Stuff You Should Know - Does the FDA Protect Americans?

Episode Date: May 12, 2015

The FDA was the first consumer protection agency in the US. Since 1906, it's been issuing regulations meant to protect Americans from tainted food, ineffective drugs and pacemakers that don't work. But is the FDA too cozy with industries it regulates? Learn more about your ad-choices at https://www.iheartpodcastnetwork.comSee omnystudio.com/listener for privacy information.

attention bachelor nation. He's back. The host of some of America's most dramatic TV moments returns with the most dramatic podcast ever with Chris Harrison. During two decades in reality TV, Chris saw it all and now he's telling all. It's going to be difficult at times. It'll be funny. We'll push the envelope. We have a lot to talk about. Listen to the most dramatic podcast ever with Chris Harrison on the iHeart Radio app, Apple Podcasts or wherever you get your podcasts. Hey guys, it's Chikis from Chikis and Chill Podcast and I want to tell you about a really exciting episode. We're going to be talking to Nancy Rodriguez from Netflix's Love is Blind Season 3. Looking back at your experience, were there any red flags that you think you missed?

What I saw as a weakness of his, I wanted to embrace. The way I thought of it was whatever love I have from you is extra for me. Like, I already love myself enough. Do I need you to validate me as a partner? Yes. Is it required for me to feel good about myself? No. Listen to Chikis and Chill on the iHeart Radio app, Apple Podcast or wherever you get your podcasts. Welcome to Stuff You Should Know from HowStuffWorks.com. Hey and welcome to the podcast. I'm Josh Clark with Charles W. Chuck Bryant and Jerry over there. So this is Stuff You Should Know, the podcast. How do sir? Doing fine. How are you? I'm great. Yeah? Yeah. That's good. I enjoyed learning about the FDA. Yeah, you know, we've

podcasted on them before. Why doesn't the FDA regulate herbal supplements? Right. Man, we did that. Long time ago. I remember that's where the herbal Elvis comes out. Oh yeah. Was that the first appearance? Pretty sure. Hey man, give me some supplements. Is that your dad talk? Yeah. He just like would go around the house. Yeah, when he was on herbal up or sure. Yeah. Man, how'd he talk on the herbal downers? He didn't. He just slept a lot. Gotcha. No, I'm just, I tease. Of course. So we have talked about the FDA before, but yeah, this is a much more in-depth look. That's right. At the FDA. Was that your Chris Walken? No. Was that Chris Walken? No, not really. I mean, the weird pauses, but other than that. I was more doing Shatner. Oh. But I didn't

go up and octave, which I should have. Sure. Pretty good though, huh? Yeah. Pretty clear. Yeah. Bill Shatner. So did you know most of the stuff? Well, I know that the FDA is, has a history of controversy of people saying, you don't act fast enough. We need these drugs to help people. Other than 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 a bit of a tough thing to reconcile. You know, there, I acknowledge they're in a tough spot. They really are. And I think that's a good, good caveat or disclaimer to put at the front of this because it is a very controversial agency. It's the first consumer protection agency in the United States ever. Yeah. It's the oldest one.

And it's, call me liberal or what have you, but I think it is a very important agency to have. Oh, I don't think that makes you liberal. Does it? Some people may say so. What? Do they don't think we should regulate anything in this country? Yeah. There's people who think that like the FDA is just completely in the way of business. It's a feather. Oh, okay. I see what you mean. A feather, right? That's a thing. Sure. Because unfettered. But if you can be unfettered, you can be feathered. Right. But is there something that can feather and would that be a feather? Sure. So it's a feather to business to some, in some people's mind. Yeah. I just think that you, when you are talking about something as

elemental as food or drugs, things we put into our bodies in the hopes that we will be, be, have a greater wellbeing, 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 going to 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 commie. Oh, boy. This one's going to 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 FDA 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 in 1906 on paper. It goes a little bit back before that. So, I think the Abraham Lincoln administration, who was a Pinko himself. Let's climb in the wayback machine, shall we? Oh, yeah. It's been a little while. Man, it smells like cat urine in here. I know. I, well, I took a little ride with Laurent in the wizard and, uh, whoa, sorry about that. Man, how are they doing? Well, they're doing great, but, um, I forgot to bring a litter box. So, yeah, there was an accident. This is gross. Um, so here we are in the wayback machine and we're going all the way back,

like you said, to the times of Lincoln. And, uh, what he did, he's, he kind of kicked, kicked the, uh, man, I couldn't say that the other day in private. 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, uh, weather roll to analyze agricultural materials. He sniffed them on the case. Yeah. He sniffed them on the case, not off. He said, hey, food and soil and fertilizer, maybe look into that. We have the new department of agriculture. And then his successors, uh, 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 that the American public was ingesting. They basically saw what was going on. It was like, Hey, we might need to step in here. Because prior to this, I mean, we talked about it in, um, our bizarre medical treatment episode, I think where we were just talking about, um, like little kids being given morphine in like a, a prescription that in no way shape or form said there was morphine in it. It's just calm, colicky babies. And it calmed them by bringing them to the brink of death on a morphine overdose.

