast. I'm Josh

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Speaker 1: Clark with Charles W. Chuck Bryant and Jerry over there.

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Speaker 1: So this is stuff you should know the podcast. How

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Speaker 1: does doing fine? How are you great? Yeah? Yeah, that's good.

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Speaker 1: I enjoyed learning about the f d A. Yeah, you

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Speaker 1: know we've podcasted on him before. Why doesn't the FDA

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Speaker 1: regulate herbal supplements? Right? Man, we did that long time ago.

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Speaker 1: Remember that's where the herbal Elvis comes out. Oh yeah,

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Speaker 1: was that the first appearance? I'm pretty sure. Hey, man,

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Speaker 1: give me some supplements. Your dad doctor, He just like

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Speaker 1: would go around the house. Yeah, when he was on

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Speaker 1: Herble Upper. Sure. Yeah man, how did you talk on

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Speaker 1: the herbal downers? He didn't. He just slept a lot, gotcha.

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Speaker 1: Um No, I'm just tease of course. So we have

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Speaker 1: talked about the FDA before, but yeah, this is um

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Speaker 1: this is a much more in depth. Look that's right

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Speaker 1: at the ft. Okay, let's set your Chris Walkin. No

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Speaker 1: was that Chris Walkin? No? Not really, I mean the

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Speaker 1: weird pauses, but I was more doing Shatner. Oh but

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Speaker 1: I didn't go up, which should have Sure pretty good though,

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Speaker 1: huh yeah, pretty clear, Bill sat So, uh did you

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Speaker 1: know most of this stuff? Um? Well, I know that

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Speaker 1: the f d A is is has a history of

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Speaker 1: controversy of people saying, uh, you're not you don't act

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Speaker 1: fast enough. We need these drugs to help people. Or

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Speaker 1: then other people are like, stop acting so much exactly,

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Speaker 1: you're going too fast and rushing these things to market,

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Speaker 1: right exactly. So it's it's a bit of a tough

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Speaker 1: thing to reconcile, you know. There. I acknowledge they're in

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Speaker 1: a tough spot. They really are. And um, I think

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Speaker 1: that's a good, good caveat or disclaimer to put it

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Speaker 1: in the front of this because it is a very

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Speaker 1: controversial agency. It's the first consumer protection agency in the

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Speaker 1: United States ever, it's the oldest one, and um it's

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Speaker 1: common liberal or what have you. But I think it

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Speaker 1: is a very um important agency to have. Oh I

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Speaker 1: don't think that makes you liberal. So some people may say,

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Speaker 1: so what they don't think we should regulate anything in

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Speaker 1: this country. Yeah, there's people who think that, like the

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Speaker 1: f d A is just completely in the way of business.

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Speaker 1: It's a a fetter right, that's a thing because unfettered,

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Speaker 1: if you can be unfettered, you can be fettered. But

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Speaker 1: is there something that can fetter and would that be

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Speaker 1: a fetter? So it's a fetter to business to some

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Speaker 1: in some people's mind. Um yeah, I just think that

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Speaker 1: you when you were talking about something as um elemental

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Speaker 1: as food or drugs, thinks we put into our bodies

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Speaker 1: and the hopes that we will be have a greater

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Speaker 1: well being that you kind of do have to have

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Speaker 1: a big kid on the block looking out for all

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Speaker 1: the little kids. Well, I mean, I think when when

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Speaker 1: big bucks are involved, it's pretty clear that companies themselves

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Speaker 1: probably aren't gonna like pull back on their profits in

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Speaker 1: order to just be super safe, like it has been

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Speaker 1: proven throughout history that they'll generally want like air on

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Speaker 1: the side of making the money. You know, you're a comic,

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Speaker 1: is gonna be fun. So Okay, now that we got

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Speaker 1: that out of the way, Chuck, let's dig into the FDA,

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Speaker 1: because if you want to see whether or not you

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Speaker 1: think the f d A is necessary, all you have

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Speaker 1: to do is go back to the days before the FDA,

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Speaker 1: which wasn't too terribly long ago. I mean, the FDA

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Speaker 1: really only finds its origins and uh nineteen o six

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Speaker 1: on paper, it goes a little bit back before that today,

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Speaker 1: I think the Abraham Lincoln administration. Yeah, who was a

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Speaker 1: pinko himself. Let's climb in the way back machine, shall we.

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Speaker 1: Oh yeah, it's been a little man. It smells like

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Speaker 1: cat in here. I know. Well I took a little

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Speaker 1: ride with Laurent and the Wizard and uh, sorry about nothing. Man,

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Speaker 1: how are they doing well? They're doing great, But um,

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Speaker 1: I forgot to bring a little box. So yeah, there

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Speaker 1: was an accident. Um, so here we are in the

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Speaker 1: way back machine and we're going all the way back,

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Speaker 1: like you said, to the Times of Lincoln. And what

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Speaker 1: he did he kind of kicked kick the man. I

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Speaker 1: couldn't say that the other day in private the bucket. No,

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Speaker 1: I want to say, get the ball rolling and kick

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Speaker 1: it off. And I said kick the ball, kick the

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Speaker 1: ball rolling. I said that the other day. It's like

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Speaker 1: twice that's okay. So he wanted to kick the ball rolling.

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Speaker 1: And so he appointed a chemist named Charles weather Roll

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Speaker 1: to analyze agricultural materials. Sniffed him on the case. Yeah,

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Speaker 1: he sniffed them on the case. Not off, said hey,

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Speaker 1: food and soil and fertilizer, maybe look into that. We

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Speaker 1: have the new Department of Agriculture. And then his successors,

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Speaker 1: Harvey Wiley and Peter Collier were the dudes who really

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Speaker 1: um kind of got things going in a in a

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Speaker 1: like a serious way for the FDA. Well, they saw

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Speaker 1: like a real um reason for an agency that was

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Speaker 1: in charge of guarding safeguarding the purity of food and

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Speaker 1: drugs at the American public was ingesting. They basically saw

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Speaker 1: what was going on. I was like, Hey, we might

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Speaker 1: need to step in here because prior to this, I mean,

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Speaker 1: we talked about it in UM are Bizarre Medical Treatments

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Speaker 1: episode I think where we were just talking about UM

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Speaker 1: like little kids being given morphine in like a prescription

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Speaker 1: that in no way, shape or form said there was

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Speaker 1: morphine and it just calm colicky babies, and it calmed

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Speaker 1: him by bringing him to the brink of death on

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Speaker 1: him morphine overdose. But you could buy it over the counter.

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Speaker 1: You shouldn't regulate that, that's business. So that's one and

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Speaker 1: that was the one that actually used morphine there. I'm

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Speaker 1: sure others that were out there that were um much

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Speaker 1: more lethal use knockoff morphine or something like that that

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Speaker 1: cousin Tony made in his basement. You could do it

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Speaker 1: bottle and if the person, if the person bought it

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Speaker 1: and they died, well, buyer beware, you know. Um. So

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Speaker 1: the guys like Um, Wiley and Collie or especially Wiley, though,

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Speaker 1: we're really adamant about getting some sort of regulation and

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Speaker 1: specifically taking this agency that they've been handed um and

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Speaker 1: and building it into into a real powerhouse. Yeah. And

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Speaker 1: over the course of about twenty five years, they got

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Speaker 1: Congress to look over about a hundred bills for the

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Speaker 1: food and drug industry. I guess Congress said, no, no, no,

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Speaker 1: we're pretty deep in the industry's pockets, so we can't

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Speaker 1: really do anything right now. We agree with you, totally

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Speaker 1: great idea, but I'm sorry, but I a car is

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Speaker 1: about to be invented and I want to own one,

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Speaker 1: and pretty bad. Well that'll change, though, my friend. In

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Speaker 1: nineteen six, UM when h reporter novelist Upton Sinclair wrote

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Speaker 1: The Jungle, which UM, like everyone sort of this very

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Speaker 1: famous book that uh exposed the practices of the meat

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Speaker 1: packing industry in Chicago in particular. But um, it was

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Speaker 1: a big deal and it caused a lot of people

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Speaker 1: to really freak out. It wasn't It was a novel,

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Speaker 1: which means it was fictitious, but it was based on

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Speaker 1: his and he was a journalist too. It was based

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Speaker 1: on his experiences I guess, working undercover in the Chicago

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Speaker 1: meat packing plants, and apparently I guess Roosevelt, Teddy Roosevelt

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Speaker 1: set up an investigation, a committee to investigate. He claims

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Speaker 1: fan of Sinclair's at all, but I think he's sort

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Speaker 1: of Everyone was so repulsed he had to do something. Yeah,

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Speaker 1: I mean, like it really got the America in public

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Speaker 1: because the stories are things like, um, they were using

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Speaker 1: disease cows for meat, and there were rats that were

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Speaker 1: calling around on the cows, and so they poisoned the rats,

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Speaker 1: and then the dead poisoned rats with the poison, and

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Speaker 1: the diseased cow meat would all be put into a

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Speaker 1: grinder and there was your potted meat on the other side. Yeah,

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Speaker 1: he was, Uh, I still won't eat potted meat. Yeah, well,

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Speaker 1: I don't care what year it is. You take me

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Speaker 1: to the future in twenty two thousand, three hundred and twelve,

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Speaker 1: and I'm not gonna eat potted meat. I wish the

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Speaker 1: way back machine could go to the future. Well, that's

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Speaker 1: the way forward machine. We have one of those well

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Speaker 1: nuls working on it. Okay, it'll be a while. Um.

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Speaker 1: So they had to do something because there were even

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Speaker 1: accusations of people being in meat um, which apparently was

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Speaker 1: not true and that was really fictitious. Right. But that

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Speaker 1: committee that investigated Sinclair's claims in the Jungle found that

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Speaker 1: pretty much everything else he said in that book was

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Speaker 1: through step for the guy being ground up with the

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Speaker 1: beef because he fell into a meat grinder. And they

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Speaker 1: were just like, again, the meat business is not able

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Speaker 1: to police itself and say maybe we shouldn't put disease

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Speaker 1: rats and meat. So the government was forced to step

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Speaker 1: in and in nineteen oh six, on June thirty, Congress

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Speaker 1: past the Food and Drugs Act a k a. The

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Speaker 1: Wiley Act, and that prohibited um trade of mislabeled and

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Speaker 1: contaminated food, bevies and medicines across state lines. So I

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Speaker 1: guess you can still sell it in Illinois, you know. Yeah,

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Speaker 1: That's the one thing I never get is the shipping thing, Like, well,

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Speaker 1: that's that's the only thing that they can enforce. Er. Well, yeah,

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Speaker 1: the the federal government is there's always been a struggle

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Speaker 1: between states in federal right, and so the kind of

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Speaker 1: the line has been drawn at the state borders where

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Speaker 1: it's like RoCE across the state border all of a sudden,

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Speaker 1: you're part of the United States rather than just the state,

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Speaker 1: and you want to leave it up to the state.

