Latest / Stuff You Should Know / Does the FDA Protect Americans?
Transcript
- 0:01Speaker 1: Welcome to Stuff you Should Know from House Stuff Works
- 0:04Speaker 1: dot com. Hey, and welcome to the podcast. I'm Josh
- 0:13Speaker 1: Clark with Charles W. Chuck Bryant and Jerry over there.
- 0:17Speaker 1: So this is stuff you should know the podcast. How
- 0:20Speaker 1: does doing fine? How are you great? Yeah? Yeah, that's good.
- 0:26Speaker 1: I enjoyed learning about the f d A. Yeah, you
- 0:29Speaker 1: know we've podcasted on him before. Why doesn't the FDA
- 0:34Speaker 1: regulate herbal supplements? Right? Man, we did that long time ago.
- 0:38Speaker 1: Remember that's where the herbal Elvis comes out. Oh yeah,
- 0:41Speaker 1: was that the first appearance? I'm pretty sure. Hey, man,
- 0:46Speaker 1: give me some supplements. Your dad doctor, He just like
- 0:50Speaker 1: would go around the house. Yeah, when he was on
- 0:52Speaker 1: Herble Upper. Sure. Yeah man, how did you talk on
- 0:56Speaker 1: the herbal downers? He didn't. He just slept a lot, gotcha.
- 1:01Speaker 1: Um No, I'm just tease of course. So we have
- 1:05Speaker 1: talked about the FDA before, but yeah, this is um
- 1:07Speaker 1: this is a much more in depth. Look that's right
- 1:12Speaker 1: at the ft. Okay, let's set your Chris Walkin. No
- 1:18Speaker 1: was that Chris Walkin? No? Not really, I mean the
- 1:20Speaker 1: weird pauses, but I was more doing Shatner. Oh but
- 1:24Speaker 1: I didn't go up, which should have Sure pretty good though,
- 1:29Speaker 1: huh yeah, pretty clear, Bill sat So, uh did you
- 1:35Speaker 1: know most of this stuff? Um? Well, I know that
- 1:38Speaker 1: the f d A is is has a history of
- 1:41Speaker 1: controversy of people saying, uh, you're not you don't act
- 1:46Speaker 1: fast enough. We need these drugs to help people. Or
- 1:48Speaker 1: then other people are like, stop acting so much exactly,
- 1:51Speaker 1: you're going too fast and rushing these things to market,
- 1:53Speaker 1: right exactly. So it's it's a bit of a tough
- 1:56Speaker 1: thing to reconcile, you know. There. I acknowledge they're in
- 1:59Speaker 1: a tough spot. They really are. And um, I think
- 2:03Speaker 1: that's a good, good caveat or disclaimer to put it
- 2:05Speaker 1: in the front of this because it is a very
- 2:08Speaker 1: controversial agency. It's the first consumer protection agency in the
- 2:12Speaker 1: United States ever, it's the oldest one, and um it's
- 2:19Speaker 1: common liberal or what have you. But I think it
- 2:21Speaker 1: is a very um important agency to have. Oh I
- 2:26Speaker 1: don't think that makes you liberal. So some people may say,
- 2:30Speaker 1: so what they don't think we should regulate anything in
- 2:33Speaker 1: this country. Yeah, there's people who think that, like the
- 2:35Speaker 1: f d A is just completely in the way of business.
- 2:38Speaker 1: It's a a fetter right, that's a thing because unfettered,
- 2:45Speaker 1: if you can be unfettered, you can be fettered. But
- 2:48Speaker 1: is there something that can fetter and would that be
- 2:50Speaker 1: a fetter? So it's a fetter to business to some
- 2:54Speaker 1: in some people's mind. Um yeah, I just think that
- 2:57Speaker 1: you when you were talking about something as um elemental
- 3:03Speaker 1: as food or drugs, thinks we put into our bodies
- 3:07Speaker 1: and the hopes that we will be have a greater
- 3:10Speaker 1: well being that you kind of do have to have
- 3:14Speaker 1: a big kid on the block looking out for all
- 3:16Speaker 1: the little kids. Well, I mean, I think when when
- 3:19Speaker 1: big bucks are involved, it's pretty clear that companies themselves
- 3:24Speaker 1: probably aren't gonna like pull back on their profits in
- 3:28Speaker 1: order to just be super safe, like it has been
- 3:31Speaker 1: proven throughout history that they'll generally want like air on
- 3:34Speaker 1: the side of making the money. You know, you're a comic,
- 3:40Speaker 1: is gonna be fun. So Okay, now that we got
- 3:43Speaker 1: that out of the way, Chuck, let's dig into the FDA,
- 3:45Speaker 1: because if you want to see whether or not you
- 3:47Speaker 1: think the f d A is necessary, all you have
- 3:50Speaker 1: to do is go back to the days before the FDA,
- 3:53Speaker 1: which wasn't too terribly long ago. I mean, the FDA
- 3:55Speaker 1: really only finds its origins and uh nineteen o six
- 3:59Speaker 1: on paper, it goes a little bit back before that today,
- 4:03Speaker 1: I think the Abraham Lincoln administration. Yeah, who was a
- 4:06Speaker 1: pinko himself. Let's climb in the way back machine, shall we.
- 4:09Speaker 1: Oh yeah, it's been a little man. It smells like
- 4:15Speaker 1: cat in here. I know. Well I took a little
- 4:18Speaker 1: ride with Laurent and the Wizard and uh, sorry about nothing. Man,
- 4:22Speaker 1: how are they doing well? They're doing great, But um,
- 4:25Speaker 1: I forgot to bring a little box. So yeah, there
- 4:27Speaker 1: was an accident. Um, so here we are in the
- 4:30Speaker 1: way back machine and we're going all the way back,
- 4:33Speaker 1: like you said, to the Times of Lincoln. And what
- 4:36Speaker 1: he did he kind of kicked kick the man. I
- 4:39Speaker 1: couldn't say that the other day in private the bucket. No,
- 4:42Speaker 1: I want to say, get the ball rolling and kick
- 4:44Speaker 1: it off. And I said kick the ball, kick the
- 4:47Speaker 1: ball rolling. I said that the other day. It's like
- 4:49Speaker 1: twice that's okay. So he wanted to kick the ball rolling.
- 4:53Speaker 1: And so he appointed a chemist named Charles weather Roll
- 4:58Speaker 1: to analyze agricultural materials. Sniffed him on the case. Yeah,
- 5:03Speaker 1: he sniffed them on the case. Not off, said hey,
- 5:06Speaker 1: food and soil and fertilizer, maybe look into that. We
- 5:09Speaker 1: have the new Department of Agriculture. And then his successors,
- 5:14Speaker 1: Harvey Wiley and Peter Collier were the dudes who really
- 5:17Speaker 1: um kind of got things going in a in a
- 5:21Speaker 1: like a serious way for the FDA. Well, they saw
- 5:23Speaker 1: like a real um reason for an agency that was
- 5:27Speaker 1: in charge of guarding safeguarding the purity of food and
- 5:32Speaker 1: drugs at the American public was ingesting. They basically saw
- 5:35Speaker 1: what was going on. I was like, Hey, we might
- 5:37Speaker 1: need to step in here because prior to this, I mean,
- 5:39Speaker 1: we talked about it in UM are Bizarre Medical Treatments
- 5:43Speaker 1: episode I think where we were just talking about UM
- 5:47Speaker 1: like little kids being given morphine in like a prescription
- 5:51Speaker 1: that in no way, shape or form said there was
- 5:53Speaker 1: morphine and it just calm colicky babies, and it calmed
- 5:57Speaker 1: him by bringing him to the brink of death on
- 5:59Speaker 1: him morphine overdose. But you could buy it over the counter.
