Behind the Bastards - Part Two: The Food And Drug Administration

Episode Date: February 3, 2022

Robert is again joined by Matt Lieb to continue to discuss the Food And Drug Administration. Learn more about your ad-choices at https://www.iheartpodcastnetwork.comSee omnystudio.com/listener for privacy information.

What would you do if a secret cabal of the most powerful folks in the United States told you, hey, let's start a coup? Back in the 1930s, a Marine named Smedley Butler was all that stood between the U.S. and fascism. I'm Ben Bullitt. I'm Alex French. And I'm Smedley Butler. Join us for this sordid tale of ambition, treason, and what happens when evil tycoons have too much time on their hands. Listen to Let's Start a Coup on the iHeart radio app, Apple podcast, or wherever you find your favorite shows. What if I told you that much of the forensic science you see on shows like CSI isn't based on actual science, and the wrongly convicted pay a horrific price? Two death sentences in a life without parole. My youngest, I was incarcerated

two days after her first birthday. Listen to CSI on trial on the iHeart radio app, Apple podcast, or wherever you get your podcasts. With the Soviet Union collapsing around him, he orbited the earth for 313 days that changed the world. Listen to The Last Soviet on the iHeart radio app, Apple podcast, or wherever you get your podcasts. Welcome back to Behind the Bastards, the only podcast with more worms than the average bottle of milk in a century ago. Tons of worms filled with them. I love your new tagline. It's great. Thank you. Thank you. People love it. We're going to move on from discussing horrible old timey foods before there were any kind of laws about what you could do with foods,

but I just came across an article in The Guardian. There's that truck convoy trying to do a January 6th in Canada. Oh, I know all about it. Next week, yeah, there's an article in The Guardian called Canada Truckers Vaccine Protests spirals into calls to repeal all public health rules. My favorite response on Twitter is someone has posted a picture of a sign outside of a swimming pool that says, persons currently having active diarrhea or who have had active diarrhea within the previous 14 days shall not be allowed to enter the pool water. And he's just responded. He's just posted that and said in all caps. Oh, captain, my captain. This concludes the part of the episode where I read to you from Twitter. Matt, you got a podcast called Pod Yourself a Gun.

Pod Yourself a Gun. The World's Only Sprouts Podcast. This is what separates us from any other TV rewatch podcast is I do a parody song every week that does the synopsis of the episode. Is it good? Kind of? Do people like it? Oh, no. Do I do it? Yes. Consistently. What a plug. Everyone loves that. Hot damn. Well, Matt, now that we have really, we've laid the groundwork here, it is time to move on to the true bastard of our episode, the FDA. We've had its Anakin Skywalker phase here and now we're about, it's about to go full vader, right? That's today's story. They put the poison back in the food. Yeah, actually. That is part of what's happening in this period. Of course, it's much bigger than that. We're

actually going to focus a bit more on the pharmaceutical industry today. There's a lot to say about food though. So we ended last episode with the creation of the FDA in 1938, after eight years after the death of Harvey Wiley. He dies in 1930. And the FDA was initially taxpayer funded, right? Again, so all of its money at first comes from the American people, because its job is to be a watchdog for the American people and to make sure they're eating healthy food. At first, that's changed. Oh, yes. That's a big part of our story today, Matt. Wow. So at first, it is taxpayer funded. And as a taxpayer funded organization, it experiences a Titanic success very early on. When we've actually discussed previously on the

show, in the late 1950s, the Grünental Corporation of Germany, which was a pharmaceutical concern staffed mainly by Nazis, tried to get approval to sell their blockbuster new sleeping pill, philitamide, which may have initially been tested on concentration camp inmates in the United States. Now, the person, and it was like some other company that was trying to sell the product for Grünental that was buying it and wanted to sell in the US, whatever, like corporations work. But this company that wants to sell philitamide in the US as a sleeping pill has to go to the FDA to get approval, right? And the person they come before is Francis Oldham Kelsey. Now, Francis Kelsey had earned a PhD the same year the FDA was founded, and she had been hired in 1960

after six years of teaching pharmacology at the University of South Dakota. So her job, she's one of the people who's supposed to evaluate new medicines and substances and decide whether or not they get FDA approval. One of her very first assignments for the FDA was philitamide, and her job is essentially to review the evidence of drug safety provided by the manufacturer, because that's what that 1938 law and the 1906 law had gradually established, that if you want to sell a medicine, you have to prove it works and that it doesn't kill people, or at least it doesn't kill too many people, right? Any kind of that is side effects and shit. You have to prove it will be worth it, you know? Right. So it's her job to review all of that evidence. Now, philitamide

is at this point in use in like 46 nations around the world, including most of Europe, but Dr. Kelsey thought their data was shit. She actually looks at the evidence they have that this stuff is safe, and she's like, because one of the big things they're selling this as is it's like this is finally a safe sleeping pill for pregnant women, right? And they're saying that based on nothing. And in fact, a lot of the data they have suggests that like, no, it's actually like it's fine for women who are nursing. They do show that that like it's probably okay for women who are nursing to have it. But there's there's evidence that it's really bad for pregnant women. And there's not to mention it was tried out in Nazi concentration camps.

Well, that is debatable. We talked about this in the episode. Yeah, there's a lot of evidence that suggests that it's not ironclad. So I don't want to be like saying, but there is some evidence that's because they were either were Nazi doctors who worked in concentration camps are the people who are doing all the medical testing for Grunitori. And there's evidence that they just like took this drug they'd been testing in camps and like tried to launder it. Listen, Robert, I'm not about nuance. We're going to call it anti-Semitic Ambien and move on. Anti-Semitic Ambien. That's right. So anti-Semitic Ambien is in use all over the world. But Francis Kelsey is like, I don't give a shit about what the rest of the world says. This data doesn't convince me. And it's my job to say

whether or not this shit is safe. So I don't give you approval. So she turns them down. And then they try to pressure her boss. And her boss backs her to the hilt. Her boss is like, no, Francis is fucking great scientist. And she's right about this. And we're not going to fucking sell Thalidomide in the United States. And Thalidomide is never approved for use on a wide scale in the US. There's a couple of like trials and stuff. So a handful of Americans do take it. But nothing like what happens in Europe where millions of people take Thalidomide. Roughly one year after she turns down Thalidomide, scientists in Germany and Australia proved that Thalidomide caused a whole host of debilitating birth defects. Babies were being born without

lungs or with their arms coming directly out of their shoulders and like no actual like, like forearms and shit. You can find pictures if you want tens of thousands of children are disabled or hundreds of thousands of children are disabled, tens of thousands are killed as a result of Thalidomide. But none of those are in the US, thanks to Dr. Kelsey and the FDA. This is a huge success. This is exactly what it's there for, right? Yeah, that's what it's meant for. This is a bulletproof vest stopping a bullet from entering your body. This is like exactly why we have this thing and proof that it is worth every goddamn penny. And Americans at the time recognize they've dodged a huge bullet. The shit that happens with