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Speaker 1: But over time the federal government has taken more and

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Speaker 1: more power from the states. With the Wily Act, though, Chuck,

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Speaker 1: I mean, it's named after Wiley, so it gives you

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Speaker 1: an idea of like the links that this guy went

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Speaker 1: too to try to establish some sort of standards for

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Speaker 1: purity and food. Right. One of the things he did

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Speaker 1: was set up what came to be called the Poison Squad. Yeah,

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Speaker 1: that's a great name, isn't it. It really isn't It

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Speaker 1: was a sensational name, and at first he fought it,

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Speaker 1: and then he finally saw like he was worried that

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Speaker 1: with a name like the poison Squad, they had their

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Speaker 1: own little poison squad. An thom and Um the articles

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Speaker 1: written about the Poison Squad really sensational and like, can

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Speaker 1: you believe how crazy these guys are? Um and at

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Speaker 1: first wild he fought it because he he was like,

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Speaker 1: this is a really serious scientific undertaking. And then finally

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Speaker 1: he saw the writing on the wall. It was like,

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Speaker 1: you can get America behind this whole idea if you

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Speaker 1: just give him the poison Squad as they want the

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Speaker 1: poison Squad. And it's like I have added everybody they

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Speaker 1: haven't had them. They did. It's in this this article

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Speaker 1: for m like the FDA Zone Consumer magazine or whatever

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Speaker 1: from I think two thousand two, The Boys and Squad,

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Speaker 1: The Boys and Squad something like. It's something it's kind

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Speaker 1: of like that. It's like, um, it's like when they

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Speaker 1: take these bites, um, they won't feel any pain, but

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Speaker 1: when they wake up in the morning, they'll probably never

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Speaker 1: be the same. Just stuff like that. It's just kind

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Speaker 1: of like, um, you know how they used to make

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Speaker 1: jokey songs in the early interesting. So what the Poison

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Speaker 1: Squad was was a group of men volunteers we should

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Speaker 1: point out who signed up for this and repeatedly signed

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Speaker 1: up for this and signed away their right to sue

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Speaker 1: or anything. They were fully on board, um to eat

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Speaker 1: poison and to basically uh in a in a kitchen

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Speaker 1: there on h Washington, d C. In the basement of

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Speaker 1: the FDA's building. Yeah, they would have had a chef

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Speaker 1: that apparently made some great meals laced with all kinds

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Speaker 1: of poison for mal hide, borax, what was a really

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Speaker 1: harmful one. It was called copper sulfate, right, which is

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Speaker 1: now pesticide. Correct. Yeah, and they used it to make

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Speaker 1: camps appear bright green, and that that kind of gets

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Speaker 1: to the heart of the matter. Chuck, Like they these

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Speaker 1: guys weren't just eating poison just for fun. Oh no,

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Speaker 1: they were testing out stuff that was being used as

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Speaker 1: preservatives and food at the time. Exactly, additives and preservatives

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Speaker 1: and stuff like you said to make your peas greener. Right,

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Speaker 1: So people used to use formaldehyde to preserve meat, makes sense,

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Speaker 1: people used to use borax formaldehyde. Look how long that

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Speaker 1: human heads? But in that bucket? Exactly, let's put it

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Speaker 1: on beef. So did you touch that head or did

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Speaker 1: you just like you didn't poke it with the end

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Speaker 1: of a mom and know, his face bobbed up at me,

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Speaker 1: and I was just like, all right, there it is,

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Speaker 1: hello sir. So Uh, the poison Squad made great headway.

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Speaker 1: They really determined a lot of stuff that shouldn't be

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Speaker 1: used as preservatives like that copper sulfate that was used

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Speaker 1: to make peas green. Yeah, national heroes in a way.

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Speaker 1: Well yeah, they also proved um overall, that selling adulterated

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Speaker 1: food wasn't just a buyer beware kind of thing, that

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Speaker 1: it actually posed a real public health hazard. They got

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Speaker 1: super sick, they did, and they got publicized. These guys

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Speaker 1: are getting sick on purpose from the same stuff that

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Speaker 1: you're feeding your kids, which is where they shut it

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Speaker 1: down eventually, right, and the public all of a sudden

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Speaker 1: it's like, well, we don't want this stuff in our peas.

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Speaker 1: I don't care whether they're green or not. I'm not

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Speaker 1: eating this, And then public pressure led to finally Congress

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Speaker 1: enacting the Food and Drug Act. I wonder if I'm

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Speaker 1: When I was reading this, I was wondering if that

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Speaker 1: has something to do with the the um the thing

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Speaker 1: with peas, Like I don't think people generally like peas,

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Speaker 1: and I wonder if that has anything to do with

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Speaker 1: I like peas. But I wonder if that was like

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Speaker 1: a stigmata on the PA when this stuff came out

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Speaker 1: and have blood on its palms, blood on its p uh.

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Speaker 1: Maybe I don't know. I don't either surely it had

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Speaker 1: some effect that would guess, well, it's like it's probably

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Speaker 1: a lot like Um, how they spray produce in the

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Speaker 1: produce section, even though it increases its rotting time dramatically.

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Speaker 1: Why did they do that to make it look pretty,

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Speaker 1: to make it look fresh. It's ridiculous, but it's probably

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Speaker 1: the same exact principle. I bet you're right. Here's some

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Speaker 1: poison to make your people. Right. So the f d

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Speaker 1: A UM when they formally evolved, Um, they evolved out

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Speaker 1: of some other agencies. Uh. They've been through a bunch

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Speaker 1: of name changes and reords through the years. Um. But

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Speaker 1: in nineteen oh six what they're they were under the

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Speaker 1: Department of Agricultures Bureau of Chemistry, and they were the

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Speaker 1: ones charged with enforcing that Food and Drugs Act. So

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Speaker 1: they split them up in ninete into two groups, the

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Speaker 1: Food and Drug Insecticide Administration they handled the regulations and

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Speaker 1: the Bureau of Chemistry and Soils handled the experiments. Before

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Speaker 1: it had been just the Bureau of Chemistry doing both. Yeah,

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Speaker 1: so they split them up. Eventually, they dropped in nineteen

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Speaker 1: thirty the name and Secticide and it just became the

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Speaker 1: f D AY and From there, they were in under

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Speaker 1: the guys or under the purview of several agencies until

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Speaker 1: the late seventies and they finally landed where they are now,

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Speaker 1: which is the Health and Human Services yea, h h S,

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Speaker 1: green PS. So today the way they're organized loosely. They're

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Speaker 1: not organized loosely, but this is a script site is this?

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Speaker 1: They have a top layer of the Office of Commissioner

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Speaker 1: of Food and Drugs a report to the director of sorry,

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Speaker 1: the Secretary of HHS who used to be Tommy Thompson. Really, yeah,

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Speaker 1: under Bush. Oh that's right. Do you know who it

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Speaker 1: is now? I don't. There's probably none there. Obama hasn't

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Speaker 1: been able to get anybody confirmed, like either term. Uh.

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Speaker 1: That first layer also has seven support supporting organizations that

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Speaker 1: support the commissioner, and they're mainly on They're not like

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Speaker 1: the rubber meets the road. They're the on the policy

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Speaker 1: side of things, basically litigation and stuff. Well, yeah, the

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Speaker 1: big stuff, the big overarching we are the f d A. Yeah,

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Speaker 1: and then below them are broken down the into components

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Speaker 1: that handle rubber meets the road stuff. Yeah. Those are

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Speaker 1: the five Deputy commissioners and um, they're they're like you

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Speaker 1: said they're the ones that really are heading up the

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Speaker 1: field offices. I think there's um four sorry two seven

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Speaker 1: field offices. And then they have their big home in

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Speaker 1: Silver Spring, Maryland, where they have about close to employees

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Speaker 1: and chuck. Um, let's do a quick quiz. You're ready, yes, okay,

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Speaker 1: the f you gotta wait, sorry that I know you're

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Speaker 1: very excited right now, is just hanging there. The FDA

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Speaker 1: regulates true or false? UM, X ray machines. Um, I'm

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Speaker 1: gonna say true, that's right. They regulate radioactive or radioactivity

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Speaker 1: emitting machines like X rays. Uh. Pesticides, that's right. Yeah,

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Speaker 1: that's the U. S d A. From what I understand. Um,

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Speaker 1: illicit drugs like cocaine and crap cocaine. They don't regulate that. No,

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Speaker 1: that's true. They don't. Uh. Let's see what else. What

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Speaker 1: about donated blood? True, that's true. They regulate biologics doing

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Speaker 1: great man vaccines and blood. Yeah, thank you, tobacco. Um,

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Speaker 1: they do regulate that, I believe. And then what about

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Speaker 1: poultry chicken? Yes, of course they do. No, because it's food.

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Speaker 1: No U s d A. Again, although the FDA does

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Speaker 1: regulate apparently the dairy industry. Yeah, but not meeting poultry. No,

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Speaker 1: talk about mind boggling. They do reulate um cosmetics, but

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Speaker 1: obviously because we did a podcast on it, they don't

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Speaker 1: regulate uh several supplements. Yeah, that was a good one,

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Speaker 1: if I remember correctly, We really like got to the

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Speaker 1: heart of the matter. Yeah, And there's a lot of

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Speaker 1: and I think you talked about it. Then there's a

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Speaker 1: lot of slippery language that can be used in body

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Speaker 1: products period, which always aggravates Emily to no end because

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Speaker 1: she has completely natural body products. But you can throw

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Speaker 1: names on packages these days, on foods too, that just

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Speaker 1: say like purer and natural and just these buzzwords that

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Speaker 1: mean nothing, and there's no regulation for when you can

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Speaker 1: use those words. And it's just it's they're trying to

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Speaker 1: sell people on something that's not true. It's truly sad.

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Speaker 1: Like light beer. I remember hearing years and years and

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Speaker 1: years ago that light beer only has to be light

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Speaker 1: and color to be called light beer. Really Yeah, But

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Speaker 1: now that I'm grown, I'm like, I'll bet like, who

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Speaker 1: regulates that, I'll bet you it doesn't even have to

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Speaker 1: be light in color and light and color compared to

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Speaker 1: what you can probably call something light beer if you

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Speaker 1: want to, Well, it's light in calories, right, buyer beware.

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Speaker 1: But your point is it's not regulated, right, Probably not

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Speaker 1: a beer has to be under this many calories to

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Speaker 1: be called a light Yeah. I don't believe it is.

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Speaker 1: And now that I think, I'd probably be the FTC

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Speaker 1: that would be in charge of that kind of thing.

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Speaker 1: But they the t F Yeah, man, the government should

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Speaker 1: just have a lot of lettered agencies. Yeah. One last

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Speaker 1: thing about the FDA though, there's a group of special

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Speaker 1: agents in the criminal unit that carried guns. Really FDA

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Speaker 1: agents that carried guns and will shoot you well for

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Speaker 1: doing what I've got a great example of it. Had

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Speaker 1: they caught whoever it was that poisoned the Chicago area

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Speaker 1: tile and all in, they probably would have shot that person. Yep.

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Speaker 1: Do you do you know about that? I do? Uh,

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Speaker 1: you want to talk about that now? Sure might as well. Huh. Yeah,

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Speaker 1: I remember this, do too, man. Yeah. I was a

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Speaker 1: six year old whose eyes were just opening to the

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Speaker 1: ideas of w things and drugs and learning to fear

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Speaker 1: things that you bought at the store. Yeah. I didn't.

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Speaker 1: I didn't. I didn't know the specifics because I was

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Speaker 1: only eleven and I never really like researched further as

349
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Speaker 1: an adult. But twelve year old girl died in a

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Speaker 1: suburban Chicago after taking Thailand all laced with cyanide as.

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Speaker 1: It turns out, Um, she was dead by the next day,

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Speaker 1: I believe know a couple of hours, Oh, a couple

353
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Speaker 1: of she took it that morning then and then dim.