- 6:03Speaker 1: You shouldn't regulate that, that's business. So that's one and
- 6:07Speaker 1: that was the one that actually used morphine there. I'm
- 6:09Speaker 1: sure others that were out there that were um much
- 6:13Speaker 1: more lethal use knockoff morphine or something like that that
- 6:17Speaker 1: cousin Tony made in his basement. You could do it
- 6:21Speaker 1: bottle and if the person, if the person bought it
- 6:23Speaker 1: and they died, well, buyer beware, you know. Um. So
- 6:28Speaker 1: the guys like Um, Wiley and Collie or especially Wiley, though,
- 6:32Speaker 1: we're really adamant about getting some sort of regulation and
- 6:36Speaker 1: specifically taking this agency that they've been handed um and
- 6:40Speaker 1: and building it into into a real powerhouse. Yeah. And
- 6:43Speaker 1: over the course of about twenty five years, they got
- 6:46Speaker 1: Congress to look over about a hundred bills for the
- 6:50Speaker 1: food and drug industry. I guess Congress said, no, no, no,
- 6:56Speaker 1: we're pretty deep in the industry's pockets, so we can't
- 6:59Speaker 1: really do anything right now. We agree with you, totally
- 7:02Speaker 1: great idea, but I'm sorry, but I a car is
- 7:06Speaker 1: about to be invented and I want to own one,
- 7:08Speaker 1: and pretty bad. Well that'll change, though, my friend. In
- 7:11Speaker 1: nineteen six, UM when h reporter novelist Upton Sinclair wrote
- 7:16Speaker 1: The Jungle, which UM, like everyone sort of this very
- 7:19Speaker 1: famous book that uh exposed the practices of the meat
- 7:23Speaker 1: packing industry in Chicago in particular. But um, it was
- 7:28Speaker 1: a big deal and it caused a lot of people
- 7:30Speaker 1: to really freak out. It wasn't It was a novel,
- 7:32Speaker 1: which means it was fictitious, but it was based on
- 7:35Speaker 1: his and he was a journalist too. It was based
- 7:38Speaker 1: on his experiences I guess, working undercover in the Chicago
- 7:41Speaker 1: meat packing plants, and apparently I guess Roosevelt, Teddy Roosevelt
- 7:47Speaker 1: set up an investigation, a committee to investigate. He claims
- 7:52Speaker 1: fan of Sinclair's at all, but I think he's sort
- 7:54Speaker 1: of Everyone was so repulsed he had to do something. Yeah,
- 7:58Speaker 1: I mean, like it really got the America in public
- 8:00Speaker 1: because the stories are things like, um, they were using
- 8:03Speaker 1: disease cows for meat, and there were rats that were
- 8:07Speaker 1: calling around on the cows, and so they poisoned the rats,
- 8:11Speaker 1: and then the dead poisoned rats with the poison, and
- 8:13Speaker 1: the diseased cow meat would all be put into a
- 8:16Speaker 1: grinder and there was your potted meat on the other side. Yeah,
- 8:21Speaker 1: he was, Uh, I still won't eat potted meat. Yeah, well,
- 8:24Speaker 1: I don't care what year it is. You take me
- 8:28Speaker 1: to the future in twenty two thousand, three hundred and twelve,
- 8:31Speaker 1: and I'm not gonna eat potted meat. I wish the
- 8:33Speaker 1: way back machine could go to the future. Well, that's
- 8:36Speaker 1: the way forward machine. We have one of those well
- 8:39Speaker 1: nuls working on it. Okay, it'll be a while. Um.
- 8:43Speaker 1: So they had to do something because there were even
- 8:45Speaker 1: accusations of people being in meat um, which apparently was
- 8:49Speaker 1: not true and that was really fictitious. Right. But that
- 8:52Speaker 1: committee that investigated Sinclair's claims in the Jungle found that
- 8:57Speaker 1: pretty much everything else he said in that book was
- 9:00Speaker 1: through step for the guy being ground up with the
- 9:03Speaker 1: beef because he fell into a meat grinder. And they
- 9:05Speaker 1: were just like, again, the meat business is not able
- 9:07Speaker 1: to police itself and say maybe we shouldn't put disease
- 9:10Speaker 1: rats and meat. So the government was forced to step
- 9:13Speaker 1: in and in nineteen oh six, on June thirty, Congress
- 9:17Speaker 1: past the Food and Drugs Act a k a. The
- 9:20Speaker 1: Wiley Act, and that prohibited um trade of mislabeled and
- 9:24Speaker 1: contaminated food, bevies and medicines across state lines. So I
- 9:29Speaker 1: guess you can still sell it in Illinois, you know. Yeah,
- 9:33Speaker 1: That's the one thing I never get is the shipping thing, Like, well,
- 9:36Speaker 1: that's that's the only thing that they can enforce. Er. Well, yeah,
- 9:39Speaker 1: the the federal government is there's always been a struggle
- 9:43Speaker 1: between states in federal right, and so the kind of
- 9:47Speaker 1: the line has been drawn at the state borders where
- 9:50Speaker 1: it's like RoCE across the state border all of a sudden,
- 9:53Speaker 1: you're part of the United States rather than just the state,
- 9:56Speaker 1: and you want to leave it up to the state.
- 9:57Speaker 1: But over time the federal government has taken more and
- 10:00Speaker 1: more power from the states. With the Wily Act, though, Chuck,
- 10:04Speaker 1: I mean, it's named after Wiley, so it gives you
- 10:06Speaker 1: an idea of like the links that this guy went
- 10:08Speaker 1: too to try to establish some sort of standards for
- 10:12Speaker 1: purity and food. Right. One of the things he did
- 10:16Speaker 1: was set up what came to be called the Poison Squad. Yeah,
- 10:19Speaker 1: that's a great name, isn't it. It really isn't It
- 10:21Speaker 1: was a sensational name, and at first he fought it,
- 10:24Speaker 1: and then he finally saw like he was worried that
- 10:27Speaker 1: with a name like the poison Squad, they had their
- 10:29Speaker 1: own little poison squad. An thom and Um the articles
- 10:34Speaker 1: written about the Poison Squad really sensational and like, can
- 10:37Speaker 1: you believe how crazy these guys are? Um and at
- 10:40Speaker 1: first wild he fought it because he he was like,
- 10:42Speaker 1: this is a really serious scientific undertaking. And then finally
- 10:45Speaker 1: he saw the writing on the wall. It was like,
- 10:47Speaker 1: you can get America behind this whole idea if you
- 10:50Speaker 1: just give him the poison Squad as they want the
- 10:53Speaker 1: poison Squad. And it's like I have added everybody they
- 10:56Speaker 1: haven't had them. They did. It's in this this article
- 10:59Speaker 1: for m like the FDA Zone Consumer magazine or whatever
- 11:04Speaker 1: from I think two thousand two, The Boys and Squad,
- 11:07Speaker 1: The Boys and Squad something like. It's something it's kind
- 11:10Speaker 1: of like that. It's like, um, it's like when they
- 11:15Speaker 1: take these bites, um, they won't feel any pain, but
- 11:20Speaker 1: when they wake up in the morning, they'll probably never
- 11:22Speaker 1: be the same. Just stuff like that. It's just kind
- 11:24Speaker 1: of like, um, you know how they used to make
- 11:26Speaker 1: jokey songs in the early interesting. So what the Poison
- 11:31Speaker 1: Squad was was a group of men volunteers we should
- 11:35Speaker 1: point out who signed up for this and repeatedly signed
- 11:38Speaker 1: up for this and signed away their right to sue
- 11:42Speaker 1: or anything. They were fully on board, um to eat
- 11:46Speaker 1: poison and to basically uh in a in a kitchen
- 11:49Speaker 1: there on h Washington, d C. In the basement of
- 11:52Speaker 1: the FDA's building. Yeah, they would have had a chef
- 11:55Speaker 1: that apparently made some great meals laced with all kinds
- 11:59Speaker 1: of poison for mal hide, borax, what was a really
- 12:03Speaker 1: harmful one. It was called copper sulfate, right, which is
- 12:07Speaker 1: now pesticide. Correct. Yeah, and they used it to make
- 12:09Speaker 1: camps appear bright green, and that that kind of gets
- 12:13Speaker 1: to the heart of the matter. Chuck, Like they these
- 12:15Speaker 1: guys weren't just eating poison just for fun. Oh no,
- 12:17Speaker 1: they were testing out stuff that was being used as
- 12:20Speaker 1: preservatives and food at the time. Exactly, additives and preservatives
- 12:24Speaker 1: and stuff like you said to make your peas greener. Right,
- 12:27Speaker 1: So people used to use formaldehyde to preserve meat, makes sense,
- 12:32Speaker 1: people used to use borax formaldehyde. Look how long that
- 12:35Speaker 1: human heads? But in that bucket? Exactly, let's put it
- 12:38Speaker 1: on beef. So did you touch that head or did
- 12:41Speaker 1: you just like you didn't poke it with the end
- 12:43Speaker 1: of a mom and know, his face bobbed up at me,
- 12:46Speaker 1: and I was just like, all right, there it is,
- 12:49Speaker 1: hello sir. So Uh, the poison Squad made great headway.
- 12:54Speaker 1: They really determined a lot of stuff that shouldn't be
- 12:57Speaker 1: used as preservatives like that copper sulfate that was used
- 13:00Speaker 1: to make peas green. Yeah, national heroes in a way.
- 13:04Speaker 1: Well yeah, they also proved um overall, that selling adulterated
- 13:10Speaker 1: food wasn't just a buyer beware kind of thing, that
- 13:14Speaker 1: it actually posed a real public health hazard. They got
- 13:17Speaker 1: super sick, they did, and they got publicized. These guys
- 13:22Speaker 1: are getting sick on purpose from the same stuff that
- 13:26Speaker 1: you're feeding your kids, which is where they shut it
- 13:28Speaker 1: down eventually, right, and the public all of a sudden
- 13:30Speaker 1: it's like, well, we don't want this stuff in our peas.