Thalidomide inspires the passage of the 1962 drug amendments. This bill is why ads for new medicines always end with like 40 seconds of a dude talking very fast about the side effects. But you'll experience like that's where that starts like being mandatory, right? And there's a bunch of other good stuff in it, including it forces a comprehensive reclassification of all available drugs based on whether or not they actually do anything. So there was all this medicine that was like grandfathered in when the FDA gets created and they're like, well, actually, why the fuck are we doing that? We should make sure this stuff all works. I don't care if people have been taking it forever. We gotta test it. I understand that dark

defeats the bright, but we gotta test it. I'm not a big law fan, but the 1962 drug amendments are pretty comprehensively like a good call. So the FDA huge fucking hit at this point, right? I mean, that's worth all the money we'd spent on it forever if they just stopped Thalidomide. And obviously, there's other shit they're stopping. There's shit they're making safer. There's stuff that they're medications that they're limiting the scope of that too many people don't take them. The FDA is doing fucking gangbusters in its first few decades in existence. So that's dope as hell. And President Kennedy even gives the agency a shout out in 1962 shortly before being gunned down by Bernard Montgomery Sanders. And it's worth noting that this massive

early dip. I mean, okay, look, there is the theory that Orenthal James Simpson, who was a young adult at this period of time, may have taken part in the assassination of John Fitzgerald Kennedy. He was a very fast runner. I believe that he may have been providing the ammunition to Bernie Sanders. There's no way to know that he wasn't, you know, that's why he's wrong internet. Prove me wrong. Yeah, what are you going to do? Show me that Bernie Sanders and OJ and the juice didn't collaborate together to assassinate John Fitzgerald Kennedy. Prove it. I hope that we all did a head shake in unison when that happened. So it's worth noting that this this this massive early dub for the FDA was due in part to the

agency's independence and large part really like the fact that this this is there's no ties to anybody but the US taxpayer. That is the only responsibility the FDA has. There's a shitload of money to be made an approving like philitimide, right? Like they could have like that like that company would have made millions before they realized that it was harming babies at a scale almost inconceivable. But the only FDA doesn't give a shit about anybody's profits. All they care about is safety. And Dr. Kelsey looked at the data and was like, no, fuck this shit. Responsible only to the taxpayers because that's what government is supposed to do. Well, that's not how the FDA works anymore. And to explain why things changed, I'm going to read a quote by a write up from

Michael White of the University of Connecticut School of Pharmacy quote. The first US case of HIV induced AIDS occurred in 1981. It was rapidly spreading with devastating complications like blindness, dementia, severe respiratory diseases and rare cancers. Well known sports stars and celebrities died of AIDS related complications. AIDS activists were incensed about long delays and getting experimental HIV drugs studied and approved by the FDA. In 1992, in response to intense pressure, Congress passed the Prescription Drug User Fee Act. It was signed into law by President George H. W. Bush. With the act, the FDA moved from a fully taxpayer funded entity to one funded through tax dollars and new prescription drug user fees. Manufacturers pay these fees

when submitting applications to the FDA for drug review and annual user fees based on the number of approved drugs they have on the market. Now, surface level, go back in time to 1992. Number one, this is in response to a real problem, right? And we saw this with like COVID, right? Sometimes you can't afford to take as much time, you know, testing shit because there's a real immediate fucking plague and you might just need to like throw some shit out there and maybe there will be some side effects with the boosters and shit. I, you know, some people like there are some side effects and shit that we probably would have caught and maybe even minimized if we had not been dealing with a global plague, right? Like you got to fucking get shit out, you know?

That's a reasonable problem. The way they, one of the ways they deal with this is that like they make this partially funded by the pharmaceutical drug companies and they allow ways for the FDA to expedite pharmaceutical drug approvals. And this is where all the problems start to come in, right? But you have to note that it does kind of sound surface level reasonable to a lot of people. And this is kind of the way a lot of the government works really, right? You go to the DMV, you have to pay fees to apply for stuff, right? To get like register a car, get a license. Why wouldn't big pharmaceutical companies have to pay the FDA for drug review and other stuff, you know? You can make a case to most people on both sides of the political

spectrum that this is a reasonable idea, right? And obviously, the reason why you don't do that for the FDA is because it might lead to a situation wherein those companies are all paying the FDA for the FDA to exist. And when the people funding your organization are the folks with a vested interest in you saying yes to their drugs, well, that can cause some problems. You are no longer the independent organization that stopped the litimide from hitting the streets, you know? Yeah, it was a short-sighted move on that law. I got where they were coming from, but sounds bad. You get why people could be convinced that this was a good idea. Yeah, because it sounds like a tax. It sounds like, oh, all we're doing is making, you know,

you're still going to get the money from the taxpayers, but you're also, we're going to tax these companies for even applying. And it's like, no, this is going to be bad. It is tying the salaries of the people who work for the FDA to the pharmaceutical industry, you know? That's what it's doing. And that's not great, you know? So over the years, new fees were introduced for the approval of generic drugs, over-the-counter drugs, biosimilar drugs, animal medications, as well as medical devices. The FDA develops a complex system of waivers, refunds, and exemptions dependent on the category of drug and the total number of drugs the manufacturer had approved. A labyrinthine expensive bureaucracy developed,

and the proceeds from this bureaucracy grew to account for 45% of the FDA's $5.9 billion budget. But wait, there's more. 65% of the funding for human drug regulation comes directly from user fees submitted by pharmaceutical companies. Now, this has had some positive outcomes. Because their funding comes from these fees, the FDA has gotten a lot faster at responding to manufacturers about what they need in their applications. The whole process of getting new medicines approved has gotten a lot speedier. In 1987, it took 29 months to get FDA approval or denial. By 2014, it took 13 months. By 2018, it was down to 10 months. President Trump personally promised to streamline the process by which drugs were approved, and his administration seems to have

delivered in this respect. Now, that can be good as we've seen in the COVID response that sometimes you need stuff approved very rapidly, but usually you don't. One of the things that these changes have done is they've led to an increase from 38% to 61% in the number of first-time approvals on new drug applications. In diseases where there are few existing medications, an even more streamlined approval process means that 89% of applications get approved the first time, often in under eight months. This has all coincided with a huge surge in the number of new drug applications, because you can get them said, yes, a lot quicker and get them out there and start making fucking money. That is impressive if you don't account for the fact that an awful lot of these new drugs

getting expedited approvals are fucking horrible. I'm going to quote from Michael White from the University of Connecticut here. While the number and speed of drug approvals have been increasing over time, so have the number of drugs that end up having serious safety issues coming to light after FDA approval. In one assessment, investigators looked at the number of newly approved medications that were subsequently removed from the market or had to include a new black box warning over 16 years from the year of approval. These black box warnings are the highest level of safety alert that the FDA can employ warning users that a very serious adverse event could occur. Before the user fee was approved, 21% of medications were removed or had new black box

warnings as compared to 27% afterwards. Now that jump alone is not great, right? But it's also like, you know, 6%. That's not the worst thing in the world. But when you really dig into the data, it sounds a lot worse than that actually, Matt. It does, it does. And I'm going to quote now from a write-up I found by CNN. About a third of the drugs the FDA approved between 2001 and 2010 were involved in some kind of safety event after reaching the market, according to a study published in Tuesday in the Journal of the American Medical Association. The authors found that in that time, 222 novel therapeutics were approved and there were 123 post-market safety events involving 71 products that required FDA action. Manufacturers needed to add 61 boxed warnings,

also commonly called a black box warning, to call attention to serious risks. In 59 cases, some communication had to warn the users about a product's safety. Three therapeutics were withdrawn from the market. Now, remember how I said that the FDA expedites approval requests for drugs to treat illnesses where there aren't a lot of existing treatments. That's good, again, if there's like a plague or something that you need to get out quick. But it also means there's an extra financial incentive for a pharmaceutical corporation to get a medicine approved to treat an illness that doesn't have a lot of medicines for it. This includes all of the mental illnesses, right? Real shortage of medicines, because maybe in a lot of cases, medicines don't help that much

with a lot of studies. We're fighting, not to be against medications, a lot of great medications out there. But there's a lot of fucking problems with mental health medications, and it's very fucking easy to get an approval for a mental health medication. For a while, mental health medication was just doing electricity on your brain. At this point, if it's in pill form, people are like, yeah, prove it. You would think that it wasn't worse now, but in some ways it is. So, that AMA Journal report noted that drugs used for mental illness had a higher number of events, like negative health and safety events, and most of these drugs and most accelerated drugs are approved on trials with fewer than a thousand patients, because the bar is lower.