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Speaker 1: So Uh. That same day, a twenty seven year old

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Speaker 1: name Adam Janice suburban Chicago died and then his brother

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Speaker 1: and sister were consoling the family. They thought it was

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Speaker 1: a heart attack. Uh, we're consoling the family and just

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00:20:44,320 --> 00:20:48,280
Speaker 1: sort of doing the post death family stuff. Very stressed,

359
00:20:48,440 --> 00:20:51,440
Speaker 1: got headaches, they took tail and all and they both died. Yeah.

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Speaker 1: I had no idea that connection. Three more people died

361
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Speaker 1: over the next couple of days, all from they found

362
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Speaker 1: out upon investigating, all of them had taken Thailand all

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Speaker 1: right before they died. So they started looking at right,

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00:21:05,040 --> 00:21:07,760
Speaker 1: they started looking into it, and um, it turned out

365
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Speaker 1: that there was poisoned thailand all in the Chicago area.

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Speaker 1: And everyone freaked out because at the time Thailand all

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Speaker 1: was like that was it. You had an over the

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Speaker 1: counter pain reliever. It was Thailand All, and they didn't

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Speaker 1: have tamper resistant bottles at the time. What they later

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Speaker 1: figured out is that somebody bought Thailand All, took it home,

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Speaker 1: I guess, laced it with cyanide, and then brought it

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Speaker 1: back and made it look like it had been unopened,

373
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Speaker 1: and people bought them and died from They still don't

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Speaker 1: know who did it. They made it look like it

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Speaker 1: was unopened by just closing the lid again. Because there again,

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Speaker 1: no tamper resistant packaging until right this changed everything. So UM,

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00:21:48,040 --> 00:21:51,119
Speaker 1: the company that makes tail and All under Johnson and

378
00:21:51,200 --> 00:21:54,879
Speaker 1: Johnson like issued like a national media alert that said, like,

379
00:21:55,080 --> 00:21:58,560
Speaker 1: everybody should probably stop taking taile and All and send

380
00:21:58,640 --> 00:22:01,080
Speaker 1: us your tailing All will send you new stuff that

381
00:22:01,200 --> 00:22:04,400
Speaker 1: we know is good, but um, don't take Kylo, which

382
00:22:04,480 --> 00:22:06,720
Speaker 1: is kind of cool for a company. Yeah, they really

383
00:22:06,840 --> 00:22:08,639
Speaker 1: like I mean, they had no choice, I think, but

384
00:22:08,800 --> 00:22:12,359
Speaker 1: the super go on the offensive with this. Uh, and

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00:22:12,480 --> 00:22:17,000
Speaker 1: it's actually due to Johnson and Johnson. Um. It wasn't

386
00:22:17,040 --> 00:22:19,320
Speaker 1: the f d A saying hey, we need to get

387
00:22:19,359 --> 00:22:22,680
Speaker 1: tamper resistant packaging. Johnson and Johnson actually said, hey, I

388
00:22:22,760 --> 00:22:26,600
Speaker 1: think we should start investigating tampa resistant packaging. So they

389
00:22:26,640 --> 00:22:30,560
Speaker 1: sort of led the charge. Yeah, and then in Congress said, um,

390
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Speaker 1: let's make tampering with medicine a federal crime. Yes. And

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Speaker 1: then just just six years later, the FDA said, let's

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00:22:39,240 --> 00:22:43,680
Speaker 1: make these awesome tamper resistant bottles um mandatory. I don't

393
00:22:43,720 --> 00:22:46,920
Speaker 1: know why it took six years that we're talking about

394
00:22:46,920 --> 00:22:49,680
Speaker 1: a federal bureaucracy here now, but it seems like that's

395
00:22:49,720 --> 00:22:52,560
Speaker 1: something you could have sped through. Just my opinion, but

396
00:22:53,080 --> 00:22:56,840
Speaker 1: anyway is when um, that's why it's so hard to

397
00:22:56,840 --> 00:22:59,920
Speaker 1: get into pill bottles these days, thankfully. Yeah, a little

398
00:23:00,000 --> 00:23:03,840
Speaker 1: boil coatings and all that stuff that makes um, doesn't

399
00:23:03,840 --> 00:23:05,800
Speaker 1: mean you can't open it, but it means you will

400
00:23:05,840 --> 00:23:09,040
Speaker 1: know if someone has opened it. Yes, you know, like

401
00:23:09,119 --> 00:23:10,520
Speaker 1: if you buy it and you're like, wait a minute,

402
00:23:10,560 --> 00:23:14,000
Speaker 1: that foil is poked through by a human thumb, I

403
00:23:14,080 --> 00:23:17,639
Speaker 1: can see it. And this stuff is glowing, yeah, Thailand,

404
00:23:17,640 --> 00:23:21,000
Speaker 1: all is not supposed to glow. Alright, So let's take

405
00:23:21,040 --> 00:23:23,119
Speaker 1: a break and after this we'll talk a little bit

406
00:23:23,200 --> 00:23:31,800
Speaker 1: more about how they regulate. You know, stop fear you

407
00:23:32,560 --> 00:23:50,840
Speaker 1: you know, stop you know stop you know. So, um,

408
00:23:51,119 --> 00:23:53,560
Speaker 1: how does well, first of all, how much do they

409
00:23:53,640 --> 00:23:57,680
Speaker 1: regulate and the answer is a ton of products. Yeah. Um,

410
00:23:58,760 --> 00:24:01,879
Speaker 1: some estimates say that twenty cents out of every dollar

411
00:24:02,000 --> 00:24:09,000
Speaker 1: consumer spend, and that's on everything TVs you know, VCRs, right,

412
00:24:09,080 --> 00:24:13,200
Speaker 1: that doesn't regulate satellite dishes, laser discs. All the money

413
00:24:13,280 --> 00:24:16,640
Speaker 1: that we spend on everything, twenty cents out of every

414
00:24:16,800 --> 00:24:20,240
Speaker 1: dollar we spend is on a product that's regulated by

415
00:24:20,280 --> 00:24:23,320
Speaker 1: the FDA. It comes under their per view, which which

416
00:24:23,359 --> 00:24:25,879
Speaker 1: means you have too much to do. Supposedly that equals

417
00:24:25,880 --> 00:24:29,200
Speaker 1: about what they regulate about one trillion dollars worth of

418
00:24:29,280 --> 00:24:33,800
Speaker 1: goods and in services, well goods. Yeah, all right, so

419
00:24:33,840 --> 00:24:36,000
Speaker 1: they regulate. We already talked about what they do regulate.

420
00:24:36,080 --> 00:24:40,440
Speaker 1: They also, um also offer guidance at times on maybe

421
00:24:40,920 --> 00:24:45,680
Speaker 1: how advice on how regulations should be carried out. So

422
00:24:45,840 --> 00:24:48,240
Speaker 1: that's one of their tasks as well. Right, Like maybe

423
00:24:48,480 --> 00:24:53,200
Speaker 1: you guys should make your pillbottles tamper resistant. Our criminal

424
00:24:53,800 --> 00:24:56,800
Speaker 1: enforcement unit isn't going to come shoot you if you don't,

425
00:24:57,200 --> 00:25:01,879
Speaker 1: because this is a guideline. But now that it's uh,

426
00:25:02,080 --> 00:25:04,879
Speaker 1: now it's mandatory or they may visit you. Um. They

427
00:25:04,960 --> 00:25:11,480
Speaker 1: do about sixteen thousand facility inspections per year. Uh, everything

428
00:25:11,560 --> 00:25:14,680
Speaker 1: from dairy farms to blood banks. But um, they, like

429
00:25:14,800 --> 00:25:17,919
Speaker 1: we said, they're way more facilities than they have field workers.

430
00:25:18,560 --> 00:25:22,359
Speaker 1: So I think they do they well, they use the

431
00:25:22,480 --> 00:25:27,520
Speaker 1: element of surprise or the potential, the element of potential surprise,

432
00:25:28,040 --> 00:25:33,119
Speaker 1: So surprise inspection, surprise visits. I hope, hope, hope. And

433
00:25:33,200 --> 00:25:36,560
Speaker 1: I'm pretty sure that the FDA doesn't call in schedule

434
00:25:37,280 --> 00:25:41,600
Speaker 1: inspections ahead of time. Right. If they do, then then

435
00:25:41,720 --> 00:25:44,040
Speaker 1: write your congress person and make sure that this gets

436
00:25:44,160 --> 00:25:48,280
Speaker 1: changed immediately, because they can't. We're talking fourteen thousand employees

437
00:25:48,359 --> 00:25:52,119
Speaker 1: in total, not just inspectors in total. For all of

438
00:25:52,160 --> 00:25:56,159
Speaker 1: the FDA, less than fifteen thousand people are in charge

439
00:25:56,240 --> 00:26:00,960
Speaker 1: of not only visiting factories and dairies in places that

440
00:26:01,240 --> 00:26:04,200
Speaker 1: that use X ray machines and all this stuff, all

441
00:26:04,240 --> 00:26:07,240
Speaker 1: the things that they regulate, not just in the US,

442
00:26:07,359 --> 00:26:11,000
Speaker 1: but like in other countries too. Yeah. They just set

443
00:26:11,119 --> 00:26:14,440
Speaker 1: up their first office in Beijing in the last decade

444
00:26:14,560 --> 00:26:18,000
Speaker 1: or so. Yeah, because they have to. They have to

445
00:26:18,160 --> 00:26:21,040
Speaker 1: watch what's coming into the country as well, because Americans

446
00:26:21,119 --> 00:26:25,360
Speaker 1: don't just ingest American products, We just products for overseas,

447
00:26:25,560 --> 00:26:28,159
Speaker 1: and those things have to they have to follow the

448
00:26:28,200 --> 00:26:31,920
Speaker 1: same guidelines as any other product that's sold er sold

449
00:26:32,000 --> 00:26:35,800
Speaker 1: or used in America, because the FDA jurisdiction isn't stuff

450
00:26:35,840 --> 00:26:39,239
Speaker 1: that's made in America, stuff that is consumed in America. Yea,

451
00:26:39,280 --> 00:26:40,800
Speaker 1: I guess I just thought that would be maybe the

452
00:26:40,880 --> 00:26:43,320
Speaker 1: FDC or something. But imagine they all kind of work

453
00:26:43,359 --> 00:26:45,600
Speaker 1: hand in hand to get the church done. They all

454
00:26:45,680 --> 00:26:49,080
Speaker 1: quietly hold hands while they do their research. Uh. And

455
00:26:49,200 --> 00:26:51,080
Speaker 1: how do they do this? They do it because they

456
00:26:51,119 --> 00:26:53,560
Speaker 1: are funded to the tune of four point four billion

457
00:26:53,600 --> 00:26:58,080
Speaker 1: dollars um. About two point six of that comes from

458
00:26:58,119 --> 00:27:02,080
Speaker 1: the Treasury and in other words, your tax dollars and

459
00:27:02,280 --> 00:27:05,200
Speaker 1: the remaining close to two billion comes from user fees,

460
00:27:05,520 --> 00:27:09,240
Speaker 1: which are very, very controversial. You want to talk about

461
00:27:09,240 --> 00:27:14,560
Speaker 1: the user fees. Yeah, let's know that. Man. So the before,

462
00:27:15,240 --> 00:27:20,920
Speaker 1: what was it. I believe the FDA was fully funded