- 13:32Speaker 1: I don't care whether they're green or not. I'm not
- 13:34Speaker 1: eating this, And then public pressure led to finally Congress
- 13:38Speaker 1: enacting the Food and Drug Act. I wonder if I'm
- 13:41Speaker 1: When I was reading this, I was wondering if that
- 13:43Speaker 1: has something to do with the the um the thing
- 13:47Speaker 1: with peas, Like I don't think people generally like peas,
- 13:51Speaker 1: and I wonder if that has anything to do with
- 13:54Speaker 1: I like peas. But I wonder if that was like
- 13:56Speaker 1: a stigmata on the PA when this stuff came out
- 13:59Speaker 1: and have blood on its palms, blood on its p uh.
- 14:05Speaker 1: Maybe I don't know. I don't either surely it had
- 14:07Speaker 1: some effect that would guess, well, it's like it's probably
- 14:10Speaker 1: a lot like Um, how they spray produce in the
- 14:13Speaker 1: produce section, even though it increases its rotting time dramatically.
- 14:17Speaker 1: Why did they do that to make it look pretty,
- 14:19Speaker 1: to make it look fresh. It's ridiculous, but it's probably
- 14:22Speaker 1: the same exact principle. I bet you're right. Here's some
- 14:25Speaker 1: poison to make your people. Right. So the f d
- 14:29Speaker 1: A UM when they formally evolved, Um, they evolved out
- 14:34Speaker 1: of some other agencies. Uh. They've been through a bunch
- 14:36Speaker 1: of name changes and reords through the years. Um. But
- 14:40Speaker 1: in nineteen oh six what they're they were under the
- 14:44Speaker 1: Department of Agricultures Bureau of Chemistry, and they were the
- 14:47Speaker 1: ones charged with enforcing that Food and Drugs Act. So
- 14:50Speaker 1: they split them up in ninete into two groups, the
- 14:53Speaker 1: Food and Drug Insecticide Administration they handled the regulations and
- 14:58Speaker 1: the Bureau of Chemistry and Soils handled the experiments. Before
- 15:02Speaker 1: it had been just the Bureau of Chemistry doing both. Yeah,
- 15:05Speaker 1: so they split them up. Eventually, they dropped in nineteen
- 15:07Speaker 1: thirty the name and Secticide and it just became the
- 15:10Speaker 1: f D AY and From there, they were in under
- 15:14Speaker 1: the guys or under the purview of several agencies until
- 15:17Speaker 1: the late seventies and they finally landed where they are now,
- 15:19Speaker 1: which is the Health and Human Services yea, h h S,
- 15:25Speaker 1: green PS. So today the way they're organized loosely. They're
- 15:32Speaker 1: not organized loosely, but this is a script site is this?
- 15:36Speaker 1: They have a top layer of the Office of Commissioner
- 15:39Speaker 1: of Food and Drugs a report to the director of sorry,
- 15:42Speaker 1: the Secretary of HHS who used to be Tommy Thompson. Really, yeah,
- 15:47Speaker 1: under Bush. Oh that's right. Do you know who it
- 15:50Speaker 1: is now? I don't. There's probably none there. Obama hasn't
- 15:53Speaker 1: been able to get anybody confirmed, like either term. Uh.
- 15:57Speaker 1: That first layer also has seven support supporting organizations that
- 16:01Speaker 1: support the commissioner, and they're mainly on They're not like
- 16:05Speaker 1: the rubber meets the road. They're the on the policy
- 16:09Speaker 1: side of things, basically litigation and stuff. Well, yeah, the
- 16:13Speaker 1: big stuff, the big overarching we are the f d A. Yeah,
- 16:18Speaker 1: and then below them are broken down the into components
- 16:22Speaker 1: that handle rubber meets the road stuff. Yeah. Those are
- 16:25Speaker 1: the five Deputy commissioners and um, they're they're like you
- 16:28Speaker 1: said they're the ones that really are heading up the
- 16:32Speaker 1: field offices. I think there's um four sorry two seven
- 16:37Speaker 1: field offices. And then they have their big home in
- 16:40Speaker 1: Silver Spring, Maryland, where they have about close to employees
- 16:44Speaker 1: and chuck. Um, let's do a quick quiz. You're ready, yes, okay,
- 16:48Speaker 1: the f you gotta wait, sorry that I know you're
- 16:52Speaker 1: very excited right now, is just hanging there. The FDA
- 16:55Speaker 1: regulates true or false? UM, X ray machines. Um, I'm
- 17:01Speaker 1: gonna say true, that's right. They regulate radioactive or radioactivity
- 17:07Speaker 1: emitting machines like X rays. Uh. Pesticides, that's right. Yeah,
- 17:15Speaker 1: that's the U. S d A. From what I understand. Um,
- 17:18Speaker 1: illicit drugs like cocaine and crap cocaine. They don't regulate that. No,
- 17:24Speaker 1: that's true. They don't. Uh. Let's see what else. What
- 17:28Speaker 1: about donated blood? True, that's true. They regulate biologics doing
- 17:36Speaker 1: great man vaccines and blood. Yeah, thank you, tobacco. Um,
- 17:40Speaker 1: they do regulate that, I believe. And then what about
- 17:44Speaker 1: poultry chicken? Yes, of course they do. No, because it's food.
- 17:49Speaker 1: No U s d A. Again, although the FDA does
- 17:53Speaker 1: regulate apparently the dairy industry. Yeah, but not meeting poultry. No,
- 17:58Speaker 1: talk about mind boggling. They do reulate um cosmetics, but
- 18:02Speaker 1: obviously because we did a podcast on it, they don't
- 18:05Speaker 1: regulate uh several supplements. Yeah, that was a good one,
- 18:08Speaker 1: if I remember correctly, We really like got to the
- 18:10Speaker 1: heart of the matter. Yeah, And there's a lot of
- 18:12Speaker 1: and I think you talked about it. Then there's a
- 18:14Speaker 1: lot of slippery language that can be used in body
- 18:18Speaker 1: products period, which always aggravates Emily to no end because
- 18:21Speaker 1: she has completely natural body products. But you can throw
- 18:25Speaker 1: names on packages these days, on foods too, that just
- 18:29Speaker 1: say like purer and natural and just these buzzwords that
- 18:33Speaker 1: mean nothing, and there's no regulation for when you can
- 18:35Speaker 1: use those words. And it's just it's they're trying to
- 18:38Speaker 1: sell people on something that's not true. It's truly sad.
- 18:41Speaker 1: Like light beer. I remember hearing years and years and
- 18:44Speaker 1: years ago that light beer only has to be light
- 18:47Speaker 1: and color to be called light beer. Really Yeah, But
- 18:50Speaker 1: now that I'm grown, I'm like, I'll bet like, who
- 18:52Speaker 1: regulates that, I'll bet you it doesn't even have to
- 18:54Speaker 1: be light in color and light and color compared to
- 18:56Speaker 1: what you can probably call something light beer if you
- 18:59Speaker 1: want to, Well, it's light in calories, right, buyer beware.
- 19:03Speaker 1: But your point is it's not regulated, right, Probably not
- 19:06Speaker 1: a beer has to be under this many calories to
- 19:08Speaker 1: be called a light Yeah. I don't believe it is.
- 19:10Speaker 1: And now that I think, I'd probably be the FTC
- 19:12Speaker 1: that would be in charge of that kind of thing.
- 19:14Speaker 1: But they the t F Yeah, man, the government should
- 19:19Speaker 1: just have a lot of lettered agencies. Yeah. One last
- 19:21Speaker 1: thing about the FDA though, there's a group of special
- 19:25Speaker 1: agents in the criminal unit that carried guns. Really FDA
- 19:29Speaker 1: agents that carried guns and will shoot you well for
- 19:32Speaker 1: doing what I've got a great example of it. Had
- 19:37Speaker 1: they caught whoever it was that poisoned the Chicago area
- 19:41Speaker 1: tile and all in, they probably would have shot that person. Yep.
- 19:47Speaker 1: Do you do you know about that? I do? Uh,
- 19:49Speaker 1: you want to talk about that now? Sure might as well. Huh. Yeah,
- 19:53Speaker 1: I remember this, do too, man. Yeah. I was a
- 19:56Speaker 1: six year old whose eyes were just opening to the
- 19:59Speaker 1: ideas of w things and drugs and learning to fear
- 20:02Speaker 1: things that you bought at the store. Yeah. I didn't.
- 20:04Speaker 1: I didn't. I didn't know the specifics because I was
- 20:06Speaker 1: only eleven and I never really like researched further as
- 20:09Speaker 1: an adult. But twelve year old girl died in a
- 20:12Speaker 1: suburban Chicago after taking Thailand all laced with cyanide as.
- 20:17Speaker 1: It turns out, Um, she was dead by the next day,
- 20:22Speaker 1: I believe know a couple of hours, Oh, a couple
- 20:24Speaker 1: of she took it that morning then and then dim.