But you could buy it over the counter. Hey, you shouldn't regulate that. That's business. Right. That's private. That's what, and that was the one that actually used morphine. There, I'm sure others that were out there that were, um, much more lethal. Sure. Use knockoff morphine or something like that, that cousin Tony made in his basement. Yeah. You could do it. You could put in a bottle and if the person, uh, if the person bought it and they died, well, buyer beware. Yeah. You know, um, so the guys like, um, Wiley and Collier, 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 25 years, they got Congress to look over, uh, about 100, uh, bills for the food and drug, um, industry. Right. And I guess Congress said, no, no, no. We're pretty deep in the industry's pocket. So we can't really do anything right now. We agree with you. Yeah. Totally great idea, but I'm sorry, but I, uh, a car is about to be invented and I want to own one pretty bad. Well, that all changed though, my friend. In 1906, um, when, uh, reporter novelist Upton Sinclair wrote The Jungle, which, um, like everyone's heard of this very famous book that, uh, exposed the practices of the meatpacking industry in Chicago in particular. But, um, it was a big deal and it caused a lot of people to really freak out. It was, and it was a novel,

which means it was fictitious, but it was based on his, and he was a journalist too. Yeah. It was based on his experiences, I guess, working undercover in the Chicago meatpacking plants. And apparently, I guess Roosevelt, Teddy Roosevelt set up an investigation, a committee to investigate the claims. He's no fan of Sinclair's at all, but I think he's sort of, uh, everyone was so repulsed he had to do something. Yeah. I mean, like it really got the American public up because the stories are things like, um, they were using disease cows for meat and there were rats that were crawling around on the cows. Yeah. And so they poisoned the rats and then the dead poisoned rats with the poison in 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. He'd take me to the future in 2,312 and I'm not going to eat potted meat. I wish the way back machine could go to the future. Well, that's the way forward machine. Oh, we have one of those. Well, no, it's working on it. Okay, good. 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 true except for the guy being ground up with

the beef because he fell into a meat grinder and they were just like, all right. Again, the meat business not able to police itself and say maybe we shouldn't put disease rats in meat. So the government was forced to step in and in 1906 on June 30th, Congress passed the Food and Drugs Act, AKA the Wiley Act. And that prohibited, um, trade of mislabeled and contaminated food, uh, bevvies and medicines across state lines. So I guess you could still sell it in Illinois. You know, yeah, that's the one thing I never get is the shipping thing. Like, Oh, well, that's the only thing that they can enforce or yeah, the federal government is there's always been a struggle between state and federal, right? Yeah.

And so the kind of the line has been drawn at the state borders where it's like, once you cross 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. Right. With the Wiley Act though, Chuck, I mean, it's named after Wiley. So it gives you an idea of like the links that this guy went to to try to establish some sort of standards for purity and food, right? Yeah. 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 is. And 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 that had their own little poison squad anthem and the articles written about the poison squad really sensational. And like, can you believe how crazy these guys are? Yeah. And at first Wiley fought it because he was like, this is a really serious scientific undertaking. And then finally saw the writing on the wall that was like, you can get America behind this whole idea if you just give them the poison squad as they want the poison squad. Give them an anthem. Have added everybody. Did they have an anthem? They did. It's in this article from like the FDA's own Consumer Magazine or whatever from I think 2002. The poison squad. The poison squad. It's something like that. It's kind of like that. It's like,

when they take these bites, they won't feel any pain. But when they wake up in the morning, they'll probably never be the same or just stuff like that. Just kind of like, how they used to make jokey songs in the early 1900s. 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 to eat poison and to basically in a kitchen there in Washington DC. In the basement of the FDA's building. Yeah, they had a chef that apparently made some great meals laced with all kinds of poison. Formaldehyde, borax. What was the really harmful one? It was called copper sulfate. Right. Which is now a

pesticide, correct? Yeah. And they used it to make canned peas appear bright green. And that kind of gets to the heart of the matter, Chuck. Like 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. Yeah. So people used to use formaldehyde to preserve meat. Makes sense. Right. People used to use borax to preserve. Look how long that human head's been in that bucket. Exactly. Let's put it on beef. So did you touch that head or did you just like see it? I didn't poke it with the end of a mob. No, no, no. His face bobbed up at me and I was just like, all right, there it is. Oh my