They don't need to show that it works on many people. If you can jig a trial with 100 people, with a thousand people, and show that it works, or like 500 people or whatnot, you can fucking get approval. And expedite it as well. Yeah, you can get it done really quickly. And there's a good book. We're not going to get into it much, because I'm kind of focusing on the FDA. There's a whole book written about all of the different ways in which the medical testing industry, like the industry that is designed to determine whether or not drugs work, is heavily compromised, because most of those studies are funded by the pharmaceutical companies. There's all sorts of ways they fuck with the data. A lot of those scientists wind up getting cushy jobs afterwards

and stuff with these companies. There's all sorts of ways. That's a big part of how a lot of very negative, that's how a lot of negative aspects of different foods, like sonas and shit, get hidden for so long, because you can kind of have a study of 500 people that you control, and you can make it kind of say whatever you want. The book is called Unsavory Truth, How Food Companies Scue the Science of What We Eat, and it includes a lot of detail on the pharmaceutical industry too. It's by a woman named Mary and Nestle, no relation to the candy people. Again, we're not really going to get into that, but yeah, I should read one quote from this about the way in which industry-funded research favors the sponsor's commercial interests.

So I'm going to read a quote from that book here. Sheldon Krimsky, a Tufts University professor who studies industry manipulation of science, dates the discovery of this funding effect to the mid-1980s when social scientists realized that if they knew who paid for a study, they could predict its results. One funding effect investigation from the late 1990s looked at studies on the safety of calcium channel blockers for reducing blood pressure. Nearly all authors, 96%, who concluded that the drugs were effective, reported financial ties to their manufacturers. Only 37% of authors who doubted the effectiveness had such ties. In 2003, a systemic review of more than 1,000 biomedical research studies came to a similar conclusion. Investigators with industry affiliations

were nearly four times more likely to come up with pro-industry conclusions than those without such ties. See, this is why we don't trust doctors. If you want to know why there's so many. Yeah, there's a reason people are so distrustful about like the vaccines in the medical industry. Like, they should be distrustful, just not in the specific case, really. Yeah. I mean, it just, it sucks because it's like every time I hear an anti-vexer talk, I'm always like, there's part of me that understands exactly where you're coming from minus the part where you're completely ignoring all subsequent data as to the efficacy of these like vaccines. But it's like, I get it. Because like, nine out of 10 doctors think that this drug is good. Also,

nine out of 10 doctors are paid for by the company that makes this drug. It's just a fuck. Yeah. Maybe a better solution would be to tax all of the billionaires until they're not billionaires, to dissolve all pharmaceutical corporations and to take all of their patents and property and money and put it in a trust run or administered by an agency made up of scientists who are purely paid and supported by the taxpayer whose job is to make the pharmaceutical stuff happen. Maybe that would be better. Did you just come up with that? Just off the top of your head? I did. I've actually invented a whole system. It's called Marxist Robertism. Yeah. That's very heavily based on what's another word I invented. Socialism. Yeah. Oh, socialism.

Yeah. I'm the first person to figure this out. I have a lot of great ideas. That's a great idea, dude. We're going to freeze a lot of seeds to see if it makes them cold, tolerant, a lot of cool stuff. Try that out. Yeah. Try that out. You're full of good ideas, bro. Hell yeah. Oh, man. Yeah. One area where all of this shit, this is horrific, and again, it's like one of those, the basic idea by which this problem started is reasonable. Well, these companies should have to prove their medicine works. They should be conducting studies to show that this stuff is safe and that it does what it says it does. A very reasonable thing to propose in 1906, 1938 when it is pushed, but you see the obvious problem, which is that, well,

they're not going to fund a study because they care so much because their primary interest is profit. Their primary interest is not helping people. A lot of the doctors and stuff, their interest is helping people. One of the things that I will say, a lot of those people, those scientists whose results are heavily skewed by the fact that they're being paid by pharmaceutical companies, it's not because they're evil or even know what they're doing, it just happens. Yeah, yeah, yeah. It's like why I don't talk about the fact that has an island where they allow you to hunt children for sport very often, you know? Because I'm swimming in those bucks, baby. Yeah, you're just filled with Salisbury steaks that

you're going to cook fresh tonight. Salisbury steaks made from the children hunted on their private island, you know? It's good stuff. You taste the fear, you know? So one area where this whole problem may have had a major impact, both the fact that the industry is conducting these studies and that this approval process, it's a lot easier to get mental health medication approved, is in the treatment of schizophrenia. In recent years, the World Health Organization has released two studies which find that long-term outcomes for schizophrenia patients in three developing countries. This is the term that they use. I don't prefer that term, but I'm reading from a study they did. So long-term outcomes for schizophrenia patients in three developing countries were

actually better than in the United States and five other developed countries. Now, why, how can this be? Well, it's not entirely known, but probably the leading theory is that the countries with better outcomes for treating schizophrenia only use anti-psychotic meds acutely, not chronically. So they give people, they're not like rejecting this medication, but they use it when someone is having an issue, when they're having a psychotic break or something. And as needed versus a taking more a day every day. Yeah, they are in not daily, you know. Only 16% of patients in those countries were on regular maintenance doses of anti-psychotics, as opposed to basically everybody with schizophrenia in the United States, right?

That is the standard of care for most people who are dealing with that here. And we have worse outcomes than these countries with a lot less money to spend on their medical system, and that may be why. A subsequent Harvard study found that schizophrenia outcomes for patients in the United States have declined over the last 20 years. And at present, they are no better than they were in the 1920s. Oh, fuck. Like the electrocution days, right? We've gone back. We had gotten a lot better for a while, but we've gone back. Journalist Robert Whitaker has investigated the subject heavily, and he puts blame on a shamefully lax testing process for medication for schizophrenia,

the result of all of the systems we've just discussed. Quote, When you look at the short-term studies of anti-depressants and anti-psychotics, the evidence of efficacy in reducing symptoms compared to placebo is really pretty marginal, and fails to rise to the level of a clinically meaningful benefit. Furthermore, the problem with all of this research is that there is no real placebo group in the studies. The placebo group is composed of patients who have been withdrawn from their psychiatric medications and then randomized to placebo. Thus, the placebo group is a drug withdrawal group. And we know that withdrawal from psychotic drugs can stir myriad

negative effects. A medication naive placebo group would have a much better outcome. In short, the research on the short-term effects of psychiatric drugs is a scientific mess. In fact, a 2017 paper that was designed to defend the long-term use of anti-psychotics nevertheless acknowledged in an offhand way that, quote, No placebo-controlled trials have been reported in first episode psychosis patients. Anti-psychotics were introduced 65 years ago, and we still don't have good evidence that they work over the short-term in first episode patients. Still? Yeah, it's a very un... Like you dig into it, and it's very messy. I should note, there are researchers and scientists