- 20:29Speaker 1: So Uh. That same day, a twenty seven year old
- 20:33Speaker 1: name Adam Janice suburban Chicago died and then his brother
- 20:38Speaker 1: and sister were consoling the family. They thought it was
- 20:41Speaker 1: a heart attack. Uh, we're consoling the family and just
- 20:44Speaker 1: sort of doing the post death family stuff. Very stressed,
- 20:48Speaker 1: got headaches, they took tail and all and they both died. Yeah.
- 20:51Speaker 1: I had no idea that connection. Three more people died
- 20:54Speaker 1: over the next couple of days, all from they found
- 20:57Speaker 1: out upon investigating, all of them had taken Thailand all
- 21:01Speaker 1: right before they died. So they started looking at right,
- 21:05Speaker 1: they started looking into it, and um, it turned out
- 21:07Speaker 1: that there was poisoned thailand all in the Chicago area.
- 21:12Speaker 1: And everyone freaked out because at the time Thailand all
- 21:16Speaker 1: was like that was it. You had an over the
- 21:18Speaker 1: counter pain reliever. It was Thailand All, and they didn't
- 21:21Speaker 1: have tamper resistant bottles at the time. What they later
- 21:24Speaker 1: figured out is that somebody bought Thailand All, took it home,
- 21:28Speaker 1: I guess, laced it with cyanide, and then brought it
- 21:32Speaker 1: back and made it look like it had been unopened,
- 21:35Speaker 1: and people bought them and died from They still don't
- 21:38Speaker 1: know who did it. They made it look like it
- 21:39Speaker 1: was unopened by just closing the lid again. Because there again,
- 21:43Speaker 1: no tamper resistant packaging until right this changed everything. So UM,
- 21:48Speaker 1: the company that makes tail and All under Johnson and
- 21:51Speaker 1: Johnson like issued like a national media alert that said, like,
- 21:55Speaker 1: everybody should probably stop taking taile and All and send
- 21:58Speaker 1: us your tailing All will send you new stuff that
- 22:01Speaker 1: we know is good, but um, don't take Kylo, which
- 22:04Speaker 1: is kind of cool for a company. Yeah, they really
- 22:06Speaker 1: like I mean, they had no choice, I think, but
- 22:08Speaker 1: the super go on the offensive with this. Uh, and
- 22:12Speaker 1: it's actually due to Johnson and Johnson. Um. It wasn't
- 22:17Speaker 1: the f d A saying hey, we need to get
- 22:19Speaker 1: tamper resistant packaging. Johnson and Johnson actually said, hey, I
- 22:22Speaker 1: think we should start investigating tampa resistant packaging. So they
- 22:26Speaker 1: sort of led the charge. Yeah, and then in Congress said, um,
- 22:31Speaker 1: let's make tampering with medicine a federal crime. Yes. And
- 22:35Speaker 1: then just just six years later, the FDA said, let's
- 22:39Speaker 1: make these awesome tamper resistant bottles um mandatory. I don't
- 22:43Speaker 1: know why it took six years that we're talking about
- 22:46Speaker 1: a federal bureaucracy here now, but it seems like that's
- 22:49Speaker 1: something you could have sped through. Just my opinion, but
- 22:53Speaker 1: anyway is when um, that's why it's so hard to
- 22:56Speaker 1: get into pill bottles these days, thankfully. Yeah, a little
- 23:00Speaker 1: boil coatings and all that stuff that makes um, doesn't
- 23:03Speaker 1: mean you can't open it, but it means you will
- 23:05Speaker 1: know if someone has opened it. Yes, you know, like
- 23:09Speaker 1: if you buy it and you're like, wait a minute,
- 23:10Speaker 1: that foil is poked through by a human thumb, I
- 23:14Speaker 1: can see it. And this stuff is glowing, yeah, Thailand,
- 23:17Speaker 1: all is not supposed to glow. Alright, So let's take
- 23:21Speaker 1: a break and after this we'll talk a little bit
- 23:23Speaker 1: more about how they regulate. You know, stop fear you
- 23:32Speaker 1: you know, stop you know stop you know. So, um,
- 23:51Speaker 1: how does well, first of all, how much do they
- 23:53Speaker 1: regulate and the answer is a ton of products. Yeah. Um,
- 23:58Speaker 1: some estimates say that twenty cents out of every dollar
- 24:02Speaker 1: consumer spend, and that's on everything TVs you know, VCRs, right,
- 24:09Speaker 1: that doesn't regulate satellite dishes, laser discs. All the money
- 24:13Speaker 1: that we spend on everything, twenty cents out of every
- 24:16Speaker 1: dollar we spend is on a product that's regulated by
- 24:20Speaker 1: the FDA. It comes under their per view, which which
- 24:23Speaker 1: means you have too much to do. Supposedly that equals
- 24:25Speaker 1: about what they regulate about one trillion dollars worth of
- 24:29Speaker 1: goods and in services, well goods. Yeah, all right, so
- 24:33Speaker 1: they regulate. We already talked about what they do regulate.
- 24:36Speaker 1: They also, um also offer guidance at times on maybe
- 24:40Speaker 1: how advice on how regulations should be carried out. So
- 24:45Speaker 1: that's one of their tasks as well. Right, Like maybe
- 24:48Speaker 1: you guys should make your pillbottles tamper resistant. Our criminal
- 24:53Speaker 1: enforcement unit isn't going to come shoot you if you don't,
- 24:57Speaker 1: because this is a guideline. But now that it's uh,
- 25:02Speaker 1: now it's mandatory or they may visit you. Um. They
- 25:04Speaker 1: do about sixteen thousand facility inspections per year. Uh, everything
- 25:11Speaker 1: from dairy farms to blood banks. But um, they, like
- 25:14Speaker 1: we said, they're way more facilities than they have field workers.
- 25:18Speaker 1: So I think they do they well, they use the
- 25:22Speaker 1: element of surprise or the potential, the element of potential surprise,
- 25:28Speaker 1: So surprise inspection, surprise visits. I hope, hope, hope. And
- 25:33Speaker 1: I'm pretty sure that the FDA doesn't call in schedule
- 25:37Speaker 1: inspections ahead of time. Right. If they do, then then
- 25:41Speaker 1: write your congress person and make sure that this gets
- 25:44Speaker 1: changed immediately, because they can't. We're talking fourteen thousand employees
- 25:48Speaker 1: in total, not just inspectors in total. For all of
- 25:52Speaker 1: the FDA, less than fifteen thousand people are in charge
- 25:56Speaker 1: of not only visiting factories and dairies in places that
- 26:01Speaker 1: that use X ray machines and all this stuff, all
- 26:04Speaker 1: the things that they regulate, not just in the US,
- 26:07Speaker 1: but like in other countries too. Yeah. They just set
- 26:11Speaker 1: up their first office in Beijing in the last decade
- 26:14Speaker 1: or so. Yeah, because they have to. They have to
- 26:18Speaker 1: watch what's coming into the country as well, because Americans
- 26:21Speaker 1: don't just ingest American products, We just products for overseas,
- 26:25Speaker 1: and those things have to they have to follow the
- 26:28Speaker 1: same guidelines as any other product that's sold er sold
- 26:32Speaker 1: or used in America, because the FDA jurisdiction isn't stuff
- 26:35Speaker 1: that's made in America, stuff that is consumed in America. Yea,
- 26:39Speaker 1: I guess I just thought that would be maybe the
- 26:40Speaker 1: FDC or something. But imagine they all kind of work
- 26:43Speaker 1: hand in hand to get the church done. They all
- 26:45Speaker 1: quietly hold hands while they do their research. Uh. And
- 26:49Speaker 1: how do they do this? They do it because they
- 26:51Speaker 1: are funded to the tune of four point four billion
- 26:53Speaker 1: dollars um. About two point six of that comes from
- 26:58Speaker 1: the Treasury and in other words, your tax dollars and
- 27:02Speaker 1: the remaining close to two billion comes from user fees,
- 27:05Speaker 1: which are very, very controversial. You want to talk about
- 27:09Speaker 1: the user fees. Yeah, let's know that. Man. So the before,
- 27:15Speaker 1: what was it. I believe the FDA was fully funded
- 27:21Speaker 1: by taxpayer dollars. It got all of its funding from
- 27:23Speaker 1: the Treasury. And then in Congress passed a law that
- 27:29Speaker 1: said the the FDA can start generating its own revenue
- 27:33Speaker 1: by accepting user fees. Yeah, the Prescription Drug User Fee Act. Right. So,
- 27:38Speaker 1: in that act, it says, if you are a prescription
- 27:41Speaker 1: drug company, a pharmaceutical company, and you want to have
- 27:46Speaker 1: your UM your drug examined by the FDA, and in
- 27:50Speaker 1: a lot of cases, most cases, you have to have
- 27:53Speaker 1: it submitted for a review by the FDA. Sure, you
- 27:56Speaker 1: also have to pay a fee called it an application fee,
- 27:59Speaker 1: call it a user fee, what have you. Well, there's
- 28:01Speaker 1: many different fees, so we'll call that. Let's say you
- 28:04Speaker 1: want to get your drug fast checked. You can pay
- 28:07Speaker 1: an exorbitant fee and we'll put it at the top
- 28:10Speaker 1: of the pile even and so all of a sudden,
- 28:12Speaker 1: out chuckers, the f d A is not policing the
- 28:17Speaker 1: pharmaceutical companies any longer. It is servicing the pharmaceutical companies,
- 28:21Speaker 1: and the pharmaceutical companies as became the FDA's clients. Yeah,
- 28:26Speaker 1: that was really really bad as far as consumer protection goes. Yeah,
- 28:32Speaker 1: and um, there are many different ways of looking at this. UM.