god. Hello, sir. So 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 overall that selling adulterated food wasn't just a buyer beware kind of thing. Right. That it actually posed a real public health hazard. Well, yeah, 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. Yeah, which is why they shut it down eventually. Right. And the public all of a sudden is 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 when I was reading this, I was wondering if that has something to do with the thing with peas. I don't think people generally like peas. And I wonder if that has anything to do with it. Peas are gross. I like peas, but I wonder if that was like a stigmata on the pea when this stuff came out, you know? It had blood on its palms. Blood on its pee. Maybe, I don't know. I don't either. Surely it had some effect. I would guess. Well, it's probably a lot like how they spray produce in the produce section, even though it increases its rotting time dramatically. Why do they do that to make it look prettier? 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 peas look great. So the FDA, when they formally evolved, they evolved out of some other agencies. They've been through a bunch of name changes and reorgs through the years, but in 1906, they were under the Department of Agriculture's Bureau of Chemistry, and they were the ones charged with enforcing that Food and Drugs Act. So they split them up in 1927 into two groups, the Food and Drug Insecticide Administration. They handled the regulations and the Bureau of Chemistry and Soils handled the experiments. Yeah, before it had been just the Bureau of Chemistry doing both. Yeah. So they split them up. Eventually,

they dropped in 1930, the name Insecticide, and it just became the FDA. And from there, they were under the purview of several agencies until the late 70s, and they finally landed where they are now, which is the Health and Human Services. That's right. Right. Yay, HHS. Green peas. So today, the way they're organized loosely, they're not organized loosely, but this is a loose description. Oh, it's pretty tight. Is this, they have a top layer of the Office of Commissioner of Food and Drugs. Right. 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 no one there. Obama's been able

to get anybody confirmed, like either term. That first layer also has seven 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. Yeah. Basically, litigation and stuff. Well, yeah, the big stuff, the big overarching, we are the FDA. Yeah. And then below them are broken down the components that handle rubber meets the road stuff. Yeah, those are the five deputy commissioners, and they're, like you said, they're the ones that really are heading up the field offices. I think there's 400, I'm sorry, 227 field offices, and then they have their big home in Silver Spring, Maryland, where they have about close to 15,000 employees. And Chuck, let's

do a quick quiz. You ready? Yes. Okay. The FDA. False. No. You got to wait. Sorry. I know you're very excited right now. I was just hanging there. The FDA regulates true or false x-ray machines. I'm going to say true. That's right. They, they regulate radioactive or radioactivity emitting machines, like x-rays, pesticides. False. That's right, Chuck. Yay. That's the USDA, from what I understand. Illicit drugs, like cocaine and crack cocaine. They don't regulate that. No, that's true. They don't. Yes. Let's see. What else? What about donated blood? Blood. True. That's true. They, they regulate biologics. Yes. They're doing great, man. Vaccines and blood. Yeah. Thank you. Tobacco? They do regulate that, I believe. Yep. And then what about

poultry? Chicken. Yes, of course they do. No. Because it's food. No. USDA again. Although the FDA does regulate, apparently, the dairy industry. Yeah, but not meat and poultry. No. Talk about mind boggling. They do regulate cosmetics, but obviously, because we did a podcast on it, they don't regulate supplements. Herbal 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. Yeah. Because she has completely natural body products, but you can throw names on packages these days, on foods too, that just say

like pure and natural. And oh yeah. Just these buzzwords that mean nothing and there's no regulation for when you can use those words. Yeah. And it's just, it's, they're trying to sell people on something that's not true. Yes. Truly sad. Like light beer. I remember hearing years and years and years ago that light beer only has to be light in 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 in color compared to what? Yeah. 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. Yeah. And now that I think about it, probably be the FTC that would be in charge of that kind of thing, but they got bigger or the ATF. Yeah. Man, the government sure does 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 carry guns. Really? FDA agents that carry guns and will shoot you. Well, for doing what? I've got a great example of it. Okay. Had they caught whoever it was that poisoned the Chicago area, Tylenol in 1982, they probably would have shot that person. Yeah. Yep. Do you know about that? I do. You want to talk about that now? Sure. Might as well, huh? Yeah. I remember this.

