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Welcome to study, should now asking for external aid and walked into the park gas than Josh Clark with Charles of each a bright jerry over their services that you should know the cat. How, dear sir, do you find great skill and you're learning about the FDA? Yet you know we Pakistan before. Why does appear regularly herbal supplements right, and we did that one time. Remember! That's where the herbal Elvis comes here was that the first appeared it's a preacher remain given supplements the aid at dark dislike would go around the house here when he was honourable aperture here man, how did talk on the Herbal Downers

he didn't catch it, I'm not a teeth. Of course. So we have talked about the day before the addresses them. This is a much in depth. Look that's right at the empty, but such as water now without Chris Walkin. None are really I mean that the but those who are doing shatner- oh, but I didn't go up Yang Active, which should ensure pretty good them briefly. The bill Shatner. So did you know most of the stuff Well, I know that the FDA is is has a history. Controversy of peace, saying You're, not you don't act fast enough. We need these drugs to help people other than other people stop acting so much exactly you're going to pass and russian these things to market right exactly so it's it's a bit of a tougher

reconcile. You know that I acknowledge their in a tough spot. They really arm in arm. I think that's a good good caviar rediscover. Where to put at the front of this, because here It is a very controversial agencies, the first consumer protection agency in the United States. Ever there it's the oldest one and dumb its call me liberal, or what have you, but I think it is very important agency to have. Oh, I don't think that makes you liberal, some people may say, Sir, what do they don't think and regulate anything in this country, others, people who think that, like that the aid is completely in the way of business, it's ok, assuming a feather right. That's the thing to his unfettered: if it can be unfettered Egon, fettered right: where is there something that can fatter and without the offender shirt so

it's a better business to some in some people's minds yeah. I just think that you, you are talking about? Something as Ellen toll as food or drugs things we put into our bodies in the hope that we will be here greater well being there you can't do you have to have a big on the block, looking out for all the little kids. Well, I mean think when, when big bucks or involve it's pretty clear, that companies themselves approach I'm gonna like pull back on them, profits in order to just super safe, like it has been proven throughout history, that soldier What like err on the side of making the money? You know your commie. Oh boy prisons can be fun so ok. Now there we got that other waits for clear dig into the FDA, because if you want to see whether or not you think the FDA necessary, are you

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 nineteen o six on paper, because a little bit back before them. That I think, will the Abraham Lincoln Administration, who is a pink I'm? So, let's cracking the way back machine showing? Oh, yes, it's not like. I can't hear in here I know I well. I took a little red with IRAN and the wizard in the womb side that man how they do while they're doing great, but am I forget, to bring a lower boxer those? excellent, his dress. So here we are the way back machine we're going all the way back when he said to the Times of Lincoln. And what he did he's. Gonna kick kick the matter. So that the other day impression it. Now. I wonder, get the ball rolling and kick it off, and I said: kick the boy

take the borrowing. I said that the other days like twice: it's ok, see you kick the ball rolling Azeri give whether the chemist. Name Charles, whether all to analyze agricultural materials, nifty Mama case sniffed, among the case not off said Edith in soil and fertilizer, maybe look into that, we have the new, Department of Agriculture and then successors, Harvey Wily and Peter call your word the due? To really can things going like a serious way the or they saw like a real reason for an agency that was in charge of guarding safety the purity of food and drugs at the murky Alec was ingesting. They basically saw what was going on right here. We might need to step in here because part of this enemy we talked about it in our bizarre

treatment episode. I think we're we're just talking about like little its being given morphine yeah, unlike a prescription in no way she performed so there's morphine aids is com a key babysitter any, thereby bringing them to the brink of death morphine overdose, but you could buy for the counter that you should regulate that that's business right, that's! What I know is the one that actually use morphine there, I'm sure others there were out there that were much more lethal cheer. You knock off Venus until I that cousin Tony Maidens Basement yeah, you could do Lord will involve a bottle and if the person to person bought it and they die well I believe there, you know, said the guys, like em wily in Collyer, especially wily though yet were really adamant about getting some sort of regulation and specifically taken agency that they ve been handed

in building in India, into a real power house yeah and over the course of about twenty five years, they got Congress to look over a hundred bills. For the food and drug industry right guess, Congress said no, no, no work deep in the industries a pocket, so we can really do anything ran out. We agree with you yeah totally great idea, but I am sorry, but I is about to be invented, and I want to own one well that I'll change, though my friend in nineteen o six, when quarter novelist, Upton Sinclair wrote the jungle which I'm like everyone's her, this very famous book that expose the prey some of the meat packing industry here in Chicago in particular, but it was a big deal that caused a lot of people to really freak out it wasn't. It was a novel way

