Does the FDA Protect Americans?

Remember that's where the herbal Elvis comes out. Oh yeah, was that the first appearance? I'm pretty sure. Hey, man, give me some supplements. Your dad doctor, He just like would go around the house. Yeah, when he was on Herble Upper. Sure. Yeah man, how did you talk on the herbal downers? He didn't. He just slept a lot, gotcha. Um No, I'm just tease of course. So we have talked about the FDA before, but yeah, this is um this is a much more in depth. Look that's right

at the ft. Okay, let's set your Chris Walkin. No was that Chris Walkin? No? Not really, I mean the weird pauses, but I was more doing Shatner. Oh but I didn't go up, which should have Sure pretty good though, huh yeah, pretty clear, Bill sat So, uh did you know most of this stuff? Um? Well, I know that the f d A is is has a history of controversy of people saying, uh, you're not you don't act

fast enough. We need these drugs to help people. Or then other people are like, stop acting so much exactly, you're going too fast and rushing these things to market, right exactly. So it's it's a bit of a tough thing to reconcile, you know. There. I acknowledge they're in a tough spot. They really are. And um, I think that's a good, good caveat or disclaimer to put it in the front of this because it is a very

controversial agency. It's the first consumer protection agency in the United States ever, it's the oldest one, and um it's common liberal or what have you. But I think it is a very um important agency to have. Oh I don't think that makes you liberal. So some people may say, so what they don't think we should regulate anything in this country. Yeah, there's people who think that, like the f d A is just completely in the way of business. It's a a fetter right, that's a thing because unfettered,

if you can be unfettered, you can be fettered. But is there something that can fetter and would that be a fetter? So it's a fetter to business to some in some people's mind. Um yeah, I just think that you when you were talking about something as um elemental as food or drugs, thinks we put into our bodies and the hopes that we will be have a greater well being that you kind of do have to have a big kid on the block looking out for all

the little kids. Well, I mean, I think when when big bucks are involved, it's pretty clear that companies themselves probably aren't gonna like pull back on their profits in order to just be super safe, like it has been proven throughout history that they'll generally want like air on the side of making the money. You know, you're a comic,

is gonna be fun. So Okay, now that we got that out of the way, Chuck, let's dig into the FDA, because if you want to see whether or not you think the f d A is necessary, all you have to do is go back to the days before the FDA, which wasn't too terribly long ago. I mean, the FDA really only finds its origins and uh nineteen o six on paper, it goes a little bit back before that today, I think the Abraham Lincoln administration. Yeah, who was a

pinko himself. Let's climb in the way back machine, shall we. Oh yeah, it's been a little man. It smells like cat in here. I know. Well I took a little ride with Laurent and the Wizard and uh, sorry about nothing. Man, how are they doing well? They're doing great, But um, I forgot to bring a little box. So yeah, there was an accident. Um, so here we are in the way back machine and we're going all the way back, like you said, to the Times of Lincoln. And what

he did he kind of kicked kick the man. I couldn't say that the other day in private the bucket. No, I want to say, get the ball rolling and kick it off. And I said kick the ball, kick the ball rolling. I said that the other day. It's like twice that's okay. So he wanted to kick the ball rolling. And so he appointed a chemist named Charles weather Roll to analyze agricultural materials. Sniffed him on the case. Yeah, he sniffed them on the case. Not off, said hey,

food and soil and fertilizer, maybe look into that. We have the new Department of Agriculture. And then his successors, Harvey Wiley and Peter Collier were the dudes who really um kind of got things going in a in a like a serious way for the FDA. Well, they saw like a real um reason for an agency that was in charge of guarding safeguarding the purity of food and drugs at the American public was ingesting. They basically saw

what was going on. I was like, Hey, we might need to step in here because prior to this, I mean, we talked about it in UM are Bizarre Medical Treatments episode I think where we were just talking about UM like little kids being given morphine in like a prescription that in no way, shape or form said there was morphine and it just calm colicky babies, and it calmed him by bringing him to the brink of death on him morphine overdose. But you could buy it over the counter.

You shouldn't regulate that, that's business. So that's one and that was the one that actually used morphine there. I'm sure others that were out there that were um much more lethal use knockoff morphine or something like that that cousin Tony made in his basement. You could do it bottle and if the person, if the person bought it

and they died, well, buyer beware, you know. Um. So the guys like Um, Wiley and Collie or especially Wiley, though, we're really adamant about getting some sort of regulation and specifically taking this agency that they've been handed um and and building it into into a real powerhouse. Yeah. And over the course of about twenty five years, they got Congress to look over about a hundred bills for the

food and drug industry. I guess Congress said, no, no, no, we're pretty deep in the industry's pockets, so we can't really do anything right now. We agree with you, totally great idea, but I'm sorry, but I a car is about to be invented and I want to own one, and pretty bad. Well that'll change, though, my friend. In nineteen six, UM when h reporter novelist Upton Sinclair wrote The Jungle, which UM, like everyone sort of this very famous book that uh exposed the practices of the meat

packing industry in Chicago in particular. But um, it was a big deal and it caused a lot of people to really freak out. It wasn't It was a novel, which means it was fictitious, but it was based on his and he was a journalist too. It was based on his experiences I guess, working undercover in the Chicago meat packing plants, and apparently I guess Roosevelt, Teddy Roosevelt set up an investigation, a committee to investigate. He claims fan of Sinclair's at all, but I think he's sort

of Everyone was so repulsed he had to do something. Yeah, I mean, like it really got the America in public because the stories are things like, um, they were using disease cows for meat, and there were rats that were calling around on the cows, and so they poisoned the rats, and then the dead poisoned rats with the poison, and the diseased cow meat would all be put into a grinder and there was your potted meat on the other side. Yeah, he was, Uh, I still won't eat potted meat. Yeah, well,

