WEBVTT - Does the FDA Protect Americans?

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<v Speaker 1>Welcome to Stuff you Should Know from House Stuff Works

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<v Speaker 1>dot com. Hey, and welcome to the podcast. I'm Josh

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<v Speaker 1>Clark with Charles W. Chuck Bryant and Jerry over there.

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<v Speaker 1>So this is stuff you should know the podcast. How

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<v Speaker 1>does doing fine? How are you great? Yeah? Yeah, that's good.

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<v Speaker 1>I enjoyed learning about the f d A. Yeah, you

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<v Speaker 1>know we've podcasted on him before. Why doesn't the FDA

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<v Speaker 1>regulate herbal supplements? Right? Man, we did that long time ago.

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<v Speaker 1>Remember that's where the herbal Elvis comes out. Oh yeah,

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<v Speaker 1>was that the first appearance? I'm pretty sure. Hey, man,

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<v Speaker 1>give me some supplements. Your dad doctor, He just like

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<v Speaker 1>would go around the house. Yeah, when he was on

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<v Speaker 1>Herble Upper. Sure. Yeah man, how did you talk on

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<v Speaker 1>the herbal downers? He didn't. He just slept a lot, gotcha.

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<v Speaker 1>Um No, I'm just tease of course. So we have

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<v Speaker 1>talked about the FDA before, but yeah, this is um

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<v Speaker 1>this is a much more in depth. Look that's right

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<v Speaker 1>at the ft. Okay, let's set your Chris Walkin. No

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<v Speaker 1>was that Chris Walkin? No? Not really, I mean the

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<v Speaker 1>weird pauses, but I was more doing Shatner. Oh but

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<v Speaker 1>I didn't go up, which should have Sure pretty good though,

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<v Speaker 1>huh yeah, pretty clear, Bill sat So, uh did you

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<v Speaker 1>know most of this stuff? Um? Well, I know that

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<v Speaker 1>the f d A is is has a history of

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<v Speaker 1>controversy of people saying, uh, you're not you don't act

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<v Speaker 1>fast enough. We need these drugs to help people. Or

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<v Speaker 1>then other people are like, stop acting so much exactly,

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<v Speaker 1>you're going too fast and rushing these things to market,

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<v Speaker 1>right exactly. So it's it's a bit of a tough

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<v Speaker 1>thing to reconcile, you know. There. I acknowledge they're in

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<v Speaker 1>a tough spot. They really are. And um, I think

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<v Speaker 1>that's a good, good caveat or disclaimer to put it

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<v Speaker 1>in the front of this because it is a very

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<v Speaker 1>controversial agency. It's the first consumer protection agency in the

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<v Speaker 1>United States ever, it's the oldest one, and um it's

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<v Speaker 1>common liberal or what have you. But I think it

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<v Speaker 1>is a very um important agency to have. Oh I

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<v Speaker 1>don't think that makes you liberal. So some people may say,

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<v Speaker 1>so what they don't think we should regulate anything in

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<v Speaker 1>this country. Yeah, there's people who think that, like the

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<v Speaker 1>f d A is just completely in the way of business.

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<v Speaker 1>It's a a fetter right, that's a thing because unfettered,

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<v Speaker 1>if you can be unfettered, you can be fettered. But

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<v Speaker 1>is there something that can fetter and would that be

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<v Speaker 1>a fetter? So it's a fetter to business to some

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<v Speaker 1>in some people's mind. Um yeah, I just think that

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<v Speaker 1>you when you were talking about something as um elemental

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<v Speaker 1>as food or drugs, thinks we put into our bodies

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<v Speaker 1>and the hopes that we will be have a greater

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<v Speaker 1>well being that you kind of do have to have

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<v Speaker 1>a big kid on the block looking out for all

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<v Speaker 1>the little kids. Well, I mean, I think when when

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<v Speaker 1>big bucks are involved, it's pretty clear that companies themselves

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<v Speaker 1>probably aren't gonna like pull back on their profits in

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<v Speaker 1>order to just be super safe, like it has been

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<v Speaker 1>proven throughout history that they'll generally want like air on

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<v Speaker 1>the side of making the money. You know, you're a comic,

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<v Speaker 1>is gonna be fun. So Okay, now that we got

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<v Speaker 1>that out of the way, Chuck, let's dig into the FDA,

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<v Speaker 1>because if you want to see whether or not you

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<v Speaker 1>think the f d A is necessary, all you have

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<v Speaker 1>to do is go back to the days before the FDA,

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<v Speaker 1>which wasn't too terribly long ago. I mean, the FDA

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<v Speaker 1>really only finds its origins and uh nineteen o six

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<v Speaker 1>on paper, it goes a little bit back before that today,

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<v Speaker 1>I think the Abraham Lincoln administration. Yeah, who was a

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<v Speaker 1>pinko himself. Let's climb in the way back machine, shall we.

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<v Speaker 1>Oh yeah, it's been a little man. It smells like

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<v Speaker 1>cat in here. I know. Well I took a little

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<v Speaker 1>ride with Laurent and the Wizard and uh, sorry about nothing. Man,

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<v Speaker 1>how are they doing well? They're doing great, But um,

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<v Speaker 1>I forgot to bring a little box. So yeah, there

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<v Speaker 1>was an accident. Um, so here we are in the

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<v Speaker 1>way back machine and we're going all the way back,

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<v Speaker 1>like you said, to the Times of Lincoln. And what

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<v Speaker 1>he did he kind of kicked kick the man. I

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<v Speaker 1>couldn't say that the other day in private the bucket. No,

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<v Speaker 1>I want to say, get the ball rolling and kick

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<v Speaker 1>it off. And I said kick the ball, kick the

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<v Speaker 1>ball rolling. I said that the other day. It's like

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<v Speaker 1>twice that's okay. So he wanted to kick the ball rolling.

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<v Speaker 1>And so he appointed a chemist named Charles weather Roll

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<v Speaker 1>to analyze agricultural materials. Sniffed him on the case. Yeah,

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<v Speaker 1>he sniffed them on the case. Not off, said hey,

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<v Speaker 1>food and soil and fertilizer, maybe look into that. We

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<v Speaker 1>have the new Department of Agriculture. And then his successors,

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<v Speaker 1>Harvey Wiley and Peter Collier were the dudes who really

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<v Speaker 1>um kind of got things going in a in a

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<v Speaker 1>like a serious way for the FDA. Well, they saw

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<v Speaker 1>like a real um reason for an agency that was

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<v Speaker 1>in charge of guarding safeguarding the purity of food and

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<v Speaker 1>drugs at the American public was ingesting. They basically saw

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<v Speaker 1>what was going on. I was like, Hey, we might

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<v Speaker 1>need to step in here because prior to this, I mean,

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<v Speaker 1>we talked about it in UM are Bizarre Medical Treatments

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<v Speaker 1>episode I think where we were just talking about UM

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<v Speaker 1>like little kids being given morphine in like a prescription

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<v Speaker 1>that in no way, shape or form said there was

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<v Speaker 1>morphine and it just calm colicky babies, and it calmed

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<v Speaker 1>him by bringing him to the brink of death on

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<v Speaker 1>him morphine overdose. But you could buy it over the counter.

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<v Speaker 1>You shouldn't regulate that, that's business. So that's one and

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<v Speaker 1>that was the one that actually used morphine there. I'm

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<v Speaker 1>sure others that were out there that were um much

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<v Speaker 1>more lethal use knockoff morphine or something like that that

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<v Speaker 1>cousin Tony made in his basement. You could do it

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<v Speaker 1>bottle and if the person, if the person bought it

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<v Speaker 1>and they died, well, buyer beware, you know. Um. So

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<v Speaker 1>the guys like Um, Wiley and Collie or especially Wiley, though,

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<v Speaker 1>we're really adamant about getting some sort of regulation and

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<v Speaker 1>specifically taking this agency that they've been handed um and

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<v Speaker 1>and building it into into a real powerhouse. Yeah. And

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<v Speaker 1>over the course of about twenty five years, they got

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<v Speaker 1>Congress to look over about a hundred bills for the

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<v Speaker 1>food and drug industry. I guess Congress said, no, no, no,

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<v Speaker 1>we're pretty deep in the industry's pockets, so we can't

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<v Speaker 1>really do anything right now. We agree with you, totally

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<v Speaker 1>great idea, but I'm sorry, but I a car is

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<v Speaker 1>about to be invented and I want to own one,

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<v Speaker 1>and pretty bad. Well that'll change, though, my friend. In

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<v Speaker 1>nineteen six, UM when h reporter novelist Upton Sinclair wrote

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<v Speaker 1>The Jungle, which UM, like everyone sort of this very

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<v Speaker 1>famous book that uh exposed the practices of the meat

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<v Speaker 1>packing industry in Chicago in particular. But um, it was

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<v Speaker 1>a big deal and it caused a lot of people

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<v Speaker 1>to really freak out. It wasn't It was a novel,

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<v Speaker 1>which means it was fictitious, but it was based on

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<v Speaker 1>his and he was a journalist too. It was based

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<v Speaker 1>on his experiences I guess, working undercover in the Chicago

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<v Speaker 1>meat packing plants, and apparently I guess Roosevelt, Teddy Roosevelt

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<v Speaker 1>set up an investigation, a committee to investigate. He claims

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<v Speaker 1>fan of Sinclair's at all, but I think he's sort

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<v Speaker 1>of Everyone was so repulsed he had to do something. Yeah,

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<v Speaker 1>I mean, like it really got the America in public

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<v Speaker 1>because the stories are things like, um, they were using

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<v Speaker 1>disease cows for meat, and there were rats that were

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<v Speaker 1>calling around on the cows, and so they poisoned the rats,

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<v Speaker 1>and then the dead poisoned rats with the poison, and

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<v Speaker 1>the diseased cow meat would all be put into a

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<v Speaker 1>grinder and there was your potted meat on the other side. Yeah,

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<v Speaker 1>he was, Uh, I still won't eat potted meat. Yeah, well,

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<v Speaker 1>I don't care what year it is. You take me

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<v Speaker 1>to the future in twenty two thousand, three hundred and twelve,

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<v Speaker 1>and I'm not gonna eat potted meat. I wish the

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<v Speaker 1>way back machine could go to the future. Well, that's

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<v Speaker 1>the way forward machine. We have one of those well

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<v Speaker 1>nuls working on it. Okay, it'll be a while. Um.

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<v Speaker 1>So they had to do something because there were even

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<v Speaker 1>accusations of people being in meat um, which apparently was

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<v Speaker 1>not true and that was really fictitious. Right. But that

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<v Speaker 1>committee that investigated Sinclair's claims in the Jungle found that

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<v Speaker 1>pretty much everything else he said in that book was

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<v Speaker 1>through step for the guy being ground up with the

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<v Speaker 1>beef because he fell into a meat grinder. And they

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<v Speaker 1>were just like, again, the meat business is not able

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<v Speaker 1>to police itself and say maybe we shouldn't put disease

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<v Speaker 1>rats and meat. So the government was forced to step

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<v Speaker 1>in and in nineteen oh six, on June thirty, Congress

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<v Speaker 1>past the Food and Drugs Act a k a. The

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<v Speaker 1>Wiley Act, and that prohibited um trade of mislabeled and

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<v Speaker 1>contaminated food, bevies and medicines across state lines. So I

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<v Speaker 1>guess you can still sell it in Illinois, you know. Yeah,

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<v Speaker 1>That's the one thing I never get is the shipping thing, Like, well,

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<v Speaker 1>that's that's the only thing that they can enforce. Er. Well, yeah,

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<v Speaker 1>the the federal government is there's always been a struggle

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<v Speaker 1>between states in federal right, and so the kind of

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<v Speaker 1>the line has been drawn at the state borders where

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<v Speaker 1>it's like RoCE across the state border all of a sudden,

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<v Speaker 1>you're part of the United States rather than just the state,

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<v Speaker 1>and you want to leave it up to the state.