media fictitious. Why was based on his news of journalists to the ears based on his experiences? I guess working under cover in the Chicago meet packing plants, and apparently I guess, Roosevelt Teddy Roosevelt set up an investigation committee to investigate yet lanes lean over then Sinclair's at all, but I think it's sort of everyone. Repulse, he had to do some yeah I mean I can really get the american public, because the stories are things like I'm very using disease cows for meat and there were a rat set, were calling around on the cows, and so they poison the rats and then the day poison rats with the poison in the disease. To tell me what are we putting new? grinder and there was you're potted on the other side here he was. I still need potted meat, nowhere near what Europe is you take me to the future and twenty two

three hundred and twelve and a mcnerney potted meat. I wish the way back to sink. You go to the future, while that's the way forward machine Are we have one of those well knows for Canada? Ok, get there will be less so they had to do something because there are even accusations of people being in meat. Apparently was not true in that was really fictitious. But the committee that investigated Sinclair's claims in the jungle found that pretty everything else he said in that book was true. Yes said for guy being ground up with the beef cause, he fell into a mere grinder. They were just like again the meat business not able to police itself and say: maybe we shouldn't put disease rats in meat, so Government was forced to step in and in nineteen o six on June, Thirtieth Congress pass the food and ACT, a wily act and prohibited trade of Miss labelled and contaminated food babies and medicines across state lines. Yo.

He could facilitate Illinois here here, that's one thing: I've ever get is the shipping thing like oh the only thing that making and forests are yet the federal government is theirs we ve been a struggle between Say, Asia and federal right, and so the candle line has been drawn at the state borders where it's like right, because the state border, all of a sudden, your part The United States, rather than just the state- and you want to leave it up to the state where over time, a federal govern, take a more and more power from the states right. The wily act, though Chuck I mean, is named after widely. So it gives you an idea of like the links that this guy went to to I do stand with some sort of standards for purity and food right near one of the things he did was set up. Came to be called the poison squad. Yeah, that's a great name! Isn't it really? Is the news a sensational name and at first he fought it and then finally saw he was worried that with a name

poison squad, they had their own little poison squad, anthem and here the goes written about the poison squire really sensational and like annually crazy. These guys are here and at First Wily fought it cause. He wears a really serious scientific undertake, azure and then finally saw the writing on the walls like you can get America behind this whole idea. If you just go the poison squad, as they want a poisoned squires many light I have added everybody they haven't at them. They did sir, this article from like the FDA, consumer magazine or wherever from I think, two thousand to the boys and squad. This is certainly something it's kind of like there is. I come it's like her. When they take these bites, they won't feel any pain, but when they wake up in the morning, though, probably never be the same stuff like that is kind of like come here, how they use them.

Joke he sounds in the early nineties. Hundreds interesting what the poison squad was. What's her of men of volunteers. We should point out who signed up for this in repeatedly signed up for this signed away their right to sue or anything. They were fully on board to eat poison and to basically in it and a kitchen there in Washington D C in the basement of workers per year, they would have had a chef that apparently made from great meals laced with all kinds of peace. Formaldehyde borax. What was really harmful one was called copper sulphate right, which is now pesticide. Yeah they use it to make, can peace appear, bright, green and the the

and it gets to the heart of the matter. Chuck like these goes words is eating poisoned just for fun. Now they were testing out stuff that was being used as preservatives yelled at the time exactly additives and preservatives and stuff, like you, said, to make your piece greener right here, so people used to use formaldehyde, preserved meat makes right people, you see you poor acts together. Now that I've looked out on that human heads, but in fact, let's put it on peace, did she touched the head, or did you just say? No impact the end of a modern and hid his face. Bobbed up at me- and I was just like our right near it is like a closer, so the boy, Skype made great headway they really determined a lot of stuff that shouldn't be used as preservatives like that, copper sulphate that was used to make these green yeah national heroes in a way. They also proved, Overall, they said

adulterated food wasn't just a buyer. Beware kind of thing right that it actually posed a real public health hazard. We ever get super said they'd they did It got publicize. These guys are getting sick on purpose. You are from the same stuff, you're feeling your kids here, which I already down eventually right in the public. Also, like we don't want the stuff in our peace, I don't care whether their greener item not eating this, and then public pressure to finally Congress, seeing the food and drug. I wonder if and when I was reading this, I was wondering if that has something to do with the the with peace, like I don't think people generally like peace. Has anything to do with that he's a corrupt. I like Yes, but I wonder if that was like a stigmata on the p when this- came out. You know have blood on its bombs, but on its b maybe I don't know not only would surely had some effect,