463
00:27:21,000 --> 00:27:23,679
Speaker 1: by taxpayer dollars. It got all of its funding from

464
00:27:23,720 --> 00:27:28,879
Speaker 1: the Treasury. And then in Congress passed a law that

465
00:27:29,080 --> 00:27:33,440
Speaker 1: said the the FDA can start generating its own revenue

466
00:27:33,840 --> 00:27:38,200
Speaker 1: by accepting user fees. Yeah, the Prescription Drug User Fee Act. Right. So,

467
00:27:38,520 --> 00:27:41,439
Speaker 1: in that act, it says, if you are a prescription

468
00:27:41,520 --> 00:27:45,119
Speaker 1: drug company, a pharmaceutical company, and you want to have

469
00:27:46,000 --> 00:27:50,560
Speaker 1: your UM your drug examined by the FDA, and in

470
00:27:50,640 --> 00:27:53,200
Speaker 1: a lot of cases, most cases, you have to have

471
00:27:53,359 --> 00:27:56,280
Speaker 1: it submitted for a review by the FDA. Sure, you

472
00:27:56,359 --> 00:27:59,359
Speaker 1: also have to pay a fee called it an application fee,

473
00:27:59,400 --> 00:28:01,720
Speaker 1: call it a user fee, what have you. Well, there's

474
00:28:01,920 --> 00:28:04,639
Speaker 1: many different fees, so we'll call that. Let's say you

475
00:28:04,800 --> 00:28:07,040
Speaker 1: want to get your drug fast checked. You can pay

476
00:28:07,080 --> 00:28:10,080
Speaker 1: an exorbitant fee and we'll put it at the top

477
00:28:10,160 --> 00:28:12,760
Speaker 1: of the pile even and so all of a sudden,

478
00:28:12,800 --> 00:28:16,920
Speaker 1: out chuckers, the f d A is not policing the

479
00:28:17,000 --> 00:28:21,280
Speaker 1: pharmaceutical companies any longer. It is servicing the pharmaceutical companies,

480
00:28:21,560 --> 00:28:26,880
Speaker 1: and the pharmaceutical companies as became the FDA's clients. Yeah,

481
00:28:26,920 --> 00:28:31,920
Speaker 1: that was really really bad as far as consumer protection goes. Yeah,

482
00:28:32,040 --> 00:28:35,000
Speaker 1: and um, there are many different ways of looking at this. UM.

483
00:28:35,160 --> 00:28:39,520
Speaker 1: One is that way, which is that the the pharma

484
00:28:39,840 --> 00:28:43,120
Speaker 1: lobby is um writing checks to the f d A

485
00:28:43,800 --> 00:28:46,600
Speaker 1: UM to the tune of billions of dollars. And that

486
00:28:46,720 --> 00:28:50,040
Speaker 1: can't be good, right, Uh the f d A. The

487
00:28:50,480 --> 00:28:53,720
Speaker 1: read this great article on pbs UM where they just

488
00:28:53,800 --> 00:28:56,520
Speaker 1: interviewed a bunch of people for a variety of opinions

489
00:28:57,440 --> 00:28:59,959
Speaker 1: it was very balanced. It was very very and balance.

490
00:29:00,000 --> 00:29:04,600
Speaker 1: It's not like us, Um it's bad. They the FDA's

491
00:29:04,640 --> 00:29:08,280
Speaker 1: rebuttal will look a little something like this. Um. What

492
00:29:08,640 --> 00:29:11,160
Speaker 1: what it's done is it's really helped us out. Um,

493
00:29:11,360 --> 00:29:15,240
Speaker 1: We've increased our productivity by close. We've been able to

494
00:29:15,320 --> 00:29:18,720
Speaker 1: hire so many more people, which means we can regulate

495
00:29:18,880 --> 00:29:21,560
Speaker 1: so much more. UM, it's really helped us in the

496
00:29:21,640 --> 00:29:24,680
Speaker 1: review process. The farm a lobby says, this is great

497
00:29:24,760 --> 00:29:29,600
Speaker 1: because it gets things going super quickly. It's very efficient

498
00:29:29,760 --> 00:29:33,320
Speaker 1: and yeah, and it hasn't changed the review processes, just

499
00:29:33,840 --> 00:29:36,800
Speaker 1: made things faster. And UM, we can get these drugs

500
00:29:36,840 --> 00:29:39,760
Speaker 1: two people quicker because people need these. So there's a

501
00:29:39,760 --> 00:29:42,040
Speaker 1: lot of different ways of looking at it. UM. If

502
00:29:42,080 --> 00:29:45,880
Speaker 1: you ask Raymond Wooseley, who was he was up for UM,

503
00:29:47,000 --> 00:29:49,600
Speaker 1: he was the vice president of health Sciences at University

504
00:29:49,600 --> 00:29:51,800
Speaker 1: of Arizona. I think it's been like two thousand two.

505
00:29:51,880 --> 00:29:55,360
Speaker 1: He was up for commission of the FDA. He's a

506
00:29:55,400 --> 00:29:58,240
Speaker 1: safety guy. Yeah, he was rejected, and he flat out

507
00:29:58,320 --> 00:30:01,440
Speaker 1: said in an interview, like it's pretty clear that people

508
00:30:01,520 --> 00:30:03,800
Speaker 1: that really care about drug safety will never get this

509
00:30:03,960 --> 00:30:07,680
Speaker 1: job again. The Commissioner of the FDA and he said,

510
00:30:07,720 --> 00:30:10,080
Speaker 1: it's great sadness to me that people who care about

511
00:30:10,120 --> 00:30:12,560
Speaker 1: drug safety and food safety to the level that they

512
00:30:12,600 --> 00:30:14,560
Speaker 1: get involved, they try to make a difference and can't

513
00:30:14,600 --> 00:30:18,520
Speaker 1: be accepted to regulate the agency. And he said, for me,

514
00:30:18,640 --> 00:30:21,720
Speaker 1: it should be protection first and then serving second, serving

515
00:30:21,800 --> 00:30:25,400
Speaker 1: meaning the industry. And that's sort of not the way

516
00:30:25,400 --> 00:30:28,320
Speaker 1: it's gone since the user fees have been introduced. Yeah,

517
00:30:28,440 --> 00:30:30,960
Speaker 1: from from the research that we've done, it seems like

518
00:30:31,880 --> 00:30:34,560
Speaker 1: every critic of the f d A from all walks

519
00:30:34,600 --> 00:30:38,000
Speaker 1: of life and all stripes, points to that user fee

520
00:30:38,160 --> 00:30:43,680
Speaker 1: as possibly the number one problem as far as coziness

521
00:30:43,760 --> 00:30:48,320
Speaker 1: between industry and the agency that they're funding regulates. Yeah,

522
00:30:49,320 --> 00:30:51,560
Speaker 1: you want to separate those two things generally. And then

523
00:30:51,600 --> 00:30:56,680
Speaker 1: the other problem is funding for the FDA itself. That

524
00:30:57,360 --> 00:31:01,480
Speaker 1: it is a grossly underfunded agency for what it's tasked

525
00:31:01,520 --> 00:31:03,960
Speaker 1: with doing, so it does have to rely on those

526
00:31:04,080 --> 00:31:07,720
Speaker 1: user fees, Whereas I think it's a lot like campaign

527
00:31:07,880 --> 00:31:11,160
Speaker 1: finance reform, where if you could just take that and

528
00:31:11,280 --> 00:31:15,560
Speaker 1: replace it with public money, um, then you can. You

529
00:31:15,640 --> 00:31:18,040
Speaker 1: can separate these two things that aren't supposed to be

530
00:31:18,120 --> 00:31:21,160
Speaker 1: cozy with one another. A government agency that's not supposed

531
00:31:21,160 --> 00:31:24,680
Speaker 1: to rely financially on the industry that it's regulating. Yeah,

532
00:31:24,760 --> 00:31:26,200
Speaker 1: and I know you want to do a show on

533
00:31:26,560 --> 00:31:30,080
Speaker 1: lobbying soon. That's uh, that's gonna be a firestorm. It is.

534
00:31:30,160 --> 00:31:32,560
Speaker 1: We're gonna just be sitting there like gripping the table

535
00:31:32,640 --> 00:31:35,000
Speaker 1: the whole time. Well, what you mentioned though, how they're

536
00:31:35,040 --> 00:31:38,280
Speaker 1: funded though, it's interesting. I think until recently, UM, the

537
00:31:38,360 --> 00:31:42,000
Speaker 1: way the money was even divided, like how the budget

538
00:31:42,040 --> 00:31:46,240
Speaker 1: money was spent was pretty hinking because you couldn't even

539
00:31:46,480 --> 00:31:50,640
Speaker 1: use any of that user fee money to regulate safety

540
00:31:50,680 --> 00:31:53,000
Speaker 1: at all. All of that had to go into the

541
00:31:53,120 --> 00:31:56,840
Speaker 1: service side of things. I think now they are starting

542
00:31:57,440 --> 00:32:00,520
Speaker 1: UM to to uh be able to use that money

543
00:32:00,600 --> 00:32:03,080
Speaker 1: for safety as well. But I think that's not happening

544
00:32:03,160 --> 00:32:05,800
Speaker 1: fast enough for people that are truly concerned about the

545
00:32:05,840 --> 00:32:09,080
Speaker 1: safety of our country. And there was this uh I

546
00:32:09,160 --> 00:32:11,200
Speaker 1: think I sent it to you. There's this Forbes article

547
00:32:11,320 --> 00:32:14,560
Speaker 1: from two thousand and fourteen. About a year ago, UM,

548
00:32:15,160 --> 00:32:17,800
Speaker 1: there was a Yale study that came out that really

549
00:32:17,960 --> 00:32:20,880
Speaker 1: just raked the FDA over the coals, and it was

550
00:32:21,360 --> 00:32:24,800
Speaker 1: an analysis of a bunch of different f d a

551
00:32:25,480 --> 00:32:29,320
Speaker 1: UM approvals from two five to two thousand twelve publicly

552
00:32:29,480 --> 00:32:32,640
Speaker 1: published stuff. It's not like they had to dig in, right,

553
00:32:32,720 --> 00:32:35,080
Speaker 1: They just went and did an analysis of it, and

554
00:32:35,200 --> 00:32:39,400
Speaker 1: they found that these FDA studies were um all over

555
00:32:39,480 --> 00:32:42,520
Speaker 1: the place as far as the data they accepted, UM,

556
00:32:43,120 --> 00:32:47,480
Speaker 1: what what got cleared and what didn't, UM, the sample size,

557
00:32:47,880 --> 00:32:52,600
Speaker 1: how long trials went on, and um. It was basically

558
00:32:52,680 --> 00:32:55,240
Speaker 1: used to publicly shame the FDA is saying like, you

559
00:32:55,280 --> 00:32:57,360
Speaker 1: guys aren't even using good science and even trying to

560
00:32:57,440 --> 00:33:00,640
Speaker 1: keep up this pretense that you're following your own standards

561
00:33:00,680 --> 00:33:03,200
Speaker 1: or that you even have standards. You guys are you're

562
00:33:03,240 --> 00:33:08,200
Speaker 1: just rubber stamping pharmaceuticals. And to kind of give an

563
00:33:08,240 --> 00:33:11,560
Speaker 1: opposing point of view, this guy on Forbes said, well,

564
00:33:11,640 --> 00:33:14,560
Speaker 1: wait a minute, Like this is totally unfair because the

565
00:33:14,640 --> 00:33:17,920
Speaker 1: FDA is actually what they're being criticized for here is

566
00:33:17,920 --> 00:33:21,840
Speaker 1: actually a certain kind of nimbleness that the end user,

567
00:33:22,000 --> 00:33:25,040
Speaker 1: the patients who are taking these drugs really want. So

568
00:33:25,120 --> 00:33:28,280
Speaker 1: they're saying, for something that's a really huge, sweeping drug

569
00:33:28,360 --> 00:33:31,000
Speaker 1: that's going to be used by a lot of people, right,

570
00:33:31,600 --> 00:33:35,920
Speaker 1: they they they should and typically do, follow some pretty

571
00:33:36,000 --> 00:33:39,520
Speaker 1: stringent guidelines. They have to have a huge population sample

572
00:33:39,920 --> 00:33:42,840
Speaker 1: they have to um carry these studies out for years

573
00:33:43,600 --> 00:33:46,200
Speaker 1: and UM they require a lot of really good data.