I don't care what year it is. You take me to the future in twenty two thousand, three hundred and twelve, and I'm not gonna eat potted meat. I wish the way back machine could go to the future. Well, that's the way forward machine. We have one of those well nuls working on it. Okay, it'll be a while. Um. So they had to do something because there were even accusations of people being in meat um, which apparently was

not true and that was really fictitious. Right. But that committee that investigated Sinclair's claims in the Jungle found that pretty much everything else he said in that book was through step for the guy being ground up with the beef because he fell into a meat grinder. And they were just like, again, the meat business is not able to police itself and say maybe we shouldn't put disease

rats and meat. So the government was forced to step in and in nineteen oh six, on June thirty, Congress past the Food and Drugs Act a k a. The Wiley Act, and that prohibited um trade of mislabeled and contaminated food, bevies and medicines across state lines. So I guess you can still sell it in Illinois, you know. Yeah, That's the one thing I never get is the shipping thing, Like, well,

that's that's the only thing that they can enforce. Er. Well, yeah, the the federal government is there's always been a struggle between states in federal right, and so the kind of the line has been drawn at the state borders where it's like RoCE across the state border all of a sudden, you're part of the United States rather than just the state, and you want to leave it up to the state. But over time the federal government has taken more and

more power from the states. With the Wily Act, though, Chuck, I mean, it's named after Wiley, so it gives you an idea of like the links that this guy went too to try to establish some sort of standards for purity and food. Right. One of the things he did was set up what came to be called the Poison Squad. Yeah,

that's a great name, isn't it. It really isn't It was a sensational name, and at first he fought it, and then he finally saw like he was worried that with a name like the poison Squad, they had their own little poison squad. An thom and Um the articles written about the Poison Squad really sensational and like, can you believe how crazy these guys are? Um and at first wild he fought it because he he was like, this is a really serious scientific undertaking. And then finally

he saw the writing on the wall. It was like, you can get America behind this whole idea if you just give him the poison Squad as they want the poison Squad. And it's like I have added everybody they haven't had them. They did. It's in this this article for m like the FDA Zone Consumer magazine or whatever from I think two thousand two, The Boys and Squad, The Boys and Squad something like. It's something it's kind

of like that. It's like, um, it's like when they take these bites, um, they won't feel any pain, but when they wake up in the morning, they'll probably never be the same. Just stuff like that. It's just kind of like, um, you know how they used to make jokey songs in the early interesting. So what the Poison Squad was was a group of men volunteers we should point out who signed up for this and repeatedly signed up for this and signed away their right to sue

or anything. They were fully on board, um to eat poison and to basically uh in a in a kitchen there on h Washington, d C. In the basement of the FDA's building. Yeah, they would have had a chef that apparently made some great meals laced with all kinds of poison for mal hide, borax, what was a really harmful one. It was called copper sulfate, right, which is now pesticide. Correct. Yeah, and they used it to make camps appear bright green, and that that kind of gets

to the heart of the matter. Chuck, Like they these guys weren't just eating poison just for fun. Oh no, they were testing out stuff that was being used as preservatives and food at the time. Exactly, additives and preservatives and stuff like you said to make your peas greener. Right, So people used to use formaldehyde to preserve meat, makes sense, people used to use borax formaldehyde. Look how long that human heads? But in that bucket? Exactly, let's put it

on beef. So did you touch that head or did you just like you didn't poke it with the end of a mom and know, his face bobbed up at me, and I was just like, all right, there it is, hello sir. So Uh, the poison Squad made great headway. They really determined a lot of stuff that shouldn't be used as preservatives like that copper sulfate that was used to make peas green. Yeah, national heroes in a way.

Well yeah, they also proved um overall, that selling adulterated food wasn't just a buyer beware kind of thing, that it actually posed a real public health hazard. They got super sick, they did, and they got publicized. These guys are getting sick on purpose from the same stuff that you're feeding your kids, which is where they shut it down eventually, right, and the public all of a sudden it's like, well, we don't want this stuff in our peas.

I don't care whether they're green or not. I'm not eating this, And then public pressure led to finally Congress enacting the Food and Drug Act. I wonder if I'm When I was reading this, I was wondering if that has something to do with the the um the thing with peas, Like I don't think people generally like peas, and I wonder if that has anything to do with I like peas. But I wonder if that was like a stigmata on the PA when this stuff came out and have blood on its palms, blood on its p uh.