I do too, man. Yeah. I was a six-year-old whose eyes were just opening to the ideas of poisoning and drugs and learning to fear things that you bought at the store. Yeah. I didn't know the specifics because I was only 11 and I never really researched further as an adult. But a 12-year-old girl died in suburban Chicago after taking Tylenol laced with cyanide as it turns out. Right. She was dead by the next day, I believe. No, a couple hours. Oh, a couple hours. She took it that morning then and then died at 7 a.m. 7 a.m. Wow. So that same day, a 27-year-old name, Adam Janus of suburban Chicago, died. And then his brother and sister were consoling the family. They thought it was a heart attack. Were consoling the family and just sort of doing the

post-death family stuff. Very stressed, got headaches. They took Tylenol and they both died. Yeah. I had no idea of that connection. Three more people died over the next couple of days. All from, they found out upon investigating, all of them had taken Tylenol right before they died. Yeah. So they started looking at it. Right. Yeah. They started looking into it and it turned out that there was poisoned Tylenol in the Chicago area. Yeah. And everyone freaked out because at the time, Tylenol was like, that was it. Sure. You had an over-the-counter pain reliever. It was Tylenol. Yeah. And they didn't have tamper-resistant bottles at the time. What they later figured out was that somebody bought Tylenol, took it home, I guess, laced it with cyanide, and then

brought it back and made it look like it had been unopened. Yeah. And people bought them and died from them. They still don't know who did it. They made it look like it was unopened by just closing the lid again. Right. Because, again, no tamper-resistant packaging. Right. Until this. Right. This changed everything. So the company that makes Tylenol under Johnson and Johnson issued a national media alert that said everybody should probably stop taking Tylenol and send us your Tylenol and we'll send you new stuff that we know is good, but don't take Tylenol, which is kind of cool for a company. Yeah. They really like, I mean, they had no choice, I think, but to super go on the offensive with this. Yeah. And it's actually due to Johnson and Johnson. It wasn't the FDA saying,

hey, we need to get tamper-resistant packaging. Johnson and Johnson actually said, hey, I think we should start investigating tamper-resistant packaging. Right. So they sort of led the charge. Yeah. And then in 1983 Congress said, let's make tampering with medicine a federal crime. Yes. And then just six years later, the FDA said, let's make these awesome tamper-resistant bottles mandatory. Yeah. I don't know why it took six years to do that. I'm talking about a federal bureaucracy here. No, but it seems like that's something you could have sped through, just my opinion. Right. But anyway, 1989 is when that's why it's so hard to get into pill bottles these days, thankfully. Yeah. Little foil coatings and all that stuff that makes, doesn't mean you can't

open it, but it means you will know if someone has opened it. Yes. Like if you buy it and you're like, wait a minute, that foil is poked through by a human thumb. Right. I can see it. And this stuff is glowing. Yeah. It's Tylenol is not supposed to glow. All right. So let's take a break. Okay. And after this, we'll talk a little bit more about how they regulate. Hey, guys, it's Cheekies from Cheekies and Chill podcast. And I want to tell you about a really exciting episode. We're going to be talking to Nancy Rodriguez from Netflix's Love is Blind Season 3. Looking back at your experience, were there any red flags that you think you missed? What I saw as a weakness of his, I wanted to embrace. The way I thought of it was whatever love I have from you is extra for me.

Like I already love myself enough. Do I need you to validate me as a partner? Yes. Is it required for me to feel good about myself? No. Listen to Cheekies and Chill on the iHeart radio app, Apple Podcast or wherever you get your podcasts. Attention, Bachelor Nation. He's back. The man who hosted some of America's most dramatic TV moments returns with a brand new Tell All podcast. The most dramatic podcast ever with Chris Harrison. It's going to be difficult at times. It'll be funny. We'll push the envelope. But I promise you this, we have a lot to talk about. For two decades, Chris Harrison saw it all. And now he's sharing the things he can't unsee. I'm looking forward to getting this off my shoulders and repairing this, moving forward, and letting everybody here for

me. What does Chris Harrison have to say now? You're going to want to find out. I have not spoken publicly for two years about this. And I have a lot of thoughts. I think about this every day. Truly, every day of my life, I think about this and what I want to say. Listen to the most dramatic podcast ever with Chris Harrison on the iHeart radio app, Apple Podcasts or wherever you get your podcasts. So, how does, well, first of all, how much do they regulate? And the answer is a ton of products. Yeah. Some estimates say that 20 cents out of every dollar a consumer spend, and that's on everything. TVs, you know, VCRs. Right. That's the, it doesn't regulate those satellite dishes, laser discs, all the money that we spend on everything 20 cents out of every dollar we spend

is on a product that's regulated by the FDA. It comes under their purview. Yeah. Which means they have too much to do. Supposedly that equals about, they regulate about one trillion dollars worth of goods and services. Well, goods. Wow. Yeah. All right. So, they regulate, we already talked about what they do regulate. They also offer guidance at times on maybe how advice on how regulation should be carried out. So, that's one of their tasks as well. Right. Like, maybe you guys should make your pill bottles tamper resistant. Right. Our criminal enforcement unit isn't going to come shoot you if you don't, because this is a guideline. Right. But now that it's 1989, now it's mandatory. Yeah. Or they may visit you. They do about 16,000 facility inspections per year.