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<v Speaker 1>But over time the federal government has taken more and

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<v Speaker 1>more power from the states. With the Wily Act, though, Chuck,

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<v Speaker 1>I mean, it's named after Wiley, so it gives you

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<v Speaker 1>an idea of like the links that this guy went

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<v Speaker 1>too to try to establish some sort of standards for

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<v Speaker 1>purity and food. Right. One of the things he did

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<v Speaker 1>was set up what came to be called the Poison Squad. Yeah,

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<v Speaker 1>that's a great name, isn't it. It really isn't It

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<v Speaker 1>was a sensational name, and at first he fought it,

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<v Speaker 1>and then he finally saw like he was worried that

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<v Speaker 1>with a name like the poison Squad, they had their

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<v Speaker 1>own little poison squad. An thom and Um the articles

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<v Speaker 1>written about the Poison Squad really sensational and like, can

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<v Speaker 1>you believe how crazy these guys are? Um and at

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<v Speaker 1>first wild he fought it because he he was like,

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<v Speaker 1>this is a really serious scientific undertaking. And then finally

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<v Speaker 1>he saw the writing on the wall. It was like,

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<v Speaker 1>you can get America behind this whole idea if you

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<v Speaker 1>just give him the poison Squad as they want the

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<v Speaker 1>poison Squad. And it's like I have added everybody they

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<v Speaker 1>haven't had them. They did. It's in this this article

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<v Speaker 1>for m like the FDA Zone Consumer magazine or whatever

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<v Speaker 1>from I think two thousand two, The Boys and Squad,

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<v Speaker 1>The Boys and Squad something like. It's something it's kind

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<v Speaker 1>of like that. It's like, um, it's like when they

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<v Speaker 1>take these bites, um, they won't feel any pain, but

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<v Speaker 1>when they wake up in the morning, they'll probably never

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<v Speaker 1>be the same. Just stuff like that. It's just kind

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<v Speaker 1>of like, um, you know how they used to make

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<v Speaker 1>jokey songs in the early interesting. So what the Poison

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<v Speaker 1>Squad was was a group of men volunteers we should

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<v Speaker 1>point out who signed up for this and repeatedly signed

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<v Speaker 1>up for this and signed away their right to sue

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<v Speaker 1>or anything. They were fully on board, um to eat

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<v Speaker 1>poison and to basically uh in a in a kitchen

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<v Speaker 1>there on h Washington, d C. In the basement of

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<v Speaker 1>the FDA's building. Yeah, they would have had a chef

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<v Speaker 1>that apparently made some great meals laced with all kinds

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<v Speaker 1>of poison for mal hide, borax, what was a really

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<v Speaker 1>harmful one. It was called copper sulfate, right, which is

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<v Speaker 1>now pesticide. Correct. Yeah, and they used it to make

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<v Speaker 1>camps appear bright green, and that that kind of gets

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<v Speaker 1>to the heart of the matter. Chuck, Like they these

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<v Speaker 1>guys weren't just eating poison just for fun. Oh no,

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<v Speaker 1>they were testing out stuff that was being used as

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<v Speaker 1>preservatives and food at the time. Exactly, additives and preservatives

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<v Speaker 1>and stuff like you said to make your peas greener. Right,

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<v Speaker 1>So people used to use formaldehyde to preserve meat, makes sense,

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<v Speaker 1>people used to use borax formaldehyde. Look how long that

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<v Speaker 1>human heads? But in that bucket? Exactly, let's put it

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<v Speaker 1>on beef. So did you touch that head or did

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<v Speaker 1>you just like you didn't poke it with the end

0:12:43.960 --> 0:12:46.480
<v Speaker 1>of a mom and know, his face bobbed up at me,

0:12:46.520 --> 0:12:48.200
<v Speaker 1>and I was just like, all right, there it is,

0:12:49.040 --> 0:12:54.960
<v Speaker 1>hello sir. So Uh, the poison Squad made great headway.

0:12:54.679 --> 0:12:57.240
<v Speaker 1>They really determined a lot of stuff that shouldn't be

0:12:57.360 --> 0:13:00.000
<v Speaker 1>used as preservatives like that copper sulfate that was used

0:13:00.040 --> 0:13:04.040
<v Speaker 1>to make peas green. Yeah, national heroes in a way.

0:13:04.120 --> 0:13:10.760
<v Speaker 1>Well yeah, they also proved um overall, that selling adulterated

0:13:10.800 --> 0:13:14.080
<v Speaker 1>food wasn't just a buyer beware kind of thing, that

0:13:14.200 --> 0:13:17.880
<v Speaker 1>it actually posed a real public health hazard. They got

0:13:17.920 --> 0:13:22.400
<v Speaker 1>super sick, they did, and they got publicized. These guys

0:13:22.520 --> 0:13:26.000
<v Speaker 1>are getting sick on purpose from the same stuff that

0:13:26.080 --> 0:13:28.439
<v Speaker 1>you're feeding your kids, which is where they shut it

0:13:28.480 --> 0:13:30.480
<v Speaker 1>down eventually, right, and the public all of a sudden

0:13:30.520 --> 0:13:32.240
<v Speaker 1>it's like, well, we don't want this stuff in our peas.

0:13:32.280 --> 0:13:34.320
<v Speaker 1>I don't care whether they're green or not. I'm not

0:13:34.360 --> 0:13:38.400
<v Speaker 1>eating this, And then public pressure led to finally Congress

0:13:38.760 --> 0:13:41.480
<v Speaker 1>enacting the Food and Drug Act. I wonder if I'm

0:13:41.480 --> 0:13:43.160
<v Speaker 1>When I was reading this, I was wondering if that

0:13:43.200 --> 0:13:47.480
<v Speaker 1>has something to do with the the um the thing

0:13:47.520 --> 0:13:50.880
<v Speaker 1>with peas, Like I don't think people generally like peas,

0:13:51.320 --> 0:13:52.840
<v Speaker 1>and I wonder if that has anything to do with

0:13:54.360 --> 0:13:56.040
<v Speaker 1>I like peas. But I wonder if that was like

0:13:56.240 --> 0:13:59.560
<v Speaker 1>a stigmata on the PA when this stuff came out

0:13:59.760 --> 0:14:05.200
<v Speaker 1>and have blood on its palms, blood on its p uh.

0:14:05.240 --> 0:14:07.600
<v Speaker 1>Maybe I don't know. I don't either surely it had

0:14:07.640 --> 0:14:10.360
<v Speaker 1>some effect that would guess, well, it's like it's probably

0:14:10.480 --> 0:14:13.120
<v Speaker 1>a lot like Um, how they spray produce in the

0:14:13.120 --> 0:14:17.640
<v Speaker 1>produce section, even though it increases its rotting time dramatically.

0:14:17.679 --> 0:14:18.959
<v Speaker 1>Why did they do that to make it look pretty,

0:14:19.160 --> 0:14:22.400
<v Speaker 1>to make it look fresh. It's ridiculous, but it's probably

0:14:22.440 --> 0:14:25.280
<v Speaker 1>the same exact principle. I bet you're right. Here's some

0:14:25.360 --> 0:14:29.440
<v Speaker 1>poison to make your people. Right. So the f d

0:14:29.560 --> 0:14:34.240
<v Speaker 1>A UM when they formally evolved, Um, they evolved out

0:14:34.240 --> 0:14:36.680
<v Speaker 1>of some other agencies. Uh. They've been through a bunch

0:14:36.680 --> 0:14:40.520
<v Speaker 1>of name changes and reords through the years. Um. But

0:14:40.600 --> 0:14:43.960
<v Speaker 1>in nineteen oh six what they're they were under the

0:14:44.000 --> 0:14:47.280
<v Speaker 1>Department of Agricultures Bureau of Chemistry, and they were the

0:14:47.320 --> 0:14:49.880
<v Speaker 1>ones charged with enforcing that Food and Drugs Act. So

0:14:50.240 --> 0:14:53.480
<v Speaker 1>they split them up in ninete into two groups, the

0:14:53.480 --> 0:14:58.240
<v Speaker 1>Food and Drug Insecticide Administration they handled the regulations and

0:14:58.280 --> 0:15:02.000
<v Speaker 1>the Bureau of Chemistry and Soils handled the experiments. Before

0:15:02.040 --> 0:15:05.000
<v Speaker 1>it had been just the Bureau of Chemistry doing both. Yeah,

0:15:05.000 --> 0:15:07.320
<v Speaker 1>so they split them up. Eventually, they dropped in nineteen

0:15:07.320 --> 0:15:10.120
<v Speaker 1>thirty the name and Secticide and it just became the

0:15:10.240 --> 0:15:14.160
<v Speaker 1>f D AY and From there, they were in under

0:15:14.200 --> 0:15:17.240
<v Speaker 1>the guys or under the purview of several agencies until

0:15:17.240 --> 0:15:19.560
<v Speaker 1>the late seventies and they finally landed where they are now,

0:15:19.920 --> 0:15:24.560
<v Speaker 1>which is the Health and Human Services yea, h h S,

0:15:25.040 --> 0:15:31.960
<v Speaker 1>green PS. So today the way they're organized loosely. They're

0:15:32.000 --> 0:15:36.320
<v Speaker 1>not organized loosely, but this is a script site is this?

0:15:36.520 --> 0:15:39.000
<v Speaker 1>They have a top layer of the Office of Commissioner

0:15:39.040 --> 0:15:42.040
<v Speaker 1>of Food and Drugs a report to the director of sorry,

0:15:42.040 --> 0:15:47.680
<v Speaker 1>the Secretary of HHS who used to be Tommy Thompson. Really, yeah,

0:15:47.840 --> 0:15:50.000
<v Speaker 1>under Bush. Oh that's right. Do you know who it

0:15:50.040 --> 0:15:53.720
<v Speaker 1>is now? I don't. There's probably none there. Obama hasn't

0:15:53.720 --> 0:15:57.680
<v Speaker 1>been able to get anybody confirmed, like either term. Uh.

0:15:57.760 --> 0:16:01.720
<v Speaker 1>That first layer also has seven support supporting organizations that

0:16:01.800 --> 0:16:05.560
<v Speaker 1>support the commissioner, and they're mainly on They're not like

0:16:05.600 --> 0:16:08.960
<v Speaker 1>the rubber meets the road. They're the on the policy

0:16:09.000 --> 0:16:13.120
<v Speaker 1>side of things, basically litigation and stuff. Well, yeah, the

0:16:13.360 --> 0:16:18.120
<v Speaker 1>big stuff, the big overarching we are the f d A. Yeah,

0:16:18.480 --> 0:16:22.320
<v Speaker 1>and then below them are broken down the into components

0:16:22.320 --> 0:16:25.240
<v Speaker 1>that handle rubber meets the road stuff. Yeah. Those are

0:16:25.240 --> 0:16:28.920
<v Speaker 1>the five Deputy commissioners and um, they're they're like you

0:16:28.960 --> 0:16:32.200
<v Speaker 1>said they're the ones that really are heading up the

0:16:32.200 --> 0:16:37.200
<v Speaker 1>field offices. I think there's um four sorry two seven

0:16:37.200 --> 0:16:40.280
<v Speaker 1>field offices. And then they have their big home in

0:16:40.320 --> 0:16:44.600
<v Speaker 1>Silver Spring, Maryland, where they have about close to employees

0:16:44.800 --> 0:16:48.320
<v Speaker 1>and chuck. Um, let's do a quick quiz. You're ready, yes, okay,

0:16:48.440 --> 0:16:52.280
<v Speaker 1>the f you gotta wait, sorry that I know you're

0:16:52.400 --> 0:16:55.320
<v Speaker 1>very excited right now, is just hanging there. The FDA

0:16:55.520 --> 0:17:01.720
<v Speaker 1>regulates true or false? UM, X ray machines. Um, I'm

0:17:01.720 --> 0:17:06.880
<v Speaker 1>gonna say true, that's right. They regulate radioactive or radioactivity

0:17:07.160 --> 0:17:14.920
<v Speaker 1>emitting machines like X rays. Uh. Pesticides, that's right. Yeah,

0:17:15.400 --> 0:17:18.520
<v Speaker 1>that's the U. S d A. From what I understand. Um,

0:17:18.560 --> 0:17:24.359
<v Speaker 1>illicit drugs like cocaine and crap cocaine. They don't regulate that. No,

0:17:24.800 --> 0:17:28.760
<v Speaker 1>that's true. They don't. Uh. Let's see what else. What

0:17:28.920 --> 0:17:36.000
<v Speaker 1>about donated blood? True, that's true. They regulate biologics doing

0:17:36.080 --> 0:17:40.760
<v Speaker 1>great man vaccines and blood. Yeah, thank you, tobacco. Um,

0:17:40.800 --> 0:17:43.760
<v Speaker 1>they do regulate that, I believe. And then what about

0:17:44.640 --> 0:17:49.040
<v Speaker 1>poultry chicken? Yes, of course they do. No, because it's food.

