Speaker 1: Welcome back to Behind the Bastards, the only podcast with
Speaker 1: more worms than the average bottle of milk in a
Speaker 1: century ago. Tougs of worms and filled with them. Love
Speaker 1: your new tagline. It's great, thank you, thank you. It's
Speaker 1: We're gonna move on from discussing horrible old timey foods
Speaker 1: before there were any kind of laws about what you
Speaker 1: could do with foods. But I just came across an
Speaker 1: article in the Guardian. Uh, you know there's that truck
Speaker 1: convoy trying to do with January six in Canada all
Speaker 1: about next week. Yeah, there's an article in the Guardian
Speaker 1: called Canada trucker's vaccine protests spirals into calls to repeal
Speaker 1: all public health rules. My favorite, my favorite response on
Speaker 1: Twitter is someone who's posted a picture of a sign
Speaker 1: outside of a swimming pool that says person is currently
Speaker 1: having active diarrhea or who have had active diarrhea within
Speaker 1: the previous fourteen days shall not be allowed to enter
Speaker 1: the pool water. And he's just responded, He's just most
Speaker 1: of that and said in all caps, oh, captain, my captain.
Speaker 1: This concludes the part of the episode where I read
Speaker 1: to you from Twitter, mad, what you you got a
Speaker 1: podcast compare yourself a gun but yourself a gun past.
Speaker 1: It's uh. You know, this is what separates us from
Speaker 1: any other TV rewatch podcast as uh I do a
Speaker 1: parody song every week that does the synopsis of the episode.
Speaker 1: Is it good kind of tow? People like it? Oh? No,
Speaker 1: do I do it? Yes? Insistently? U what a plug?
Speaker 1: Everyone loves that hot damn Matt. Now now that we
Speaker 1: have really we've laid the groundwork here, it is time
Speaker 1: to move on to the true bastard of our episode,
Speaker 1: the f d A. We've had it's it's it's Anakin
Speaker 1: Skywalker phase here and now we're about it's about to
Speaker 1: go full Vader, right, That's that's today's story. Pub poisoned
Speaker 1: back in the food Yeah, actually, yes, that is a
Speaker 1: part of what's happening in this period. Um, of course,
Speaker 1: it is much bigger than that. We're actually going to
Speaker 1: focus a bit more in the pharmaceutical industry today. There's
Speaker 1: a lot to say about food though. So we ended
Speaker 1: last episode with the creation of the f d A
Speaker 1: in nineteen thirty eight, after eight years after the death
Speaker 1: of Harley Whitley. Harvey Whitley, he dies in nineteen thirty uh.
Speaker 1: And the FDA was initially taxpayer funded. Right again, so
Speaker 1: all of its money at first comes from the American
Speaker 1: people because its job is to be a watchdog for
Speaker 1: the American people and to make sure they're eating. That's changed. Oh, yes,
Speaker 1: that's a big part of our story today, Matt. So
Speaker 1: at first it is taxpayer funded, and as a taxpayer
Speaker 1: funded organization, it experiences a titanic success very early on.
Speaker 1: When we've actually discussed previously on the show. In the
Speaker 1: late nineteen fifties, the grun in Tall Corporation of Germany,
Speaker 1: which was a pharmaceutical concern staffed mainly by Nazis, tried
Speaker 1: to get approval to sell their blockbust a new sleeping pill, philidamide,
Speaker 1: which may have initially been tested on concentration camp inmates
Speaker 1: in the United States now for the person and it
Speaker 1: was like some other company that was trying to sell
Speaker 1: the product for gruden Tal was buying and wanted to
Speaker 1: sell in the U S. Whatever, Like you know, corporations work.
Speaker 1: But this company that wants to sell palidamide in the
Speaker 1: U s as a sleeping pill, UH, has to go
Speaker 1: to the FDA to get approval, right, and the person
Speaker 1: they come before is Francis Oldham Kelsey. Now Francis Kelsey
Speaker 1: had earned a PhD the same year the FDA was founded,
Speaker 1: and she had been hired in nineteen sixty after six
Speaker 1: years of teaching pharmacology at the University of South Dakota.