Everything from dairy farms to blood banks, but like we said, they're way more facilities than they have field workers. So, what do you do? Well, they use the element of surprise. Sure. Or the potential, the element of potential surprise. Right. So, surprise inspection, surprise visits. Yeah. I hope, hope, hope. And I'm pretty sure that the FDA doesn't call and schedule inspections ahead of time. Right. If they do, then write your congressperson and make sure that this gets changed immediately. Yeah. Because they can't, we're talking 14,000 employees in total. Yeah. Not just inspectors in total for all of the FDA. Oh, yeah. Less than 15,000 people are in charge of not only visiting factories and dairies and places that use x-ray machines and

all this stuff, all the things that they regulate. Yeah. Not just in the US, but like in other countries too. Oh, they do? Yeah. They just set up their first office in Beijing in the last decade or so. What? 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. Yeah. We ingest products overseas. And those things have to, they have to follow the same guidelines as any other product that's sold or, sold or used in America. Because the FDA's jurisdiction isn't stuff that's made in America. Right. It's stuff that is consumed in America. Yeah. I guess I just thought that would be maybe the FTC or something, but I imagine they all kind of work hand in hand to get the job done.

They all quietly hold hands while they do their research. And how do they do this? They do it because they are funded through the tune of $4.4 billion. About 2.6 of that comes from the treasury and, in other words, your tax dollars. And the remaining close to $2 billion comes from user fees, which are very, very controversial. You want to talk about the user fees? Yeah. Let's do that, man. So before, what was it? 1992, I believe? I think so. The FDA was fully funded by taxpayer dollars. It got all of its funding from the treasury. And then in 1992, Congress passed a law that said 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 drug examined by the FDA, and in a lot of cases, most cases, you have to have it submitted for review by the FDA. Sure. You also have to pay a fee. Call it an application fee. Call it a user fee. What have you? Well, there are many different fees. Right. So I'll call that. Let's say you want to get your drug fast-checked. You can pay an exorbitant fee. Yeah. And we'll put it at the top of the pile, even. Yeah. And so all of a sudden, now, Chuckers, the FDA is not policing the pharmaceutical companies any longer. It is servicing the pharmaceutical companies. Yeah. And the pharmaceutical companies, as of 1992, became the FDA's clients. Yeah. That was really, really bad as far as

consumer protection goes. Yeah. And there are many different ways of looking at this. One is that way, which is that the pharma lobby is writing checks to the FDA to the tune of billions of dollars. And that can't be good, right? Right. The FDA, I read this great article on PBS where they just interviewed a bunch of people for a variety of opinions. Yeah. It was very balanced. It was very balanced. Not like us. It's bad. The FDA's rebuttal will look a little something like this. What it's done is it's really helped us out. We've increased our productivity by close to 80 percent. We've been able to hire so many more people, which means we can regulate so much more. It's really helped us in the review process. Right. The pharma lobby says this is

great because it gets things going super quickly. Right. It's very efficient. It's not feathering. Yeah. And it hasn't changed the review process. It's just made things faster. And we can get these drugs to people quicker because people need these. Yeah. So there's a lot of different ways of looking at it. If you ask Raymond Woosley, who was up for, he was the vice president of Health Sciences at University of Arizona. I think this was in like 2002. 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. Right. 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. Right. And that's sort of not the way it's gone since the user fees have been introduced. Yeah. From the research that we've done, it seems like every critic of the FDA from all walks of life and all stripes points to that user fee as possibly the number one problem. Yeah. As far as coziness between industry and the agency that their funding regulates. Yeah. That makes total sense. 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. Yeah. Where if you could just take that and replace it with public money, then 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. Yeah. That's going to be a firestorm. It is. We're going to 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 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. Right. I think now they are starting to be able to use that money for safety as well. Yeah. But I think that's not happening fast enough for people that are truly concerned about the safety of our country. I think I said it to you. There's this Forbes article from 2014, about a year ago. 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 FDA approvals from 2005 to 2012. Yeah, 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

all over the place as far as the data they accepted, what got cleared and what didn't, the sample size, how long trials went on. And it was basically used to publicly shame the FDA saying, you guys aren't even using good science. You're not even trying to keep up this pretense that you're following your own standards or that you even have standards. It's not consistent. 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, 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. Like a heart drug. Right. They should and typically do follow some pretty stringent guidelines. They have to have a huge population sample. They have to carry these studies out for years. And 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 a really obscure disease. Like morgolons. Sure. They're going to accept this data that used a population size of like 100 people. Yeah. 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 like three or four times. So he did a good job of presenting the other case and really pointing out how the FDA is very typically, it's in a damned if you do damned if you don't situation on a daily basis. Sure. Because in that same study that found that it will accept a population of 100 in a study. And it goes out the door very quickly and the approval process happens fast in that sense. On the other hand, 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 in the 80s. Sure. HIV drugs were being tested and people in the HIV community and at the large in the country were 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 dragging their feet. Yeah, going too fast and finding a 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. Yeah, 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. Like there are people dying. Yeah, you want a safe drug. But also,