0:17:49.240 --> 0:17:53.640
<v Speaker 1>No U s d A. Again, although the FDA does

0:17:53.760 --> 0:17:57.960
<v Speaker 1>regulate apparently the dairy industry. Yeah, but not meeting poultry. No,

0:17:58.160 --> 0:18:02.480
<v Speaker 1>talk about mind boggling. They do reulate um cosmetics, but

0:18:02.680 --> 0:18:05.480
<v Speaker 1>obviously because we did a podcast on it, they don't

0:18:05.520 --> 0:18:08.919
<v Speaker 1>regulate uh several supplements. Yeah, that was a good one,

0:18:08.920 --> 0:18:10.919
<v Speaker 1>if I remember correctly, We really like got to the

0:18:10.920 --> 0:18:12.919
<v Speaker 1>heart of the matter. Yeah, And there's a lot of

0:18:12.960 --> 0:18:14.399
<v Speaker 1>and I think you talked about it. Then there's a

0:18:14.440 --> 0:18:18.040
<v Speaker 1>lot of slippery language that can be used in body

0:18:18.040 --> 0:18:21.800
<v Speaker 1>products period, which always aggravates Emily to no end because

0:18:21.840 --> 0:18:25.160
<v Speaker 1>she has completely natural body products. But you can throw

0:18:25.800 --> 0:18:28.960
<v Speaker 1>names on packages these days, on foods too, that just

0:18:29.000 --> 0:18:32.919
<v Speaker 1>say like purer and natural and just these buzzwords that

0:18:33.000 --> 0:18:35.719
<v Speaker 1>mean nothing, and there's no regulation for when you can

0:18:35.800 --> 0:18:38.280
<v Speaker 1>use those words. And it's just it's they're trying to

0:18:38.320 --> 0:18:41.040
<v Speaker 1>sell people on something that's not true. It's truly sad.

0:18:41.280 --> 0:18:44.320
<v Speaker 1>Like light beer. I remember hearing years and years and

0:18:44.400 --> 0:18:47.040
<v Speaker 1>years ago that light beer only has to be light

0:18:47.080 --> 0:18:49.919
<v Speaker 1>and color to be called light beer. Really Yeah, But

0:18:50.000 --> 0:18:52.400
<v Speaker 1>now that I'm grown, I'm like, I'll bet like, who

0:18:52.400 --> 0:18:54.399
<v Speaker 1>regulates that, I'll bet you it doesn't even have to

0:18:54.400 --> 0:18:56.600
<v Speaker 1>be light in color and light and color compared to

0:18:56.680 --> 0:18:59.240
<v Speaker 1>what you can probably call something light beer if you

0:18:59.280 --> 0:19:02.400
<v Speaker 1>want to, Well, it's light in calories, right, buyer beware.

0:19:03.040 --> 0:19:06.040
<v Speaker 1>But your point is it's not regulated, right, Probably not

0:19:06.080 --> 0:19:07.960
<v Speaker 1>a beer has to be under this many calories to

0:19:08.000 --> 0:19:09.720
<v Speaker 1>be called a light Yeah. I don't believe it is.

0:19:10.240 --> 0:19:12.400
<v Speaker 1>And now that I think, I'd probably be the FTC

0:19:12.680 --> 0:19:14.480
<v Speaker 1>that would be in charge of that kind of thing.

0:19:14.480 --> 0:19:19.280
<v Speaker 1>But they the t F Yeah, man, the government should

0:19:19.320 --> 0:19:21.920
<v Speaker 1>just have a lot of lettered agencies. Yeah. One last

0:19:21.920 --> 0:19:25.080
<v Speaker 1>thing about the FDA though, there's a group of special

0:19:25.119 --> 0:19:29.600
<v Speaker 1>agents in the criminal unit that carried guns. Really FDA

0:19:29.680 --> 0:19:32.560
<v Speaker 1>agents that carried guns and will shoot you well for

0:19:32.680 --> 0:19:37.080
<v Speaker 1>doing what I've got a great example of it. Had

0:19:37.119 --> 0:19:41.399
<v Speaker 1>they caught whoever it was that poisoned the Chicago area

0:19:41.520 --> 0:19:46.880
<v Speaker 1>tile and all in, they probably would have shot that person. Yep.

0:19:47.359 --> 0:19:49.639
<v Speaker 1>Do you do you know about that? I do? Uh,

0:19:49.800 --> 0:19:52.840
<v Speaker 1>you want to talk about that now? Sure might as well. Huh. Yeah,

0:19:53.840 --> 0:19:56.679
<v Speaker 1>I remember this, do too, man. Yeah. I was a

0:19:56.840 --> 0:19:59.159
<v Speaker 1>six year old whose eyes were just opening to the

0:19:59.200 --> 0:20:02.400
<v Speaker 1>ideas of w things and drugs and learning to fear

0:20:02.480 --> 0:20:04.680
<v Speaker 1>things that you bought at the store. Yeah. I didn't.

0:20:04.680 --> 0:20:06.480
<v Speaker 1>I didn't. I didn't know the specifics because I was

0:20:06.560 --> 0:20:09.359
<v Speaker 1>only eleven and I never really like researched further as

0:20:09.359 --> 0:20:12.359
<v Speaker 1>an adult. But twelve year old girl died in a

0:20:12.880 --> 0:20:17.760
<v Speaker 1>suburban Chicago after taking Thailand all laced with cyanide as.

0:20:17.800 --> 0:20:22.520
<v Speaker 1>It turns out, Um, she was dead by the next day,

0:20:22.600 --> 0:20:24.840
<v Speaker 1>I believe know a couple of hours, Oh, a couple

0:20:24.880 --> 0:20:28.280
<v Speaker 1>of she took it that morning then and then dim.

0:20:29.600 --> 0:20:33.080
<v Speaker 1>So Uh. That same day, a twenty seven year old

0:20:33.200 --> 0:20:38.359
<v Speaker 1>name Adam Janice suburban Chicago died and then his brother

0:20:38.440 --> 0:20:41.440
<v Speaker 1>and sister were consoling the family. They thought it was

0:20:41.440 --> 0:20:44.240
<v Speaker 1>a heart attack. Uh, we're consoling the family and just

0:20:44.320 --> 0:20:48.280
<v Speaker 1>sort of doing the post death family stuff. Very stressed,

0:20:48.440 --> 0:20:51.440
<v Speaker 1>got headaches, they took tail and all and they both died. Yeah.

0:20:51.600 --> 0:20:54.600
<v Speaker 1>I had no idea that connection. Three more people died

0:20:54.760 --> 0:20:57.720
<v Speaker 1>over the next couple of days, all from they found

0:20:57.800 --> 0:21:01.439
<v Speaker 1>out upon investigating, all of them had taken Thailand all

0:21:01.560 --> 0:21:04.639
<v Speaker 1>right before they died. So they started looking at right,

0:21:05.040 --> 0:21:07.760
<v Speaker 1>they started looking into it, and um, it turned out

0:21:07.840 --> 0:21:12.000
<v Speaker 1>that there was poisoned thailand all in the Chicago area.

0:21:12.640 --> 0:21:16.080
<v Speaker 1>And everyone freaked out because at the time Thailand all

0:21:16.240 --> 0:21:18.440
<v Speaker 1>was like that was it. You had an over the

0:21:18.520 --> 0:21:21.280
<v Speaker 1>counter pain reliever. It was Thailand All, and they didn't

0:21:21.359 --> 0:21:24.560
<v Speaker 1>have tamper resistant bottles at the time. What they later

0:21:24.640 --> 0:21:28.440
<v Speaker 1>figured out is that somebody bought Thailand All, took it home,

0:21:28.520 --> 0:21:31.960
<v Speaker 1>I guess, laced it with cyanide, and then brought it

0:21:32.040 --> 0:21:35.080
<v Speaker 1>back and made it look like it had been unopened,

0:21:35.680 --> 0:21:38.040
<v Speaker 1>and people bought them and died from They still don't

0:21:38.080 --> 0:21:39.520
<v Speaker 1>know who did it. They made it look like it

0:21:39.560 --> 0:21:42.880
<v Speaker 1>was unopened by just closing the lid again. Because there again,

0:21:43.000 --> 0:21:47.879
<v Speaker 1>no tamper resistant packaging until right this changed everything. So UM,

0:21:48.040 --> 0:21:51.119
<v Speaker 1>the company that makes tail and All under Johnson and

0:21:51.200 --> 0:21:54.879
<v Speaker 1>Johnson like issued like a national media alert that said, like,

0:21:55.080 --> 0:21:58.560
<v Speaker 1>everybody should probably stop taking taile and All and send

0:21:58.640 --> 0:22:01.080
<v Speaker 1>us your tailing All will send you new stuff that

0:22:01.200 --> 0:22:04.400
<v Speaker 1>we know is good, but um, don't take Kylo, which

0:22:04.480 --> 0:22:06.720
<v Speaker 1>is kind of cool for a company. Yeah, they really

0:22:06.840 --> 0:22:08.639
<v Speaker 1>like I mean, they had no choice, I think, but

0:22:08.800 --> 0:22:12.359
<v Speaker 1>the super go on the offensive with this. Uh, and

0:22:12.480 --> 0:22:17.000
<v Speaker 1>it's actually due to Johnson and Johnson. Um. It wasn't

0:22:17.040 --> 0:22:19.320
<v Speaker 1>the f d A saying hey, we need to get

0:22:19.359 --> 0:22:22.680
<v Speaker 1>tamper resistant packaging. Johnson and Johnson actually said, hey, I

0:22:22.760 --> 0:22:26.600
<v Speaker 1>think we should start investigating tampa resistant packaging. So they

0:22:26.640 --> 0:22:30.560
<v Speaker 1>sort of led the charge. Yeah, and then in Congress said, um,

0:22:31.520 --> 0:22:35.320
<v Speaker 1>let's make tampering with medicine a federal crime. Yes. And

0:22:35.400 --> 0:22:39.160
<v Speaker 1>then just just six years later, the FDA said, let's

0:22:39.240 --> 0:22:43.680
<v Speaker 1>make these awesome tamper resistant bottles um mandatory. I don't

0:22:43.720 --> 0:22:46.920
<v Speaker 1>know why it took six years that we're talking about

0:22:46.920 --> 0:22:49.680
<v Speaker 1>a federal bureaucracy here now, but it seems like that's

0:22:49.720 --> 0:22:52.560
<v Speaker 1>something you could have sped through. Just my opinion, but

0:22:53.080 --> 0:22:56.840
<v Speaker 1>anyway is when um, that's why it's so hard to

0:22:56.840 --> 0:22:59.920
<v Speaker 1>get into pill bottles these days, thankfully. Yeah, a little

0:23:00.000 --> 0:23:03.840
<v Speaker 1>boil coatings and all that stuff that makes um, doesn't

0:23:03.840 --> 0:23:05.800
<v Speaker 1>mean you can't open it, but it means you will

0:23:05.840 --> 0:23:09.040
<v Speaker 1>know if someone has opened it. Yes, you know, like

0:23:09.119 --> 0:23:10.520
<v Speaker 1>if you buy it and you're like, wait a minute,

0:23:10.560 --> 0:23:14.000
<v Speaker 1>that foil is poked through by a human thumb, I

0:23:14.080 --> 0:23:17.639
<v Speaker 1>can see it. And this stuff is glowing, yeah, Thailand,

0:23:17.640 --> 0:23:21.000
<v Speaker 1>all is not supposed to glow. Alright, So let's take

0:23:21.040 --> 0:23:23.119
<v Speaker 1>a break and after this we'll talk a little bit

0:23:23.200 --> 0:23:31.800
<v Speaker 1>more about how they regulate. You know, stop fear you

0:23:32.560 --> 0:23:50.840
<v Speaker 1>you know, stop you know stop you know. So, um,

0:23:51.119 --> 0:23:53.560
<v Speaker 1>how does well, first of all, how much do they

0:23:53.640 --> 0:23:57.680
<v Speaker 1>regulate and the answer is a ton of products. Yeah. Um,

0:23:58.760 --> 0:24:01.879
<v Speaker 1>some estimates say that twenty cents out of every dollar

0:24:02.000 --> 0:24:09.000
<v Speaker 1>consumer spend, and that's on everything TVs you know, VCRs, right,

0:24:09.080 --> 0:24:13.200
<v Speaker 1>that doesn't regulate satellite dishes, laser discs. All the money

0:24:13.280 --> 0:24:16.640
<v Speaker 1>that we spend on everything, twenty cents out of every

0:24:16.800 --> 0:24:20.240
<v Speaker 1>dollar we spend is on a product that's regulated by

0:24:20.280 --> 0:24:23.320
<v Speaker 1>the FDA. It comes under their per view, which which

0:24:23.359 --> 0:24:25.879
<v Speaker 1>means you have too much to do. Supposedly that equals

0:24:25.880 --> 0:24:29.200
<v Speaker 1>about what they regulate about one trillion dollars worth of

0:24:29.280 --> 0:24:33.800
<v Speaker 1>goods and in services, well goods. Yeah, all right, so

0:24:33.840 --> 0:24:36.000
<v Speaker 1>they regulate. We already talked about what they do regulate.