who criticize Whitaker's work here. One of the reasons I tend to trust him, number one, there's other experts that back him. And number two, when he's interviewed by... I found this in a Scientific American article. He lists lengthily all of the different criticisms of his work, and he links to responses he's made to all of them. And he points out the ones I think these guys have some points. I think these guys are facile. One of the reasons that I tend to think he's probably onto something. Yeah, because he actually addresses the criticism and has rebuttals to it. Yeah, he's taking it seriously as a scientist as opposed to going for the thing. And his arguments feel extra credible to me because the same sorts of problems that he

outlies are endemic when you look at other major failures of the FDA. So it's not just with these medications he's criticizing. It happens all over the goddamn time. And a strong argument could be made that if Thalidomide came before the FDA approval board today, it probably would have wound up in pharmacies across the country because there were no sleeping medications that were safe for pregnant women. And if Thalidomide is able to get like a thousand person study that kind of sort of shows that, then yeah, then suddenly, boom, we got a lot of Thalidomide up in here, you know? Put it in the water. Yeah, we did the study, and I'll know those babies who's like arms are on their legs and legs on their arms. That's actually just, that's like part of it. They like

to... They like that. Everybody likes it. They like that. Yeah, it helps them swim. You fucking risks are just holding you back. Yeah, exactly. It's, trust me, dude, he's into it. We're all, we're Mr. Potatoheading all these babies. They don't need elbows. Why do you want to get cooked by an elbow? No, thank you. Yeah. Straight onto the shoulder blade with the hand. Oh, yeah. We've got machines for them to breathe through. It's fine. Exactly. Yeah. So this all brings me to the very sad story of Vioxx. Near the end of the 1990s, Merck went to the FDA to get approval for Vioxx, a painkiller meant for patients with arthritis. They believed it was superior to older painkillers because it had fewer gastrointestinal side effects. So they're

arguing like this is a safer painkiller for people with arthritis. Yeah. To support their case, they presented the FDA with eight studies, which had a grand total of 5,400 total subjects. So that is well under an average of 1,000 subjects per study, right? Oh, yeah. That's not a lot of people to prove that your, for number one, arthritis is very common, right? Yeah. Ton of people need medication for arthritis. That's not a shitload of subjects to prove that a medication is safe, right? Yeah. It really is not. In November of 1998, they asked the FDA for approval. They seem to have realized their case that it was safer rested on pretty thin ground. So as they're going for approval, they launched the Vioxx Gastrointestinal Outcomes Research Study

or VIGR. This study would have more than 8,000 participants. So that's good. That's almost twice as many participants as they've had in total in all of the other studies. Now we're starting to get, you know, that could establish a broader base to show that this is safe. Now we're doing some science here. But this is after they start this big study after they've approved or after they have filed for approval with the FDA. And before the VIGR study is finished, the FDA approves Vioxx in May of 1999 off the strength of those small studies and nothing else. Fuck it, roll the dice. Fuck it, roll the dice. What do you give a shit? They got arthritis, they're old. Fuck them. VIGR doesn't report its first results from the study until October of 1999. And they were

promising. Vioxx patients seemed to have fewer ulcers and less bleeding than patients taking naproxen, which was the kind of standard previously. But then in November of 1999, things started to turn. Now I'm going to quote from NPR here. At the second meeting of the VIGR safety panel, the discussion focuses on heart problems. As of November 1st, 1999, 79 patients out of 4,000 taking Vioxx have had serious heart problems or have died compared with 41 taking naproxen. The minutes of the panel's November meeting note that while the trends are disconcerting, the numbers of events are small. The panel votes to continue the study and to meet again in a month. And this would have been fine if the medicine hadn't already been out, right? If you're

just doing this research, sure, this is what happens, right? If you're studying some number of people that you test medications on are going to die. It's going to happen. Yeah, this is what you sign up for. You can't get medication and not have that happen from time to time. In an ideal world, you would not start selling it en masse until you had concluded this research, you know? Yeah, yeah, yeah, yeah, yeah, yeah. You would finish the project and then decide whether or not the public can have it. So in December of 1999, the safety panel has what will be its last meeting. They're told that as of December 1st, 1999, the risk of serious heart problems and death among Vioxx patients is twice as high as the naproxen group. So no,

it's not a safer. It is twice as likely to kill your ass. But your stomach feels better when you're dying of heart attacks. Yeah, your tummy feels better as you fucking drop to the ground. Now, the research board monitoring, this like safety board monitoring the study, decides to continue on, which is a questionable decision in and of itself, right? Continuing the study at this point is like, well, but it kills twice as many. Maybe that's all we need to know about this stuff. Bring in a thousand more guys. Let's just, let's just be sure. Let's run through some more of them. Come on. So they did tell Merck, like this board is like, you can keep doing the study, but you should develop a plan to analyze the cardiovascular results of the study

before the study ends, right? So that you can actually determine really what the effect on people's hearts is as soon as the study's over, because we're seeing some stuff that's concerning. And Merck is like, no, we're not going to do that. We're going to, we're going to wait. We're going to let a couple of more studies get done, wait another couple of years, and then we'll see if it's bad for people's hearts. And the safety panel is like, cool. That sounds cool too. Okay. We wanted to do it now, but it sounds fine to do it later or never. Yeah. Oh, no, I never looked at it like that before, but thank you for opening our eyes. That will just not do the thing. Okay. Funnily enough, Matt, the head of that safety panel was a guy named Wineblatt, who also served on

an advisory board for Merck, owned $72,000 in Merck stock and worked as a paid consultant for Merck. Hell yeah. He seems, he seems unbiased, right? No, that's a legit guy. That's a legit guy. That's a legit dude. Yeah. How would you like it if I read your resume every time you're advocating for things that put money in your pocket, huh? Yeah. Now, the company pushed the can down the road and sold Vioxx for nearly two years. In January of 2002, epidemiological studies started coming out that warned that Vioxx was giving people heart attacks and strokes and huge numbers. That's January. Nothing gets done until September when the weight of evidence is so high that Merck begins to withdraw their drug from the market. And it's still being sold until I think like 2004

to a lot of people. Jesus Christ. By the time they finally get it off the market, 20 million Americans have taken it. Now, the Lancet estimates that 38,000 people at least died from taking Vioxx. That's pretty good dectile. Yeah, we call that being Merkt. That was the first. Yeah, they got Merkt. Now, this estimate is likely optimistic. Dr. David Graham was a scientist at the FDA for more than 20 years when he started speaking out about Vioxx. And he's actually still working for the FDA when he begins doing interviews about how this happened. Here is a write up on him from fraud magazine. Quote, between 1999 and 2004, an estimated 20 million Americans took Vioxx, 80 million worldwide, said Graham, the recipient of the