574
00:33:46,480 --> 00:33:48,800
Speaker 1: But if you have something that is like a really

575
00:33:48,880 --> 00:33:51,840
Speaker 1: obscure disease or a drug that treats are really obscure disease,

576
00:33:53,280 --> 00:33:56,880
Speaker 1: sure they're going to accept the data that used the

577
00:33:56,960 --> 00:34:00,480
Speaker 1: population size of like a hundred people because there's just

578
00:34:00,560 --> 00:34:03,120
Speaker 1: not that many people out there with this disease. And

579
00:34:03,640 --> 00:34:06,480
Speaker 1: it may be a shorter lived study because if it's

580
00:34:06,480 --> 00:34:09,800
Speaker 1: a really fatal disease, these people want this drug and

581
00:34:09,920 --> 00:34:12,319
Speaker 1: to get it out the door quicker. And there may

582
00:34:12,360 --> 00:34:14,120
Speaker 1: only be the one study. You may not have to

583
00:34:14,200 --> 00:34:16,560
Speaker 1: duplicate it and replicate it three or four times. So

584
00:34:16,680 --> 00:34:19,279
Speaker 1: he did a good job of like presenting the other

585
00:34:19,400 --> 00:34:22,680
Speaker 1: case in really pointing out how the FDA is very

586
00:34:22,760 --> 00:34:25,680
Speaker 1: typically it's it's in a damned if you do, damned

587
00:34:25,680 --> 00:34:29,800
Speaker 1: if you don't situation on a daily basis, because in

588
00:34:29,920 --> 00:34:32,640
Speaker 1: that same study that found you know that they it

589
00:34:32,719 --> 00:34:36,399
Speaker 1: will accept the population of one hundred in the study, UM,

590
00:34:36,680 --> 00:34:39,120
Speaker 1: and it goes out the door very quickly in the

591
00:34:39,200 --> 00:34:43,080
Speaker 1: approval process happens fast in that. In that sense, on

592
00:34:43,200 --> 00:34:45,840
Speaker 1: the other hand, UM, when the FDA doesn't do that

593
00:34:45,920 --> 00:34:48,840
Speaker 1: and really takes its time and digs in and studies.

594
00:34:49,000 --> 00:34:52,040
Speaker 1: It gets accused of basically just letting people die, which

595
00:34:52,120 --> 00:34:55,799
Speaker 1: was the case with the advent of AIDS eighties. Sure

596
00:34:55,960 --> 00:34:58,920
Speaker 1: HIV drugs were being tested in people in the HIV

597
00:34:59,040 --> 00:35:03,080
Speaker 1: community and in at large in the country. We're saying,

598
00:35:04,000 --> 00:35:06,880
Speaker 1: advocates were saying, hey, people are dying and like these

599
00:35:06,960 --> 00:35:10,080
Speaker 1: drugs are very promising, like let us try them out.

600
00:35:10,680 --> 00:35:13,840
Speaker 1: And so I do get it, man, Like they've been

601
00:35:13,880 --> 00:35:16,320
Speaker 1: accused of dragon their feet. We're going too fast and

602
00:35:16,960 --> 00:35:20,239
Speaker 1: finding that happy medium or I think I don't know,

603
00:35:20,520 --> 00:35:21,880
Speaker 1: I don't know if it's a happy medium or if

604
00:35:21,920 --> 00:35:24,239
Speaker 1: it's you should only strive for safety, and if it

605
00:35:24,320 --> 00:35:26,680
Speaker 1: takes too long, it takes too long, or if it

606
00:35:26,840 --> 00:35:30,200
Speaker 1: is super quick, it's super quick. Like safety is should

607
00:35:30,239 --> 00:35:33,320
Speaker 1: be the most important thing, and it doesn't seem like

608
00:35:33,880 --> 00:35:37,480
Speaker 1: that that's the case. No, it should be the most

609
00:35:37,520 --> 00:35:40,640
Speaker 1: important thing. But at the same time, there should also

610
00:35:40,760 --> 00:35:44,600
Speaker 1: be an awareness of you know, what's going on outside

611
00:35:44,640 --> 00:35:47,359
Speaker 1: the doors of the lab, but there are people dying,

612
00:35:47,680 --> 00:35:50,319
Speaker 1: so yeah, you want a safe drug. But also if

613
00:35:50,360 --> 00:35:52,800
Speaker 1: you have people are saying, like remember with the ebowl

614
00:35:52,840 --> 00:35:57,000
Speaker 1: out right, they're people are like, I will die from

615
00:35:57,040 --> 00:35:59,239
Speaker 1: this drug. I will sign whatever you need. Just give

616
00:35:59,320 --> 00:36:01,920
Speaker 1: me the draw, let me try it. Right, And they

617
00:36:02,040 --> 00:36:06,560
Speaker 1: went ahead and and let people used unapproved drugs. It's

618
00:36:06,600 --> 00:36:09,359
Speaker 1: like the Poison Squad almost these people were volunteering, right,

619
00:36:10,000 --> 00:36:12,560
Speaker 1: willfully volunteering so well they were also dying of a

620
00:36:12,680 --> 00:36:16,160
Speaker 1: bowla at the time. Well, um, the Poison Squad were

621
00:36:16,200 --> 00:36:20,160
Speaker 1: totally healthy, untied the squad, right, yeah it did you know?

622
00:36:20,280 --> 00:36:24,240
Speaker 1: Also the poison Squad. Um, it was a very scientific study.

623
00:36:24,840 --> 00:36:27,960
Speaker 1: The guys were not allowed to eat or drink anything

624
00:36:28,120 --> 00:36:31,520
Speaker 1: outside of this dining room except for water. They had

625
00:36:31,520 --> 00:36:35,680
Speaker 1: to turn in all of it. Not a drop or

626
00:36:35,719 --> 00:36:40,759
Speaker 1: a speck was allowed to go unmeasured on a skid mok.

627
00:36:42,280 --> 00:36:46,600
Speaker 1: But the the the f d A and AI's activist

628
00:36:46,800 --> 00:36:49,000
Speaker 1: collision from the early eighties. Have you seen How to

629
00:36:49,040 --> 00:36:54,680
Speaker 1: Survive a Plague? Great documentary, But the documentary deals in

630
00:36:54,760 --> 00:36:58,200
Speaker 1: part with that and it's really really interesting. And that

631
00:36:58,640 --> 00:37:02,320
Speaker 1: was actually score. The soundtrack was scored by our friends

632
00:37:02,640 --> 00:37:05,640
Speaker 1: Superhuman Happiness. Oh nice to listen to this show, hey guys,

633
00:37:05,719 --> 00:37:08,000
Speaker 1: good for them. Yeah, so go see it. It's a

634
00:37:08,120 --> 00:37:10,440
Speaker 1: very good, good documentary. I will check it out. Is

635
00:37:10,480 --> 00:37:16,839
Speaker 1: that on the old red streaming service. Yes, I'm sure

636
00:37:16,880 --> 00:37:20,959
Speaker 1: it's I'm sure it is called something like Netflix. That's

637
00:37:21,239 --> 00:37:25,279
Speaker 1: that's exactly what it's called. Okay, you're confusing me. All right,

638
00:37:25,480 --> 00:37:27,400
Speaker 1: So let's take another break here, and when we come back,

639
00:37:27,480 --> 00:37:29,279
Speaker 1: we'll talk a little bit more about some of the

640
00:37:30,440 --> 00:37:37,240
Speaker 1: various successes and failures of the f D A you know, stop,

641
00:37:39,200 --> 00:37:57,719
Speaker 1: you know, you know, stop, you know all right, Um,

642
00:37:58,760 --> 00:38:02,520
Speaker 1: can we talk about this Harvard paper? Yeah, this is

643
00:38:02,640 --> 00:38:06,440
Speaker 1: from an article titled Risky Drugs Colan Why the FDA

644
00:38:06,520 --> 00:38:11,400
Speaker 1: Cannot be Trusted, And it was basically about a paper

645
00:38:11,600 --> 00:38:13,719
Speaker 1: published in the Journal of Law, Medicine and Ethics from

646
00:38:13,760 --> 00:38:19,880
Speaker 1: Hobvid University where they contend that, um, they present evidence

647
00:38:20,000 --> 00:38:24,279
Speaker 1: actually that roughly of all new drugs approved by the

648
00:38:24,360 --> 00:38:27,640
Speaker 1: FDA over the past thirty years are little own or

649
00:38:27,840 --> 00:38:33,640
Speaker 1: no more effective for patients than existing drugs. Um they're saying.

650
00:38:33,719 --> 00:38:37,439
Speaker 1: It's they still beat placebo typically. Yeah. What they're saying

651
00:38:37,560 --> 00:38:40,000
Speaker 1: is like, all these new drugs aren't any better than

652
00:38:40,120 --> 00:38:43,160
Speaker 1: the old drugs. There's just competition on an already saturated

653
00:38:43,239 --> 00:38:46,920
Speaker 1: market exactly. So it's like, why put the FDA through

654
00:38:47,000 --> 00:38:53,000
Speaker 1: that if they're already overstretched, then why can't those resources

655
00:38:53,120 --> 00:38:56,600
Speaker 1: be allocated to something else that it's dropping the ball

656
00:38:56,719 --> 00:38:59,480
Speaker 1: on right sure. And they also, you know, try to

657
00:38:59,560 --> 00:39:03,160
Speaker 1: make a point about the safety level of these drugs

658
00:39:03,200 --> 00:39:05,440
Speaker 1: that we are taking when they point out things like

659
00:39:06,080 --> 00:39:12,120
Speaker 1: every week, every week, fifty three thousand hospitalizations occur and

660
00:39:13,440 --> 00:39:16,720
Speaker 1: deaths occur every week in the US because of people

661
00:39:16,800 --> 00:39:20,880
Speaker 1: taking properly prescribed drugs to be healthier. So that's just

662
00:39:21,040 --> 00:39:25,239
Speaker 1: a bad reaction to an approved drug. That's how I

663
00:39:25,320 --> 00:39:28,080
Speaker 1: read it. Everyone, I'm reading that wrong. One in five

664
00:39:28,160 --> 00:39:33,040
Speaker 1: drugs approved ends up causing serious harm, while one in

665
00:39:33,160 --> 00:39:36,920
Speaker 1: ten provide a benefit compared to existing established So that's

666
00:39:36,920 --> 00:39:39,000
Speaker 1: the ten percent. So the data is then this is