0:24:36.080 --> 0:24:40.440
<v Speaker 1>They also, um also offer guidance at times on maybe

0:24:40.920 --> 0:24:45.680
<v Speaker 1>how advice on how regulations should be carried out. So

0:24:45.840 --> 0:24:48.240
<v Speaker 1>that's one of their tasks as well. Right, Like maybe

0:24:48.480 --> 0:24:53.200
<v Speaker 1>you guys should make your pillbottles tamper resistant. Our criminal

0:24:53.800 --> 0:24:56.800
<v Speaker 1>enforcement unit isn't going to come shoot you if you don't,

0:24:57.200 --> 0:25:01.879
<v Speaker 1>because this is a guideline. But now that it's uh,

0:25:02.080 --> 0:25:04.879
<v Speaker 1>now it's mandatory or they may visit you. Um. They

0:25:04.960 --> 0:25:11.480
<v Speaker 1>do about sixteen thousand facility inspections per year. Uh, everything

0:25:11.560 --> 0:25:14.680
<v Speaker 1>from dairy farms to blood banks. But um, they, like

0:25:14.800 --> 0:25:17.919
<v Speaker 1>we said, they're way more facilities than they have field workers.

0:25:18.560 --> 0:25:22.359
<v Speaker 1>So I think they do they well, they use the

0:25:22.480 --> 0:25:27.520
<v Speaker 1>element of surprise or the potential, the element of potential surprise,

0:25:28.040 --> 0:25:33.119
<v Speaker 1>So surprise inspection, surprise visits. I hope, hope, hope. And

0:25:33.200 --> 0:25:36.560
<v Speaker 1>I'm pretty sure that the FDA doesn't call in schedule

0:25:37.280 --> 0:25:41.600
<v Speaker 1>inspections ahead of time. Right. If they do, then then

0:25:41.720 --> 0:25:44.040
<v Speaker 1>write your congress person and make sure that this gets

0:25:44.160 --> 0:25:48.280
<v Speaker 1>changed immediately, because they can't. We're talking fourteen thousand employees

0:25:48.359 --> 0:25:52.119
<v Speaker 1>in total, not just inspectors in total. For all of

0:25:52.160 --> 0:25:56.159
<v Speaker 1>the FDA, less than fifteen thousand people are in charge

0:25:56.240 --> 0:26:00.960
<v Speaker 1>of not only visiting factories and dairies in places that

0:26:01.240 --> 0:26:04.200
<v Speaker 1>that use X ray machines and all this stuff, all

0:26:04.240 --> 0:26:07.240
<v Speaker 1>the things that they regulate, not just in the US,

0:26:07.359 --> 0:26:11.000
<v Speaker 1>but like in other countries too. Yeah. They just set

0:26:11.119 --> 0:26:14.440
<v Speaker 1>up their first office in Beijing in the last decade

0:26:14.560 --> 0:26:18.000
<v Speaker 1>or so. Yeah, because they have to. They have to

0:26:18.160 --> 0:26:21.040
<v Speaker 1>watch what's coming into the country as well, because Americans

0:26:21.119 --> 0:26:25.360
<v Speaker 1>don't just ingest American products, We just products for overseas,

0:26:25.560 --> 0:26:28.159
<v Speaker 1>and those things have to they have to follow the

0:26:28.200 --> 0:26:31.920
<v Speaker 1>same guidelines as any other product that's sold er sold

0:26:32.000 --> 0:26:35.800
<v Speaker 1>or used in America, because the FDA jurisdiction isn't stuff

0:26:35.840 --> 0:26:39.239
<v Speaker 1>that's made in America, stuff that is consumed in America. Yea,

0:26:39.280 --> 0:26:40.800
<v Speaker 1>I guess I just thought that would be maybe the

0:26:40.880 --> 0:26:43.320
<v Speaker 1>FDC or something. But imagine they all kind of work

0:26:43.359 --> 0:26:45.600
<v Speaker 1>hand in hand to get the church done. They all

0:26:45.680 --> 0:26:49.080
<v Speaker 1>quietly hold hands while they do their research. Uh. And

0:26:49.200 --> 0:26:51.080
<v Speaker 1>how do they do this? They do it because they

0:26:51.119 --> 0:26:53.560
<v Speaker 1>are funded to the tune of four point four billion

0:26:53.600 --> 0:26:58.080
<v Speaker 1>dollars um. About two point six of that comes from

0:26:58.119 --> 0:27:02.080
<v Speaker 1>the Treasury and in other words, your tax dollars and

0:27:02.280 --> 0:27:05.200
<v Speaker 1>the remaining close to two billion comes from user fees,

0:27:05.520 --> 0:27:09.240
<v Speaker 1>which are very, very controversial. You want to talk about

0:27:09.240 --> 0:27:14.560
<v Speaker 1>the user fees. Yeah, let's know that. Man. So the before,

0:27:15.240 --> 0:27:20.920
<v Speaker 1>what was it. I believe the FDA was fully funded

0:27:21.000 --> 0:27:23.679
<v Speaker 1>by taxpayer dollars. It got all of its funding from

0:27:23.720 --> 0:27:28.879
<v Speaker 1>the Treasury. And then in Congress passed a law that

0:27:29.080 --> 0:27:33.440
<v Speaker 1>said the the FDA can start generating its own revenue

0:27:33.840 --> 0:27:38.200
<v Speaker 1>by accepting user fees. Yeah, the Prescription Drug User Fee Act. Right. So,

0:27:38.520 --> 0:27:41.439
<v Speaker 1>in that act, it says, if you are a prescription

0:27:41.520 --> 0:27:45.119
<v Speaker 1>drug company, a pharmaceutical company, and you want to have

0:27:46.000 --> 0:27:50.560
<v Speaker 1>your UM your drug examined by the FDA, and in

0:27:50.640 --> 0:27:53.200
<v Speaker 1>a lot of cases, most cases, you have to have

0:27:53.359 --> 0:27:56.280
<v Speaker 1>it submitted for a review by the FDA. Sure, you

0:27:56.359 --> 0:27:59.359
<v Speaker 1>also have to pay a fee called it an application fee,

0:27:59.400 --> 0:28:01.720
<v Speaker 1>call it a user fee, what have you. Well, there's

0:28:01.920 --> 0:28:04.639
<v Speaker 1>many different fees, so we'll call that. Let's say you

0:28:04.800 --> 0:28:07.040
<v Speaker 1>want to get your drug fast checked. You can pay

0:28:07.080 --> 0:28:10.080
<v Speaker 1>an exorbitant fee and we'll put it at the top

0:28:10.160 --> 0:28:12.760
<v Speaker 1>of the pile even and so all of a sudden,

0:28:12.800 --> 0:28:16.920
<v Speaker 1>out chuckers, the f d A is not policing the

0:28:17.000 --> 0:28:21.280
<v Speaker 1>pharmaceutical companies any longer. It is servicing the pharmaceutical companies,

0:28:21.560 --> 0:28:26.880
<v Speaker 1>and the pharmaceutical companies as became the FDA's clients. Yeah,

0:28:26.920 --> 0:28:31.920
<v Speaker 1>that was really really bad as far as consumer protection goes. Yeah,

0:28:32.040 --> 0:28:35.000
<v Speaker 1>and um, there are many different ways of looking at this. UM.

0:28:35.160 --> 0:28:39.520
<v Speaker 1>One is that way, which is that the the pharma

0:28:39.840 --> 0:28:43.120
<v Speaker 1>lobby is um writing checks to the f d A

0:28:43.800 --> 0:28:46.600
<v Speaker 1>UM to the tune of billions of dollars. And that

0:28:46.720 --> 0:28:50.040
<v Speaker 1>can't be good, right, Uh the f d A. The

0:28:50.480 --> 0:28:53.720
<v Speaker 1>read this great article on pbs UM where they just

0:28:53.800 --> 0:28:56.520
<v Speaker 1>interviewed a bunch of people for a variety of opinions

0:28:57.440 --> 0:28:59.959
<v Speaker 1>it was very balanced. It was very very and balance.

0:29:00.000 --> 0:29:04.600
<v Speaker 1>It's not like us, Um it's bad. They the FDA's

0:29:04.640 --> 0:29:08.280
<v Speaker 1>rebuttal will look a little something like this. Um. What

0:29:08.640 --> 0:29:11.160
<v Speaker 1>what it's done is it's really helped us out. Um,

0:29:11.360 --> 0:29:15.240
<v Speaker 1>We've increased our productivity by close. We've been able to

0:29:15.320 --> 0:29:18.720
<v Speaker 1>hire so many more people, which means we can regulate

0:29:18.880 --> 0:29:21.560
<v Speaker 1>so much more. UM, it's really helped us in the

0:29:21.640 --> 0:29:24.680
<v Speaker 1>review process. The farm a lobby says, this is great

0:29:24.760 --> 0:29:29.600
<v Speaker 1>because it gets things going super quickly. It's very efficient

0:29:29.760 --> 0:29:33.320
<v Speaker 1>and yeah, and it hasn't changed the review processes, just

0:29:33.840 --> 0:29:36.800
<v Speaker 1>made things faster. And UM, we can get these drugs

0:29:36.840 --> 0:29:39.760
<v Speaker 1>two people quicker because people need these. So there's a

0:29:39.760 --> 0:29:42.040
<v Speaker 1>lot of different ways of looking at it. UM. If

0:29:42.080 --> 0:29:45.880
<v Speaker 1>you ask Raymond Wooseley, who was he was up for UM,

0:29:47.000 --> 0:29:49.600
<v Speaker 1>he was the vice president of health Sciences at University

0:29:49.600 --> 0:29:51.800
<v Speaker 1>of Arizona. I think it's been like two thousand two.

0:29:51.880 --> 0:29:55.360
<v Speaker 1>He was up for commission of the FDA. He's a

0:29:55.400 --> 0:29:58.240
<v Speaker 1>safety guy. Yeah, he was rejected, and he flat out

0:29:58.320 --> 0:30:01.440
<v Speaker 1>said in an interview, like it's pretty clear that people

0:30:01.520 --> 0:30:03.800
<v Speaker 1>that really care about drug safety will never get this

0:30:03.960 --> 0:30:07.680
<v Speaker 1>job again. The Commissioner of the FDA and he said,

0:30:07.720 --> 0:30:10.080
<v Speaker 1>it's great sadness to me that people who care about

0:30:10.120 --> 0:30:12.560
<v Speaker 1>drug safety and food safety to the level that they

0:30:12.600 --> 0:30:14.560
<v Speaker 1>get involved, they try to make a difference and can't

0:30:14.600 --> 0:30:18.520
<v Speaker 1>be accepted to regulate the agency. And he said, for me,

0:30:18.640 --> 0:30:21.720
<v Speaker 1>it should be protection first and then serving second, serving

0:30:21.800 --> 0:30:25.400
<v Speaker 1>meaning the industry. And that's sort of not the way

0:30:25.400 --> 0:30:28.320
<v Speaker 1>it's gone since the user fees have been introduced. Yeah,

0:30:28.440 --> 0:30:30.960
<v Speaker 1>from from the research that we've done, it seems like

0:30:31.880 --> 0:30:34.560
<v Speaker 1>every critic of the f d A from all walks

0:30:34.600 --> 0:30:38.000
<v Speaker 1>of life and all stripes, points to that user fee

0:30:38.160 --> 0:30:43.680
<v Speaker 1>as possibly the number one problem as far as coziness

0:30:43.760 --> 0:30:48.320
<v Speaker 1>between industry and the agency that they're funding regulates. Yeah,

0:30:49.320 --> 0:30:51.560
<v Speaker 1>you want to separate those two things generally. And then

0:30:51.600 --> 0:30:56.680
<v Speaker 1>the other problem is funding for the FDA itself. That

0:30:57.360 --> 0:31:01.480
<v Speaker 1>it is a grossly underfunded agency for what it's tasked

0:31:01.520 --> 0:31:03.960
<v Speaker 1>with doing, so it does have to rely on those

0:31:04.080 --> 0:31:07.720
<v Speaker 1>user fees, Whereas I think it's a lot like campaign

0:31:07.880 --> 0:31:11.160
<v Speaker 1>finance reform, where if you could just take that and

0:31:11.280 --> 0:31:15.560
<v Speaker 1>replace it with public money, um, then you can. You

0:31:15.640 --> 0:31:18.040
<v Speaker 1>can separate these two things that aren't supposed to be

0:31:18.120 --> 0:31:21.160
<v Speaker 1>cozy with one another. A government agency that's not supposed

0:31:21.160 --> 0:31:24.680
<v Speaker 1>to rely financially on the industry that it's regulating. Yeah,

0:31:24.760 --> 0:31:26.200
<v Speaker 1>and I know you want to do a show on

0:31:26.560 --> 0:31:30.080
<v Speaker 1>lobbying soon. That's uh, that's gonna be a firestorm. It is.