Speaker 1: Um So, her job, she's one of the people who's
Speaker 1: supposed to evaluate new medical sins and substances and decide
Speaker 1: whether or not they get FDA approval. One of her
Speaker 1: very first assignments for the FDA was the litamide and
Speaker 1: her job is essentially to review the evidence of drug
Speaker 1: safety provided by the manufacturer, because that's what that nineteen
Speaker 1: thirty eight law, in the nineteen o six law had
Speaker 1: gradually established that if you want to sell a medicine,
Speaker 1: you have to prove it works and that it doesn't
Speaker 1: kill people, or at least it doesn't kill too many people, right,
Speaker 1: any kind of effect. Yeah, you have two shows. You
Speaker 1: have to prove it alike, be worth it, you know.
Speaker 1: Um So, it's her job to review all of that evidence. Now,
Speaker 1: Solidamite is at this point in use in like forty
Speaker 1: six nations around the world, including most of Europe. But
Speaker 1: Dr Kelsey thought their data was shipped. She actually looks
Speaker 1: at the evidence they have that this stuff is safe,
Speaker 1: and she's like, because one of the big things they're
Speaker 1: selling this as is it's like this is finally a
Speaker 1: safe sleeping pill for pregnant women, right, and they're they're
Speaker 1: saying that based on nothing, and in fact, a lot
Speaker 1: of the data they have suggests that, like, no, it's
Speaker 1: actually like it's fine for women who are nursing. They
Speaker 1: do show that that, like, it's probably okay for women
Speaker 1: who are nursing to have it, but there's there's evidence
Speaker 1: that it's really bad for pregnant women. Um, and there's
Speaker 1: really tried out and Nazi concentration camps. Well, that is debatable.
Speaker 1: We talked about this in the episode. Yeah, there's a
Speaker 1: lot of evidence that suggests that it's not ironclad. So
Speaker 1: I don't want to be like saying, but there is
Speaker 1: some evidence that's because they were they were Nazi doctors
Speaker 1: who were in concentration camps are the people who are
Speaker 1: doing all of the medical testing for Grooon at all,
Speaker 1: and there's evidence that they just like took this drug
Speaker 1: they've been testing in camps and like tried to launder its. Robert,
Speaker 1: I'm not about nuance. We're gonna call it anti semitic
Speaker 1: ambient and anti semitic ambient. That's right. So anti semitic
Speaker 1: ambient is in use all over the world. Um. But
Speaker 1: Francis Kelsey is like, I don't give a shit about
Speaker 1: what the rest of the world says. This data doesn't
Speaker 1: convince me, and it's my job to say whether or
Speaker 1: not this ship is safe, So I don't give you approval. UM.
Speaker 1: So she turns them down, and then they try to
Speaker 1: pressure her boss, and her boss backs her to the hilt.
Speaker 1: Her boss is like, no, Frances is fucking great scientist,
Speaker 1: and she's right about this, and we're not gonna fucking
Speaker 1: self phillidamite in the United States, and the litamite has
Speaker 1: never approved for use on a wide scale in the
Speaker 1: U S. There's a couple of like trials and stuff.
Speaker 1: A handful of Americans do take it um, but nothing
Speaker 1: like what happens in Europe, where millions of people take
Speaker 1: the litamide. Roughly one year after she turns down philidamide,
Speaker 1: scientists and Urbany and Australia proved that the litamide caused
Speaker 1: a whole host of debilitating birth defects. Babies were being
Speaker 1: born without lungs or with their arms coming directly out
Speaker 1: of their shoulders and like no actual like like foe
Speaker 1: arms and ship. You can find pictures if you want.
Speaker 1: Tens of thousands of children are disabled, hundreds of thousands
Speaker 1: of children that are disabled, Tens of thousands are killed
Speaker 1: as a result of the litamide. Um, but none of
Speaker 1: those are in the US, thanks to Dr Kelsey and
Speaker 1: the f d A. This is a huge success. Is
Speaker 1: exactly what it's there for, right, that's for this is
Speaker 1: a bullet proof vest stopping a bullet from entering your body.