667
00:39:39,040 --> 00:39:43,680
Speaker 1: what this Harvard paper is saying. It's saying that yes,

668
00:39:43,880 --> 00:39:46,840
Speaker 1: one in ten drugs that comes onto the market that

669
00:39:47,000 --> 00:39:51,000
Speaker 1: the FDA has approved is it provides a benefit that

670
00:39:51,200 --> 00:39:54,120
Speaker 1: no other drug does in the past thirty years, which

671
00:39:54,160 --> 00:39:56,400
Speaker 1: I think and now that I kind of make a

672
00:39:56,440 --> 00:39:59,719
Speaker 1: connection with something else another article that that they were

673
00:39:59,760 --> 00:40:02,040
Speaker 1: really touting like there's no other drug like this, This

674
00:40:02,160 --> 00:40:04,360
Speaker 1: provides the benefit of that other drugs don't, right, So

675
00:40:04,400 --> 00:40:07,799
Speaker 1: I think that's a big like buzzword. It provides other benefits, right,

676
00:40:08,480 --> 00:40:10,840
Speaker 1: but one in five of those drugs will go on

677
00:40:11,000 --> 00:40:16,319
Speaker 1: to cause some sort of harm, right, that's crazy. Yeah,

678
00:40:16,440 --> 00:40:18,200
Speaker 1: And the they go on to say in that paper

679
00:40:18,280 --> 00:40:21,719
Speaker 1: that the f d A they feel um Len's credibility

680
00:40:21,800 --> 00:40:25,680
Speaker 1: to widening and lowering criteria for prescribing drugs what they

681
00:40:25,760 --> 00:40:29,000
Speaker 1: call the selling of sickness and um what you're talking

682
00:40:29,040 --> 00:40:32,440
Speaker 1: about like a new and improved drug. Basically, drug companies

683
00:40:32,480 --> 00:40:35,120
Speaker 1: are raising prices from year to year on the same drug.

684
00:40:35,640 --> 00:40:37,480
Speaker 1: And they said, we're the only country in the world

685
00:40:38,320 --> 00:40:42,080
Speaker 1: that allows a drug to have its price increased without

686
00:40:42,320 --> 00:40:46,960
Speaker 1: showing like here's why, here's the benefit, here's why it's improved,

687
00:40:47,040 --> 00:40:50,000
Speaker 1: and here's why it costs more. And apparently the US

688
00:40:50,080 --> 00:40:53,880
Speaker 1: is the only country that does that. So Yeah, if

689
00:40:53,920 --> 00:40:56,719
Speaker 1: you want to um read that article, really all the

690
00:40:56,880 --> 00:40:59,520
Speaker 1: articles we've mentioned, you can go to our podcast page

691
00:41:00,360 --> 00:41:03,200
Speaker 1: on Stuff you Should Know dot com, the part the

692
00:41:03,280 --> 00:41:06,319
Speaker 1: page for this episode. It's got all the additional links. Yeah,

693
00:41:06,480 --> 00:41:08,439
Speaker 1: I'm glad we're doing that now. I think that's good. Yeah,

694
00:41:08,520 --> 00:41:12,680
Speaker 1: it's definitely open things up for the truly curious. You

695
00:41:12,800 --> 00:41:15,279
Speaker 1: really want to dig in, baby, we got it for

696
00:41:15,440 --> 00:41:19,400
Speaker 1: you can we talk about antibiotics and livestock. Yeah, this

697
00:41:19,560 --> 00:41:22,359
Speaker 1: is a big one. You found this in the Atlantic, right, Yeah,

698
00:41:22,400 --> 00:41:24,040
Speaker 1: and this is a big uh. I mean, it's just

699
00:41:24,160 --> 00:41:27,040
Speaker 1: a big issue these days period about what is going

700
00:41:27,160 --> 00:41:31,120
Speaker 1: into the meat and that people are eating, uh like

701
00:41:31,360 --> 00:41:35,239
Speaker 1: in factory farms and stuff. Um. The f d A

702
00:41:35,840 --> 00:41:39,359
Speaker 1: in n seven basically said we're not gonna put antibiotics

703
00:41:39,440 --> 00:41:44,440
Speaker 1: in livestock because it's dangerous, and just in twelve they

704
00:41:44,520 --> 00:41:48,839
Speaker 1: filed papers in court that acknowledge that they weren't safe. Um,

705
00:41:49,200 --> 00:41:52,279
Speaker 1: it says more studies. A series of additional studies were

706
00:41:52,280 --> 00:41:56,879
Speaker 1: conducted by other government agencies and non governmental organizations during

707
00:41:56,920 --> 00:41:59,920
Speaker 1: the nineties, all of which generally support the FDA's concerned

708
00:42:00,040 --> 00:42:04,359
Speaker 1: guarding public health threat posed by anti microbial resistance. Yes,

709
00:42:04,440 --> 00:42:08,480
Speaker 1: so what happens is you you give healthy live stock,

710
00:42:08,560 --> 00:42:12,680
Speaker 1: otherwise healthy live stock, antibiotics in their food, right, because

711
00:42:12,840 --> 00:42:18,520
Speaker 1: the living conditions are basically right for an epidemic, or

712
00:42:18,560 --> 00:42:21,279
Speaker 1: it helps them grow faster. Right. So, but if they're

713
00:42:21,280 --> 00:42:25,319
Speaker 1: on antibiotics, they stay healthy despite these living conditions. Well,

714
00:42:25,360 --> 00:42:28,359
Speaker 1: the problem is is the bugs that these antibiotics are

715
00:42:28,440 --> 00:42:33,399
Speaker 1: fighting off develop resistance to the antibiotics, and they can,

716
00:42:33,640 --> 00:42:36,960
Speaker 1: some of which are zoonotic, these bugs, and so they

717
00:42:37,080 --> 00:42:40,760
Speaker 1: leap from say cattle, to humans, and they're already resistant

718
00:42:40,800 --> 00:42:44,520
Speaker 1: to our antibiotics that we've been giving healthy cows. So

719
00:42:44,680 --> 00:42:49,040
Speaker 1: now you have an antibiotic resistant superbug and that's a

720
00:42:49,120 --> 00:42:51,840
Speaker 1: really dangerous thing. And what you've just said is that

721
00:42:52,080 --> 00:42:55,440
Speaker 1: since the seventies, the FDA has publicly said that this

722
00:42:55,640 --> 00:42:58,480
Speaker 1: is dangerous and it should should not go on any longer,

723
00:42:58,960 --> 00:43:01,480
Speaker 1: but they still they didn't do anything about it. Now.

724
00:43:01,560 --> 00:43:04,080
Speaker 1: Their their attack right now is to say that the

725
00:43:04,160 --> 00:43:07,440
Speaker 1: livestock industry can police itself. Uh. It doesn't seem like

726
00:43:07,520 --> 00:43:11,359
Speaker 1: that's happening, but um, that is their position at this point. Uh.

727
00:43:11,560 --> 00:43:14,120
Speaker 1: And this is why you see a lot of meats

728
00:43:14,160 --> 00:43:16,560
Speaker 1: now in your store that say antibiotic free. It's like

729
00:43:16,640 --> 00:43:19,520
Speaker 1: a big selling point because, uh, even like you said,

730
00:43:19,560 --> 00:43:22,560
Speaker 1: even the FDA says it's really dangerous, but they just

731
00:43:22,680 --> 00:43:26,719
Speaker 1: haven't enacted any law about that. Although they have, that's

732
00:43:26,760 --> 00:43:30,040
Speaker 1: not entirely true. They have listed some antibiotics that, um,

733
00:43:30,360 --> 00:43:31,880
Speaker 1: I know they called out one in the article that

734
00:43:31,920 --> 00:43:34,279
Speaker 1: said you can't use this one, but apparently it's only

735
00:43:34,360 --> 00:43:43,200
Speaker 1: used in like point to five or it's only so

736
00:43:43,840 --> 00:43:46,360
Speaker 1: people that are you know, want to live more purely

737
00:43:46,400 --> 00:43:49,319
Speaker 1: are saying they're not taking enough efforts. I mean, they

738
00:43:49,320 --> 00:43:53,520
Speaker 1: were sued by the National Resources Defense Counsel UH saying

739
00:43:53,560 --> 00:43:55,480
Speaker 1: you have to take action on this. Well, and that's

740
00:43:56,320 --> 00:43:59,479
Speaker 1: us that that that it takes the courts to force

741
00:43:59,560 --> 00:44:02,439
Speaker 1: the government an agency to protect consumers in that way,

742
00:44:02,640 --> 00:44:05,759
Speaker 1: in a way that the agency itself is saying like, yes,

743
00:44:05,920 --> 00:44:09,960
Speaker 1: this is dangerous, somebody should do something. Who will do something?

744
00:44:10,360 --> 00:44:12,719
Speaker 1: And then everybody's like, well, it's kind of your job

745
00:44:12,840 --> 00:44:15,040
Speaker 1: to do that, and they're like, oh, well, don't worry

746
00:44:15,040 --> 00:44:17,080
Speaker 1: about it. That's fine. Yeah. I mean they actually the

747
00:44:17,200 --> 00:44:20,320
Speaker 1: FDA pulled public notices at the Federal Register that have

748
00:44:20,400 --> 00:44:23,440
Speaker 1: been around for thirty years. They literally just made them

749
00:44:23,480 --> 00:44:29,080
Speaker 1: disappear overnight. When this became controversial in the two thousand

750
00:44:29,280 --> 00:44:33,600
Speaker 1: early tens, UM, they just said, we're gonna take the

751
00:44:33,840 --> 00:44:36,600
Speaker 1: that those briefs where we said that it's dangerous and

752
00:44:36,640 --> 00:44:40,480
Speaker 1: somebody should do something, We're gonna stop having those published. Um.

753
00:44:40,920 --> 00:44:45,319
Speaker 1: They also were largely criticized, UM a few years back

754
00:44:46,200 --> 00:44:49,880
Speaker 1: for basically like just sitting on their hands about the

755
00:44:50,600 --> 00:44:55,840
Speaker 1: GMO labeling. Yeah, that's yeah, dan quayle uh kind of

756
00:44:55,920 --> 00:44:58,080
Speaker 1: change history with that many years ago. What did you do?

757
00:44:58,480 --> 00:45:00,320
Speaker 1: I think he was the one that which for the

758
00:45:00,400 --> 00:45:05,799
Speaker 1: legislation that allowed GMOs. Okay, so this is fine. You've

759
00:45:05,800 --> 00:45:09,880
Speaker 1: got GMOs. You've got a label food that contains GMOs.