- 28:35Speaker 1: One is that way, which is that the the pharma
- 28:39Speaker 1: lobby is um writing checks to the f d A
- 28:43Speaker 1: UM to the tune of billions of dollars. And that
- 28:46Speaker 1: can't be good, right, Uh the f d A. The
- 28:50Speaker 1: read this great article on pbs UM where they just
- 28:53Speaker 1: interviewed a bunch of people for a variety of opinions
- 28:57Speaker 1: it was very balanced. It was very very and balance.
- 29:00Speaker 1: It's not like us, Um it's bad. They the FDA's
- 29:04Speaker 1: rebuttal will look a little something like this. Um. What
- 29:08Speaker 1: what it's done is it's really helped us out. Um,
- 29:11Speaker 1: We've increased our productivity by close. We've been able to
- 29:15Speaker 1: hire so many more people, which means we can regulate
- 29:18Speaker 1: so much more. UM, it's really helped us in the
- 29:21Speaker 1: review process. The farm a lobby says, this is great
- 29:24Speaker 1: because it gets things going super quickly. It's very efficient
- 29:29Speaker 1: and yeah, and it hasn't changed the review processes, just
- 29:33Speaker 1: made things faster. And UM, we can get these drugs
- 29:36Speaker 1: two people quicker because people need these. So there's a
- 29:39Speaker 1: lot of different ways of looking at it. UM. If
- 29:42Speaker 1: you ask Raymond Wooseley, who was he was up for UM,
- 29:47Speaker 1: he was the vice president of health Sciences at University
- 29:49Speaker 1: of Arizona. I think it's been like two thousand two.
- 29:51Speaker 1: He was up for commission of the FDA. He's a
- 29:55Speaker 1: safety guy. Yeah, he was rejected, and he flat out
- 29:58Speaker 1: said in an interview, like it's pretty clear that people
- 30:01Speaker 1: that really care about drug safety will never get this
- 30:03Speaker 1: job again. The Commissioner of the FDA and he said,
- 30:07Speaker 1: it's great sadness to me that people who care about
- 30:10Speaker 1: drug safety and food safety to the level that they
- 30:12Speaker 1: get involved, they try to make a difference and can't
- 30:14Speaker 1: be accepted to regulate the agency. And he said, for me,
- 30:18Speaker 1: it should be protection first and then serving second, serving
- 30:21Speaker 1: meaning the industry. And that's sort of not the way
- 30:25Speaker 1: it's gone since the user fees have been introduced. Yeah,
- 30:28Speaker 1: from from the research that we've done, it seems like
- 30:31Speaker 1: every critic of the f d A from all walks
- 30:34Speaker 1: of life and all stripes, points to that user fee
- 30:38Speaker 1: as possibly the number one problem as far as coziness
- 30:43Speaker 1: between industry and the agency that they're funding regulates. Yeah,
- 30:49Speaker 1: you want to separate those two things generally. And then
- 30:51Speaker 1: the other problem is funding for the FDA itself. That
- 30:57Speaker 1: it is a grossly underfunded agency for what it's tasked
- 31:01Speaker 1: with doing, so it does have to rely on those
- 31:04Speaker 1: user fees, Whereas I think it's a lot like campaign
- 31:07Speaker 1: finance reform, where if you could just take that and
- 31:11Speaker 1: replace it with public money, um, then you can. You
- 31:15Speaker 1: can separate these two things that aren't supposed to be
- 31:18Speaker 1: cozy with one another. A government agency that's not supposed
- 31:21Speaker 1: to rely financially on the industry that it's regulating. Yeah,
- 31:24Speaker 1: and I know you want to do a show on
- 31:26Speaker 1: lobbying soon. That's uh, that's gonna be a firestorm. It is.
- 31:30Speaker 1: We're gonna just be sitting there like gripping the table
- 31:32Speaker 1: the whole time. Well, what you mentioned though, how they're
- 31:35Speaker 1: funded though, it's interesting. I think until recently, UM, the
- 31:38Speaker 1: way the money was even divided, like how the budget
- 31:42Speaker 1: money was spent was pretty hinking because you couldn't even
- 31:46Speaker 1: use any of that user fee money to regulate safety
- 31:50Speaker 1: at all. All of that had to go into the
- 31:53Speaker 1: service side of things. I think now they are starting
- 31:57Speaker 1: UM to to uh be able to use that money
- 32:00Speaker 1: for safety as well. But I think that's not happening
- 32:03Speaker 1: fast enough for people that are truly concerned about the
- 32:05Speaker 1: safety of our country. And there was this uh I
- 32:09Speaker 1: think I sent it to you. There's this Forbes article
- 32:11Speaker 1: from two thousand and fourteen. About a year ago, UM,
- 32:15Speaker 1: there was a Yale study that came out that really
- 32:17Speaker 1: just raked the FDA over the coals, and it was
- 32:21Speaker 1: an analysis of a bunch of different f d a
- 32:25Speaker 1: UM approvals from two five to two thousand twelve publicly
- 32:29Speaker 1: published stuff. It's not like they had to dig in, right,
- 32:32Speaker 1: They just went and did an analysis of it, and
- 32:35Speaker 1: they found that these FDA studies were um all over
- 32:39Speaker 1: the place as far as the data they accepted, UM,
- 32:43Speaker 1: what what got cleared and what didn't, UM, the sample size,
- 32:47Speaker 1: how long trials went on, and um. It was basically
- 32:52Speaker 1: used to publicly shame the FDA is saying like, you
- 32:55Speaker 1: guys aren't even using good science and even trying to
- 32:57Speaker 1: keep up this pretense that you're following your own standards
- 33:00Speaker 1: or that you even have standards. You guys are you're
- 33:03Speaker 1: just rubber stamping pharmaceuticals. And to kind of give an
- 33:08Speaker 1: opposing point of view, this guy on Forbes said, well,
- 33:11Speaker 1: wait a minute, Like this is totally unfair because the
- 33:14Speaker 1: FDA is actually what they're being criticized for here is
- 33:17Speaker 1: actually a certain kind of nimbleness that the end user,
- 33:22Speaker 1: the patients who are taking these drugs really want. So
- 33:25Speaker 1: they're saying, for something that's a really huge, sweeping drug
- 33:28Speaker 1: that's going to be used by a lot of people, right,
- 33:31Speaker 1: they they they should and typically do, follow some pretty
- 33:36Speaker 1: stringent guidelines. They have to have a huge population sample
- 33:39Speaker 1: they have to um carry these studies out for years
- 33:43Speaker 1: and UM they require a lot of really good data.
- 33:46Speaker 1: But if you have something that is like a really
- 33:48Speaker 1: obscure disease or a drug that treats are really obscure disease,
- 33:53Speaker 1: sure they're going to accept the data that used the
- 33:56Speaker 1: population size of like a hundred people because there's just
- 34:00Speaker 1: not that many people out there with this disease. And
- 34:03Speaker 1: it may be a shorter lived study because if it's
- 34:06Speaker 1: a really fatal disease, these people want this drug and
- 34:09Speaker 1: to get it out the door quicker. And there may
- 34:12Speaker 1: only be the one study. You may not have to
- 34:14Speaker 1: duplicate it and replicate it three or four times. So
- 34:16Speaker 1: he did a good job of like presenting the other
- 34:19Speaker 1: case in really pointing out how the FDA is very
- 34:22Speaker 1: typically it's it's in a damned if you do, damned
- 34:25Speaker 1: if you don't situation on a daily basis, because in
- 34:29Speaker 1: that same study that found you know that they it
- 34:32Speaker 1: will accept the population of one hundred in the study, UM,
- 34:36Speaker 1: and it goes out the door very quickly in the
- 34:39Speaker 1: approval process happens fast in that. In that sense, on
- 34:43Speaker 1: the other hand, UM, when the FDA doesn't do that
- 34:45Speaker 1: and really takes its time and digs in and studies.
- 34:49Speaker 1: It gets accused of basically just letting people die, which
- 34:52Speaker 1: was the case with the advent of AIDS eighties. Sure
- 34:55Speaker 1: HIV drugs were being tested in people in the HIV
- 34:59Speaker 1: community and in at large in the country. We're saying,
- 35:04Speaker 1: advocates were saying, hey, people are dying and like these
- 35:06Speaker 1: drugs are very promising, like let us try them out.
