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