if you have people are saying like, remember with the Ebola outbreak, there are people are like, I will die from this drug. I'll sign whatever you need. Just give me the drug. Let me try it. Right. And they they went ahead and let people use unapproved drugs. It's like the poison squad almost these people were volunteering, right? Willfully volunteering. So well, they were also dying of Ebola at the time. Well, yeah, those sure. The poison squad were totally healthy. Yeah. And so they joined the poison squad. Right. Yeah. And did you know also the poison squad? It was a very scientific study. The guys were not allowed to eat or drink anything outside of this dining room. Yeah, except for water. They had to turn in all their poo and pee. All of it.

All of it. Not a drop or a spec was allowed to go unmeasured and unanalyzed. Not a drop, not a skid mark. But the that the FDA and AIDS activist collision from the early 80s. Have you seen how to survive a plague? No. Great documentary. Yeah. But the the documentary deals in part with that. And it's really, really interesting. And that was actually scored. The soundtrack was scored by our friends. Super human happiness. Oh, nice. 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 on. I'm sure it is called something like Netflix. That's that's exactly what it's called. Oh, 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 FDA. Hey, guys, it's Chiquis from Chiquis and Chill podcast. And I want to tell you about a really exciting episode. We're going to be talking to Nancy Rodriguez from Netflix's love is blind season three. Looking back at your experience, were there any red flags that you think you missed? What I saw as a weakness of his, I wanted to embrace the way I thought of it was whatever love I have from you is extra for me. Like, I already love myself enough. Do I need you to validate me as a partner? Yes. Is it required for me to feel good about myself? No. Listen to Chiquis and Chill on the iHeart radio app,

Apple podcast or wherever you get your podcasts. Attention, bachelor nation. He's back. The man who hosted some of America's most dramatic TV moments returns with a brand new tell all podcast, the most dramatic podcast ever with Chris Harrison. It's going to be difficult at times. It'll be funny. We'll push the envelope. But I promise you this, we have a lot to talk about. For two decades, Chris Harrison saw it all. And now he's sharing the things he can't unsee. I'm looking forward to getting this off my shoulders and repairing this, moving forward and letting everybody hear from me. What does Chris Harrison have to say now? You're going to want to find out. I have not spoken publicly for two years about this. And I have a lot of thoughts. I think about this every

day. Truly every day of my life, I think about this and what I want to say. Listen to the most dramatic podcast ever with Chris Harrison on the iHeart radio app, Apple podcasts or wherever you get your podcasts. All right. Can we talk about this Harvard paper? Yeah. This is from an article titled Risky Drugs, colon, why the FDA cannot be trusted. And it was basically about a paper published in the Journal of Law Medicine and Ethics from Harvard University where they contend that they present evidence actually that 90% roughly of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs. They're saying they still beat placebo typically. Yeah. What they're saying is like all these new

drugs aren't any better than the old drugs. They're 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 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, 53,000 hospitalizations occur and 2,400 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 every week. That's how I'm reading that wrong. One in five drugs approved ends up causing serious harm

while one in 10 provide a benefit compared to existing established drugs. So that's the 10%. So the data is then, this is what this Harvard paper is saying. It's saying that, yes, one in 10 drugs that comes onto the market that the FDA has approved provides a benefit that no other drug does. In the past 30 years. Which I think, and now that I kind of make a connection with something else, another article that they were really touting like, there's no other drug like this. This provides a benefit that other drugs don't. So I think that's a big 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 they go on to say in that paper that the FDA, they feel

um, lends 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 wow. Yeah. If you want to read that article, really all the articles we mentioned, you can go to our podcast page on stuff you should know.com, 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 opened things up for the truly curious. Yeah. 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 FDA in 1977 basically said, we're not going to put antibiotics and livestock, um, because it's dangerous. And just in 2012, they filed papers in court that acknowledged 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 concern regarding public health threat posed by anti-microbial resistance. Yeah. So what happens is you, you give healthy livestock, otherwise healthy livestock, antibiotics in their food, right? Because the, the living conditions are basically ripe for an epidemic. Yeah. 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. Right. 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. Yeah. 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. No, their, their tack right now is to say that the livestock industry can police itself. It doesn't seem like that's happening, but that is their position at this point. 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 even like you said, even the FDA says it's really dangerous. Yeah. But they just haven't enacted any law about that. Although they have, that's not entirely true.