0:31:30.160 --> 0:31:32.560
<v Speaker 1>We're gonna just be sitting there like gripping the table

0:31:32.640 --> 0:31:35.000
<v Speaker 1>the whole time. Well, what you mentioned though, how they're

0:31:35.040 --> 0:31:38.280
<v Speaker 1>funded though, it's interesting. I think until recently, UM, the

0:31:38.360 --> 0:31:42.000
<v Speaker 1>way the money was even divided, like how the budget

0:31:42.040 --> 0:31:46.240
<v Speaker 1>money was spent was pretty hinking because you couldn't even

0:31:46.480 --> 0:31:50.640
<v Speaker 1>use any of that user fee money to regulate safety

0:31:50.680 --> 0:31:53.000
<v Speaker 1>at all. All of that had to go into the

0:31:53.120 --> 0:31:56.840
<v Speaker 1>service side of things. I think now they are starting

0:31:57.440 --> 0:32:00.520
<v Speaker 1>UM to to uh be able to use that money

0:32:00.600 --> 0:32:03.080
<v Speaker 1>for safety as well. But I think that's not happening

0:32:03.160 --> 0:32:05.800
<v Speaker 1>fast enough for people that are truly concerned about the

0:32:05.840 --> 0:32:09.080
<v Speaker 1>safety of our country. And there was this uh I

0:32:09.160 --> 0:32:11.200
<v Speaker 1>think I sent it to you. There's this Forbes article

0:32:11.320 --> 0:32:14.560
<v Speaker 1>from two thousand and fourteen. About a year ago, UM,

0:32:15.160 --> 0:32:17.800
<v Speaker 1>there was a Yale study that came out that really

0:32:17.960 --> 0:32:20.880
<v Speaker 1>just raked the FDA over the coals, and it was

0:32:21.360 --> 0:32:24.800
<v Speaker 1>an analysis of a bunch of different f d a

0:32:25.480 --> 0:32:29.320
<v Speaker 1>UM approvals from two five to two thousand twelve publicly

0:32:29.480 --> 0:32:32.640
<v Speaker 1>published stuff. It's not like they had to dig in, right,

0:32:32.720 --> 0:32:35.080
<v Speaker 1>They just went and did an analysis of it, and

0:32:35.200 --> 0:32:39.400
<v Speaker 1>they found that these FDA studies were um all over

0:32:39.480 --> 0:32:42.520
<v Speaker 1>the place as far as the data they accepted, UM,

0:32:43.120 --> 0:32:47.480
<v Speaker 1>what what got cleared and what didn't, UM, the sample size,

0:32:47.880 --> 0:32:52.600
<v Speaker 1>how long trials went on, and um. It was basically

0:32:52.680 --> 0:32:55.240
<v Speaker 1>used to publicly shame the FDA is saying like, you

0:32:55.280 --> 0:32:57.360
<v Speaker 1>guys aren't even using good science and even trying to

0:32:57.440 --> 0:33:00.640
<v Speaker 1>keep up this pretense that you're following your own standards

0:33:00.680 --> 0:33:03.200
<v Speaker 1>or that you even have standards. You guys are you're

0:33:03.240 --> 0:33:08.200
<v Speaker 1>just rubber stamping pharmaceuticals. And to kind of give an

0:33:08.240 --> 0:33:11.560
<v Speaker 1>opposing point of view, this guy on Forbes said, well,

0:33:11.640 --> 0:33:14.560
<v Speaker 1>wait a minute, Like this is totally unfair because the

0:33:14.640 --> 0:33:17.920
<v Speaker 1>FDA is actually what they're being criticized for here is

0:33:17.920 --> 0:33:21.840
<v Speaker 1>actually a certain kind of nimbleness that the end user,

0:33:22.000 --> 0:33:25.040
<v Speaker 1>the patients who are taking these drugs really want. So

0:33:25.120 --> 0:33:28.280
<v Speaker 1>they're saying, for something that's a really huge, sweeping drug

0:33:28.360 --> 0:33:31.000
<v Speaker 1>that's going to be used by a lot of people, right,

0:33:31.600 --> 0:33:35.920
<v Speaker 1>they they they should and typically do, follow some pretty

0:33:36.000 --> 0:33:39.520
<v Speaker 1>stringent guidelines. They have to have a huge population sample

0:33:39.920 --> 0:33:42.840
<v Speaker 1>they have to um carry these studies out for years

0:33:43.600 --> 0:33:46.200
<v Speaker 1>and UM they require a lot of really good data.

0:33:46.480 --> 0:33:48.800
<v Speaker 1>But if you have something that is like a really

0:33:48.880 --> 0:33:51.840
<v Speaker 1>obscure disease or a drug that treats are really obscure disease,

0:33:53.280 --> 0:33:56.880
<v Speaker 1>sure they're going to accept the data that used the

0:33:56.960 --> 0:34:00.480
<v Speaker 1>population size of like a hundred people because there's just

0:34:00.560 --> 0:34:03.120
<v Speaker 1>not that many people out there with this disease. And

0:34:03.640 --> 0:34:06.480
<v Speaker 1>it may be a shorter lived study because if it's

0:34:06.480 --> 0:34:09.800
<v Speaker 1>a really fatal disease, these people want this drug and

0:34:09.920 --> 0:34:12.319
<v Speaker 1>to get it out the door quicker. And there may

0:34:12.360 --> 0:34:14.120
<v Speaker 1>only be the one study. You may not have to

0:34:14.200 --> 0:34:16.560
<v Speaker 1>duplicate it and replicate it three or four times. So

0:34:16.680 --> 0:34:19.279
<v Speaker 1>he did a good job of like presenting the other

0:34:19.400 --> 0:34:22.680
<v Speaker 1>case in really pointing out how the FDA is very

0:34:22.760 --> 0:34:25.680
<v Speaker 1>typically it's it's in a damned if you do, damned

0:34:25.680 --> 0:34:29.800
<v Speaker 1>if you don't situation on a daily basis, because in

0:34:29.920 --> 0:34:32.640
<v Speaker 1>that same study that found you know that they it

0:34:32.719 --> 0:34:36.399
<v Speaker 1>will accept the population of one hundred in the study, UM,

0:34:36.680 --> 0:34:39.120
<v Speaker 1>and it goes out the door very quickly in the

0:34:39.200 --> 0:34:43.080
<v Speaker 1>approval process happens fast in that. In that sense, on

0:34:43.200 --> 0:34:45.840
<v Speaker 1>the other hand, UM, when the FDA doesn't do that

0:34:45.920 --> 0:34:48.840
<v Speaker 1>and really takes its time and digs in and studies.

0:34:49.000 --> 0:34:52.040
<v Speaker 1>It gets accused of basically just letting people die, which

0:34:52.120 --> 0:34:55.799
<v Speaker 1>was the case with the advent of AIDS eighties. Sure

0:34:55.960 --> 0:34:58.920
<v Speaker 1>HIV drugs were being tested in people in the HIV

0:34:59.040 --> 0:35:03.080
<v Speaker 1>community and in at large in the country. We're saying,

0:35:04.000 --> 0:35:06.880
<v Speaker 1>advocates were saying, hey, people are dying and like these

0:35:06.960 --> 0:35:10.080
<v Speaker 1>drugs are very promising, like let us try them out.

0:35:10.680 --> 0:35:13.840
<v Speaker 1>And so I do get it, man, Like they've been

0:35:13.880 --> 0:35:16.320
<v Speaker 1>accused of dragon their feet. We're going too fast and

0:35:16.960 --> 0:35:20.239
<v Speaker 1>finding that happy medium or I think I don't know,

0:35:20.520 --> 0:35:21.880
<v Speaker 1>I don't know if it's a happy medium or if

0:35:21.920 --> 0:35:24.239
<v Speaker 1>it's you should only strive for safety, and if it

0:35:24.320 --> 0:35:26.680
<v Speaker 1>takes too long, it takes too long, or if it

0:35:26.840 --> 0:35:30.200
<v Speaker 1>is super quick, it's super quick. Like safety is should

0:35:30.239 --> 0:35:33.320
<v Speaker 1>be the most important thing, and it doesn't seem like

0:35:33.880 --> 0:35:37.480
<v Speaker 1>that that's the case. No, it should be the most

0:35:37.520 --> 0:35:40.640
<v Speaker 1>important thing. But at the same time, there should also

0:35:40.760 --> 0:35:44.600
<v Speaker 1>be an awareness of you know, what's going on outside

0:35:44.640 --> 0:35:47.359
<v Speaker 1>the doors of the lab, but there are people dying,

0:35:47.680 --> 0:35:50.319
<v Speaker 1>so yeah, you want a safe drug. But also if

0:35:50.360 --> 0:35:52.800
<v Speaker 1>you have people are saying, like remember with the ebowl

0:35:52.840 --> 0:35:57.000
<v Speaker 1>out right, they're people are like, I will die from

0:35:57.040 --> 0:35:59.239
<v Speaker 1>this drug. I will sign whatever you need. Just give

0:35:59.320 --> 0:36:01.920
<v Speaker 1>me the draw, let me try it. Right, And they

0:36:02.040 --> 0:36:06.560
<v Speaker 1>went ahead and and let people used unapproved drugs. It's

0:36:06.600 --> 0:36:09.359
<v Speaker 1>like the Poison Squad almost these people were volunteering, right,

0:36:10.000 --> 0:36:12.560
<v Speaker 1>willfully volunteering so well they were also dying of a

0:36:12.680 --> 0:36:16.160
<v Speaker 1>bowla at the time. Well, um, the Poison Squad were

0:36:16.200 --> 0:36:20.160
<v Speaker 1>totally healthy, untied the squad, right, yeah it did you know?

0:36:20.280 --> 0:36:24.240
<v Speaker 1>Also the poison Squad. Um, it was a very scientific study.

0:36:24.840 --> 0:36:27.960
<v Speaker 1>The guys were not allowed to eat or drink anything

0:36:28.120 --> 0:36:31.520
<v Speaker 1>outside of this dining room except for water. They had

0:36:31.520 --> 0:36:35.680
<v Speaker 1>to turn in all of it. Not a drop or

0:36:35.719 --> 0:36:40.759
<v Speaker 1>a speck was allowed to go unmeasured on a skid mok.