It gets worse like at probably a lot like gum how they spray producing the produce section right, even though it increases its rotting time dramatically. Why did you do that? You make it with prettier to make it look fresh. It's ridiculous but it's probably the same exact principle. I bet you right. There's some poison to make peace, so FDA on women, formerly evolve. They evolve out to some other agencies. They ve been through a bunch, a name changes and reorganise through the years, but at night Oh six, what they're there the Department of Agriculture is Bureau of Chemistry and they were the ones charged with enforcing that food and drugs act. So they split him up and in twenty seven into two groups: the food, and Insecticide administration, they handle the regulations and the bureau, chemistry and soils handled the experiments yearbook. Where it had been just the bureau, the Amsterdam, both yes

put them up. Eventually, they dropped in nineteen, thirty, the name insecticide, came the FDA yet and from there they were then, under the guise or under the purview of several agencies. Boy, seventies and they finally landed where they are now, which is the help Human services, forthright yea, H, H S, green peas, so, Day. The way the organised, loosely they're not organise loosely, but This is very high, is this: they have a atop layer of the Office of Commissioner of Food and drugs. I report to the direct Sorry, secretary of H, H us these three Tommy Thomson under Bush. Bilateral. Do you notice I don't know probably know in their Obama's whenever get thereby confirming either term firstly, are also has seven supporting supporting organisations that sport, the commissioner,

and their mainly on their not like the rubber meets the road there. The on the policy side of things yeah, basically litigation and stuff. Well, you that's the big step, the big over Ching. We are the FDA here and then below them are broken down there in the components that handle rubber meets the roadster, the others deputy commissioners and their there like they're the ones who really are heading up the field offices, I think, there's four hundred two hundred twenty seven field offices and then they big home and Silver Spring Maryland. Were they have about close to? Fifteen thousand employs a check list. You quick with your Eddie: yes, ok, the mouse! you got away there. I know you're very excited right. Now is a thing. You know the FDA regulates, true or false. X, Ray machines

and a true that's right. They they regulate radioactive radio activity emitting machines like X, rays, pesticides False, that's right sure, yeah, that's the USDA from what I understand: illicit drugs, keen and crack cocaine. They regulate that. No that's true! They dont, yes, Let's see what else, what about donated blood. True, that's true: they they regulate, biologics, they're, doing great man vaccines and provide. Thank you, tobacco they deregulate that, I believe Europe and then what about poultry chicken? Yes, of course they do now has its food. Now, USDA again, although the day does regulate, apparently the dairy industry

not. Meeting poultry now talk about mind boggling they deregulate cosmetics, but obviously because we did a Pakistan it they dont regulator, several supplement their business. What? If I remember correctly, we really like cut to the heart of the matter yet and there's a lot of anything had talked about it then there's a lot of slippery language that can be used in body products read, which always aggravates Emily to no end yeah could she is completely, your body products, but you can throw names unpack. Does these days on foods to that to sail pure and natural, and oh yeah, decease buzzwords. That mean nothing, and there is no regulation for when you can use those words near injustice, its they're trying to sell people in some. That's not true choice at like, like beer I remember, hearing years and years and years ago, that light beer only

to be light in color to be called light. Beer really yeah, but now that I'm grown on like a bit like who regulates that I'll bet, you doesn't even have to be lighting, color and lighting colored. Compared to what yeah you can probably call something like bear. If you want to welcome calories. Buyer, beware, but your point this is not regulated bright pie, a beer has to be under this many calories to be called a lawyer. I dont believe it is not. I think, about Polly, be the f tc that will be in charge of that kind of thing, but they get bigger than the F and the government should have a lot to learn agencies, yeah one last thing about the FDA: that there is a group of special agents in the criminal unit that carry guns really at the agency arrogance. It will shoot you but war for doing what I've got a great example of it had they caught. Whoever was that poisoned the Chicago area Tylenol

eighteen, eighty two. They Polly shot that person yeah yeah. Do you know about that I do you like webinar might well. I remember this I two men yeah. I was a six year old, whose eyes were just opening the ideas hoisting in drugs. In learning that, if a few things that you bought at the store yeah, I didn't at an added another specific skills. I was only eleven in Everley like researched further as an adult, but twelve year old, girl died and US suburban Chicago after take? Tylenol laced with cyanide it turns out right. Was dead and by the next day I believe I know a couple hours. Forget that morning, their diet, seventy and seventy m so that same day a twenty seven year old, name, Adam Janis of Suburban Chicken oh died in His brother and sister were concerned

the family, they thought was a heart attack. We're consoling family and distorted. Doing the posts, death family, stuff very stressed, got headaches, they took tylenol and they, died here. I had no idea that connection three more. Died over the next couple of days, all firm they found out upon investigating all limited in Thailand all right before they died yet so they serve little right yeah, they started looking into it and it turned out that there was poisoned tylenol, the Chicago area yeah and everyone for rigged out, because I get Time Thailand always like that was it sure you hadn't over the counter pain reliever, it was Tylenol yeah and they didn't have tamper resistant bottles at the time with a Figured out is that somebody bought Tylenol took it. My guess, wasted with cyanide and brought it back.