Maybe I don't know. I don't either surely it had some effect that would guess, well, it's like it's probably a lot like Um, how they spray produce in the produce section, even though it increases its rotting time dramatically. Why did they do that to make it look pretty, to make it look fresh. It's ridiculous, but it's probably the same exact principle. I bet you're right. Here's some poison to make your people. Right. So the f d A UM when they formally evolved, Um, they evolved out

of some other agencies. Uh. They've been through a bunch of name changes and reords through the years. Um. But in nineteen oh six what they're they were under the Department of Agricultures Bureau of Chemistry, and they were the ones charged with enforcing that Food and Drugs Act. So they split them up in ninete into two groups, the Food and Drug Insecticide Administration they handled the regulations and the Bureau of Chemistry and Soils handled the experiments. Before

it had been just the Bureau of Chemistry doing both. Yeah, so they split them up. Eventually, they dropped in nineteen thirty the name and Secticide and it just became the f D AY and From there, they were in under the guys or under the purview of several agencies until the late seventies and they finally landed where they are now, which is the Health and Human Services yea, h h S,

green PS. So today the way they're organized loosely. They're not organized loosely, but this is a script site is this? They have a top layer of the Office of Commissioner of Food and Drugs a report to the director of sorry, the Secretary of HHS who used to be Tommy Thompson. Really, yeah, under Bush. Oh that's right. Do you know who it is now? I don't. There's probably none there. Obama hasn't

been able to get anybody confirmed, like either term. Uh. That first layer also has seven support supporting organizations that support the commissioner, and they're mainly on They're not like the rubber meets the road. They're the on the policy side of things, basically litigation and stuff. Well, yeah, the big stuff, the big overarching we are the f d A. Yeah, and then below them are broken down the into components

that handle rubber meets the road stuff. Yeah. Those are the five Deputy commissioners and um, they're they're like you said they're the ones that really are heading up the field offices. I think there's um four sorry two seven field offices. And then they have their big home in Silver Spring, Maryland, where they have about close to employees and chuck. Um, let's do a quick quiz. You're ready, yes, okay, the f you gotta wait, sorry that I know you're

very excited right now, is just hanging there. The FDA regulates true or false? UM, X ray machines. Um, I'm gonna say true, that's right. They regulate radioactive or radioactivity emitting machines like X rays. Uh. Pesticides, that's right. Yeah, that's the U. S d A. From what I understand. Um, illicit drugs like cocaine and crap cocaine. They don't regulate that. No, that's true. They don't. Uh. Let's see what else. What about donated blood? True, that's true. They regulate biologics doing

great man vaccines and blood. Yeah, thank you, tobacco. Um, they do regulate that, I believe. And then what about poultry chicken? Yes, of course they do. No, because it's food. No U s d A. Again, although the FDA does regulate apparently the dairy industry. Yeah, but not meeting poultry. No, talk about mind boggling. They do reulate um cosmetics, but obviously because we did a podcast on it, they don't

regulate uh several supplements. Yeah, that was a good one, if I remember correctly, We really like got to the heart of the matter. Yeah, And there's a lot of and I think you talked about it. Then there's a lot of slippery language that can be used in body products period, which always aggravates Emily to no end because

she has completely natural body products. But you can throw names on packages these days, on foods too, that just say like purer and natural and just these buzzwords that mean nothing, and there's no regulation for when you can use those words. And it's just it's they're trying to sell people on something that's not true. It's truly sad. Like light beer. I remember hearing years and years and years ago that light beer only has to be light

and color to be called light beer. Really Yeah, But now that I'm grown, I'm like, I'll bet like, who regulates that, I'll bet you it doesn't even have to be light in color and light and color compared to what you can probably call something light beer if you want to, Well, it's light in calories, right, buyer beware. But your point is it's not regulated, right, Probably not a beer has to be under this many calories to be called a light Yeah. I don't believe it is.

And now that I think, I'd probably be the FTC that would be in charge of that kind of thing. But they the t F Yeah, man, the government should just have a lot of lettered agencies. Yeah. One last thing about the FDA though, there's a group of special agents in the criminal unit that carried guns. Really FDA agents that carried guns and will shoot you well for doing what I've got a great example of it. Had they caught whoever it was that poisoned the Chicago area

tile and all in, they probably would have shot that person. Yep. Do you do you know about that? I do? Uh, you want to talk about that now? Sure might as well. Huh. Yeah, I remember this, do too, man. Yeah. I was a six year old whose eyes were just opening to the ideas of w things and drugs and learning to fear things that you bought at the store. Yeah. I didn't. I didn't. I didn't know the specifics because I was only eleven and I never really like researched further as

an adult. But twelve year old girl died in a suburban Chicago after taking Thailand all laced with cyanide as. It turns out, Um, she was dead by the next day, I believe know a couple of hours, Oh, a couple of she took it that morning then and then dim. So Uh. That same day, a twenty seven year old name Adam Janice suburban Chicago died and then his brother and sister were consoling the family. They thought it was a heart attack. Uh, we're consoling the family and just

sort of doing the post death family stuff. Very stressed, got headaches, they took tail and all and they both died. Yeah. I had no idea that connection. Three more people died over the next couple of days, all from they found out upon investigating, all of them had taken Thailand all right before they died. So they started looking at right, they started looking into it, and um, it turned out that there was poisoned thailand all in the Chicago area.