0:36:42.280 --> 0:36:46.600
<v Speaker 1>But the the the f d A and AI's activist

0:36:46.800 --> 0:36:49.000
<v Speaker 1>collision from the early eighties. Have you seen How to

0:36:49.040 --> 0:36:54.680
<v Speaker 1>Survive a Plague? Great documentary, But the documentary deals in

0:36:54.760 --> 0:36:58.200
<v Speaker 1>part with that and it's really really interesting. And that

0:36:58.640 --> 0:37:02.320
<v Speaker 1>was actually score. The soundtrack was scored by our friends

0:37:02.640 --> 0:37:05.640
<v Speaker 1>Superhuman Happiness. Oh nice to listen to this show, hey guys,

0:37:05.719 --> 0:37:08.000
<v Speaker 1>good for them. Yeah, so go see it. It's a

0:37:08.120 --> 0:37:10.440
<v Speaker 1>very good, good documentary. I will check it out. Is

0:37:10.480 --> 0:37:16.839
<v Speaker 1>that on the old red streaming service. Yes, I'm sure

0:37:16.880 --> 0:37:20.959
<v Speaker 1>it's I'm sure it is called something like Netflix. That's

0:37:21.239 --> 0:37:25.279
<v Speaker 1>that's exactly what it's called. Okay, you're confusing me. All right,

0:37:25.480 --> 0:37:27.400
<v Speaker 1>So let's take another break here, and when we come back,

0:37:27.480 --> 0:37:29.279
<v Speaker 1>we'll talk a little bit more about some of the

0:37:30.440 --> 0:37:37.240
<v Speaker 1>various successes and failures of the f D A you know, stop,

0:37:39.200 --> 0:37:57.719
<v Speaker 1>you know, you know, stop, you know all right, Um,

0:37:58.760 --> 0:38:02.520
<v Speaker 1>can we talk about this Harvard paper? Yeah, this is

0:38:02.640 --> 0:38:06.440
<v Speaker 1>from an article titled Risky Drugs Colan Why the FDA

0:38:06.520 --> 0:38:11.400
<v Speaker 1>Cannot be Trusted, And it was basically about a paper

0:38:11.600 --> 0:38:13.719
<v Speaker 1>published in the Journal of Law, Medicine and Ethics from

0:38:13.760 --> 0:38:19.880
<v Speaker 1>Hobvid University where they contend that, um, they present evidence

0:38:20.000 --> 0:38:24.279
<v Speaker 1>actually that roughly of all new drugs approved by the

0:38:24.360 --> 0:38:27.640
<v Speaker 1>FDA over the past thirty years are little own or

0:38:27.840 --> 0:38:33.640
<v Speaker 1>no more effective for patients than existing drugs. Um they're saying.

0:38:33.719 --> 0:38:37.439
<v Speaker 1>It's they still beat placebo typically. Yeah. What they're saying

0:38:37.560 --> 0:38:40.000
<v Speaker 1>is like, all these new drugs aren't any better than

0:38:40.120 --> 0:38:43.160
<v Speaker 1>the old drugs. There's just competition on an already saturated

0:38:43.239 --> 0:38:46.920
<v Speaker 1>market exactly. So it's like, why put the FDA through

0:38:47.000 --> 0:38:53.000
<v Speaker 1>that if they're already overstretched, then why can't those resources

0:38:53.120 --> 0:38:56.600
<v Speaker 1>be allocated to something else that it's dropping the ball

0:38:56.719 --> 0:38:59.480
<v Speaker 1>on right sure. And they also, you know, try to

0:38:59.560 --> 0:39:03.160
<v Speaker 1>make a point about the safety level of these drugs

0:39:03.200 --> 0:39:05.440
<v Speaker 1>that we are taking when they point out things like

0:39:06.080 --> 0:39:12.120
<v Speaker 1>every week, every week, fifty three thousand hospitalizations occur and

0:39:13.440 --> 0:39:16.720
<v Speaker 1>deaths occur every week in the US because of people

0:39:16.800 --> 0:39:20.880
<v Speaker 1>taking properly prescribed drugs to be healthier. So that's just

0:39:21.040 --> 0:39:25.239
<v Speaker 1>a bad reaction to an approved drug. That's how I

0:39:25.320 --> 0:39:28.080
<v Speaker 1>read it. Everyone, I'm reading that wrong. One in five

0:39:28.160 --> 0:39:33.040
<v Speaker 1>drugs approved ends up causing serious harm, while one in

0:39:33.160 --> 0:39:36.920
<v Speaker 1>ten provide a benefit compared to existing established So that's

0:39:36.920 --> 0:39:39.000
<v Speaker 1>the ten percent. So the data is then this is

0:39:39.040 --> 0:39:43.680
<v Speaker 1>what this Harvard paper is saying. It's saying that yes,

0:39:43.880 --> 0:39:46.840
<v Speaker 1>one in ten drugs that comes onto the market that

0:39:47.000 --> 0:39:51.000
<v Speaker 1>the FDA has approved is it provides a benefit that

0:39:51.200 --> 0:39:54.120
<v Speaker 1>no other drug does in the past thirty years, which

0:39:54.160 --> 0:39:56.400
<v Speaker 1>I think and now that I kind of make a

0:39:56.440 --> 0:39:59.719
<v Speaker 1>connection with something else another article that that they were

0:39:59.760 --> 0:40:02.040
<v Speaker 1>really touting like there's no other drug like this, This

0:40:02.160 --> 0:40:04.360
<v Speaker 1>provides the benefit of that other drugs don't, right, So

0:40:04.400 --> 0:40:07.799
<v Speaker 1>I think that's a big like buzzword. It provides other benefits, right,

0:40:08.480 --> 0:40:10.840
<v Speaker 1>but one in five of those drugs will go on

0:40:11.000 --> 0:40:16.319
<v Speaker 1>to cause some sort of harm, right, that's crazy. Yeah,

0:40:16.440 --> 0:40:18.200
<v Speaker 1>And the they go on to say in that paper

0:40:18.280 --> 0:40:21.719
<v Speaker 1>that the f d A they feel um Len's credibility

0:40:21.800 --> 0:40:25.680
<v Speaker 1>to widening and lowering criteria for prescribing drugs what they

0:40:25.760 --> 0:40:29.000
<v Speaker 1>call the selling of sickness and um what you're talking

0:40:29.040 --> 0:40:32.440
<v Speaker 1>about like a new and improved drug. Basically, drug companies

0:40:32.480 --> 0:40:35.120
<v Speaker 1>are raising prices from year to year on the same drug.

0:40:35.640 --> 0:40:37.480
<v Speaker 1>And they said, we're the only country in the world

0:40:38.320 --> 0:40:42.080
<v Speaker 1>that allows a drug to have its price increased without

0:40:42.320 --> 0:40:46.960
<v Speaker 1>showing like here's why, here's the benefit, here's why it's improved,

0:40:47.040 --> 0:40:50.000
<v Speaker 1>and here's why it costs more. And apparently the US

0:40:50.080 --> 0:40:53.880
<v Speaker 1>is the only country that does that. So Yeah, if

0:40:53.920 --> 0:40:56.719
<v Speaker 1>you want to um read that article, really all the

0:40:56.880 --> 0:40:59.520
<v Speaker 1>articles we've mentioned, you can go to our podcast page

0:41:00.360 --> 0:41:03.200
<v Speaker 1>on Stuff you Should Know dot com, the part the

0:41:03.280 --> 0:41:06.319
<v Speaker 1>page for this episode. It's got all the additional links. Yeah,

0:41:06.480 --> 0:41:08.439
<v Speaker 1>I'm glad we're doing that now. I think that's good. Yeah,

0:41:08.520 --> 0:41:12.680
<v Speaker 1>it's definitely open things up for the truly curious. You

0:41:12.800 --> 0:41:15.279
<v Speaker 1>really want to dig in, baby, we got it for

0:41:15.440 --> 0:41:19.400
<v Speaker 1>you can we talk about antibiotics and livestock. Yeah, this

0:41:19.560 --> 0:41:22.359
<v Speaker 1>is a big one. You found this in the Atlantic, right, Yeah,

0:41:22.400 --> 0:41:24.040
<v Speaker 1>and this is a big uh. I mean, it's just

0:41:24.160 --> 0:41:27.040
<v Speaker 1>a big issue these days period about what is going

0:41:27.160 --> 0:41:31.120
<v Speaker 1>into the meat and that people are eating, uh like

0:41:31.360 --> 0:41:35.239
<v Speaker 1>in factory farms and stuff. Um. The f d A

0:41:35.840 --> 0:41:39.359
<v Speaker 1>in n seven basically said we're not gonna put antibiotics

0:41:39.440 --> 0:41:44.440
<v Speaker 1>in livestock because it's dangerous, and just in twelve they

0:41:44.520 --> 0:41:48.839
<v Speaker 1>filed papers in court that acknowledge that they weren't safe. Um,

0:41:49.200 --> 0:41:52.279
<v Speaker 1>it says more studies. A series of additional studies were

0:41:52.280 --> 0:41:56.879
<v Speaker 1>conducted by other government agencies and non governmental organizations during

0:41:56.920 --> 0:41:59.920
<v Speaker 1>the nineties, all of which generally support the FDA's concerned

0:42:00.040 --> 0:42:04.359
<v Speaker 1>guarding public health threat posed by anti microbial resistance. Yes,

0:42:04.440 --> 0:42:08.480
<v Speaker 1>so what happens is you you give healthy live stock,

0:42:08.560 --> 0:42:12.680
<v Speaker 1>otherwise healthy live stock, antibiotics in their food, right, because

0:42:12.840 --> 0:42:18.520
<v Speaker 1>the living conditions are basically right for an epidemic, or

0:42:18.560 --> 0:42:21.279
<v Speaker 1>it helps them grow faster. Right. So, but if they're

0:42:21.280 --> 0:42:25.319
<v Speaker 1>on antibiotics, they stay healthy despite these living conditions. Well,

0:42:25.360 --> 0:42:28.359
<v Speaker 1>the problem is is the bugs that these antibiotics are

0:42:28.440 --> 0:42:33.399
<v Speaker 1>fighting off develop resistance to the antibiotics, and they can,

0:42:33.640 --> 0:42:36.960
<v Speaker 1>some of which are zoonotic, these bugs, and so they

0:42:37.080 --> 0:42:40.760
<v Speaker 1>leap from say cattle, to humans, and they're already resistant

0:42:40.800 --> 0:42:44.520
<v Speaker 1>to our antibiotics that we've been giving healthy cows. So

0:42:44.680 --> 0:42:49.040
<v Speaker 1>now you have an antibiotic resistant superbug and that's a

0:42:49.120 --> 0:42:51.840
<v Speaker 1>really dangerous thing. And what you've just said is that

0:42:52.080 --> 0:42:55.440
<v Speaker 1>since the seventies, the FDA has publicly said that this

0:42:55.640 --> 0:42:58.480
<v Speaker 1>is dangerous and it should should not go on any longer,

0:42:58.960 --> 0:43:01.480
<v Speaker 1>but they still they didn't do anything about it. Now.

0:43:01.560 --> 0:43:04.080
<v Speaker 1>Their their attack right now is to say that the

0:43:04.160 --> 0:43:07.440
<v Speaker 1>livestock industry can police itself. Uh. It doesn't seem like

0:43:07.520 --> 0:43:11.359
<v Speaker 1>that's happening, but um, that is their position at this point. Uh.

0:43:11.560 --> 0:43:14.120
<v Speaker 1>And this is why you see a lot of meats

0:43:14.160 --> 0:43:16.560
<v Speaker 1>now in your store that say antibiotic free. It's like

0:43:16.640 --> 0:43:19.520
<v Speaker 1>a big selling point because, uh, even like you said,

0:43:19.560 --> 0:43:22.560
<v Speaker 1>even the FDA says it's really dangerous, but they just

0:43:22.680 --> 0:43:26.719
<v Speaker 1>haven't enacted any law about that. Although they have, that's

0:43:26.760 --> 0:43:30.040
<v Speaker 1>not entirely true. They have listed some antibiotics that, um,

0:43:30.360 --> 0:43:31.880
<v Speaker 1>I know they called out one in the article that

0:43:31.920 --> 0:43:34.279
<v Speaker 1>said you can't use this one, but apparently it's only

0:43:34.360 --> 0:43:43.200
<v Speaker 1>used in like point to five or it's only so

0:43:43.840 --> 0:43:46.360
<v Speaker 1>people that are you know, want to live more purely

0:43:46.400 --> 0:43:49.319
<v Speaker 1>are saying they're not taking enough efforts. I mean, they

0:43:49.320 --> 0:43:53.520
<v Speaker 1>were sued by the National Resources Defense Counsel UH saying

0:43:53.560 --> 0:43:55.480
<v Speaker 1>you have to take action on this. Well, and that's

0:43:56.320 --> 0:43:59.479
<v Speaker 1>us that that that it takes the courts to force

0:43:59.560 --> 0:44:02.439
<v Speaker 1>the government an agency to protect consumers in that way,

0:44:02.640 --> 0:44:05.759
<v Speaker 1>in a way that the agency itself is saying like, yes,

0:44:05.920 --> 0:44:09.960
<v Speaker 1>this is dangerous, somebody should do something. Who will do something?