It made it look like it had been an open and people bottom and died from they still owner. Who did it they made it look like it was opened by just closing the lid again wreck because through again, no tamper resistant packaging right this right. This changed everything, so the company that makes tylenol under Johnson Johnson like issues like a national media alert, that's it. Everybody should probably start taking tylenol and send us you're the island. Almost thank you new stuff that we know is good, but arm take power which is kind of cool for a car. Yeah. They really like. I mean they had no choice. I think, but the super go on offensive with this year, it's actually due to Johnson and Johnson. It was the FDA, saying hey, we need, Temper resistant packaging Johnson Johnson actually said hey I think we should start investing

ever, as is the baggage and right. So they sort of lead the charge here and they may come in nineteen through Congress Adam. Let's make tampering medicine, a federal crime. Yes, yes, just six years later, the FDA said: let's These are some tamper, resistant bottles, mandatory dont know why it took six years. The do We talk about a federal bureaucracy here now, but that seems like that sent me Kurdish sped through just my right, but any directive, eighty nine is when that's, why the hard to get into pill bottles he stays. Thankfully, yeah well coatings and all that stuff does it mean open it, but it means you will now. If someone has opened it. Yes, by it? And you like wait a minute that foil was pushed through by human thumb, Frank. I can It is a glowing yeah towers. Ass was the glow

all right. So we take a break in after this will talk a little bit more about how they regulate Stop stop! You should now here's the thing, Saving money with Geico was almost better than playing pick up. Basketball is always that guy who joined your game he never passes, the rock he instantly bricks theories and who can We have you and then put his hands up and say no foul, no foul with Geico it's easy to switch and save on car insurance. No need to fake an angel sprang because you're absolutely exhausted. So which in save with back it's almost

better than sports, so, how does the well first of all, much do they regulate? The answer is a ton of products yeah estimate say that twenty cents out of every dollar consumer spanned and that's on everything Yes, you know viziers doesn't regulate satellite dishes, laser discs, all the money that we spend on everything any sense out of every dollar we spend is on approval this regulated by the FDA answer. Another purview which means you have too much to do supposedly their equals about what they they regulate about: one trillion dollars worth of goods and services where goods I too, they regulate. We already talked about what they deregulate. The also also offer guidance at times

me: how advice on how regulation be carried out. So that's one of their tasks. Oh right, like maybe you guys should make your pill. Vitals tamper resistant our criminal enforcement unit, I'm gonna come shoot you if you don't get it guideline right, but now that it eighteen, eighty nine. Now it's meant, or they may visit you. They do about sixteen thousand facility elections per year, everything from dairy fund. The blood banks, but they like, we said their way more facilities than they have field workers. Oh, I think they do they, while they use the element of surprise sure for potential there. Potential surprise right, so surprised, inspection, surprise visits here. I hope hope hope in I'm pretty sure that Fifty eight doesn't Collins schedule inspect

ahead of time. If they do then then Congress person and make sure that this gets changed immediately. They can't we're talking. Fourteen thousand employees in total here, not just inspectors in time, for all the FDA area. Less than fifteen thousand p are in charge of not only visiting factories and dairies in places that that use x, Ray machines and all the stuff, all the things that they regulate it, just in the U S but like in other countries to do yeah. They just set up their first office in Beijing in the last decade or so yeah because they have to they have to work what's coming into the country as well as Americans, don't just in just a minute in products just products for overseas? things have to be to follow the same guidelines as any other product that soldier solar used in America, because the FDA jurisdiction isn't stuff

the Maiden America right up. There is consumed in Amerika. I guess I just thought that would be. Maybe the fcc or something, but I'm not imagine they can work hand in hand to get the quietly whole hands while they do their research and haven't they do this. They do it because they are funded to the tune of four point. Four billion dollars about two point: Six of that comes from the treasury and another at your text. And the remaining across the two billion comes from user fees, which some are very very controversial you're inside with visa fees yeah. Well, I know that man, so The before was nineteen. Ninety two, I believe I think so the the FDA was fully funded by taxpayers, dollars all of its funding from the Treasury here and then United to Congress passed a law that said the the FDA