And everyone freaked out because at the time Thailand all was like that was it. You had an over the counter pain reliever. It was Thailand All, and they didn't have tamper resistant bottles at the time. What they later figured out is that somebody bought Thailand All, took it home, I guess, laced it with cyanide, and then brought it back and made it look like it had been unopened, and people bought them and died from They still don't know who did it. They made it look like it

was unopened by just closing the lid again. Because there again, no tamper resistant packaging until right this changed everything. So UM, the company that makes tail and All under Johnson and Johnson like issued like a national media alert that said, like, everybody should probably stop taking taile and All and send us your tailing All will send you new stuff that we know is good, but um, don't take Kylo, which

is kind of cool for a company. Yeah, they really like I mean, they had no choice, I think, but the super go on the offensive with this. Uh, and it's actually due to Johnson and Johnson. Um. It wasn't the f d A saying hey, we need to get tamper resistant packaging. Johnson and Johnson actually said, hey, I think we should start investigating tampa resistant packaging. So they sort of led the charge. Yeah, and then in Congress said, um,

let's make tampering with medicine a federal crime. Yes. And then just just six years later, the FDA said, let's make these awesome tamper resistant bottles um mandatory. I don't know why it took six years that we're talking about a federal bureaucracy here now, but it seems like that's something you could have sped through. Just my opinion, but anyway is when um, that's why it's so hard to

get into pill bottles these days, thankfully. Yeah, a little boil coatings and all that stuff that makes um, doesn't mean you can't open it, but it means you will know if someone has opened it. Yes, you know, like if you buy it and you're like, wait a minute, that foil is poked through by a human thumb, I can see it. And this stuff is glowing, yeah, Thailand, all is not supposed to glow. Alright, So let's take a break and after this we'll talk a little bit

more about how they regulate. You know, stop fear you you know, stop you know stop you know. So, um, how does well, first of all, how much do they regulate and the answer is a ton of products. Yeah. Um, some estimates say that twenty cents out of every dollar consumer spend, and that's on everything TVs you know, VCRs, right,

that doesn't regulate satellite dishes, laser discs. All the money that we spend on everything, twenty cents out of every dollar we spend is on a product that's regulated by the FDA. It comes under their per view, which which means you have too much to do. Supposedly that equals about what they regulate about one trillion dollars worth of goods and in services, well goods. Yeah, all right, so they regulate. We already talked about what they do regulate.

They also, um also offer guidance at times on maybe how advice on how regulations should be carried out. So that's one of their tasks as well. Right, Like maybe you guys should make your pillbottles tamper resistant. Our criminal enforcement unit isn't going to come shoot you if you don't, because this is a guideline. But now that it's uh, now it's mandatory or they may visit you. Um. They do about sixteen thousand facility inspections per year. Uh, everything

from dairy farms to blood banks. But um, they, like we said, they're way more facilities than they have field workers. So I think they do they well, they use the element of surprise or the potential, the element of potential surprise, So surprise inspection, surprise visits. I hope, hope, hope. And I'm pretty sure that the FDA doesn't call in schedule inspections ahead of time. Right. If they do, then then write your congress person and make sure that this gets

changed immediately, because they can't. We're talking fourteen thousand employees in total, not just inspectors in total. For all of the FDA, less than fifteen thousand people are in charge of not only visiting factories and dairies in places that that use X ray machines and all this stuff, all the things that they regulate, not just in the US, but like in other countries too. Yeah. They just set up their first office in Beijing in the last decade

or so. Yeah, because they have to. They have to watch what's coming into the country as well, because Americans don't just ingest American products, We just products for overseas, and those things have to they have to follow the same guidelines as any other product that's sold er sold or used in America, because the FDA jurisdiction isn't stuff that's made in America, stuff that is consumed in America. Yea, I guess I just thought that would be maybe the

FDC or something. But imagine they all kind of work hand in hand to get the church done. They all quietly hold hands while they do their research. Uh. And how do they do this? They do it because they are funded to the tune of four point four billion dollars um. About two point six of that comes from the Treasury and in other words, your tax dollars and the remaining close to two billion comes from user fees, which are very, very controversial. You want to talk about

the user fees. Yeah, let's know that. Man. So the before, what was it. I believe the FDA was fully funded by taxpayer dollars. It got all of its funding from the Treasury. And then in Congress passed a law that said the the FDA can start generating its own revenue

by accepting user fees. Yeah, the Prescription Drug User Fee Act. Right. So, in that act, it says, if you are a prescription drug company, a pharmaceutical company, and you want to have your UM your drug examined by the FDA, and in a lot of cases, most cases, you have to have it submitted for a review by the FDA. Sure, you also have to pay a fee called it an application fee, call it a user fee, what have you. Well, there's many different fees, so we'll call that. Let's say you

want to get your drug fast checked. You can pay an exorbitant fee and we'll put it at the top of the pile even and so all of a sudden, out chuckers, the f d A is not policing the pharmaceutical companies any longer. It is servicing the pharmaceutical companies, and the pharmaceutical companies as became the FDA's clients. Yeah, that was really really bad as far as consumer protection goes. Yeah,