2005 Cliff Robertson Sentinel Award at the recent 16th annual ACFE Fraud Conference and Exhibition. We've estimated that up to 140,000 patients who took Vioxx suffered heart attacks. Of this number, 60,000 died, said Graham. Vioxx is a poster child for what's wrong with the FDA and why I believe FDA reform is so urgently needed. And if Dr. Graham's calculations are correct, if 60,000 people died from Vioxx, that's tooth. Vioxx killed more Americans than Vietnam. Holy shit. Right. And based on just like who tends to get arthritis most likely, a number of the people that killed probably survived Vietnam only get iced by Vioxx. They got Merkt by Vioxx. They lived through a pungy stick trap, but they couldn't make it

through the new FDA. Well, you lose to the Viet Cong and then you lose to Merk. Merk in the Viet Cong shaking hands with killing old, killing Americans. So it, yeah. And Dr. Graham has since claimed that the FDA, not only did they, was it, were they lax in allowing this to happen, they actually took direct steps, he alleges, to stop scientists from speaking out against the drug before it could be approved. In November of last year, Graham testified before the Senate Finance Committee that the FDA had silenced him and his colleagues from reporting on the risks of Vioxx and other drugs. The FDA has let the American people down and sadly betrayed a public trust,

Graham said during his testimony. He alleged that because the FDA is unduly influenced by the pharmacy industry, it is incapable of protecting America against another Vioxx. We are virtually defenseless. So that's good. Yeah, that's nice to know. You know, it's good to know that they, you know, they started off good, but this is, they've fallen into the lava at this point, you know, they're in the suit, they're choking people to death. They're breathing hard through a mask and they're like FDA. Yeah, there's fingerprints all over their helmet if you watch the high res versions of the original movies because they, they didn't expect TVs would ever get that good. Yeah, yeah, yeah. It's supposed to be blurry. So this is a claim that

the America is defenseless because the FDA is fundamentally compromised by the pharmaceutical industry. This is a claim that does deserve further focus. To do that, we're going to have to turn back to the story of a drug you might be a fan of. I certainly am a fan of our old buddy Oxycodone. Hell yeah. Now, I love me some opiates, right? Me too. We have to acknowledge they're a problem for the country. Oh, they were a problem for me. I had to stop. I could no longer party. That is a problem for me that I had to, couldn't continue that after I left Central America. Yeah. Oh God, it was pretty fun just being able to pick up a bottle of liquor and a box of Codone like on the same trip that I got my

tortillas. God. Oh man. Those are the days, man. I, you know, I for years as an addict, I would dream of going to a place where I could just get over the counter like morphine and whatnot. And I mean, I do think that is how it should work. And I think I think so too. Not really a problem if you were not getting millions of people hooked on opiates telling them that it's going to manage their pain when in reality it makes the pain much worse and like makes their problems long term much worse. No, Oxy, Oxycontin is one of the most evil things in the world. Yeah. Because of the fact that it, uh, it sucks. Like it's not, it's not good. It's, it's not like morphine, which has like a great rush. Oh baby. Delotted. Oh my God. Oh, Delotted. Now, yeah. I mean,

fucking, now these drugs, these actually, you know, feel good. They will destroy your life by the way. Sure. Of course. They will destroy, you know, lots of things will. But what's, what's even more evil about Oxycontin is that like this, they got people hooked on an opiate that sucks. Yeah. Better than content, but like, yeah, we're getting into the weeds of which ones are good and which ones are bad. All of them are better than fucking coding, which is trash. Oh yeah. The worst. And you cannot IV, uh, you can't shoot up coding. Just let, let you guys know that. Don't even try it. You go through anaphylaxis. I learned that the hard way. I was blind for 60 seconds. Anyways. That's the good stuff. I'm glad you brought me on for this one.

Oh, we're both fans. But the opiate crisis is obviously a massive titanic tragedy that has caused maybe more damage than almost anything else to particularly middle America. And we've got, we did a two-parter on Purdue Pharmaceutical and the Sackler family who profited off of this primarily. But now it's time to talk about the FDA's complicity. But before we do that, Matt, you know who else is complicit and you having a good time? Oh, is it the sponsors and products? That's right. All conspiring to make you happy. Oh, hell yeah. And, and to push oxycodone. Fuck. Yeah. Yeah. For sure. All right. During the summer of 2020, some Americans suspected that the FBI had secretly infiltrated

the racial justice demonstrations. And you know what? They were right. I'm Trevor Aronson, and I'm hosting a new podcast series, Alphabet Boys. As the FBI, sometimes you get to grab the little guy to go after the big guy. Each season will take you inside an undercover investigation. In the first season of Alphabet Boys, we're revealing how the FBI spied on protesters in Denver. At the center of this story is a raspy-voiced, cigar-smoking man who drives a silver hearse. And inside his hearse was like a lot of guns. He's a shark, and not in the good, bad-ass way. He's a nasty shark. He was just waiting for me to set the date, the time,

and then for sure he was trying to get it to heaven. Listen to Alphabet Boys on the iHeart Radio app, Apple Podcast, or wherever you get your podcasts. I'm Lance Bass, and you may know me from a little band called NSYNC. What you may not know is that when I was 23, I traveled to Moscow to train to become the youngest person to go to space. And when I was there, as you can imagine, I heard some pretty wild stories. But there was this one that really stuck with me. About a Soviet astronaut who found himself stuck in space with no country to bring him down. It's 1991, and that man, Sergei Krekalev, is floating in orbit when he gets a message that down on Earth, his beloved country, the Soviet Union, is falling apart. And now he's left

defending the Union's last outpost. This is the crazy story of the 313 days he spent in space, 313 days that changed the world. Listen to The Last Soviet on the iHeart radio app, Apple Podcast, or wherever you get your podcasts. What if I told you that much of the forensic science you see on shows like CSI isn't based on actual science? The problem with forensic science in the criminal legal system today is that it's an awful lot of forensic and not an awful lot of science. And the wrongly convicted pay a horrific price. Two death sentences in a life without parole. My youngest, I was incarcerated two days after her first birthday. I'm Molly Herman. Join me as we put

forensic science on trial to discover what happens when a match isn't a match and when there's no science in CSI. How many people have to be wrongly convicted before they realize that this stuff's all bogus. It's all made up. Listen to CSI on trial on the iHeart radio app, Apple Podcast, or wherever you get your podcasts. Ugh, we're back. Back, baby. Yeah, get a dim right there. I just want to point out I am 12 years sober for anyone out there. For anyone out there who was just like, maybe I should try that to a lot of stuff. It has been, I always had a rule. I would always take it to an honestly problematic degree when I was in places outside of the country where I could get it. I've always

had a rule where I do not ever purchase it in the United States. Never have, never will. Every now and then maybe theoretically a friend has surgery and winds up with some extra pills and stuff. But like, I've seen it's too, it's actually like pretty horrible. Yeah, I don't have that ability. You're like a fucking superhero to me. I got addicted to hooker after I got clean. Straight up. I got addicted to stuff. I can't help it. I know that if I were to let myself let it be anything but like a vacation thing, I would immediately have a problem and it would destroy my life. Yeah, because I have had problems with other substances before to the point where I'm like, I can see you in the rear view mirror running at me, you know. Yeah. That anecdote is

doing push-ups in the brain ready to fuck your party up. That is how it works. So let's talk about the FDA's complicity in the opiate epidemic. In 2019, a state court in Oklahoma tied, quote, false misleading and dangerous marketing campaigns by drug manufacturers to, quote, exponentially increasing rates of addiction, overdose deaths and babies born exposed to opioids. This is yet another damning black mark on an industry whose executives should all be flung into the sun via catapult. But as this write up from the Journal of Ethics of the American Medical Association argues, quote, the fact that opioid manufacturers disseminated false claims regarding the risks and benefits of opioids for the past 25 years points to a dereliction of duty by the