Speaker 1: This is like exactly why we have this thing in
Speaker 1: proof that it is worth every goddamn penny. Um. And
Speaker 1: Americans at the time recognize that they have dodged a
Speaker 1: huge bullet. H The ship that happens with the litamide
Speaker 1: inspires the passage of the nineteen sixty two Drug Amendments.
Speaker 1: This bill is why ads for new medicines always end
Speaker 1: with like forty seconds of a dude talking very fast
Speaker 1: about the side effects experience. Like that's that's where that starts,
Speaker 1: like being mandatory, right, um, And there's a bunch of
Speaker 1: other good stuff and it including it forces a comprehensive
Speaker 1: reclassification of all available drugs based on whether or not
Speaker 1: they actually do anything. So there were all this medicine
Speaker 1: that was like grandfathered in when the FDA gets created,
Speaker 1: and they're right, well, actually, why the funk are we
Speaker 1: doing that? We should make sure this stuff all works.
Speaker 1: You know, I don't care we got tested. I understand
Speaker 1: that dark defeats the bright, but we gotta test it.
Speaker 1: I'm not a big law fan, but the nineteen sixty
Speaker 1: two drug ammendments are pretty comprehensively, like a good, good,
Speaker 1: good call, you know. Um So, the f D a
Speaker 1: huge fucking hit at this point, right, Like, that's that's
Speaker 1: I mean, that's worth all the money we'd spent on
Speaker 1: it forever if they just stopped the litamide. And obviously
Speaker 1: there's other ship they're stopping their ship they're making safer.
Speaker 1: There's stuff that they're you know, medications that they're limiting
Speaker 1: the scope of that too many people don't take them.
Speaker 1: The FDA is doing fucking gang busters, and it's it's
Speaker 1: first few decades in existence. Um So, that's dope as hell.
Speaker 1: And President Kennedy even gives the agency a shout out
Speaker 1: in nineteen sixty two shortly but or being gunned down
Speaker 1: by Bernard Montgomery Sanders. And it's worth noting that this
Speaker 1: massively but I mean, okay, look, there is the theory
Speaker 1: that Orenthal James Simpson, who was a young adult at
Speaker 1: this period of time, may have taken part in the
Speaker 1: assassination of John Fitzgerald Kennedy. He was a very fast runner.
Speaker 1: I believe that he may have been providing the ammunition
Speaker 1: to Bernie Sanders. Um, there's no way to know that
Speaker 1: he wasn't you know. That's why proved me wrong. Yeah,
Speaker 1: what are you gonna do? Show me that Bernie Sanders
Speaker 1: and O J and the Juice didn't collaborate together to
Speaker 1: assassinate John Fitzgerald Kennedy. Prove it. I hope that we
Speaker 1: all did a headshake in Unison when that happened. So
Speaker 1: it's worth noting that this, uh, this, this massive early
Speaker 1: dub for the f d A was due in part
Speaker 1: to the agency's independence in large part. Really like the
Speaker 1: fact that this this is there's no ties to anybody
Speaker 1: but the U. S. Taxpayer. That is the only response
Speaker 1: posibility the f d A has. There's a shipload of
Speaker 1: money to be made in approving like philidamide right, Like
Speaker 1: they could have been like that, Like that company would
Speaker 1: have made millions before they realized that it was harming
Speaker 1: babies at a scale almost inconceivable. But the only FDA
Speaker 1: doesn't give a shit about anybody's profits. All they care
Speaker 1: about his safety. And Dr Kelsey looked at the data
Speaker 1: and was like, no, funk, this ship responsible only to
Speaker 1: the taxpayers, because that's what government is supposed to do. Well,
Speaker 1: that's not how the FDA works anymore. Um. And to
Speaker 1: explain why things changed, I'm going to read a quote
Speaker 1: by a write up from Michael White of the University
Speaker 1: of Connecticut School of Pharmacy. Quote. The first US case
Speaker 1: of HIV induced AIDS occurred in nineteen eighty one. It
Speaker 1: was rapidly spreading, with devastating complications like blindness, dementias, severe
Speaker 1: respiratory diseases, and rare cancers. Well known sports stars and
Speaker 1: celebrities died of AIDS related complications. AIDS activists were incensed
Speaker 1: about long delays and getting experimental HIV drugs studied and
Speaker 1: approved by the f d A. In nineteen nine two,
Speaker 1: in response to intense pressure, Congress passed the Prescription Drug
Speaker 1: User Fee Act. It was signed into law by President
Speaker 1: George H. W. Bush. With the Act, the FDA moved
Speaker 1: from a fully taxpayer funded entity to one funded through
Speaker 1: tax dollars and new prescription drug user fees. Manufacturers pay
Speaker 1: these fees when submitting applications to the FDA for drug review,
Speaker 1: and annual user fees based on the number of approved
Speaker 1: drugs they have on the market. Now surface level go
Speaker 1: back in time. Number one. This is in response to
Speaker 1: a real problem, right, the and this we saw this
Speaker 1: with like COVID. Right, sometimes you can't afford to take
Speaker 1: as much time, you know, testing ship because there's a
Speaker 1: real immediate fucking plague and you might just need to
Speaker 1: like throw some ship out there. And maybe there will
Speaker 1: be some side effects with the boosters and ship I.