and um, there are many different ways of looking at this. UM. One is that way, which is that the the pharma lobby is um writing checks to the f d A UM to the tune of billions of dollars. And that can't be good, right, Uh the f d A. The read this great article on pbs UM where they just interviewed a bunch of people for a variety of opinions it was very balanced. It was very very and balance. It's not like us, Um it's bad. They the FDA's rebuttal will look a little something like this. Um. What

what it's done is it's really helped us out. Um, We've increased our productivity by close. We've been able to hire so many more people, which means we can regulate so much more. UM, it's really helped us in the review process. The farm a lobby says, this is great because it gets things going super quickly. It's very efficient and yeah, and it hasn't changed the review processes, just made things faster. And UM, we can get these drugs two people quicker because people need these. So there's a

lot of different ways of looking at it. UM. If you ask Raymond Wooseley, who was he was up for UM, he was the vice president of health Sciences at University of Arizona. I think it's been like two thousand two. He was up for commission of the FDA. He's a safety guy. Yeah, he was rejected, and he flat out said in an interview, like it's pretty clear that people that really care about drug safety will never get this

job again. The Commissioner of the FDA and he said, it's great sadness to me that people who care about drug safety and food safety to the level that they get involved, they try to make a difference and can't be accepted to regulate the agency. And he said, for me, it should be protection first and then serving second, serving meaning the industry. And that's sort of not the way

it's gone since the user fees have been introduced. Yeah, from from the research that we've done, it seems like every critic of the f d A from all walks of life and all stripes, points to that user fee as possibly the number one problem as far as coziness between industry and the agency that they're funding regulates. Yeah, you want to separate those two things generally. And then

the other problem is funding for the FDA itself. That it is a grossly underfunded agency for what it's tasked with doing, so it does have to rely on those user fees, Whereas I think it's a lot like campaign finance reform, where if you could just take that and replace it with public money, um, then you can. You can separate these two things that aren't supposed to be cozy with one another. A government agency that's not supposed

to rely financially on the industry that it's regulating. Yeah, and I know you want to do a show on lobbying soon. That's uh, that's gonna be a firestorm. It is. We're gonna just be sitting there like gripping the table the whole time. Well, what you mentioned though, how they're

funded though, it's interesting. I think until recently, UM, the way the money was even divided, like how the budget money was spent was pretty hinking because you couldn't even use any of that user fee money to regulate safety at all. All of that had to go into the service side of things. I think now they are starting UM to to uh be able to use that money for safety as well. But I think that's not happening fast enough for people that are truly concerned about the

safety of our country. And there was this uh I think I sent it to you. There's this Forbes article from two thousand and fourteen. About a year ago, UM, there was a Yale study that came out that really just raked the FDA over the coals, and it was an analysis of a bunch of different f d a UM approvals from two five to two thousand twelve publicly

published stuff. It's not like they had to dig in, right, They just went and did an analysis of it, and they found that these FDA studies were um all over the place as far as the data they accepted, UM, what what got cleared and what didn't, UM, the sample size, how long trials went on, and um. It was basically used to publicly shame the FDA is saying like, you guys aren't even using good science and even trying to keep up this pretense that you're following your own standards

or that you even have standards. You guys are you're just rubber stamping pharmaceuticals. And to kind of give an opposing point of view, this guy on Forbes said, well, wait a minute, Like this is totally unfair because the FDA is actually what they're being criticized for here is actually a certain kind of nimbleness that the end user,

the patients who are taking these drugs really want. So they're saying, for something that's a really huge, sweeping drug that's going to be used by a lot of people, right, they they they should and typically do, follow some pretty stringent guidelines. They have to have a huge population sample they have to um carry these studies out for years and UM they require a lot of really good data.

But if you have something that is like a really obscure disease or a drug that treats are really obscure disease, sure they're going to accept the data that used the population size of like a hundred people because there's just not that many people out there with this disease. And it may be a shorter lived study because if it's a really fatal disease, these people want this drug and to get it out the door quicker. And there may only be the one study. You may not have to

duplicate it and replicate it three or four times. So he did a good job of like presenting the other case in really pointing out how the FDA is very typically it's it's in a damned if you do, damned if you don't situation on a daily basis, because in that same study that found you know that they it will accept the population of one hundred in the study, UM, and it goes out the door very quickly in the

approval process happens fast in that. In that sense, on the other hand, UM, when the FDA doesn't do that and really takes its time and digs in and studies. It gets accused of basically just letting people die, which was the case with the advent of AIDS eighties. Sure HIV drugs were being tested in people in the HIV community and in at large in the country. We're saying, advocates were saying, hey, people are dying and like these drugs are very promising, like let us try them out.