start generating its own revenue by accepting user fees year. The purse Option 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 your drug, examined by the FDA in another, of cases most cases you have to have it submitted review by the FDA nature. You also have to pay a fee. Call it why can t call it a user fee? Why have you father many different fees right so called that? Let's say you want to do your drug fast track. You can pay an exorbitant fee, would put it at the top of the pile, even and so all of a sudden, now checkers there yea is now policing, the pharmaceutical When is any longer. It is servicing the pharmaceutical companies and the pharmaceutical companies. As of ninety nine to two became

if these clients, yet I was really really bad as far as consumer protection go here, and there are many different ways of looking at this one is that way which is that the the farmer? lobby is writing checks to the FDA to the tune of billions of dollars, and that can't be good right right. The FDA that I read this great article on Pcbs, where they does interviewed a bunch of people for a variety of opinions. Yeah very balanced there was very, very unbalanced. Not like us is bad the FDA. Rebuttal will look a little something like this one, it's done. Is it's really help us out? We increase our productivity by cluster for certain we ve been able to higher so many more people which We can regulate so much more

it's really helped us in the review process. The farming lobby says this is great because it gets things going soup. Quickly rise, very efficient, not fluttering yet, and it hasn't changed. The review process has just made faster, and we can get these drugs to people quicker. Has people need these yet So there's lots of different ways of looking at it. If you ass Raymond loosely, he was he was up, for he was that. Vice president of Health Sciences at University of Arizona things like two thousand. He was upper commish of the FDA here, he's a safety guy, yet he was rejected and he felt said in an interview like it's pretty clear that people it the care about drug safety will never get this job again, but the sure the FDA, and he said great sadness to me the people care about drug safety and food safety to the level. That get involved, they try to make a difference and cannot be accepted to regulate the agency.

And he said for me, it should be protection first and then said the second serving meaning the industry right and that's sorting out of since the user fees have been introduced, yeah from the research that we ve done. It seems like every cow give of the FDA from all walks of life and all stripes points that user fee as past is the number one problem cars cosiness between industry and the the agency that that their funding regulates yet had makes total you wanna separate those two things. Generally, then, the other problem is funding. After you itself that is a grossly under funded agencies for what it's tasked with doing so it does have to rely on those user fees, whereas I think it's all a lot like campaign finance reform, where, if you could just take their and replace it with public money, then you can. You came,

separate these two things that are supposed to be cosy with one another that a government agency this not supposed to rely financially on the industry that is regulating yeah. I know you want to do a show and lobbying soon. Another less can be a fire, so but it is really let us be sitting there like gripping the table, the whole time. Well, she meant to know how their funded, though it's interesting, I think, until recently, The way the money was even divided, like how them budget money was spent was pretty because couldn't even use any of that for money, to read safety at all. To go into the service side of things right. I think now they are starting to to be. Is that money for safety as well, but I think that's not happening fast enough for people better, truly concerned about the safety of our country and there is the so I think it t theirs is Forbes article from two thousand and four, about a year ago,

But there is a Yale study that came out that really does raked the FDA over the calls, and it was an analysis of a bunch of different FDA approvals He doesn't five. Two thousand twelve year publicly published write stuff, it's him. Had it again right biggest when didn't announced together, and they found that these FDA studies were all over the as far as the data they accepted your arm, why? What got clear knew what didn't the sample size, how long trials went on here and there basically used to publicly shame the FDA thing like, because anyone using good site and even trying to keep up this pretence right that you're following your own standards that you even have steered, you got it you just rubber, stamping pharmaceuticals and two cunning given

hosting plan view this guy, I'm Forbes, said wait a minute like this is totally unfair because there Actually, what their being criticized for here is actually certain cut a nobleness led the end user. The patients who are taking these drugs really want. Yes, they're saying for something that really huge, sweeping jug, that's gonna be used by a lot of people like I learnt drug dry there. They they. Should an typically do follow some pretty stringent guidelines. They have to have a huge population sample there. To carry these studies out four year. Yes, They require a lot of really good data, but if you something that is like a really obscure disease or drugs to treat a really obscured is like more Morgan's share. But they are going to accept this data that use the population size of like a hundred people here, because it is not their many people out there with this disease and maybe a shorter lives study, because if it really