U.S. Food and Drug Administration, the federal agency charged with regulating pharmaceutical companies. The FDA's regulatory failures with respect to opioids have not gone unnoticed. In 2017, the President's Commission on Combating Drug Addiction and the Opioid Crisis found that the opioid crisis was caused in part by inadequate oversight by the Food and Drug Administration, and the National Academy of Sciences publicly called on the FDA to overhaul its opioid policies. Last year, a former FDA commissioner rebuked the agency he had previously led, saying on the television program 60 Minutes that the FDA was wrong to allow the promotion of opioids for chronic pain. Maybe a little late on that one, buddy. You know, better late than never,

right? That's what I was. Not in this case, really. That's kind of like going drunk driving, killing six people, and then getting on the news and being like, you know what, drunk driving, people shouldn't be doing that. Yeah, it's bad. It's bad. Did you know that? No, it's like drunk driving and killing people, hundreds of thousands of people for decades, hundreds of thousands of people wiping out entire towns. Yeah. And then just going on TV and going, you know, it's bigger than just me. Yeah. This is really a systemic problem. It's a systemic problem. Because the roads I use are everywhere to drunk drive through neighborhoods. Yeah. If you think about it, the taxpayers just as culpable in the death of others. We're all part

of this, you know? Yeah. You, with the making roads, me with the drunkenly driving through intersections and hitting groups of children, coming up to the bus, you know, everybody's a part of that bus driver. Stopping for those kids is a part of this, you know? No one's hands are clean here. Nobody's hands. So let's stop playing the blame game, you know? Why do I have to blame people every time I kill 600,000 Americans? So you might expect all of this potent criticism from like, again, the president, pretty big names saying the FDA has a problem with the way it approves opioids. You might expect that to lead to some changes. But FDA policies for approving and labeling opioids remain basically unmodified. As the Journal of Ethics right up notes, the

agency has refused to undertake a root cause analysis to determine what regulatory errors contributed to the opiate crisis. Instead, they've closed ranks and sought to defend themselves. When Senator Maggie Hassan criticized the agency, the FDA drug evaluation director responded by claiming the agency had properly enforced the Food Drug and Cosmetic Act when it approved Purdue's new extended release Oxycodone in 1995. Now, that's a lie, Matt, not just because it turned out to be bad, but because they broke the law when they approved it. If they had followed the law, the pills would have been listed as having a narrow indication. It's kind of what we talked about with schizophrenia meds. This should be used in a few specific

conditions acutely, right? I.e., yeah, only be prescribed in limited duration for specific issues. Instead, the drug received a broad indication, which allowed Purdue to be like, oh yeah, this is good for back pain. You got five more of mine out. You take some of this shit. You got a slight headache? Go ahead. Pull up, pull up your car. We'll fill your trunk. We'll send it direct to your house, dude. Don't worry about it. Don't worry about it. Yeah. It's so fucking evil because it's like, you know, chronic pain is a thing. Opiates are incredibly useful for treating people with chronic pain. And there are people out there who do need it. And so it's like, I'm not one of those people who's like, opiates are all bad and

whatnot. No. What's fucked up is to make it into something that you would take, like you would give it out like it's fucking Tylenol. It's just monstrous. Yeah, like some people need it for chronic pain. Most kinds of long-term pain, there's better ways to deal with it. And like, you don't actually solve the, you can actually make it better if you go into like therapy and stuff and you aren't medicating it away, which leads to, it's, yeah, there's, we talk about all this in the Sackler episodes. So I'm going to quote from that AMA Journal of Ethics write up again to talk about like how illegal it was for the FDA to give this broad approval. In 2002, faced with evidence that opioid prescribing had risen beyond levels that could be clinically

warranted, the FDA convened an advisory committee meeting of 10 outside experts and asked if the broad indication on opioid labels should be narrowed to prohibit marketing for common chronic pain conditions. Eight of these experts had financial ties to pharmaceutical companies, including Purdue, and advised the FDA against narrowing the indication. An opportunity to reign in over prescribing early in the crisis was lost. And by 2013, enough opioids were prescribed to provide every adult in the country with a full pill bottle. It's ridiculous how many fucking opiates we flooded in. Like, the fact that we have a bigger problem with opiates now than when you could buy morphine at the drugstore, it should say some things. It says something.

It does. I'm sorry, but it says something. It's like, it's one thing to have it like available over the counter and people discover it and they are able to take it. Some of them will have a problem. Some of them will use it as needed. Exactly. If your doctor says you have to take this forever now, this is great for you to take forever. And then you get horribly addicted. And then the doctor says, actually, no, we found out it's bad and you can't take it anymore. And then you wind up buying fucking heroin. Exactly. Exactly, man. Yeah. Now, the Food, Drug, and Cosmetic Act requires that adequate and well-controlled studies be conducted before products can be approved as safe and effective. The FDA generally requires

two randomized trials demonstrating efficacy for approval. There were a lot of problems with this process, but it was not even followed in the case of oxycodone. They approved oxy for chronic pain based on a two-week clinical trial in osteoarthritis patients. That should be enough time. People don't live longer than two weeks, do they? It takes me 24 hours to realize whether or not an opiate is good or not. I'll just tell you. I just try it out. I have a human test subject, so yeah. You take it and you're like, yeah, that's good. Give it to everyone. Give it to every man, woman, and child in the Midwest. Oh my God. You know what? Empty the swimming, public swimming pools. Fill them with pills. Just fill it with oxys, extended release. We'll just dive into it like a fucking junkie, Scrooge

McDuck. So for the next 25 years, as the opiate crisis sparked off and then deepened, the FDA continued to approve new opioid formulations for chronic pain via the same shoddy, lack-daisical controls. In 2006, the agency moved to a new methodology for conducting efficacy trials on opiates. This new methodology, enriched enrollment randomized withdrawal, or EERW, became their primary method of determining evidence of opioid efficacy for chronic pain. EERW trials are not standard, double-blind, randomized, controlled styles. And here's the AMA again. In an EERW trial, prior to randomization for a double-blind phase, all subjects are made physiologically dependent on the opioid in a four- to six-week open-label phase. Then only the patients who

tolerated the opioid and found it helpful during the open-label phase are randomized to remain on the opioid or switch to a placebo. Critics of EERW have correctly described this methodology as cooking the books for two reasons. First, because only patients who tolerated the opioid and found it helpful are allowed to proceed to randomization, the study is not representative of the general population, and the results cannot be generalized to clinical practice. Second, because daily use of opioids causes physiological dependence, efficacy studies are skewed in favor of the subjects who remain on the opioid. This is because opioid-dependent subjects who are switched to placebo experience opiate withdrawal symptoms, including increased sensitivity to pain. Moreover,

switching opioid-dependent subjects to placebo renders the study not double-blind. Boy, all these addicts really like opiates. Seems like it works. You know, and here's how you know it works, is when you stop giving it to them, they get fucking weird. They don't like it at all. It must mean it's helping. It's helping, clearly. You got to take it or else you start, they just start crying and being in pain, man. That's weird. Nine out of ten alcoholic says it makes them a better driver. Exactly, man. Oh, I love that. That is like such a, such like an evil thing to do. It's really fucked up, right? It's so evil. Like the amount of people who like just got addicted to this thing because they were just like, you know, cooking the books on this test too, man. Fuck it. But I'll