And so I do get it, man, Like they've been accused of dragon their feet. We're going too fast and finding that happy medium or I think I don't know, I don't know if it's a happy medium or if it's you should only strive for safety, and if it takes too long, it takes too long, or if it is super quick, it's super quick. Like safety is should be the most important thing, and it doesn't seem like that that's the case. No, it should be the most

important thing. But at the same time, there should also be an awareness of you know, what's going on outside the doors of the lab, but there are people dying, so yeah, you want a safe drug. But also if you have people are saying, like remember with the ebowl out right, they're people are like, I will die from this drug. I will sign whatever you need. Just give me the draw, let me try it. Right, And they

went ahead and and let people used unapproved drugs. It's like the Poison Squad almost these people were volunteering, right, willfully volunteering so well they were also dying of a bowla at the time. Well, um, the Poison Squad were totally healthy, untied the squad, right, yeah it did you know? Also the poison Squad. Um, it was a very scientific study. The guys were not allowed to eat or drink anything outside of this dining room except for water. They had

to turn in all of it. Not a drop or a speck was allowed to go unmeasured on a skid mok. But the the the f d A and AI's activist collision from the early eighties. Have you seen How to Survive a Plague? Great documentary, But the documentary deals in part with that and it's really really interesting. And that was actually score. The soundtrack was scored by our friends Superhuman Happiness. Oh nice to listen to this show, hey guys, good for them. Yeah, so go see it. It's a

very good, good documentary. I will check it out. Is that on the old red streaming service. Yes, I'm sure it's I'm sure it is called something like Netflix. That's that's exactly what it's called. Okay, you're confusing me. All right, So let's take another break here, and when we come back, we'll talk a little bit more about some of the various successes and failures of the f D A you know, stop, you know, you know, stop, you know all right, Um,

can we talk about this Harvard paper? Yeah, this is from an article titled Risky Drugs Colan Why the FDA Cannot be Trusted, And it was basically about a paper published in the Journal of Law, Medicine and Ethics from Hobvid University where they contend that, um, they present evidence actually that roughly of all new drugs approved by the FDA over the past thirty years are little own or no more effective for patients than existing drugs. Um they're saying.

It's they still beat placebo typically. Yeah. What they're saying is like, all these new drugs aren't any better than the old drugs. There's just competition on an already saturated market exactly. So it's like, why put the FDA through that if they're already overstretched, then why can't those resources be allocated to something else that it's dropping the ball

on right sure. And they also, you know, try to make a point about the safety level of these drugs that we are taking when they point out things like every week, every week, fifty three thousand hospitalizations occur and deaths occur every week in the US because of people taking properly prescribed drugs to be healthier. So that's just a bad reaction to an approved drug. That's how I

read it. Everyone, I'm reading that wrong. One in five drugs approved ends up causing serious harm, while one in ten provide a benefit compared to existing established So that's the ten percent. So the data is then this is

what this Harvard paper is saying. It's saying that yes, one in ten drugs that comes onto the market that the FDA has approved is it provides a benefit that no other drug does in the past thirty years, which I think and now that I kind of make a connection with something else another article that that they were really touting like there's no other drug like this, This provides the benefit of that other drugs don't, right, So

I think that's a big like buzzword. It provides other benefits, right, but one in five of those drugs will go on to cause some sort of harm, right, that's crazy. Yeah, And the they go on to say in that paper that the f d A they feel um Len's credibility to widening and lowering criteria for prescribing drugs what they call the selling of sickness and um what you're talking about like a new and improved drug. Basically, drug companies are raising prices from year to year on the same drug.

And they said, we're the only country in the world that allows a drug to have its price increased without showing like here's why, here's the benefit, here's why it's improved, and here's why it costs more. And apparently the US is the only country that does that. So Yeah, if you want to um read that article, really all the articles we've mentioned, you can go to our podcast page on Stuff you Should Know dot com, the part the page for this episode. It's got all the additional links. Yeah,

I'm glad we're doing that now. I think that's good. Yeah, it's definitely open things up for the truly curious. You really want to dig in, baby, we got it for you can we talk about antibiotics and livestock. Yeah, this is a big one. You found this in the Atlantic, right, Yeah, and this is a big uh. I mean, it's just a big issue these days period about what is going into the meat and that people are eating, uh like

in factory farms and stuff. Um. The f d A in n seven basically said we're not gonna put antibiotics in livestock because it's dangerous, and just in twelve they filed papers in court that acknowledge that they weren't safe. Um, it says more studies. A series of additional studies were conducted by other government agencies and non governmental organizations during the nineties, all of which generally support the FDA's concerned

guarding public health threat posed by anti microbial resistance. Yes, so what happens is you you give healthy live stock, otherwise healthy live stock, antibiotics in their food, right, because the living conditions are basically right for an epidemic, or it helps them grow faster. Right. So, but if they're

on antibiotics, they stay healthy despite these living conditions. Well, the problem is is the bugs that these antibiotics are fighting off develop resistance to the antibiotics, and they can, some of which are zoonotic, these bugs, and so they leap from say cattle, to humans, and they're already resistant to our antibiotics that we've been giving healthy cows. So now you have an antibiotic resistant superbug and that's a

really dangerous thing. And what you've just said is that since the seventies, the FDA has publicly said that this is dangerous and it should should not go on any longer, but they still they didn't do anything about it. Now. Their their attack right now is to say that the livestock industry can police itself. Uh. It doesn't seem like that's happening, but um, that is their position at this point. Uh. And this is why you see a lot of meats

now in your store that say antibiotic free. It's like a big selling point because, uh, even like you said, even the FDA says it's really dangerous, but they just haven't enacted any law about that. Although they have, that's not entirely true. They have listed some antibiotics that, um, I know they called out one in the article that said you can't use this one, but apparently it's only used in like point to five or it's only so people that are you know, want to live more purely

are saying they're not taking enough efforts. I mean, they were sued by the National Resources Defense Counsel UH saying you have to take action on this. Well, and that's us that that that it takes the courts to force the government an agency to protect consumers in that way, in a way that the agency itself is saying like, yes, this is dangerous, somebody should do something. Who will do something?