fatal diseases. People want this drug and to get it out the door here quicker, and there may only be the one study you may not have the direct aid and replicate it vitally important. So he did a good job of presenting the the other casing, really pointing out how the FDA is very typically, It's a damned if you do damned, if you dont situation here on a daily basis, her because in that same study that found you know that they will accept a population of one hundred in a study, and goes out. The door very quickly in the approval process happens fast in that sense, On the other hand, after doesn't do that really takes its time and dignity. Studies it gets accused of basically just letting people die, which was the case the advent of AIDS eighty Toby drugs were being tested in people and HIV Community in and at large in the country were saying advocates were saying: hey people are dying and like these

you're, very promising layer. Let try them out and so, I do get a man like they ve been accused of dragging their feet, you're going too fast in funding happy medium or I think Canada, a happy medium or fits you should only. I for safety and if it takes too long, it takes too long or if it is super quick at super quick new, like say, thieves, should be the most important thing, and it doesn't seem like that. That's the case no it. 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. Where there are people die here, you want to save drug by all if you have people are saying like remember with the above all outbreak, people like I will die from strong outside whatever you need give me the year. I let me try right they they wanna hidden in let people used unapproved drugs. Technical,

and swallow mostly people, volunteering, my fully volunteering, so what they were also dying of a ball at the time, while the other is sure that the points covered early, healthy, hear and obey twenty persons. But I've heard it did. You know also the poison squad There was a very scientific study, the guy were not allowed to eat or drink any outside of this diningroom, except for water. They return and other plenty all of it all of it nodded rob or a speck and was allowed to go fun. Measured it I'm not a drive nor Skidmore, but the the the FDA in Asia. Collision from early eighties. Have you seen how to survive a plague now greater by the year the memory deals in part with that in its really really interesting, and that was actually scored. The soundtrack with scored by our friends, superhuman happiness nicely.

The show Hager good for them so go see as very good good document get out get out the old red streaming service, yes I'm sure it's. I am sure it is called something like Netflix. That's exactly what is called. Thank you confusing meeting. So, let's take another break here and when we come back, we'll talk a little bit more about some of the very successes and failures of the FDA

stop, stop stop! You should now the world yours, the border. So how can the new cars with a fresh perspective, culture they'll, do not just got here in a bail dial. One city investors talk about this there. All eighty every order is. Seventy the only way out creep in all social media, ok occurs. I got a quality or whatever they think wipe out by any measure does also really right. Right. I'll shells were explained city girl summer right out, like a like dollar alot, more males and start like someone else. I know it's not right, but I really can't take when I feel what should I do even coupled with your very keen for everything is make sure you check out on our brand of self available now on the radio have on package or whatever you get. Your podcast array

talk about this Harvard paper. This is from an article title, the risky drugs Colin. Why the ep cannot be trusted. Women, basically about a paper published in the Journal of LA medicine and ethics from Harvard University. Where they contain that they produce evidence actually that thirty percent, roughly of all new drugs approved by the FDA over the past thirty years, Our little or no or no more effective for patients, then existing drug They're saying it lets they still beat placebo. Typically year were the same as like all these new drugs are any better than the old drugs. This competition on an already saturated mark. Exactly so, it's like why potassium through If they're already overstretched, then I can't those resources be allocated to something else that its drive,

the ball on right sure, and they also mean to 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, when he four hundred deaths occur every week in the: U S, because of people taking properly prescribed drugs to be healthier, so, let's just a bad reaction do own approved. Drug. That's how I read it. Everyone reading that wrong, one in five drugs approved and causing serious harm while in ten- provide a benefit compared to existing, establish Sylvester, ten percent. So the data is then this is what this Harvard paper saying it saying that Yes, one in ten drugs that comes onto the market at the FDA is approved,

It provides a benefit that no other dragged us. There was in the past thirty years, which I think it now that I'm gonna make a connection with something else, another article that that there really touting like there's. No other job like this is provide benefits. Further drugs, don't write, I think it's a big like buzz word. It provides other benefits right, but five, those drugs will go on caused some sort of harm right. That's easy yeah, and they go on to say that paper that the FDA they feel Linz Craig. Lady to widening and lowering criteria for prescribing drugs called the selling of sickness, and What you're talking about like a new and improved drug base, drug companies are raising prices from ear to ear on the same drug and they where the only country in the world. That allows a drug to Heaven, price increase without showing like here's, I hears the benefit. Here's! What improved and he's like us more.