- 35:10Speaker 1: And so I do get it, man, Like they've been
- 35:13Speaker 1: accused of dragon their feet. We're going too fast and
- 35:16Speaker 1: finding that happy medium or I think I don't know,
- 35:20Speaker 1: I don't know if it's a happy medium or if
- 35:21Speaker 1: it's you should only strive for safety, and if it
- 35:24Speaker 1: takes too long, it takes too long, or if it
- 35:26Speaker 1: is super quick, it's super quick. Like safety is should
- 35:30Speaker 1: be the most important thing, and it doesn't seem like
- 35:33Speaker 1: that that's the case. No, it should be the most
- 35:37Speaker 1: important thing. But at the same time, there should also
- 35:40Speaker 1: be an awareness of you know, what's going on outside
- 35:44Speaker 1: the doors of the lab, but there are people dying,
- 35:47Speaker 1: so yeah, you want a safe drug. But also if
- 35:50Speaker 1: you have people are saying, like remember with the ebowl
- 35:52Speaker 1: out right, they're people are like, I will die from
- 35:57Speaker 1: this drug. I will sign whatever you need. Just give
- 35:59Speaker 1: me the draw, let me try it. Right, And they
- 36:02Speaker 1: went ahead and and let people used unapproved drugs. It's
- 36:06Speaker 1: like the Poison Squad almost these people were volunteering, right,
- 36:10Speaker 1: willfully volunteering so well they were also dying of a
- 36:12Speaker 1: bowla at the time. Well, um, the Poison Squad were
- 36:16Speaker 1: totally healthy, untied the squad, right, yeah it did you know?
- 36:20Speaker 1: Also the poison Squad. Um, it was a very scientific study.
- 36:24Speaker 1: The guys were not allowed to eat or drink anything
- 36:28Speaker 1: outside of this dining room except for water. They had
- 36:31Speaker 1: to turn in all of it. Not a drop or
- 36:35Speaker 1: a speck was allowed to go unmeasured on a skid mok.
- 36:42Speaker 1: But the the the f d A and AI's activist
- 36:46Speaker 1: collision from the early eighties. Have you seen How to
- 36:49Speaker 1: Survive a Plague? Great documentary, But the documentary deals in
- 36:54Speaker 1: part with that and it's really really interesting. And that
- 36:58Speaker 1: was actually score. The soundtrack was scored by our friends
- 37:02Speaker 1: Superhuman Happiness. Oh nice to listen to this show, hey guys,
- 37:05Speaker 1: good for them. Yeah, so go see it. It's a
- 37:08Speaker 1: very good, good documentary. I will check it out. Is
- 37:10Speaker 1: that on the old red streaming service. Yes, I'm sure
- 37:16Speaker 1: it's I'm sure it is called something like Netflix. That's
- 37:21Speaker 1: that's exactly what it's called. Okay, you're confusing me. All right,
- 37:25Speaker 1: So let's take another break here, and when we come back,
- 37:27Speaker 1: we'll talk a little bit more about some of the
- 37:30Speaker 1: various successes and failures of the f D A you know, stop,
- 37:39Speaker 1: you know, you know, stop, you know all right, Um,
- 37:58Speaker 1: can we talk about this Harvard paper? Yeah, this is
- 38:02Speaker 1: from an article titled Risky Drugs Colan Why the FDA
- 38:06Speaker 1: Cannot be Trusted, And it was basically about a paper
- 38:11Speaker 1: published in the Journal of Law, Medicine and Ethics from
- 38:13Speaker 1: Hobvid University where they contend that, um, they present evidence
- 38:20Speaker 1: actually that roughly of all new drugs approved by the
- 38:24Speaker 1: FDA over the past thirty years are little own or
- 38:27Speaker 1: no more effective for patients than existing drugs. Um they're saying.
- 38:33Speaker 1: It's they still beat placebo typically. Yeah. What they're saying
- 38:37Speaker 1: is like, all these new drugs aren't any better than
- 38:40Speaker 1: the old drugs. There's just competition on an already saturated
- 38:43Speaker 1: market exactly. So it's like, why put the FDA through
- 38:47Speaker 1: that if they're already overstretched, then why can't those resources
- 38:53Speaker 1: be allocated to something else that it's dropping the ball
- 38:56Speaker 1: on right sure. And they also, you know, try to
- 38:59Speaker 1: make a point about the safety level of these drugs
- 39:03Speaker 1: that we are taking when they point out things like
- 39:06Speaker 1: every week, every week, fifty three thousand hospitalizations occur and
- 39:13Speaker 1: deaths occur every week in the US because of people
- 39:16Speaker 1: taking properly prescribed drugs to be healthier. So that's just
- 39:21Speaker 1: a bad reaction to an approved drug. That's how I
- 39:25Speaker 1: read it. Everyone, I'm reading that wrong. One in five
- 39:28Speaker 1: drugs approved ends up causing serious harm, while one in
- 39:33Speaker 1: ten provide a benefit compared to existing established So that's
- 39:36Speaker 1: the ten percent. So the data is then this is
- 39:39Speaker 1: what this Harvard paper is saying. It's saying that yes,
- 39:43Speaker 1: one in ten drugs that comes onto the market that
- 39:47Speaker 1: the FDA has approved is it provides a benefit that
- 39:51Speaker 1: no other drug does in the past thirty years, which
- 39:54Speaker 1: I think and now that I kind of make a
- 39:56Speaker 1: connection with something else another article that that they were
- 39:59Speaker 1: really touting like there's no other drug like this, This
- 40:02Speaker 1: provides the benefit of that other drugs don't, right, So
- 40:04Speaker 1: I think that's a big like buzzword. It provides other benefits, right,
- 40:08Speaker 1: but one in five of those drugs will go on
- 40:11Speaker 1: to cause some sort of harm, right, that's crazy. Yeah,
- 40:16Speaker 1: And the they go on to say in that paper
- 40:18Speaker 1: that the f d A they feel um Len's credibility
- 40:21Speaker 1: to widening and lowering criteria for prescribing drugs what they
- 40:25Speaker 1: call the selling of sickness and um what you're talking
- 40:29Speaker 1: about like a new and improved drug. Basically, drug companies
- 40:32Speaker 1: are raising prices from year to year on the same drug.
- 40:35Speaker 1: And they said, we're the only country in the world
- 40:38Speaker 1: that allows a drug to have its price increased without
- 40:42Speaker 1: showing like here's why, here's the benefit, here's why it's improved,
- 40:47Speaker 1: and here's why it costs more. And apparently the US
- 40:50Speaker 1: is the only country that does that. So Yeah, if
- 40:53Speaker 1: you want to um read that article, really all the
- 40:56Speaker 1: articles we've mentioned, you can go to our podcast page
- 41:00Speaker 1: on Stuff you Should Know dot com, the part the
- 41:03Speaker 1: page for this episode. It's got all the additional links. Yeah,
- 41:06Speaker 1: I'm glad we're doing that now. I think that's good. Yeah,
- 41:08Speaker 1: it's definitely open things up for the truly curious. You
- 41:12Speaker 1: really want to dig in, baby, we got it for
- 41:15Speaker 1: you can we talk about antibiotics and livestock. Yeah, this
- 41:19Speaker 1: is a big one. You found this in the Atlantic, right, Yeah,
- 41:22Speaker 1: and this is a big uh. I mean, it's just
- 41:24Speaker 1: a big issue these days period about what is going
- 41:27Speaker 1: into the meat and that people are eating, uh like
- 41:31Speaker 1: in factory farms and stuff. Um. The f d A
- 41:35Speaker 1: in n seven basically said we're not gonna put antibiotics
- 41:39Speaker 1: in livestock because it's dangerous, and just in twelve they
- 41:44Speaker 1: filed papers in court that acknowledge that they weren't safe. Um,
- 41:49Speaker 1: it says more studies. A series of additional studies were
- 41:52Speaker 1: conducted by other government agencies and non governmental organizations during
- 41:56Speaker 1: the nineties, all of which generally support the FDA's concerned
- 42:00Speaker 1: guarding public health threat posed by anti microbial resistance. Yes,
- 42:04Speaker 1: so what happens is you you give healthy live stock,
- 42:08Speaker 1: otherwise healthy live stock, antibiotics in their food, right, because
- 42:12Speaker 1: the living conditions are basically right for an epidemic, or
- 42:18Speaker 1: it helps them grow faster. Right. So, but if they're
- 42:21Speaker 1: on antibiotics, they stay healthy despite these living conditions. Well,
- 42:25Speaker 1: the problem is is the bugs that these antibiotics are
- 42:28Speaker 1: fighting off develop resistance to the antibiotics, and they can,
- 42:33Speaker 1: some of which are zoonotic, these bugs, and so they
- 42:37Speaker 1: leap from say cattle, to humans, and they're already resistant
- 42:40Speaker 1: to our antibiotics that we've been giving healthy cows. So
- 42:44Speaker 1: now you have an antibiotic resistant superbug and that's a
- 42:49Speaker 1: really dangerous thing. And what you've just said is that
- 42:52Speaker 1: since the seventies, the FDA has publicly said that this
- 42:55Speaker 1: is dangerous and it should should not go on any longer,
- 42:58Speaker 1: but they still they didn't do anything about it. Now.