And then everybody's like, well, it's kind of your job to do that, and they're like, oh, well, don't worry about it. That's fine. Yeah. I mean they actually the FDA pulled public notices at the Federal Register that have been around for thirty years. They literally just made them disappear overnight. When this became controversial in the two thousand early tens, UM, they just said, we're gonna take the that those briefs where we said that it's dangerous and

somebody should do something, We're gonna stop having those published. Um. They also were largely criticized, UM a few years back for basically like just sitting on their hands about the GMO labeling. Yeah, that's yeah, dan quayle uh kind of change history with that many years ago. What did you do? I think he was the one that which for the legislation that allowed GMOs. Okay, so this is fine. You've got GMOs. You've got a label food that contains GMOs.

That's it. Don't do anything else. You just have to say on the label, this product may contain GMOs. Right, there was a big push. Apparently a million signatures were generated from the just label at campaign and we're submitted properly to the f d A, and the FDA rejected all but three ninety four of the signatures that were given to it because about a million of them were in a single electronic document and they were like, these don't count. So they didn't do anything about it. And

there's still no GMO labeling. So, regardless of how you feel about GMOs and GMO labeling, that's pretty shady stuff to just overtly reject a million signatures, especially as part of a large national public campaign. Absolutely. Buyox is a pain killer that was approved by the FDA, And just

to go over this stuff. Uh. In two thousand, a study showed that the drug posed a big heart attack risk when compared to a similar pain killer, and Mark, who was a manufacturer biox, kind of blew it off and said it's really beneficial, and the FDA said okay, and biox pretty much. Biox remained on the market for another four years and UM they estimate between eight thousand and a hundred and forty thousand heart attacks were caused by biox in that time. And it wasn't It wasn't

the FDA whoever removed by Ox. It was Murk bowing to public pressure. FDA never never, Mark just took it off the market itself because it was starting to look bad, and the FDU was like, what's going on, what are you guys doing? How about a success UM. In the nineteen fifties, UH in Germany there were scientists who created something called Philidamie, which was a sleeping pill, and they said it it's over the counter, it's totally safe for

Europe for pregnant women. Even is a sleeping pill? Not so safe though, because UM children were being born with malform limbs to the tune of ten thousand worldwide, but not very many in the United States. Because Francis Oldham Kelsey of the f D a was really resistant and made a big push to not allow the Lita mics. She didn't think it was safe. No, she was in charge of reviewing the data and said, what is this.

This is basically anecdotal, like where's your real data, and would not withstood a lot of pressure to approve this

drug and would not cave in. And as a result, only seventeen babies were born um with um malformations because of in the US, and the whole reason that there were any was because they found out that the drug maker was pushing the drugs for free onto a man are conductors to distribute as samples while this while the FDA was holding up approval, and so seventeen children were born with deformities because of it, because of this these free drugs. Apparently, in Canada, this story was even different.

The Canadian government, it was totally it was totally legal and approved in Canada and for months after it became worldwide known that thelidamide caused birth effects because it it crosses the placental barrier and arrests development of the fetus. Right Canada knew, everybody knew about it, and it took months before Canada finally outlawed it. So there's like this real big public shame hanging over Canada's um government agency regulating drugs still to this day because of that. And

Billy Joel wrote a song about it. Oh yeah, well it was in that terrible talk we didn't start the children. I forgot about that. Um, but yeah, that was one of the FDA's great successes. And as a result, actually, um, the Congress passed something an amendment to the Food and Drug Act, the Father Harris Amendments of nineteen sixty two, that really expanded the f d a's um scope of duties. It put, um, you know how you know those have drug ads, have all those disclaimers. That's from the nineteen

sixty two amendments. Advertising is under the juristic scene. They read those so fast, and the last one is an early death right exactly like do you need to say early death? No? Um, they And prior to nineteen sixty two, the FDA had sixty days to respond to an application and if they didn't get to it in time, well

that's fine. I'm sure it's fine. You can go to market. Um. That changed to I think a hundred and eighty days, and it's just to respond um and then also drug makers only had to demonstrate that the or drug was UM safe not effective. That changed the two as well. Yep. They also said that they had to control the marketing of generic drugs to keep them from being sold as uh just like jacking up the price under a new name basically. So um, yeah, that was a great amendment,

the Kerfuffle Harris amendment. Is that right? That's father So another great success. Well that was the same one. Well no, I mean in addition to the lido Uh. And then in the news recently you dug this up, the Zohydra painkiller. Didn't hear about this? No, I haven't heard of this until today. It's uh, apparently it's pure oxycodone, correct it is.