Apparently the: U S is only country the desert. So why are we here If you want to read that article, really, all the articles remitting, you can go to our podcast page and stuff. No doubt come the part that the page for this it's got all the additional links here, we're doing it now. I think that's the stiffly, then things up for the truly curious there. We dig in baby. We got it for you can we talk about any and livestock yet the big when you found us in the Atlantic Right yet is a bigger miss the big issue these days period about what is going into the meat and that people are eating like in factory farms and stuff, the FDA. Nineteen. Seventy seven basically said we're not gonna, put antibiotics and livestock because it's dangerous Just in twenty twelve, they filed papers in court that ignore that they weren't safe

it says more studies. A series of additional studies were conducted by others. Agencies and non governmental organisations during the nineties, all of which generally support These concern regarding public health threat posed by T microbial resistance. Yes, sir, what happens is youth? You give healthy livestock, otherwise healthy livestock antibiotics in their food might be as the their living conditions are basically for an epidemic or it helps them grow faster right, so but if there on antibiotics they stay healthy despite these living conditions, while the problem is the bugs. These antibiotics are fighting off Bela resistance to the anti virus x ray and they can, some of which do not take these bugs, and so they leap from Say, cattle to humans, and there are already resistant to orient by art except we ve been giving healthy cows. So now you have an antibiotic resistant super bug, yeah! That's it!

a really dangerous thing and in what you just said, is that the Seventys the FDA as publicly said that is dangerous in it should should not go on any longer, but they no, they didn't do anything about it. Now. There there tat right now is to say that the livestock industry can police itself. MIKE, that's happening, but that is their position at this point, and this is why you see a lot of meat. On your store, they say antibiotic free. It's like a big selling point, because right like you said, even if the ages through a dangerous but let us have an inaccurate any law about that, although they have. That's not entirely true? They have listed some antibiotics that they called out one in the article that city can't use this one. But apparently it's only used to my point to five or its only point two five, yet in volume bionic syphilis for India. So people that are. You now want to live more well saying they're not taking enough,

efforts and they pursued by the national resources. Defence counsel thing you have to take it why not you sad protector state that the EU takes the key 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. Yes, somebody should do something who will do something and then a revised like. Well, it's kind of your job to do that, and there like our thoughts about that's fine yeah. I mean they actually that he pulled public notices at the federal register that have been around for thirty years They literally dismayed them disappear overnight here when became controversial in the two thousand early tens they just said take those that does brief where we said that it's dangerous and somebody should do something were instead of having those published right, They also were largely criticized a few years back for

ethically, like two sitting on their hands about the GMO labeling. That's the idea quail change history with that many years ago. What did you do? I think he was the one that the push for the legislation that allowed Gmos so. This is fine you got gmos- GMO label food that contains GM rights. It don't do anything else, use had to say on the label, this product contain Gmos right. There is a big push Currently, a million signatures were were generated from the just label at Campagna and were submitted properly to the FDA and the FDA rejected all four three hundred and ninety four, the signatures that were given to it, because about a million of them were in a single electronic document in their like these, don't count so they didn't do anything about it.

There is still no gmo labeling. So, regardless of how you feel about Gmos, GMO labeling That's pretty shady stuff charges. Overtly reject a million signatures. Especially as part of a large national public campaign area. Absolutely by acts is a painkiller that was approved. The FDA. Ninety, ninety nine, as defined by the forehead, is to cover the stuff. Two thousand. A study showed that the drug posed to big heart attack risk when compared to a similar painkiller and mark he was the manufacture of acts. Can it blew off, and said we ve, been official in the FDA, said: okay fire treatments box remain on the market for For years, and they estimate between eighty eight thousand and hundred and forty thousand heart attacks work by thy Alex in that time? And it was a it wasn't birthday who have removed

it was Merk bowing to public pressure if he had never. Everyday mergers, take it off the market itself, because it was starting to look bad and they have to use like what's goin on. What are you going to help us Yes, the nineteen fifty's in Germany there were scientists do created some called thalidomide which was sleeping bill right and they said it's over the counter, it's totally safe, They all over Europe for pregnant women. Even here, is the sleeping not so safe, though because children were being born. Malformed limbs to that of ten thousand worldwide but very many in the United States, because France's Oldham. Kelsey of the FDA, was really resistant and made a big push, do not allow. It MIKE's shielding safe. No, she was in charge of reviewing the data and yet what is? This is basically anecdotal, like where's your real data here and would not

stood a lot of pressure to approve this drug. Him would not cave in and as a result, only team. Babies were born with malformations there, because for women in the? U S and the whole reason that there are any with because they found out the drug maker was pushed The drugs for free under american doctors to distribute as samples while this, while the FDA was holding up approval and so seventeen children were born with deformities because of it, this for this free drugs, parenting, Canada, this even differently. Canadian government, it was totally it- was totally legal and and approved in Canada, India and four months after it, worldwide known that thalidomide cause birth defects cause it. Process. The placenta barrier, bright and arrests, development of the feed us right