- 43:01Speaker 1: Their their attack right now is to say that the
- 43:04Speaker 1: livestock industry can police itself. Uh. It doesn't seem like
- 43:07Speaker 1: that's happening, but um, that is their position at this point. Uh.
- 43:11Speaker 1: And this is why you see a lot of meats
- 43:14Speaker 1: now in your store that say antibiotic free. It's like
- 43:16Speaker 1: a big selling point because, uh, even like you said,
- 43:19Speaker 1: even the FDA says it's really dangerous, but they just
- 43:22Speaker 1: haven't enacted any law about that. Although they have, that's
- 43:26Speaker 1: not entirely true. They have listed some antibiotics that, um,
- 43:30Speaker 1: I know they called out one in the article that
- 43:31Speaker 1: said you can't use this one, but apparently it's only
- 43:34Speaker 1: used in like point to five or it's only so
- 43:43Speaker 1: people that are you know, want to live more purely
- 43:46Speaker 1: are saying they're not taking enough efforts. I mean, they
- 43:49Speaker 1: were sued by the National Resources Defense Counsel UH saying
- 43:53Speaker 1: you have to take action on this. Well, and that's
- 43:56Speaker 1: us that that that it takes the courts to force
- 43:59Speaker 1: the government an agency to protect consumers in that way,
- 44:02Speaker 1: in a way that the agency itself is saying like, yes,
- 44:05Speaker 1: this is dangerous, somebody should do something. Who will do something?
- 44:10Speaker 1: And then everybody's like, well, it's kind of your job
- 44:12Speaker 1: to do that, and they're like, oh, well, don't worry
- 44:15Speaker 1: about it. That's fine. Yeah. I mean they actually the
- 44:17Speaker 1: FDA pulled public notices at the Federal Register that have
- 44:20Speaker 1: been around for thirty years. They literally just made them
- 44:23Speaker 1: disappear overnight. When this became controversial in the two thousand
- 44:29Speaker 1: early tens, UM, they just said, we're gonna take the
- 44:33Speaker 1: that those briefs where we said that it's dangerous and
- 44:36Speaker 1: somebody should do something, We're gonna stop having those published. Um.
- 44:40Speaker 1: They also were largely criticized, UM a few years back
- 44:46Speaker 1: for basically like just sitting on their hands about the
- 44:50Speaker 1: GMO labeling. Yeah, that's yeah, dan quayle uh kind of
- 44:55Speaker 1: change history with that many years ago. What did you do?
- 44:58Speaker 1: I think he was the one that which for the
- 45:00Speaker 1: legislation that allowed GMOs. Okay, so this is fine. You've
- 45:05Speaker 1: got GMOs. You've got a label food that contains GMOs.
- 45:10Speaker 1: That's it. Don't do anything else. You just have to
- 45:12Speaker 1: say on the label, this product may contain GMOs. Right,
- 45:16Speaker 1: there was a big push. Apparently a million signatures were
- 45:20Speaker 1: generated from the just label at campaign and we're submitted
- 45:24Speaker 1: properly to the f d A, and the FDA rejected
- 45:28Speaker 1: all but three ninety four of the signatures that were
- 45:31Speaker 1: given to it because about a million of them were
- 45:35Speaker 1: in a single electronic document and they were like, these
- 45:38Speaker 1: don't count. So they didn't do anything about it. And
- 45:42Speaker 1: there's still no GMO labeling. So, regardless of how you
- 45:45Speaker 1: feel about GMOs and GMO labeling, that's pretty shady stuff
- 45:50Speaker 1: to just overtly reject a million signatures, especially as part
- 45:55Speaker 1: of a large national public campaign. Absolutely. Buyox is a
- 46:00Speaker 1: pain killer that was approved by the FDA, And just
- 46:06Speaker 1: to go over this stuff. Uh. In two thousand, a
- 46:09Speaker 1: study showed that the drug posed a big heart attack
- 46:12Speaker 1: risk when compared to a similar pain killer, and Mark,
- 46:16Speaker 1: who was a manufacturer biox, kind of blew it off
- 46:19Speaker 1: and said it's really beneficial, and the FDA said okay,
- 46:24Speaker 1: and biox pretty much. Biox remained on the market for
- 46:28Speaker 1: another four years and UM they estimate between eight thousand
- 46:33Speaker 1: and a hundred and forty thousand heart attacks were caused
- 46:36Speaker 1: by biox in that time. And it wasn't It wasn't
- 46:39Speaker 1: the FDA whoever removed by Ox. It was Murk bowing
- 46:42Speaker 1: to public pressure. FDA never never, Mark just took it
- 46:46Speaker 1: off the market itself because it was starting to look bad,
- 46:48Speaker 1: and the FDU was like, what's going on, what are
- 46:51Speaker 1: you guys doing? How about a success UM. In the
- 46:56Speaker 1: nineteen fifties, UH in Germany there were scientists who created
- 47:00Speaker 1: something called Philidamie, which was a sleeping pill, and they
- 47:04Speaker 1: said it it's over the counter, it's totally safe for
- 47:08Speaker 1: Europe for pregnant women. Even is a sleeping pill? Not
- 47:12Speaker 1: so safe though, because UM children were being born with
- 47:15Speaker 1: malform limbs to the tune of ten thousand worldwide, but
- 47:19Speaker 1: not very many in the United States. Because Francis Oldham
- 47:23Speaker 1: Kelsey of the f D a was really resistant and
- 47:26Speaker 1: made a big push to not allow the Lita mics.
- 47:29Speaker 1: She didn't think it was safe. No, she was in
- 47:30Speaker 1: charge of reviewing the data and said, what is this.
- 47:33Speaker 1: This is basically anecdotal, like where's your real data, and
- 47:37Speaker 1: would not withstood a lot of pressure to approve this
- 47:40Speaker 1: drug and would not cave in. And as a result,
- 47:45Speaker 1: only seventeen babies were born um with um malformations because
- 47:51Speaker 1: of in the US, and the whole reason that there
- 47:54Speaker 1: were any was because they found out that the drug
- 47:56Speaker 1: maker was pushing the drugs for free onto a man
- 48:00Speaker 1: are conductors to distribute as samples while this while the
- 48:04Speaker 1: FDA was holding up approval, and so seventeen children were
- 48:09Speaker 1: born with deformities because of it, because of this these
- 48:12Speaker 1: free drugs. Apparently, in Canada, this story was even different.
- 48:16Speaker 1: The Canadian government, it was totally it was totally legal
- 48:20Speaker 1: and approved in Canada and for months after it became
- 48:24Speaker 1: worldwide known that thelidamide caused birth effects because it it
- 48:29Speaker 1: crosses the placental barrier and arrests development of the fetus.
- 48:33Speaker 1: Right Canada knew, everybody knew about it, and it took
- 48:37Speaker 1: months before Canada finally outlawed it. So there's like this
- 48:40Speaker 1: real big public shame hanging over Canada's um government agency
- 48:46Speaker 1: regulating drugs still to this day because of that. And
- 48:50Speaker 1: Billy Joel wrote a song about it. Oh yeah, well
- 48:53Speaker 1: it was in that terrible talk we didn't start the children.
- 48:58Speaker 1: I forgot about that. Um, but yeah, that was one
- 49:01Speaker 1: of the FDA's great successes. And as a result, actually, um,
- 49:05Speaker 1: the Congress passed something an amendment to the Food and
- 49:11Speaker 1: Drug Act, the Father Harris Amendments of nineteen sixty two,
- 49:15Speaker 1: that really expanded the f d a's um scope of duties.
- 49:20Speaker 1: It put, um, you know how you know those have
- 49:23Speaker 1: drug ads, have all those disclaimers. That's from the nineteen
- 49:27Speaker 1: sixty two amendments. Advertising is under the juristic scene. They
- 49:31Speaker 1: read those so fast, and the last one is an
- 49:33Speaker 1: early death right exactly like do you need to say
- 49:35Speaker 1: early death? No? Um, they And prior to nineteen sixty two,
- 49:42Speaker 1: the FDA had sixty days to respond to an application
- 49:47Speaker 1: and if they didn't get to it in time, well
- 49:49Speaker 1: that's fine. I'm sure it's fine. You can go to market. Um.
- 49:52Speaker 1: That changed to I think a hundred and eighty days,
- 49:54Speaker 1: and it's just to respond um and then also drug
- 49:57Speaker 1: makers only had to demonstrate that the or drug was
- 50:01Speaker 1: UM safe not effective. That changed the two as well. Yep.