0:44:10.360 --> 0:44:12.719
<v Speaker 1>And then everybody's like, well, it's kind of your job

0:44:12.840 --> 0:44:15.040
<v Speaker 1>to do that, and they're like, oh, well, don't worry

0:44:15.040 --> 0:44:17.080
<v Speaker 1>about it. That's fine. Yeah. I mean they actually the

0:44:17.200 --> 0:44:20.320
<v Speaker 1>FDA pulled public notices at the Federal Register that have

0:44:20.400 --> 0:44:23.440
<v Speaker 1>been around for thirty years. They literally just made them

0:44:23.480 --> 0:44:29.080
<v Speaker 1>disappear overnight. When this became controversial in the two thousand

0:44:29.280 --> 0:44:33.600
<v Speaker 1>early tens, UM, they just said, we're gonna take the

0:44:33.840 --> 0:44:36.600
<v Speaker 1>that those briefs where we said that it's dangerous and

0:44:36.640 --> 0:44:40.480
<v Speaker 1>somebody should do something, We're gonna stop having those published. Um.

0:44:40.920 --> 0:44:45.319
<v Speaker 1>They also were largely criticized, UM a few years back

0:44:46.200 --> 0:44:49.880
<v Speaker 1>for basically like just sitting on their hands about the

0:44:50.600 --> 0:44:55.840
<v Speaker 1>GMO labeling. Yeah, that's yeah, dan quayle uh kind of

0:44:55.920 --> 0:44:58.080
<v Speaker 1>change history with that many years ago. What did you do?

0:44:58.480 --> 0:45:00.320
<v Speaker 1>I think he was the one that which for the

0:45:00.400 --> 0:45:05.799
<v Speaker 1>legislation that allowed GMOs. Okay, so this is fine. You've

0:45:05.800 --> 0:45:09.880
<v Speaker 1>got GMOs. You've got a label food that contains GMOs.

0:45:10.040 --> 0:45:11.960
<v Speaker 1>That's it. Don't do anything else. You just have to

0:45:12.200 --> 0:45:15.560
<v Speaker 1>say on the label, this product may contain GMOs. Right,

0:45:16.160 --> 0:45:20.279
<v Speaker 1>there was a big push. Apparently a million signatures were

0:45:20.400 --> 0:45:24.080
<v Speaker 1>generated from the just label at campaign and we're submitted

0:45:24.560 --> 0:45:28.040
<v Speaker 1>properly to the f d A, and the FDA rejected

0:45:28.320 --> 0:45:31.759
<v Speaker 1>all but three ninety four of the signatures that were

0:45:31.960 --> 0:45:35.399
<v Speaker 1>given to it because about a million of them were

0:45:35.719 --> 0:45:38.640
<v Speaker 1>in a single electronic document and they were like, these

0:45:38.719 --> 0:45:42.080
<v Speaker 1>don't count. So they didn't do anything about it. And

0:45:42.280 --> 0:45:45.279
<v Speaker 1>there's still no GMO labeling. So, regardless of how you

0:45:45.320 --> 0:45:50.080
<v Speaker 1>feel about GMOs and GMO labeling, that's pretty shady stuff

0:45:50.480 --> 0:45:55.160
<v Speaker 1>to just overtly reject a million signatures, especially as part

0:45:55.200 --> 0:46:00.520
<v Speaker 1>of a large national public campaign. Absolutely. Buyox is a

0:46:00.719 --> 0:46:06.120
<v Speaker 1>pain killer that was approved by the FDA, And just

0:46:06.280 --> 0:46:09.040
<v Speaker 1>to go over this stuff. Uh. In two thousand, a

0:46:09.160 --> 0:46:12.400
<v Speaker 1>study showed that the drug posed a big heart attack

0:46:12.520 --> 0:46:16.120
<v Speaker 1>risk when compared to a similar pain killer, and Mark,

0:46:16.160 --> 0:46:18.480
<v Speaker 1>who was a manufacturer biox, kind of blew it off

0:46:19.120 --> 0:46:23.720
<v Speaker 1>and said it's really beneficial, and the FDA said okay,

0:46:24.440 --> 0:46:28.120
<v Speaker 1>and biox pretty much. Biox remained on the market for

0:46:28.200 --> 0:46:33.320
<v Speaker 1>another four years and UM they estimate between eight thousand

0:46:33.400 --> 0:46:36.360
<v Speaker 1>and a hundred and forty thousand heart attacks were caused

0:46:36.400 --> 0:46:39.160
<v Speaker 1>by biox in that time. And it wasn't It wasn't

0:46:39.200 --> 0:46:42.600
<v Speaker 1>the FDA whoever removed by Ox. It was Murk bowing

0:46:42.680 --> 0:46:46.400
<v Speaker 1>to public pressure. FDA never never, Mark just took it

0:46:46.440 --> 0:46:48.719
<v Speaker 1>off the market itself because it was starting to look bad,

0:46:48.960 --> 0:46:51.759
<v Speaker 1>and the FDU was like, what's going on, what are

0:46:51.760 --> 0:46:55.920
<v Speaker 1>you guys doing? How about a success UM. In the

0:46:56.080 --> 0:47:00.840
<v Speaker 1>nineteen fifties, UH in Germany there were scientists who created

0:47:00.920 --> 0:47:04.640
<v Speaker 1>something called Philidamie, which was a sleeping pill, and they

0:47:04.680 --> 0:47:08.239
<v Speaker 1>said it it's over the counter, it's totally safe for

0:47:08.480 --> 0:47:12.400
<v Speaker 1>Europe for pregnant women. Even is a sleeping pill? Not

0:47:12.560 --> 0:47:15.480
<v Speaker 1>so safe though, because UM children were being born with

0:47:15.600 --> 0:47:19.440
<v Speaker 1>malform limbs to the tune of ten thousand worldwide, but

0:47:19.880 --> 0:47:23.560
<v Speaker 1>not very many in the United States. Because Francis Oldham

0:47:23.600 --> 0:47:26.440
<v Speaker 1>Kelsey of the f D a was really resistant and

0:47:26.520 --> 0:47:28.919
<v Speaker 1>made a big push to not allow the Lita mics.

0:47:29.000 --> 0:47:30.520
<v Speaker 1>She didn't think it was safe. No, she was in

0:47:30.680 --> 0:47:33.440
<v Speaker 1>charge of reviewing the data and said, what is this.

0:47:33.560 --> 0:47:36.920
<v Speaker 1>This is basically anecdotal, like where's your real data, and

0:47:37.040 --> 0:47:40.719
<v Speaker 1>would not withstood a lot of pressure to approve this

0:47:40.840 --> 0:47:44.600
<v Speaker 1>drug and would not cave in. And as a result,

0:47:45.040 --> 0:47:51.200
<v Speaker 1>only seventeen babies were born um with um malformations because

0:47:51.280 --> 0:47:54.759
<v Speaker 1>of in the US, and the whole reason that there

0:47:54.760 --> 0:47:56.759
<v Speaker 1>were any was because they found out that the drug

0:47:56.840 --> 0:47:59.920
<v Speaker 1>maker was pushing the drugs for free onto a man

0:48:00.000 --> 0:48:04.840
<v Speaker 1>are conductors to distribute as samples while this while the

0:48:04.920 --> 0:48:09.000
<v Speaker 1>FDA was holding up approval, and so seventeen children were

0:48:09.120 --> 0:48:12.880
<v Speaker 1>born with deformities because of it, because of this these

0:48:12.960 --> 0:48:16.280
<v Speaker 1>free drugs. Apparently, in Canada, this story was even different.

0:48:16.320 --> 0:48:19.879
<v Speaker 1>The Canadian government, it was totally it was totally legal

0:48:20.040 --> 0:48:24.200
<v Speaker 1>and approved in Canada and for months after it became

0:48:24.719 --> 0:48:29.120
<v Speaker 1>worldwide known that thelidamide caused birth effects because it it

0:48:29.719 --> 0:48:33.800
<v Speaker 1>crosses the placental barrier and arrests development of the fetus.

0:48:33.960 --> 0:48:36.960
<v Speaker 1>Right Canada knew, everybody knew about it, and it took

0:48:37.120 --> 0:48:40.759
<v Speaker 1>months before Canada finally outlawed it. So there's like this

0:48:40.920 --> 0:48:46.000
<v Speaker 1>real big public shame hanging over Canada's um government agency

0:48:46.160 --> 0:48:50.080
<v Speaker 1>regulating drugs still to this day because of that. And

0:48:50.200 --> 0:48:53.120
<v Speaker 1>Billy Joel wrote a song about it. Oh yeah, well

0:48:53.200 --> 0:48:56.800
<v Speaker 1>it was in that terrible talk we didn't start the children.

0:48:58.080 --> 0:49:01.200
<v Speaker 1>I forgot about that. Um, but yeah, that was one

0:49:01.239 --> 0:49:04.640
<v Speaker 1>of the FDA's great successes. And as a result, actually, um,

0:49:05.320 --> 0:49:11.480
<v Speaker 1>the Congress passed something an amendment to the Food and

0:49:11.520 --> 0:49:14.759
<v Speaker 1>Drug Act, the Father Harris Amendments of nineteen sixty two,

0:49:15.239 --> 0:49:19.920
<v Speaker 1>that really expanded the f d a's um scope of duties.

0:49:20.600 --> 0:49:23.279
<v Speaker 1>It put, um, you know how you know those have

0:49:23.440 --> 0:49:27.120
<v Speaker 1>drug ads, have all those disclaimers. That's from the nineteen

0:49:27.160 --> 0:49:31.160
<v Speaker 1>sixty two amendments. Advertising is under the juristic scene. They

0:49:31.239 --> 0:49:33.120
<v Speaker 1>read those so fast, and the last one is an

0:49:33.160 --> 0:49:35.879
<v Speaker 1>early death right exactly like do you need to say

0:49:35.920 --> 0:49:42.440
<v Speaker 1>early death? No? Um, they And prior to nineteen sixty two,

0:49:42.560 --> 0:49:46.560
<v Speaker 1>the FDA had sixty days to respond to an application

0:49:47.000 --> 0:49:49.319
<v Speaker 1>and if they didn't get to it in time, well

0:49:49.400 --> 0:49:52.319
<v Speaker 1>that's fine. I'm sure it's fine. You can go to market. Um.

0:49:52.480 --> 0:49:54.640
<v Speaker 1>That changed to I think a hundred and eighty days,

0:49:54.640 --> 0:49:57.520
<v Speaker 1>and it's just to respond um and then also drug

0:49:57.600 --> 0:50:00.719
<v Speaker 1>makers only had to demonstrate that the or drug was

0:50:01.440 --> 0:50:05.919
<v Speaker 1>UM safe not effective. That changed the two as well. Yep.

0:50:06.320 --> 0:50:09.240
<v Speaker 1>They also said that they had to control the marketing

0:50:09.280 --> 0:50:12.600
<v Speaker 1>of generic drugs to keep them from being sold as

0:50:13.480 --> 0:50:15.719
<v Speaker 1>uh just like jacking up the price under a new

0:50:15.800 --> 0:50:19.600
<v Speaker 1>name basically. So um, yeah, that was a great amendment,

0:50:19.640 --> 0:50:27.040
<v Speaker 1>the Kerfuffle Harris amendment. Is that right? That's father So

0:50:27.239 --> 0:50:31.800
<v Speaker 1>another great success. Well that was the same one. Well no,

0:50:31.960 --> 0:50:35.080
<v Speaker 1>I mean in addition to the lido Uh. And then

0:50:35.280 --> 0:50:39.280
<v Speaker 1>in the news recently you dug this up, the Zohydra painkiller.

0:50:39.440 --> 0:50:41.279
<v Speaker 1>Didn't hear about this? No, I haven't heard of this

0:50:41.440 --> 0:50:46.360
<v Speaker 1>until today. It's uh, apparently it's pure oxycodone, correct it is.