760
00:45:10,040 --> 00:45:11,960
Speaker 1: That's it. Don't do anything else. You just have to

761
00:45:12,200 --> 00:45:15,560
Speaker 1: say on the label, this product may contain GMOs. Right,

762
00:45:16,160 --> 00:45:20,279
Speaker 1: there was a big push. Apparently a million signatures were

763
00:45:20,400 --> 00:45:24,080
Speaker 1: generated from the just label at campaign and we're submitted

764
00:45:24,560 --> 00:45:28,040
Speaker 1: properly to the f d A, and the FDA rejected

765
00:45:28,320 --> 00:45:31,759
Speaker 1: all but three ninety four of the signatures that were

766
00:45:31,960 --> 00:45:35,399
Speaker 1: given to it because about a million of them were

767
00:45:35,719 --> 00:45:38,640
Speaker 1: in a single electronic document and they were like, these

768
00:45:38,719 --> 00:45:42,080
Speaker 1: don't count. So they didn't do anything about it. And

769
00:45:42,280 --> 00:45:45,279
Speaker 1: there's still no GMO labeling. So, regardless of how you

770
00:45:45,320 --> 00:45:50,080
Speaker 1: feel about GMOs and GMO labeling, that's pretty shady stuff

771
00:45:50,480 --> 00:45:55,160
Speaker 1: to just overtly reject a million signatures, especially as part

772
00:45:55,200 --> 00:46:00,520
Speaker 1: of a large national public campaign. Absolutely. Buyox is a

773
00:46:00,719 --> 00:46:06,120
Speaker 1: pain killer that was approved by the FDA, And just

774
00:46:06,280 --> 00:46:09,040
Speaker 1: to go over this stuff. Uh. In two thousand, a

775
00:46:09,160 --> 00:46:12,400
Speaker 1: study showed that the drug posed a big heart attack

776
00:46:12,520 --> 00:46:16,120
Speaker 1: risk when compared to a similar pain killer, and Mark,

777
00:46:16,160 --> 00:46:18,480
Speaker 1: who was a manufacturer biox, kind of blew it off

778
00:46:19,120 --> 00:46:23,720
Speaker 1: and said it's really beneficial, and the FDA said okay,

779
00:46:24,440 --> 00:46:28,120
Speaker 1: and biox pretty much. Biox remained on the market for

780
00:46:28,200 --> 00:46:33,320
Speaker 1: another four years and UM they estimate between eight thousand

781
00:46:33,400 --> 00:46:36,360
Speaker 1: and a hundred and forty thousand heart attacks were caused

782
00:46:36,400 --> 00:46:39,160
Speaker 1: by biox in that time. And it wasn't It wasn't

783
00:46:39,200 --> 00:46:42,600
Speaker 1: the FDA whoever removed by Ox. It was Murk bowing

784
00:46:42,680 --> 00:46:46,400
Speaker 1: to public pressure. FDA never never, Mark just took it

785
00:46:46,440 --> 00:46:48,719
Speaker 1: off the market itself because it was starting to look bad,

786
00:46:48,960 --> 00:46:51,759
Speaker 1: and the FDU was like, what's going on, what are

787
00:46:51,760 --> 00:46:55,920
Speaker 1: you guys doing? How about a success UM. In the

788
00:46:56,080 --> 00:47:00,840
Speaker 1: nineteen fifties, UH in Germany there were scientists who created

789
00:47:00,920 --> 00:47:04,640
Speaker 1: something called Philidamie, which was a sleeping pill, and they

790
00:47:04,680 --> 00:47:08,239
Speaker 1: said it it's over the counter, it's totally safe for

791
00:47:08,480 --> 00:47:12,400
Speaker 1: Europe for pregnant women. Even is a sleeping pill? Not

792
00:47:12,560 --> 00:47:15,480
Speaker 1: so safe though, because UM children were being born with

793
00:47:15,600 --> 00:47:19,440
Speaker 1: malform limbs to the tune of ten thousand worldwide, but

794
00:47:19,880 --> 00:47:23,560
Speaker 1: not very many in the United States. Because Francis Oldham

795
00:47:23,600 --> 00:47:26,440
Speaker 1: Kelsey of the f D a was really resistant and

796
00:47:26,520 --> 00:47:28,919
Speaker 1: made a big push to not allow the Lita mics.

797
00:47:29,000 --> 00:47:30,520
Speaker 1: She didn't think it was safe. No, she was in

798
00:47:30,680 --> 00:47:33,440
Speaker 1: charge of reviewing the data and said, what is this.

799
00:47:33,560 --> 00:47:36,920
Speaker 1: This is basically anecdotal, like where's your real data, and

800
00:47:37,040 --> 00:47:40,719
Speaker 1: would not withstood a lot of pressure to approve this

801
00:47:40,840 --> 00:47:44,600
Speaker 1: drug and would not cave in. And as a result,

802
00:47:45,040 --> 00:47:51,200
Speaker 1: only seventeen babies were born um with um malformations because

803
00:47:51,280 --> 00:47:54,759
Speaker 1: of in the US, and the whole reason that there

804
00:47:54,760 --> 00:47:56,759
Speaker 1: were any was because they found out that the drug

805
00:47:56,840 --> 00:47:59,920
Speaker 1: maker was pushing the drugs for free onto a man

806
00:48:00,000 --> 00:48:04,840
Speaker 1: are conductors to distribute as samples while this while the

807
00:48:04,920 --> 00:48:09,000
Speaker 1: FDA was holding up approval, and so seventeen children were

808
00:48:09,120 --> 00:48:12,880
Speaker 1: born with deformities because of it, because of this these

809
00:48:12,960 --> 00:48:16,280
Speaker 1: free drugs. Apparently, in Canada, this story was even different.

810
00:48:16,320 --> 00:48:19,879
Speaker 1: The Canadian government, it was totally it was totally legal

811
00:48:20,040 --> 00:48:24,200
Speaker 1: and approved in Canada and for months after it became

812
00:48:24,719 --> 00:48:29,120
Speaker 1: worldwide known that thelidamide caused birth effects because it it

813
00:48:29,719 --> 00:48:33,800
Speaker 1: crosses the placental barrier and arrests development of the fetus.

814
00:48:33,960 --> 00:48:36,960
Speaker 1: Right Canada knew, everybody knew about it, and it took

815
00:48:37,120 --> 00:48:40,759
Speaker 1: months before Canada finally outlawed it. So there's like this

816
00:48:40,920 --> 00:48:46,000
Speaker 1: real big public shame hanging over Canada's um government agency

817
00:48:46,160 --> 00:48:50,080
Speaker 1: regulating drugs still to this day because of that. And

818
00:48:50,200 --> 00:48:53,120
Speaker 1: Billy Joel wrote a song about it. Oh yeah, well

819
00:48:53,200 --> 00:48:56,800
Speaker 1: it was in that terrible talk we didn't start the children.

820
00:48:58,080 --> 00:49:01,200
Speaker 1: I forgot about that. Um, but yeah, that was one

821
00:49:01,239 --> 00:49:04,640
Speaker 1: of the FDA's great successes. And as a result, actually, um,

822
00:49:05,320 --> 00:49:11,480
Speaker 1: the Congress passed something an amendment to the Food and

823
00:49:11,520 --> 00:49:14,759
Speaker 1: Drug Act, the Father Harris Amendments of nineteen sixty two,

824
00:49:15,239 --> 00:49:19,920
Speaker 1: that really expanded the f d a's um scope of duties.

825
00:49:20,600 --> 00:49:23,279
Speaker 1: It put, um, you know how you know those have

826
00:49:23,440 --> 00:49:27,120
Speaker 1: drug ads, have all those disclaimers. That's from the nineteen

827
00:49:27,160 --> 00:49:31,160
Speaker 1: sixty two amendments. Advertising is under the juristic scene. They

828
00:49:31,239 --> 00:49:33,120
Speaker 1: read those so fast, and the last one is an

829
00:49:33,160 --> 00:49:35,879
Speaker 1: early death right exactly like do you need to say

830
00:49:35,920 --> 00:49:42,440
Speaker 1: early death? No? Um, they And prior to nineteen sixty two,

831
00:49:42,560 --> 00:49:46,560
Speaker 1: the FDA had sixty days to respond to an application

832
00:49:47,000 --> 00:49:49,319
Speaker 1: and if they didn't get to it in time, well

833
00:49:49,400 --> 00:49:52,319
Speaker 1: that's fine. I'm sure it's fine. You can go to market. Um.

834
00:49:52,480 --> 00:49:54,640
Speaker 1: That changed to I think a hundred and eighty days,

835
00:49:54,640 --> 00:49:57,520
Speaker 1: and it's just to respond um and then also drug

836
00:49:57,600 --> 00:50:00,719
Speaker 1: makers only had to demonstrate that the or drug was

837
00:50:01,440 --> 00:50:05,919
Speaker 1: UM safe not effective. That changed the two as well. Yep.

838
00:50:06,320 --> 00:50:09,240
Speaker 1: They also said that they had to control the marketing

839
00:50:09,280 --> 00:50:12,600
Speaker 1: of generic drugs to keep them from being sold as

840
00:50:13,480 --> 00:50:15,719
Speaker 1: uh just like jacking up the price under a new

841
00:50:15,800 --> 00:50:19,600
Speaker 1: name basically. So um, yeah, that was a great amendment,

842
00:50:19,640 --> 00:50:27,040
Speaker 1: the Kerfuffle Harris amendment. Is that right? That's father So

843
00:50:27,239 --> 00:50:31,800
Speaker 1: another great success. Well that was the same one. Well no,

844
00:50:31,960 --> 00:50:35,080
Speaker 1: I mean in addition to the lido Uh. And then

845
00:50:35,280 --> 00:50:39,280
Speaker 1: in the news recently you dug this up, the Zohydra painkiller.

846
00:50:39,440 --> 00:50:41,279
Speaker 1: Didn't hear about this? No, I haven't heard of this

847
00:50:41,440 --> 00:50:46,360
Speaker 1: until today. It's uh, apparently it's pure oxycodone, correct it is.

848
00:50:46,800 --> 00:50:50,160
Speaker 1: There's the first time. Yeah, there is. Um. All the

849
00:50:50,239 --> 00:50:53,680
Speaker 1: other stuff like vik it in and oxyconton even or

850
00:50:54,400 --> 00:50:58,680
Speaker 1: are safer because they contain at least something else like

851
00:50:58,800 --> 00:51:01,719
Speaker 1: a seed, a mena fan or some other drug. This

852
00:51:01,960 --> 00:51:06,600
Speaker 1: is just pure hydrocodone. And um. You remember like there

853
00:51:06,680 --> 00:51:09,759
Speaker 1: was a huge, huge problem with pill addiction to oxyconton

854
00:51:09,760 --> 00:51:12,640
Speaker 1: in particular. Yeah, it wasn't just rush limball with a

855
00:51:12,719 --> 00:51:15,520
Speaker 1: lot of people. Yeah, we're really hooked on oxycont and

856
00:51:15,560 --> 00:51:19,200
Speaker 1: as a matter of fact, the current um heroin addiction

857
00:51:19,320 --> 00:51:22,400
Speaker 1: crisis in the US is a direct result of the

858
00:51:22,560 --> 00:51:25,799
Speaker 1: FDA stepping in and saying like, hey, you guys need

859
00:51:25,880 --> 00:51:28,360
Speaker 1: to do something with oxyconton. Like people are crushing it

860
00:51:28,480 --> 00:51:30,799
Speaker 1: up and injecting it. You gotta do something. So now

861
00:51:31,719 --> 00:51:34,160
Speaker 1: there's well, there's a Tampa resistant thing where when you

862
00:51:34,280 --> 00:51:36,880
Speaker 1: crush up oxyconton, now it turns into this goog that

863
00:51:37,000 --> 00:51:39,840
Speaker 1: you can inject or snort. Right, Can you lick it

864
00:51:39,880 --> 00:51:42,879
Speaker 1: off a mirror? You can? I guess, but I don't

865
00:51:42,920 --> 00:51:45,239
Speaker 1: think it has the same effect, right because when you

866
00:51:45,360 --> 00:51:47,120
Speaker 1: when you crush it up, it was time released. When

867
00:51:47,120 --> 00:51:49,680
Speaker 1: you crush it up, it's not time released anymore. It's

868
00:51:49,719 --> 00:51:54,560
Speaker 1: like all there to give you this a media, right.