There's the first time. Yeah, there is. Um. All the other stuff like vik it in and oxyconton even or are safer because they contain at least something else like a seed, a mena fan or some other drug. This is just pure hydrocodone. And um. You remember like there was a huge, huge problem with pill addiction to oxyconton in particular. Yeah, it wasn't just rush limball with a

lot of people. Yeah, we're really hooked on oxycont and as a matter of fact, the current um heroin addiction crisis in the US is a direct result of the FDA stepping in and saying like, hey, you guys need to do something with oxyconton. Like people are crushing it up and injecting it. You gotta do something. So now there's well, there's a Tampa resistant thing where when you crush up oxyconton, now it turns into this goog that you can inject or snort. Right, Can you lick it

off a mirror? You can? I guess, but I don't think it has the same effect, right because when you when you crush it up, it was time released. When you crush it up, it's not time released anymore. It's like all there to give you this a media, right. So now that when you crush up oxyconton it turns into a Google. Everybody's turned to hair one, right, So

now there's a heroin epidemic. This company making zo Hydra came along and said, well, that's cool, just released this completely pure hydro code un pill without any tamper resistance. So we're gonna go back to square one, everybody, okay, And there's a huge outcry against this drug, and the

FDA had stepped up and became a mouthpiece for it. Yeah, and the FDA will, um, they will defend the decision by saying, well, putting things like a set of menifin has well known liver damage risk, so this is actually more pure. You can actually take hydro coda. Now, people in severe pain can take this drug without that liver toxicity risk. I mean that's a point. Now, it is a point. And if you're in severe pain in life and need this to to function or live out your life,

then great, But make it tamper resistance. Yeah, that's not what people are arguing about. They're saying that this is a very high level for abuse because there's no tamper resistance. Yeah, exactly, So people are going to die because of this drub Yeah, I think. Um. In two thousand and ten, uh, prescription hydro codone and other prescription opiates accounting for almost seventeen thousand deaths, which is a fourfold increase from just ten or eleven years earlier. Right, and that was all Oh

see before they made it tamper resistant. Orange County. There's probably a lot of it in county. I bet there is so there you go, crazy stuff. It is crazy stuff. Um. I kind of with that professor from Arizona. That's just like safety, Like it's it's sad that the chief of that organization can't be someone who's super pro safety above all else. Yeah, that's their job. There's such a tug of war between the public and I guess corporations over safety. Yeah, and the f d A is not pulling on our

side necessarily. Yeah. And I'm sure we'll hear from all kinds of people from the pharmaceutical industry that will tout how seriously they take their testing and stuff. And we're not saying they don't. But um no, I think it is a There are great protocols and standards and procedures, but there's also plenty of times where they just overtly dropped the ball and public safety suffered as a result. Agreed. Uh. If you want to know more about the f d A, you can go to the FDA website FDA dot gov.

You can go to how Stuff Works dot com and type in f d A in the search bar. Don't forget to go to our podcast page on Stuff you Should Know dot com for the f d A episode that you're listening to now, and since I said search bar in there somewhere, it's time for listener mail. I'm gonna call this uh we inspired a writer awesome. Hey guys and Jerry, first off, thank you so much for

what you do. I've been a fan for over three years, steadily working my way through the back living in constant fear of the existential dread that will settle upon me the day I finish UM. I poked my sister as well. And whereas our conversations used to be Simpsons quotes, now it is nine Simpson's ten percent stuff. You should know that, she says. But I digress. I'm writing because I'm an author of dark humor novels for young adults, and I wanted to express how health of your podcast has been

with inspiring and informing various elements of my books. For example, the one I'm currently writing is about a creepy candle factory in a creepy small town with a big, creepy mountain wherein wax sculptures come to life, and after listening to your ear Wax episode, Mount Ceremon was born pretty neat. Ever since the Haunted House episode of Been Itching, to write a horror about a horror attraction that goes terribly and hilariously wrong. Number stations equals something awesome, and so

on and so on. So we're inspiring her all over the place. I never know where your inspirations go and come from, but your so provides me with a steady stream of delicious possibilities. I want to thank you the best way I could, So I named a couple of off screen high school characters after you, guys in my most recently published book, Hellhole. So wait, how about that? That is a huge honor, pretty neat And she's gonna send us some copies and one for Jerry too, of course,

she says, So I'm gonna send our mailing address. And she says, thanks for the brain snacks. And that was from Gina Domico d A M I c O. And she has a website and you can check out her kind of a weird, funny, twisted young adult novels at her site and support support writing creativity. Thanks lord, Gina. Right, yeah, and uh, make sure you get l old so you can see our names in print. You don't like that was waiting for government joke? Oh? Was it? Oh? You'll

explain to me later. Right, how are you uh? If you want to, you get in touch with us to find out the waiting for gufnment joke Chuck just made. He'll respond to each each inquiry personally. Right. You can tweet to us at s y ESK Podcast. You can join us on Facebook dot com. You can join us on Facebook dot com, slash stuff you Should Know. You can send us an email to Stuff Podcast at how stuff Works dot com, and as always, joined us at at home on the web Stuff you Should Know dot com.

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