0:50:46.800 --> 0:50:50.160
<v Speaker 1>There's the first time. Yeah, there is. Um. All the

0:50:50.239 --> 0:50:53.680
<v Speaker 1>other stuff like vik it in and oxyconton even or

0:50:54.400 --> 0:50:58.680
<v Speaker 1>are safer because they contain at least something else like

0:50:58.800 --> 0:51:01.719
<v Speaker 1>a seed, a mena fan or some other drug. This

0:51:01.960 --> 0:51:06.600
<v Speaker 1>is just pure hydrocodone. And um. You remember like there

0:51:06.680 --> 0:51:09.759
<v Speaker 1>was a huge, huge problem with pill addiction to oxyconton

0:51:09.760 --> 0:51:12.640
<v Speaker 1>in particular. Yeah, it wasn't just rush limball with a

0:51:12.719 --> 0:51:15.520
<v Speaker 1>lot of people. Yeah, we're really hooked on oxycont and

0:51:15.560 --> 0:51:19.200
<v Speaker 1>as a matter of fact, the current um heroin addiction

0:51:19.320 --> 0:51:22.400
<v Speaker 1>crisis in the US is a direct result of the

0:51:22.560 --> 0:51:25.799
<v Speaker 1>FDA stepping in and saying like, hey, you guys need

0:51:25.880 --> 0:51:28.360
<v Speaker 1>to do something with oxyconton. Like people are crushing it

0:51:28.480 --> 0:51:30.799
<v Speaker 1>up and injecting it. You gotta do something. So now

0:51:31.719 --> 0:51:34.160
<v Speaker 1>there's well, there's a Tampa resistant thing where when you

0:51:34.280 --> 0:51:36.880
<v Speaker 1>crush up oxyconton, now it turns into this goog that

0:51:37.000 --> 0:51:39.840
<v Speaker 1>you can inject or snort. Right, Can you lick it

0:51:39.880 --> 0:51:42.879
<v Speaker 1>off a mirror? You can? I guess, but I don't

0:51:42.920 --> 0:51:45.239
<v Speaker 1>think it has the same effect, right because when you

0:51:45.360 --> 0:51:47.120
<v Speaker 1>when you crush it up, it was time released. When

0:51:47.120 --> 0:51:49.680
<v Speaker 1>you crush it up, it's not time released anymore. It's

0:51:49.719 --> 0:51:54.560
<v Speaker 1>like all there to give you this a media, right.

0:51:54.760 --> 0:51:57.759
<v Speaker 1>So now that when you crush up oxyconton it turns

0:51:57.800 --> 0:52:00.960
<v Speaker 1>into a Google. Everybody's turned to hair one, right, So

0:52:01.080 --> 0:52:04.840
<v Speaker 1>now there's a heroin epidemic. This company making zo Hydra

0:52:05.239 --> 0:52:08.440
<v Speaker 1>came along and said, well, that's cool, just released this

0:52:08.560 --> 0:52:12.440
<v Speaker 1>completely pure hydro code un pill without any tamper resistance.

0:52:13.080 --> 0:52:16.280
<v Speaker 1>So we're gonna go back to square one, everybody, okay,

0:52:16.600 --> 0:52:20.239
<v Speaker 1>And there's a huge outcry against this drug, and the

0:52:20.440 --> 0:52:24.160
<v Speaker 1>FDA had stepped up and became a mouthpiece for it. Yeah,

0:52:24.200 --> 0:52:27.840
<v Speaker 1>and the FDA will, um, they will defend the decision

0:52:27.920 --> 0:52:30.880
<v Speaker 1>by saying, well, putting things like a set of menifin

0:52:31.800 --> 0:52:35.240
<v Speaker 1>has well known liver damage risk, so this is actually

0:52:35.320 --> 0:52:38.200
<v Speaker 1>more pure. You can actually take hydro coda. Now, people

0:52:38.239 --> 0:52:42.239
<v Speaker 1>in severe pain can take this drug without that liver

0:52:42.360 --> 0:52:45.480
<v Speaker 1>toxicity risk. I mean that's a point. Now, it is

0:52:45.520 --> 0:52:48.600
<v Speaker 1>a point. And if you're in severe pain in life

0:52:48.640 --> 0:52:51.640
<v Speaker 1>and need this to to function or live out your life,

0:52:51.719 --> 0:52:54.759
<v Speaker 1>then great, But make it tamper resistance. Yeah, that's not

0:52:55.000 --> 0:52:56.840
<v Speaker 1>what people are arguing about. They're saying that this is

0:52:56.920 --> 0:53:02.280
<v Speaker 1>a very high level for abuse because there's no tamper resistance. Yeah, exactly,

0:53:02.520 --> 0:53:06.359
<v Speaker 1>So people are going to die because of this drub Yeah,

0:53:06.520 --> 0:53:11.239
<v Speaker 1>I think. Um. In two thousand and ten, uh, prescription

0:53:11.480 --> 0:53:15.400
<v Speaker 1>hydro codone and other prescription opiates accounting for almost seventeen

0:53:15.440 --> 0:53:19.399
<v Speaker 1>thousand deaths, which is a fourfold increase from just ten

0:53:19.520 --> 0:53:22.200
<v Speaker 1>or eleven years earlier. Right, and that was all Oh

0:53:22.320 --> 0:53:27.160
<v Speaker 1>see before they made it tamper resistant. Orange County. There's

0:53:27.160 --> 0:53:29.360
<v Speaker 1>probably a lot of it in county. I bet there

0:53:29.520 --> 0:53:36.120
<v Speaker 1>is so there you go, crazy stuff. It is crazy stuff. Um.

0:53:36.800 --> 0:53:39.920
<v Speaker 1>I kind of with that professor from Arizona. That's just

0:53:40.120 --> 0:53:44.960
<v Speaker 1>like safety, Like it's it's sad that the chief of

0:53:45.080 --> 0:53:48.439
<v Speaker 1>that organization can't be someone who's super pro safety above

0:53:48.480 --> 0:53:51.399
<v Speaker 1>all else. Yeah, that's their job. There's such a tug

0:53:51.480 --> 0:53:58.719
<v Speaker 1>of war between the public and I guess corporations over safety. Yeah,

0:53:58.880 --> 0:54:00.719
<v Speaker 1>and the f d A is not pulling on our

0:54:00.800 --> 0:54:03.719
<v Speaker 1>side necessarily. Yeah. And I'm sure we'll hear from all

0:54:03.800 --> 0:54:06.480
<v Speaker 1>kinds of people from the pharmaceutical industry that will tout

0:54:06.560 --> 0:54:09.480
<v Speaker 1>how seriously they take their testing and stuff. And we're

0:54:09.480 --> 0:54:12.840
<v Speaker 1>not saying they don't. But um no, I think it

0:54:13.000 --> 0:54:16.600
<v Speaker 1>is a There are great protocols and standards and procedures,

0:54:16.640 --> 0:54:20.400
<v Speaker 1>but there's also plenty of times where they just overtly

0:54:20.480 --> 0:54:25.359
<v Speaker 1>dropped the ball and public safety suffered as a result. Agreed. Uh.

0:54:25.440 --> 0:54:27.200
<v Speaker 1>If you want to know more about the f d A,

0:54:27.360 --> 0:54:31.480
<v Speaker 1>you can go to the FDA website FDA dot gov.

0:54:31.600 --> 0:54:33.880
<v Speaker 1>You can go to how Stuff Works dot com and

0:54:34.120 --> 0:54:36.319
<v Speaker 1>type in f d A in the search bar. Don't

0:54:36.360 --> 0:54:38.960
<v Speaker 1>forget to go to our podcast page on Stuff you

0:54:38.960 --> 0:54:41.800
<v Speaker 1>Should Know dot com for the f d A episode

0:54:41.840 --> 0:54:44.799
<v Speaker 1>that you're listening to now, and since I said search

0:54:44.880 --> 0:54:49.520
<v Speaker 1>bar in there somewhere, it's time for listener mail. I'm

0:54:49.520 --> 0:54:54.000
<v Speaker 1>gonna call this uh we inspired a writer awesome. Hey

0:54:54.080 --> 0:54:55.960
<v Speaker 1>guys and Jerry, first off, thank you so much for

0:54:56.000 --> 0:54:57.919
<v Speaker 1>what you do. I've been a fan for over three years,

0:54:58.480 --> 0:55:00.920
<v Speaker 1>steadily working my way through the back living in constant

0:55:00.960 --> 0:55:03.560
<v Speaker 1>fear of the existential dread that will settle upon me

0:55:03.640 --> 0:55:06.520
<v Speaker 1>the day I finish UM. I poked my sister as well.

0:55:06.680 --> 0:55:11.480
<v Speaker 1>And whereas our conversations used to be Simpsons quotes, now

0:55:11.800 --> 0:55:15.920
<v Speaker 1>it is nine Simpson's ten percent stuff. You should know that,

0:55:18.040 --> 0:55:20.120
<v Speaker 1>she says. But I digress. I'm writing because I'm an

0:55:20.120 --> 0:55:23.520
<v Speaker 1>author of dark humor novels for young adults, and I

0:55:23.600 --> 0:55:25.520
<v Speaker 1>wanted to express how health of your podcast has been

0:55:25.560 --> 0:55:29.520
<v Speaker 1>with inspiring and informing various elements of my books. For example,

0:55:29.600 --> 0:55:31.960
<v Speaker 1>the one I'm currently writing is about a creepy candle

0:55:32.040 --> 0:55:35.280
<v Speaker 1>factory in a creepy small town with a big, creepy

0:55:35.320 --> 0:55:40.160
<v Speaker 1>mountain wherein wax sculptures come to life, and after listening

0:55:40.239 --> 0:55:44.919
<v Speaker 1>to your ear Wax episode, Mount Ceremon was born pretty neat.

0:55:46.000 --> 0:55:48.320
<v Speaker 1>Ever since the Haunted House episode of Been Itching, to

0:55:48.360 --> 0:55:51.360
<v Speaker 1>write a horror about a horror attraction that goes terribly

0:55:51.440 --> 0:55:55.200
<v Speaker 1>and hilariously wrong. Number stations equals something awesome, and so

0:55:55.400 --> 0:55:57.880
<v Speaker 1>on and so on. So we're inspiring her all over

0:55:57.960 --> 0:56:00.040
<v Speaker 1>the place. I never know where your inspirations go and

0:56:00.160 --> 0:56:01.920
<v Speaker 1>come from, but your so provides me with a steady

0:56:02.000 --> 0:56:05.320
<v Speaker 1>stream of delicious possibilities. I want to thank you the

0:56:05.360 --> 0:56:06.920
<v Speaker 1>best way I could, So I named a couple of

0:56:07.000 --> 0:56:11.239
<v Speaker 1>off screen high school characters after you, guys in my

0:56:11.360 --> 0:56:14.800
<v Speaker 1>most recently published book, Hellhole. So wait, how about that?

0:56:15.000 --> 0:56:17.959
<v Speaker 1>That is a huge honor, pretty neat And she's gonna

0:56:18.000 --> 0:56:20.799
<v Speaker 1>send us some copies and one for Jerry too, of course,

0:56:20.840 --> 0:56:24.520
<v Speaker 1>she says, So I'm gonna send our mailing address. And

0:56:25.600 --> 0:56:27.200
<v Speaker 1>she says, thanks for the brain snacks. And that was

0:56:27.239 --> 0:56:31.000
<v Speaker 1>from Gina Domico d A M I c O. And

0:56:31.080 --> 0:56:33.319
<v Speaker 1>she has a website and you can check out her

0:56:34.040 --> 0:56:37.080
<v Speaker 1>kind of a weird, funny, twisted young adult novels at

0:56:37.120 --> 0:56:44.000
<v Speaker 1>her site and support support writing creativity. Thanks lord, Gina. Right, yeah,

0:56:44.080 --> 0:56:46.440
<v Speaker 1>and uh, make sure you get l old so you

0:56:46.480 --> 0:56:51.440
<v Speaker 1>can see our names in print. You don't like that

0:56:51.560 --> 0:56:55.399
<v Speaker 1>was waiting for government joke? Oh? Was it? Oh? You'll

0:56:55.440 --> 0:56:59.000
<v Speaker 1>explain to me later. Right, how are you uh? If

0:56:59.040 --> 0:57:02.160
<v Speaker 1>you want to, you get in touch with us to

0:57:02.280 --> 0:57:05.200
<v Speaker 1>find out the waiting for gufnment joke Chuck just made.

0:57:05.400 --> 0:57:10.880
<v Speaker 1>He'll respond to each each inquiry personally. Right. You can

0:57:10.960 --> 0:57:13.719
<v Speaker 1>tweet to us at s y ESK Podcast. You can

0:57:13.800 --> 0:57:16.160
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0:57:16.200 --> 0:57:18.440
<v Speaker 1>on Facebook dot com, slash stuff you Should Know. You

0:57:18.560 --> 0:57:21.040
<v Speaker 1>can send us an email to Stuff Podcast at how

0:57:21.120 --> 0:57:24.320
<v Speaker 1>stuff Works dot com, and as always, joined us at

0:57:24.320 --> 0:57:26.480
<v Speaker 1>at home on the web Stuff you Should Know dot com.

0:57:31.800 --> 0:57:34.200
<v Speaker 1>For more on this and thousands of other topics, is

0:57:34.280 --> 0:57:35.520
<v Speaker 1>it how stuff Works dot com