tell you, I would have loved to have been a part of that study. I mean, absolutely. Yeah, I'll just check it out a little bit. So the AMA Journal of Ethics article that blames the FDA's decision to rely on EERW as a consequence of their close, some would say incestuous, ties to the pharmaceutical industry. It turns out that that the decision to use EERW had been based on a series of private meetings between FDA officials and pharmaceutical executives, hosted at a conference called Impact with 2M. It's an acronym. You don't need to know what it's an acronym for. The drug companies that attended Impact each paid $35,000 to meet directly with FDA staff. So they have a big meeting where these guys pay and money goes to the FDA officials who were invited guests. I don't see how that's

a problem, Robert. I don't see that as a conflict of interest. No, no, that's totally normal. That's like fucking listen, it's a donation. Yeah. You know, and if you don't want to donate, you don't get access. Now, when this information dropped, there was a lot of complaints about this as being like, oh, it seems like rank cronyism is why this is the method by which we determine whether or not opiates are good. Despite all this, the FDA continues to rely on EERW for approving opiates. And as the, yeah, yeah, no, they ain't changed that shit. At least not as of the writing of that article. Yeah, it's cool. It's good shit. So as the AMA Journal of Ethics details, the cronyism does not stop here. Quote, for example, the two principal FDA reviewers who

originally approved Purdue's oxycodone application took both took positions at Purdue after leaving the agency. Hey, that's just a coincidence though, dude. Over the past, yeah, that's just a weird coinkie dink. Listen, you're emailing all your ex contacts and you're just like, hey, do you have like a job with a fucking seven figure salary? Yeah. And I don't want to like go in, you know, if that's possible. Yeah, yeah, yeah. If you could just, you know, I'll write it off on my taxes as hush money. Yeah. I'm going to continue that quote. Over the past 20 years, several other FDA staff involved in opioid approvals also left the FDA to work for opioid makers. Last January, the head of the FDA's analgesic division retired from the FDA to start her own consulting business,

which promises drug makers help to successfully and efficiently bring your products to market with more than 30 years of experience at the FDA. Oh, that's fine. That's legal. You know, it's good. I mean, you know, you get a day inside track on how to get more people addicted to opiates. Yeah. And obviously, this is how the whole government works, right? But it didn't used to be how the FDA works. Yeah. And I should note that the revolving door as this article states, the revolving door between the FDA and the pharmaceutical industry is not just opiates. A 2018 study found that 11 of 16 FDA medical reviewers involved in approving 28 products now work for the companies whose products they regulated.

Wow. It's good stuff, right? It's fine. It's great. I mean, it's just, it's so blatant. This is why, like, I, oh, this is, every time I come on this podcast, man, I lose faith in humanity. But obviously, some version of this would still be happening if they'd never moved to a fact where, like, the FDA is half funded by pharmaceutical company applications, right? Corruption. This is how it's endemic. But it, this, I think that really sped up the process. It's had an impact, right? It's very clear to see in the data. Because now the relationships are built on money already. And you have, like, people, you know, it's one thing to spend 30 years, like, being completely fucking government funded and

just telling people, no, no, no, no, on their applications, not, you know, fucking have no financial ties to them. But now you have, like, kind of a sugar daddy that who's going to be courting you. Well, they've always been paying my salary, you know? Why shouldn't I go to work for that? Right. Well, why is this any different? And I know this guy, I know Roger over at fucking Pfizer. Like, why wouldn't I work there? Yeah. He's been paying me since fucking day one. Yeah. Yeah. And the FDA's complicity with both the opioid crisis and the viax disaster have the highest definite body counts for sure. But some of the ways that they've really, that the FDA has really fucked up are less obviously dead, deadly, but still very unsettling. Now, if you'll remember,

the whole reason we have an FDA is because Harvey Wiley was pissed that all kinds of foods and drugs and quack gears were being shoved full of random horrible shit that was not listed in the product and people didn't know what they were getting, right? That's why we got an FDA is a bunch of people, Harvey Wiley and others were like, well, this seems bad. Yeah, no more poison. The main, the primary goal of the FDA was to make sure people know what the fuck they're putting in their bodies, right? At the end of the day, that's the number one reason we have the FDA to know what you're putting in your body and what it does to you. Yeah. During the summer of 2020, some Americans suspected that the FBI had secretly infiltrated the racial justice demonstrations. And you know what?

They were right. I'm Trevor Aronson, and I'm hosting a new podcast series, Alphabet Boys. As the FBI, sometimes you got to grab the little guy to go after the big guy. Each season will take you inside an undercover investigation. In the first season of Alphabet Boys, we're revealing how the FBI spied on protesters in Denver. At the center of this story is a raspy voiced cigar smoking man who drives a silver hearse. And inside his hearse was like a lot of guns. He's a shark. And on the gun badass way. And nasty sharks. He was just waiting for me to set the date, the time, and then for sure he was trying to get it to heaven. Listen to Alphabet Boys on the iHeart radio app, Apple podcast, or wherever you get your podcasts. I'm Lance Bass,

and you may know me from a little band called NSYNC. What you may not know is that when I was 23, I traveled to Moscow to train to become the youngest person to go to space. And when I was there, as you can imagine, I heard some pretty wild stories. But there was this one that really stuck with me about a Soviet astronaut who found himself stuck in space with no country to bring him down. It's 1991. And that man, Sergei Krekalev, is floating in orbit when he gets a message that down on earth, his beloved country, the Soviet Union, is falling apart. And now he's left defending the Union's last outpost. This is the crazy story of the 313 days he spent in space, 313 days that changed the world. Listen to the last Soviet on the iHeart radio app,

Apple podcast, or wherever you get your podcasts. What if I told you that much of the forensic science you see on shows like CSI isn't based on actual science? The problem with forensic science in the criminal legal system today is that it's an awful lot of forensic and not an awful lot of science. And the wrongly convicted pay a horrific price. Two death sentences and a life without parole. My youngest, I was incarcerated two days after her first birthday. I'm Molly Herman. Join me as we put forensic science on trial to discover what happens when a match isn't a match and when there's no science in CSI. How many people have to be wrongly convicted before they realize

that this stuff's all bogus. It's all made up. Listen to CSI on trial on the iHeart radio app, Apple podcast, or wherever you get your podcasts. GRAS is an acronym that stands for Generally Recognized as Safe. This is a category the FDA created for food additives that might be stuck in new products without being specifically approved, but that don't need any specific additional approval because they're generally recognized as safe. Now, this starts again from a pretty reasonable place. It's so that like if you're making a processed meat, you can add vinegar or salt to it. And you don't have to like get approval from meat with vinegar. It's because we know what vinegar and salt do. We know when the meat does, it's fine. You can stick it in there.

So I'm going to quote from NPR again. Over time, companies have found that it's far more efficient to take advantage of the exemption to get their products up on shelves quickly. Some of these products contain additives that the FDA has found to pose dangers. And even ingredients, the agency has agreed our GRAS are now drawing scrutiny from scientists and consumer groups that dispute their safety. Critics of the system say the biggest concern, however, is that companies regularly introduce new additives without ever informing the FDA. This means people are consuming foods with added flavors, preservatives, and other ingredients that are not reviewed at all by regulators for immediate dangers or long-term

health effects. The vast majority of food additives are safe. Some, however, have proved to cause serious allergic reactions or other long-term health effects. Now, a good example of this would be mycoprotein. This is a kind of fungus product used to add protein to vegetarian foods. It counts as GRAS, but there's a bunch of lawsuits right now that allege a significant number of people have had really negative allergic reactions to mycoprotein. Some of them anaphylactic shock, which doesn't mean nobody should take it, but it means it shouldn't be listed as generally recognized as safe if a lot of people have allergic reactions to it. Yeah, anaphylaxis is incredibly dangerous. I know I've injected coding.