They have listed some antibiotics that 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 0.25 or it's only. Yeah. 0.25% of all antibiotics, cephalosporins. Yeah. 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 Council saying you have to take action on this. Well, and that's sad protect us. That it takes the courts to force a government agency to protect consumers in that way in a way that the agency itself is saying like, yes, this is dangerous. Yeah. 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 30 years. They literally just made them disappear overnight. Yeah. When this became controversial in the 2000 early 10s, they just said, we're going to take those briefs where we said that it's dangerous and somebody should do something. We're going to stop having those published. Right. They also were largely criticized a few years back for basically like just sitting on their hands about the GMO labeling. Yeah. That's, yeah. Dan Quayle kind of changed history with that many years ago. What did he do? I think he was the one that pushed for the legislation that allowed GMOs.

Okay. So this is fine. You got GMOs. You 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 it campaign and were submitted properly to the FDA and the FDA rejected all, but 394 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. Wow. 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. Sure. Just overtly reject a million signatures,

especially as part of a large national public campaign. Oh yeah. Absolutely. Vioxx is a painkiller that was approved by the FDA in 1999. This is fun, by the way. A two letters to cover this stuff. In 2000, a study showed that the drug posed a big heart attack risk when compared to a similar painkiller. And Merck, who was a manufacturer of Vioxx, kind of blew it off and said, it's really beneficial. And the FDA said, okay. And Vioxx. That's pretty much how it went. Vioxx remained on the market for another four years and they estimate between 88,000 and 140,000 heart attacks were caused by Vioxx in that time. And it wasn't the FDA who ever removed Vioxx. It was Merck bowing to public pressure.

Oh, FDA never, Merck just took it off the market itself because it was starting to look bad. And the FDA was like, what's going on? What are you guys doing? How about a success? In the 1950s, in Germany, there were scientists who created something called Thalidomide, which was a sleeping pill. And they said it's over the counter. It's totally safe. It's all over Europe. For pregnant women, even, is a sleeping pill. Not so safe, though, because children were being born with malformed limbs to the tune of 10,000 worldwide, but not very many in the United States because Francis Oldham Kelsey of the FDA was really resistant and made a big push to not allow Thalidomide because 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 17 babies were born with malformations because of Thalidomide 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 American doctors to distribute as samples while the FDA was holding up approval. And so 17 children were born with deformities because of it. Because of these free drugs. Apparently in Canada, this story was even different. The Canadian government, it was totally legal and approved in Canada. And for months after it

became worldwide known that Thalidomide caused birth defects because 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 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 fire. Oh, yeah, children of Thalidomide. I forgot about that. But yeah, that was one of the FDA's great successes. And as a result, actually, the Congress passed something, an amendment to the Food and Drug Act, the Kefauver-Harris amendments of 1962 that really expanded the FDA's

scope of duties. It put, you know, those drug ads have all those disclaimers. Oh, yeah. That's from the 1962 amendments. Advertising is under the jurisdiction of the FDA. They read those so fast and the last one is an early death. Right, exactly. Like, they need to say early death? Right. No. They, and prior to 1962, the FDA had 60 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. That changed to, I think, 180 days and it's just to respond. And then also drug makers only had to demonstrate that their drug was safe, not effective. That changed in 1962 as well. Yep. They also said that they had to control the marketing of generic drugs to keep them from being sold as

just like jacking up the price under a new name, basically. So, yeah, that was a great amendment, the kerfuffle Harris amendment. Is that right? Kefauver. Oh, Kefauver. That's just Kefauver. So, another great success. Yeah. Oh, that was the same one. Well, no, I mean, in addition to the lid mine. Gotcha. Yeah. And then in the news recently, you dug this up, the Zohydra painkiller. You didn't hear about this? No, I haven't heard of this until today. It's apparently, it's pure oxycodone, correct? It is. There's for the first time. Yeah. There is all the other stuff like Vicodin and oxycontin even are safer because they contain at least something else like acetaminophen or some other drug. Yeah. This is just pure hydrocodone. And you remember like there was a

huge, huge problem with pill addiction to oxycontin in particular. Yeah. It wasn't just Rush Limbaugh. There were a lot of people. Yeah. We're really hooked on oxycontin. And as a matter of fact, the current heroin addiction crisis in the U.S. is a direct result of the FDA stepping in and saying like, Hey, you guys need to do something with oxycontin. Like people are crushing it up and injecting it. You got to do something. So now, we'll just do heroin. There's, well, there's a tamper resistant thing where when you crush up oxycontin, now it turns into this goo 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 release. When you