Canada, new everybody knew about it and it took months before Canada. Finally outlawed Elsa, there's like this real big gun, public, shame hanging over cannon. Governor you can see regulating drugs now still to this day, because of that and village. Already some about oh yeah. Well, it was in it. A terrible thought we'd instructive area children at the level. Might I forgot about that for you That was one of the FDA, great successes and, as salt. Actually, the Congress past something of an amendment to the full drug act. The cafe cover Harris amendments. Nineteen sixty two there really expanded the FDA is scope of duties. Put you know how you know. Have drug adds have all those disclaimer terrier. That's from the nineteen fifty two amendments

advertising is under the jurisdiction of the said. I guess they re there so fast and the last one is an early death rate like the EU to say early death, no Lamb, they of empire to nineteen. Sixty two, the FDA, had sixty days to respond to an application and they face and getting a time. Well, it's fine, I'm sure it's fine in go to market that and to I think, a hundred eighty days not just to respond, and then also drug makers only had to demonstrate their drug was safe, not effective, that change the nineteen sixty Well yeah. They also said that they had to control the marketing of generic drugs to keep them being sold is just like. I can up the price under a new name, basically so arm yet I was a great amendment. The kerfuffle Harris Amendment, the right key father, Oki Farmer- has this t father of another great

here. While I was the same one. Well now I mean, in addition to fill it might catch you then in the news. Recently, you take this up the Zeal Hydra painkiller Europe is now I have heard this until today, its apparently it's pure, Oxy codeine correct it is There is for the first time yeah there is some all the other stuff like I get an ox cart and even heard far safer because they contain at least something else like a sea, the manifest or some other drug. Yet this just pure Hydra, CO down and You remember like there is a huge problem with pill. Addiction. Actually, cotton in particular It wasn't just rush Limbaugh who alot of people yeah we're, really hooked on ice economies, matter of fact the current heroin addiction crisis in the? U S is as result of the FDA, stepping in and saying like, hey you

We need to do something with actually kind like people are crushing it up in injecting it yet they set out to do here, and there is well there's a temper resistant thing where, when you crush a boxer caught now, it turns into this good that you can inject or snored right get off a mere you can I go but I don't think it has the same effect joy, because when you, when you crusted up those time released when you crush it up, time, release anymore. It's like all there, Give you some media drug abusers often do right. So now there, when you cross party cotton, it turns into a Jew. Every These turned a heroine right so knows a heroine epidemic this company. Kings a hydra came along and said This really is completely pure hydro code on pill, without any tamper resistance, so We're gonna go back to square one, everybody, okay, and there is a huge outcry against this drug and the FDA had stepped up and became a mouthpiece for

yeah, and that the able bomb they will do did the decision by saying, while putting things like a seed? A well known, liver damage risk account it actually more pure. You can actually hydrocarbon, our people in severe pain can take this drug without liver toxicity risk. I mean, what's the point, It is a point in if you're, in severe pain and life in need this to suffer. In all about your wife and great, but they make hampers astir. That's what people are arguing about. They're, saying that this is a very high level for abuse right, because there's no tamper resist exactly so. People are going to die because of the strong yeah. I think so. In two thousand and ten description hydropower down and other prescription opiates account for almost said thousand deaths, which is a four fold increase from Vista,

ten or eleven years earlier right- and that was all oh see before they made a temper resistant Orange County There is probably a lot of ignorance attorney and that there is, So there you go crazy, stuff, this crazy stuff, I can't I'm with that, for or from Arizona. That's dislike. Safety like it is sad that The chief of that organization can't be someone who's superposed. If the above our dinner is there. That is our job to such a tug of war between the public and I guess, corporations over safety near if the aim is not pulling on our side, necessarily yeah and I'm sure will hear from all kinds of people from the pharmaceutical industry that will tat how seriously they too, their testing and stuff and we're not saying they don't know, but I'm not I think it is a. There are great protocols, and and procedures. That there's also

many times were they just overtly drop the Bosnia and public safety suffered as a result agreed I feel I know more about the FDA. You can go to the FDA website after that. You can go to has the words that calm and typing in the search bar, don't forget. To our pie, cascades. Instead, we should know dot com for the FDA, episode that you're listening to now and as incisive search bar in there somewhere it's time for listener. Mail all this spider writer awesome and Jerry foresaw. Thank you so much for you have been a fan for over three years steadily. My way through the backlog living in constant fear of the existing? dread that will settle upon me the day I finish, My sister is well and whereas conversations used to be one hundred per Simpsons quotes. Now it is ninety since Simpsons ten percent stuffy should now, but that at the high

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