The FDA did eventually revoke its GRAS status in 2011, but a lot of people had to get sick. It's an example of how you can just shoehorn this stuff in. It's a loophole, and it's not watched that closely. Probably the most serious problem, though, is with all the weird preservatives being stuck into foods. Again, most are benign. Most preservatives are, as far as we know, benign, but GRAS exemptions mean that we don't really have data on how a lot of the stuff affects children differently or whether or not it builds up in the body. And I'm not trying to be like, hippie-dippy, like, oh, no preservatives in your food, man, some of the stuff's necessary. But we should know what it does, and we shouldn't call it safe or put it in everything

unless we have really good data that it's safe. We're going backwards here. We already established we want to know what's inside the food. Like, Wiley, I'm not against preservatives or even fucking chemicals in food. I eat all sorts of chemicals. We should know what they do. Yeah, test it. It's like basic shit. That's important. Yeah. I found a recent study by the Environmental Defense Fund that looked through 877 GRAS notices by the FDA and found that only one of them was for an additive that the manufacturer had done a cumulative effect study on. This is like determining whether or not it builds up in the body and could be harmful. One out of 877 had had this done. And this isn't optional. These are required by law.

You have to do this one out of 877 that the FDA had approved had actually done this. As the EDF notes, quote, we found no evidence that the agency either recognized the single attempt to follow the law or had objected to the emissions in the 876 other notices. They're just fucking rubber stamping this shit. They don't give a fuck. Yeah, they don't even force them to pinky swear. They're just like, nah, right? They get money for every one of these applications. You know what? You don't want people to not send in an application if they haven't done the research. You want that fucking box sheesh, baby? Jesus. Well, you know, it's good. That's fine. It's all really, again, this is like anti FDA in that there's huge problems with the FDA,

but like we need an FDA. Oh, yeah. I don't care what it's called, but we need an agency doing that, right? Like that's why we started with like Thalidomide. This is an absolutely necessary part of any society vaguely similar to the one we live in, but we've broken it. We've allowed it to become broken and it doesn't work great anymore. And it's a really dangerous thing to have as a corrupt organization. Yeah. And again, there's like as that we quoted from that FDA researcher who was like, you know, has been howling about Vioxx and stuff. And it's like, yeah, it's, I'm sure most of the people trying to do those jobs are fucking rad. And even I'm sure most of the people who wind up joining the pharmaceutical industry, they're not thinking

like, haha, I'm gonna write. No, but it's like there should be a bias towards distrust and dislike of the pharmaceutical companies by the scientists doing this, right? Like they should be untrustworthy of them. Right. I expect the pharmaceutical companies to lie about shit. That's what they do. They're salesmen, you know, they're like, they make, they fucking patent just random compounds or like, does that do anything? No, it's like basically just trying out a bunch of things to see if it makes your dick hard. And then eventually they'll just be like, yeah, that makes your dick hard. You need an agency that takes the medication and goes like, my dick is still soft. Yeah, you can't just pay someone to be like, yeah, I don't know enough

people's dicks got hard. You got to know that it gets you bricked up, Robert. Yeah, it's, it's, you got, you got to know that it allows you to fucking lay some goddamn pipe. Lay some pipe, dude. That's right. That's right. That's what America, when America was great, we knew that was what the the FDA was for now. Yeah, you're goddamn right. So I don't know, you know, I, I would like to have an FDA that does not have the problems of our current FDA. I don't think that's too much to ask of society. There's a lot of, a lot of our problems are kind of intractable and difficult to figure out a solution to, but like, yeah, we should probably have like, they should probably be advocates for us and not a wing of the pharmaceutical industry.

I mean, honestly, it's like weird for us to be going backwards on such like, obvious fucking thing. It's, we don't want to drink the poison milk. And we don't want people pushing a bunch of fucking drugs that don't work or fuck up your life. Yeah, those would be it. You just eat a low bar, dude. Go back to the Francis Hagan days. She was dope. Let's, let's hire a bunch of people like her and give them all very large salaries to be distrustful of the pharmaceutical industry. That's like their job. That's the whole job. And we spend so much money on stupid shit. We could have a, we could have a sufficiently sized team of people to, to, to distrust the pharmaceutical industry professionally for

the price of a couple of F 35s. Yeah, right. Literally two less fucking, you know, just jets that, that bomb Yemen. Yeah. And we, we take money away from them when they let a drug through that kills way more people than is reasonable as like, you know, some side effects. And then we're bribing them to make sure we don't die. Exactly. That's literally how it's supposed to work. Yeah. I mean, it just, yeah, we should be, you know, we should be making money off of, uh, or the FDA should be making money off of destroying these pharmaceutical agencies as soon as they fuck up. That's what I say. Yeah. I would be sick. That's one way to tie it. Tie it in. Well, oxy sucks in. Fuck it. Well, Matt, do you ready? Do you have any pluggables for us?

Yeah. Try it. No, I'm just kidding. Pod yourself a gun. The world's only Sopranos podcast and the film drunk broadcast me and Vince Mancini talking about movies, talking about just life in general. Matt Leib jokes on Instagram. I love you guys. Oh, well, you can find me nowhere, but I have a novel that you can preorder. And if you preorder it, you'll get a signed copy. Just Google a K press after the revolution, order a book. Now it'll come to you with my signature in it. That's pretty neat. Um, we also have a live show. We do on February 17th, the ticket info will be in the episode description or you can go to allegedly. I'll do it.

Allegedly in the episode description. Momenthouse.com slash pond the bastards. Allegedly. All right. Well, until next time, you know, skim the cream off some milk, fill it up with water, pour some worms in there and, you know, have yourself a nice breakfast. Yeah. A little bit of cow brains, get some extra protein up in there. You know, you get to go. Double brains helps you think. That's right. What would you do if a secret cabal of the most powerful folks in the United States told you, hey, let's start a coup. Back in the 1930s, a marine named Smedley Butler was all that stood between the US and fascism. I'm Ben Bullitt. I'm Alex French. And I'm Smedley Butler.

Join us for this sorted tale of ambition, treason and what happens when evil tycoons have too much time on their hands. Listen to Let's Start a Coup on the iHeart radio app, Apple Podcast or wherever you find your favorite shows. What if I told you that much of the forensic science you see on shows like CSI isn't based on actual science and the wrongly convicted pay a horrific price? Two death sentences and a life without parole. My youngest, I was incarcerated two days after her first birthday. Listen to CSI on trial on the iHeart radio app, Apple Podcast or wherever you get your podcasts. Did you know Lance Bass is a Russian trained astronaut that he went through

training in a secret facility outside Moscow, hoping to become the youngest person to go to space? Well, I ought to know because I'm Lance Bass and I'm hosting a new podcast that tells my crazy story and an even crazier story about a Russian astronaut who found himself stuck in space with no country to bring him down. With the Soviet Union collapsing around him, he orbited the earth for 313 days that changed the world. Listen to The Last Soviet on the iHeart radio app, Apple Podcast or wherever you get your podcasts.