869
00:51:54,760 --> 00:51:57,759
Speaker 1: So now that when you crush up oxyconton it turns

870
00:51:57,800 --> 00:52:00,960
Speaker 1: into a Google. Everybody's turned to hair one, right, So

871
00:52:01,080 --> 00:52:04,840
Speaker 1: now there's a heroin epidemic. This company making zo Hydra

872
00:52:05,239 --> 00:52:08,440
Speaker 1: came along and said, well, that's cool, just released this

873
00:52:08,560 --> 00:52:12,440
Speaker 1: completely pure hydro code un pill without any tamper resistance.

874
00:52:13,080 --> 00:52:16,280
Speaker 1: So we're gonna go back to square one, everybody, okay,

875
00:52:16,600 --> 00:52:20,239
Speaker 1: And there's a huge outcry against this drug, and the

876
00:52:20,440 --> 00:52:24,160
Speaker 1: FDA had stepped up and became a mouthpiece for it. Yeah,

877
00:52:24,200 --> 00:52:27,840
Speaker 1: and the FDA will, um, they will defend the decision

878
00:52:27,920 --> 00:52:30,880
Speaker 1: by saying, well, putting things like a set of menifin

879
00:52:31,800 --> 00:52:35,240
Speaker 1: has well known liver damage risk, so this is actually

880
00:52:35,320 --> 00:52:38,200
Speaker 1: more pure. You can actually take hydro coda. Now, people

881
00:52:38,239 --> 00:52:42,239
Speaker 1: in severe pain can take this drug without that liver

882
00:52:42,360 --> 00:52:45,480
Speaker 1: toxicity risk. I mean that's a point. Now, it is

883
00:52:45,520 --> 00:52:48,600
Speaker 1: a point. And if you're in severe pain in life

884
00:52:48,640 --> 00:52:51,640
Speaker 1: and need this to to function or live out your life,

885
00:52:51,719 --> 00:52:54,759
Speaker 1: then great, But make it tamper resistance. Yeah, that's not

886
00:52:55,000 --> 00:52:56,840
Speaker 1: what people are arguing about. They're saying that this is

887
00:52:56,920 --> 00:53:02,280
Speaker 1: a very high level for abuse because there's no tamper resistance. Yeah, exactly,

888
00:53:02,520 --> 00:53:06,359
Speaker 1: So people are going to die because of this drub Yeah,

889
00:53:06,520 --> 00:53:11,239
Speaker 1: I think. Um. In two thousand and ten, uh, prescription

890
00:53:11,480 --> 00:53:15,400
Speaker 1: hydro codone and other prescription opiates accounting for almost seventeen

891
00:53:15,440 --> 00:53:19,399
Speaker 1: thousand deaths, which is a fourfold increase from just ten

892
00:53:19,520 --> 00:53:22,200
Speaker 1: or eleven years earlier. Right, and that was all Oh

893
00:53:22,320 --> 00:53:27,160
Speaker 1: see before they made it tamper resistant. Orange County. There's

894
00:53:27,160 --> 00:53:29,360
Speaker 1: probably a lot of it in county. I bet there

895
00:53:29,520 --> 00:53:36,120
Speaker 1: is so there you go, crazy stuff. It is crazy stuff. Um.

896
00:53:36,800 --> 00:53:39,920
Speaker 1: I kind of with that professor from Arizona. That's just

897
00:53:40,120 --> 00:53:44,960
Speaker 1: like safety, Like it's it's sad that the chief of

898
00:53:45,080 --> 00:53:48,439
Speaker 1: that organization can't be someone who's super pro safety above

899
00:53:48,480 --> 00:53:51,399
Speaker 1: all else. Yeah, that's their job. There's such a tug

900
00:53:51,480 --> 00:53:58,719
Speaker 1: of war between the public and I guess corporations over safety. Yeah,

901
00:53:58,880 --> 00:54:00,719
Speaker 1: and the f d A is not pulling on our

902
00:54:00,800 --> 00:54:03,719
Speaker 1: side necessarily. Yeah. And I'm sure we'll hear from all

903
00:54:03,800 --> 00:54:06,480
Speaker 1: kinds of people from the pharmaceutical industry that will tout

904
00:54:06,560 --> 00:54:09,480
Speaker 1: how seriously they take their testing and stuff. And we're

905
00:54:09,480 --> 00:54:12,840
Speaker 1: not saying they don't. But um no, I think it

906
00:54:13,000 --> 00:54:16,600
Speaker 1: is a There are great protocols and standards and procedures,

907
00:54:16,640 --> 00:54:20,400
Speaker 1: but there's also plenty of times where they just overtly

908
00:54:20,480 --> 00:54:25,359
Speaker 1: dropped the ball and public safety suffered as a result. Agreed. Uh.

909
00:54:25,440 --> 00:54:27,200
Speaker 1: If you want to know more about the f d A,

910
00:54:27,360 --> 00:54:31,480
Speaker 1: you can go to the FDA website FDA dot gov.

911
00:54:31,600 --> 00:54:33,880
Speaker 1: You can go to how Stuff Works dot com and

912
00:54:34,120 --> 00:54:36,319
Speaker 1: type in f d A in the search bar. Don't

913
00:54:36,360 --> 00:54:38,960
Speaker 1: forget to go to our podcast page on Stuff you

914
00:54:38,960 --> 00:54:41,800
Speaker 1: Should Know dot com for the f d A episode

915
00:54:41,840 --> 00:54:44,799
Speaker 1: that you're listening to now, and since I said search

916
00:54:44,880 --> 00:54:49,520
Speaker 1: bar in there somewhere, it's time for listener mail. I'm

917
00:54:49,520 --> 00:54:54,000
Speaker 1: gonna call this uh we inspired a writer awesome. Hey

918
00:54:54,080 --> 00:54:55,960
Speaker 1: guys and Jerry, first off, thank you so much for

919
00:54:56,000 --> 00:54:57,919
Speaker 1: what you do. I've been a fan for over three years,

920
00:54:58,480 --> 00:55:00,920
Speaker 1: steadily working my way through the back living in constant

921
00:55:00,960 --> 00:55:03,560
Speaker 1: fear of the existential dread that will settle upon me

922
00:55:03,640 --> 00:55:06,520
Speaker 1: the day I finish UM. I poked my sister as well.

923
00:55:06,680 --> 00:55:11,480
Speaker 1: And whereas our conversations used to be Simpsons quotes, now

924
00:55:11,800 --> 00:55:15,920
Speaker 1: it is nine Simpson's ten percent stuff. You should know that,

925
00:55:18,040 --> 00:55:20,120
Speaker 1: she says. But I digress. I'm writing because I'm an

926
00:55:20,120 --> 00:55:23,520
Speaker 1: author of dark humor novels for young adults, and I

927
00:55:23,600 --> 00:55:25,520
Speaker 1: wanted to express how health of your podcast has been

928
00:55:25,560 --> 00:55:29,520
Speaker 1: with inspiring and informing various elements of my books. For example,

929
00:55:29,600 --> 00:55:31,960
Speaker 1: the one I'm currently writing is about a creepy candle

930
00:55:32,040 --> 00:55:35,280
Speaker 1: factory in a creepy small town with a big, creepy

931
00:55:35,320 --> 00:55:40,160
Speaker 1: mountain wherein wax sculptures come to life, and after listening

932
00:55:40,239 --> 00:55:44,919
Speaker 1: to your ear Wax episode, Mount Ceremon was born pretty neat.

933
00:55:46,000 --> 00:55:48,320
Speaker 1: Ever since the Haunted House episode of Been Itching, to

934
00:55:48,360 --> 00:55:51,360
Speaker 1: write a horror about a horror attraction that goes terribly

935
00:55:51,440 --> 00:55:55,200
Speaker 1: and hilariously wrong. Number stations equals something awesome, and so

936
00:55:55,400 --> 00:55:57,880
Speaker 1: on and so on. So we're inspiring her all over

937
00:55:57,960 --> 00:56:00,040
Speaker 1: the place. I never know where your inspirations go and

938
00:56:00,160 --> 00:56:01,920
Speaker 1: come from, but your so provides me with a steady

939
00:56:02,000 --> 00:56:05,320
Speaker 1: stream of delicious possibilities. I want to thank you the

940
00:56:05,360 --> 00:56:06,920
Speaker 1: best way I could, So I named a couple of

941
00:56:07,000 --> 00:56:11,239
Speaker 1: off screen high school characters after you, guys in my

942
00:56:11,360 --> 00:56:14,800
Speaker 1: most recently published book, Hellhole. So wait, how about that?

943
00:56:15,000 --> 00:56:17,959
Speaker 1: That is a huge honor, pretty neat And she's gonna

944
00:56:18,000 --> 00:56:20,799
Speaker 1: send us some copies and one for Jerry too, of course,

945
00:56:20,840 --> 00:56:24,520
Speaker 1: she says, So I'm gonna send our mailing address. And

946
00:56:25,600 --> 00:56:27,200
Speaker 1: she says, thanks for the brain snacks. And that was

947
00:56:27,239 --> 00:56:31,000
Speaker 1: from Gina Domico d A M I c O. And

948
00:56:31,080 --> 00:56:33,319
Speaker 1: she has a website and you can check out her

949
00:56:34,040 --> 00:56:37,080
Speaker 1: kind of a weird, funny, twisted young adult novels at

950
00:56:37,120 --> 00:56:44,000
Speaker 1: her site and support support writing creativity. Thanks lord, Gina. Right, yeah,

951
00:56:44,080 --> 00:56:46,440
Speaker 1: and uh, make sure you get l old so you

952
00:56:46,480 --> 00:56:51,440
Speaker 1: can see our names in print. You don't like that

953
00:56:51,560 --> 00:56:55,399
Speaker 1: was waiting for government joke? Oh? Was it? Oh? You'll

954
00:56:55,440 --> 00:56:59,000
Speaker 1: explain to me later. Right, how are you uh? If

955
00:56:59,040 --> 00:57:02,160
Speaker 1: you want to, you get in touch with us to

956
00:57:02,280 --> 00:57:05,200
Speaker 1: find out the waiting for gufnment joke Chuck just made.

957
00:57:05,400 --> 00:57:10,880
Speaker 1: He'll respond to each each inquiry personally. Right. You can

958
00:57:10,960 --> 00:57:13,719
Speaker 1: tweet to us at s y ESK Podcast. You can

959
00:57:13,800 --> 00:57:16,160
Speaker 1: join us on Facebook dot com. You can join us

960
00:57:16,200 --> 00:57:18,440
Speaker 1: on Facebook dot com, slash stuff you Should Know. You

961
00:57:18,560 --> 00:57:21,040
Speaker 1: can send us an email to Stuff Podcast at how

962
00:57:21,120 --> 00:57:24,320
Speaker 1: stuff Works dot com, and as always, joined us at

963
00:57:24,320 --> 00:57:26,480
Speaker 1: at home on the web Stuff you Should Know dot com.

964
00:57:31,800 --> 00:57:34,200
Speaker 1: For more on this and thousands of other topics, is

965
00:57:34,280 --> 00:57:35,520
Speaker 1: it how stuff Works dot com