- 50:06Speaker 1: They also said that they had to control the marketing
- 50:09Speaker 1: of generic drugs to keep them from being sold as
- 50:13Speaker 1: uh just like jacking up the price under a new
- 50:15Speaker 1: name basically. So um, yeah, that was a great amendment,
- 50:19Speaker 1: the Kerfuffle Harris amendment. Is that right? That's father So
- 50:27Speaker 1: another great success. Well that was the same one. Well no,
- 50:31Speaker 1: I mean in addition to the lido Uh. And then
- 50:35Speaker 1: in the news recently you dug this up, the Zohydra painkiller.
- 50:39Speaker 1: Didn't hear about this? No, I haven't heard of this
- 50:41Speaker 1: until today. It's uh, apparently it's pure oxycodone, correct it is.
- 50:46Speaker 1: There's the first time. Yeah, there is. Um. All the
- 50:50Speaker 1: other stuff like vik it in and oxyconton even or
- 50:54Speaker 1: are safer because they contain at least something else like
- 50:58Speaker 1: a seed, a mena fan or some other drug. This
- 51:01Speaker 1: is just pure hydrocodone. And um. You remember like there
- 51:06Speaker 1: was a huge, huge problem with pill addiction to oxyconton
- 51:09Speaker 1: in particular. Yeah, it wasn't just rush limball with a
- 51:12Speaker 1: lot of people. Yeah, we're really hooked on oxycont and
- 51:15Speaker 1: as a matter of fact, the current um heroin addiction
- 51:19Speaker 1: crisis in the US is a direct result of the
- 51:22Speaker 1: FDA stepping in and saying like, hey, you guys need
- 51:25Speaker 1: to do something with oxyconton. Like people are crushing it
- 51:28Speaker 1: up and injecting it. You gotta do something. So now
- 51:31Speaker 1: there's well, there's a Tampa resistant thing where when you
- 51:34Speaker 1: crush up oxyconton, now it turns into this goog that
- 51:37Speaker 1: you can inject or snort. Right, Can you lick it
- 51:39Speaker 1: off a mirror? You can? I guess, but I don't
- 51:42Speaker 1: think it has the same effect, right because when you
- 51:45Speaker 1: when you crush it up, it was time released. When
- 51:47Speaker 1: you crush it up, it's not time released anymore. It's
- 51:49Speaker 1: like all there to give you this a media, right.
- 51:54Speaker 1: So now that when you crush up oxyconton it turns
- 51:57Speaker 1: into a Google. Everybody's turned to hair one, right, So
- 52:01Speaker 1: now there's a heroin epidemic. This company making zo Hydra
- 52:05Speaker 1: came along and said, well, that's cool, just released this
- 52:08Speaker 1: completely pure hydro code un pill without any tamper resistance.
- 52:13Speaker 1: So we're gonna go back to square one, everybody, okay,
- 52:16Speaker 1: And there's a huge outcry against this drug, and the
- 52:20Speaker 1: FDA had stepped up and became a mouthpiece for it. Yeah,
- 52:24Speaker 1: and the FDA will, um, they will defend the decision
- 52:27Speaker 1: by saying, well, putting things like a set of menifin
- 52:31Speaker 1: has well known liver damage risk, so this is actually
- 52:35Speaker 1: more pure. You can actually take hydro coda. Now, people
- 52:38Speaker 1: in severe pain can take this drug without that liver
- 52:42Speaker 1: toxicity risk. I mean that's a point. Now, it is
- 52:45Speaker 1: a point. And if you're in severe pain in life
- 52:48Speaker 1: and need this to to function or live out your life,
- 52:51Speaker 1: then great, But make it tamper resistance. Yeah, that's not
- 52:55Speaker 1: what people are arguing about. They're saying that this is
- 52:56Speaker 1: a very high level for abuse because there's no tamper resistance. Yeah, exactly,
- 53:02Speaker 1: So people are going to die because of this drub Yeah,
- 53:06Speaker 1: I think. Um. In two thousand and ten, uh, prescription
- 53:11Speaker 1: hydro codone and other prescription opiates accounting for almost seventeen
- 53:15Speaker 1: thousand deaths, which is a fourfold increase from just ten
- 53:19Speaker 1: or eleven years earlier. Right, and that was all Oh
- 53:22Speaker 1: see before they made it tamper resistant. Orange County. There's
- 53:27Speaker 1: probably a lot of it in county. I bet there
- 53:29Speaker 1: is so there you go, crazy stuff. It is crazy stuff. Um.
- 53:36Speaker 1: I kind of with that professor from Arizona. That's just
- 53:40Speaker 1: like safety, Like it's it's sad that the chief of
- 53:45Speaker 1: that organization can't be someone who's super pro safety above
- 53:48Speaker 1: all else. Yeah, that's their job. There's such a tug
- 53:51Speaker 1: of war between the public and I guess corporations over safety. Yeah,
- 53:58Speaker 1: and the f d A is not pulling on our
- 54:00Speaker 1: side necessarily. Yeah. And I'm sure we'll hear from all
- 54:03Speaker 1: kinds of people from the pharmaceutical industry that will tout
- 54:06Speaker 1: how seriously they take their testing and stuff. And we're
- 54:09Speaker 1: not saying they don't. But um no, I think it
- 54:13Speaker 1: is a There are great protocols and standards and procedures,
- 54:16Speaker 1: but there's also plenty of times where they just overtly
- 54:20Speaker 1: dropped the ball and public safety suffered as a result. Agreed. Uh.
- 54:25Speaker 1: If you want to know more about the f d A,
- 54:27Speaker 1: you can go to the FDA website FDA dot gov.
- 54:31Speaker 1: You can go to how Stuff Works dot com and
- 54:34Speaker 1: type in f d A in the search bar. Don't
- 54:36Speaker 1: forget to go to our podcast page on Stuff you
- 54:38Speaker 1: Should Know dot com for the f d A episode
- 54:41Speaker 1: that you're listening to now, and since I said search
- 54:44Speaker 1: bar in there somewhere, it's time for listener mail. I'm
- 54:49Speaker 1: gonna call this uh we inspired a writer awesome. Hey
- 54:54Speaker 1: guys and Jerry, first off, thank you so much for
- 54:56Speaker 1: what you do. I've been a fan for over three years,
- 54:58Speaker 1: steadily working my way through the back living in constant
- 55:00Speaker 1: fear of the existential dread that will settle upon me
- 55:03Speaker 1: the day I finish UM. I poked my sister as well.
- 55:06Speaker 1: And whereas our conversations used to be Simpsons quotes, now
- 55:11Speaker 1: it is nine Simpson's ten percent stuff. You should know that,
- 55:18Speaker 1: she says. But I digress. I'm writing because I'm an
- 55:20Speaker 1: author of dark humor novels for young adults, and I
- 55:23Speaker 1: wanted to express how health of your podcast has been
- 55:25Speaker 1: with inspiring and informing various elements of my books. For example,
- 55:29Speaker 1: the one I'm currently writing is about a creepy candle
- 55:32Speaker 1: factory in a creepy small town with a big, creepy
- 55:35Speaker 1: mountain wherein wax sculptures come to life, and after listening
- 55:40Speaker 1: to your ear Wax episode, Mount Ceremon was born pretty neat.
- 55:46Speaker 1: Ever since the Haunted House episode of Been Itching, to
- 55:48Speaker 1: write a horror about a horror attraction that goes terribly
- 55:51Speaker 1: and hilariously wrong. Number stations equals something awesome, and so
- 55:55Speaker 1: on and so on. So we're inspiring her all over
- 55:57Speaker 1: the place. I never know where your inspirations go and
- 56:00Speaker 1: come from, but your so provides me with a steady
- 56:02Speaker 1: stream of delicious possibilities. I want to thank you the
- 56:05Speaker 1: best way I could, So I named a couple of
- 56:07Speaker 1: off screen high school characters after you, guys in my
- 56:11Speaker 1: most recently published book, Hellhole. So wait, how about that?
- 56:15Speaker 1: That is a huge honor, pretty neat And she's gonna
- 56:18Speaker 1: send us some copies and one for Jerry too, of course,
- 56:20Speaker 1: she says, So I'm gonna send our mailing address. And
- 56:25Speaker 1: she says, thanks for the brain snacks. And that was
- 56:27Speaker 1: from Gina Domico d A M I c O. And
- 56:31Speaker 1: she has a website and you can check out her
- 56:34Speaker 1: kind of a weird, funny, twisted young adult novels at
- 56:37Speaker 1: her site and support support writing creativity. Thanks lord, Gina. Right, yeah,
- 56:44Speaker 1: and uh, make sure you get l old so you
- 56:46Speaker 1: can see our names in print. You don't like that
- 56:51Speaker 1: was waiting for government joke? Oh? Was it? Oh? You'll
- 56:55Speaker 1: explain to me later. Right, how are you uh? If
- 56:59Speaker 1: you want to, you get in touch with us to
- 57:02Speaker 1: find out the waiting for gufnment joke Chuck just made.
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- 57:31Speaker 1: For more on this and thousands of other topics, is
- 57:34Speaker 1: it how stuff Works dot com