crush it up, it's not time release anymore. It's like all there to give you this immediate dose, right? Which is what drug abusers will often do. Right. So now that when you crush up oxycontin, it turns into a goo, everybody's turned a heroin. Right. So now there's a heroin epidemic. This company making zohydra came along and said, well, that's cool. We'll just release this completely pure hydrocodone pill without any tamper resistance. So we're going to 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 it. The decision by saying, well, putting things like acetaminophen has well known liver damage risk. Okay. So this is actually more

pure. You can actually take hydrocodone. Now people in severe pain can take this drug without that liver toxicity risk. I mean, that's a point. No, it is a point. And if you're in severe pain in life and need this to function or live out your life, then great, but that's tamper resistant. Yeah. That's not what people are arguing about. They're saying that this is a very high level for abuse. Right. Because there's no tamper resistant. Yeah, exactly. So people are going to die because of this drug. Yeah. I think, um, in 2010, uh, prescription hydrocodone and other prescription opiates accounted for almost 17,000 deaths, which is a fourfold increase from just, uh, 10 or 11 years earlier. Right. And that was all OC before they made it tamper resistant.

Orange County. There's probably a lot of it in Orange County. I bet there is. So there you go. Crazy stuff. It is crazy stuff. Um, I kind of am with that professor from Arizona that's just like safety. Like it's sad that the chief of that organization can't be someone who's super pro safety above all else. Yeah. Because that's their job. There's such a tug of war between the public and, um, I guess corporations over safety. Yeah. And the FDA 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 know, 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. Yeah. And public safety suffered as a result. Agreed. Uh, if you want to know more about the FDA, you can go to the FDA website, fda.gov. You can go to howstuffworks.com and type in FDA in the search bar. Don't forget to go to our podcast page on stuff you should know.com for the FDA episode that you're listening to now. And, uh, since I said search bar in there somewhere, it's time for listener mail. Uh, I'm going to call this, uh, we inspired a writer. Awesome. Hey guys, this is 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 backlog, living in constant fear of the

existential dread that will settle upon me the day I finish. Um, I've hooked my sister as well, and whereas our conversations used to be 100% Simpsons quotes, now it is 90% Simpsons, 10% stuff you should know. That's a high honor. Uh, she says, but I digress. I'm writing because I'm an author of dark humor novels for young adults and I want to express how helpful 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 wearing wax sculptures come to life. And after listening to your earwax episode, Mount Seremon was born. Pretty neat. Uh, ever since the haunted house episode of men itching to

write a horror, uh, about a horror attraction that goes terribly and hilariously wrong, number stations equal something awesome and so on and so on. So we're inspiring her all over the place. I never know where your inspiration is going to come from, but your show provides me the steady stream of delicious possibilities. I wanted 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. Sweet. How about that? That is a huge honor. Pretty neat. Uh, and she's going to send us some copies and one for Jerry too, of course she says. So, uh, I'm going to send her our mailing address and, um, thank you. She says, thanks for the brain snacks. And that was from Gina, uh,

Damico, D-A-M-I-C-O and she has a website and you can check out her, uh, kind of a weird, funny, twisted, uh, young adult novels at her site and support, support writing. Yeah. Creativity. Uh, thanks a lot. Gina, right? Yeah. And, uh, make sure you get L all so you can see our names in print. You don't like H's, do you? That was a waiting for Guffman joke. Oh, was it? Well, you'll explain to me later, right? How are you? Uh, if you want to, uh, get in touch with us to find out the waiting for Guffman joke Chuck just made, he'll respond to each, each inquiry. Personally. Right. Uh, you can tweet to us at syskpodcast. You can join us on facebook.com. You can join us on facebook.com slash stuff you should know. You can send us

an email to stuffpodcast at howstuffworks.com. And as always, join us at our home on the web, stuffyoushouldknow.com. For more on this and thousands of other topics, visit howstuffworks.com. Hey guys, it's Cheekies from Cheekies and Chill Podcast. And I want to tell you about a really exciting episode. We're going to be talking to Nancy Rodriguez from Netflix's Love is Blind Season 3. Looking back at your experience, were there any red flags that you think you missed? What I saw as a weakness of his, I wanted to embrace. The way I thought of it was whatever love I have from you is extra for me. Like, I already love myself enough. Do I need you to

validate me as a partner? Yes. Is it required for me to feel good about myself? No. Listen to Cheekies and Chill on the iHeartRadio App, Apple Podcast, or wherever you get your podcasts. Attention Bachelor Nation. He's back. The host of some of America's most dramatic TV moments returns with the most dramatic podcast ever with Chris Harrison. During two decades in reality TV, Chris saw it all. And now he's telling all. It's going to be difficult at times. It'll be funny. We'll push the envelope. We have a lot to talk about. Listen to the most dramatic podcast ever with Chris Harrison on the iHeartRadio App, Apple Podcasts, or wherever you get your podcasts.