Speaker 1: You know, some people like there are some side effects
Speaker 1: and ship um that we probably would have caught and
Speaker 1: maybe even minimized if we had not been dealing with
Speaker 1: a global play, right, Like you gotta fucking get shipped out.
Speaker 1: You know, that's a reasonable problem. The way they one
Speaker 1: of the ways they deal with this is that like
Speaker 1: they make this partially funded by the pharmaceutical drug companies,
Speaker 1: and they allow ways for the FDA to expedite um
Speaker 1: pharmaceutical drug approvals. And this is where all the problems
Speaker 1: start to come in. Right, But you have to note
Speaker 1: that it does kind of sound surface level reasonable to
Speaker 1: a lot of people. And this is kind of the
Speaker 1: way a lot of the government works really. Right, you
Speaker 1: go to the d m V. You have to pay
Speaker 1: fees to apply for stuff, right to get like register
Speaker 1: a car, get a license. Why wouldn't big pharmaceutical companies
Speaker 1: have to pay the FDA for drug review and other stuff?
Speaker 1: You know, you can make a case to most people
Speaker 1: on both sides of the political spectrum that this is
Speaker 1: a reasonable idea, right um. And obviously the reason why
Speaker 1: you don't do that for the f d A is
Speaker 1: because it might lead to a situation wherein those companies
Speaker 1: are all paying the FDA for the FDA to exist.
Speaker 1: And when the people funding your organization are the folks
Speaker 1: with a vested interest in you saying yes to their drugs, well,
Speaker 1: that can cause some problems. You are no longer the
Speaker 1: independent organization that stopped philetamide from hitting the streets. You
Speaker 1: know it was there was a short sighted move on
Speaker 1: that law. You know, I got where they were coming
Speaker 1: from But uh, it sounds bad. You get why people
Speaker 1: could be convinced that this was a good idea because
Speaker 1: it sounds like a tax. It sounds like, Oh, all
Speaker 1: we're doing is like making you know, you're you're still
Speaker 1: going to get the money from the taxpayers, but you're
Speaker 1: also we're gonna a tax these companies for you even applying.
Speaker 1: And it's like it is tying these salaries of uh,
Speaker 1: the of of the people who work for the FDA
Speaker 1: to the pharmaceutical industry. You know, that's that's what it's doing,
Speaker 1: and that's not great, you know. Um So, over the years,
Speaker 1: new fees were introduced for the approval of generic drugs,
Speaker 1: over the counter drugs, biosimilar drugs, animal medications, as well
Speaker 1: as medical devices. The FDA develops a complex system of waivers, refunds,
Speaker 1: and exemptions dependent on the category of drug and the
Speaker 1: total number of drugs the manufacturer had approved. A LABYRINTHI
Speaker 1: an expensive bureaucracy developed, and the proceeds from this bureaucracy
Speaker 1: grew to account for forty of the f d a's
Speaker 1: five point nine billion dollar budget. But wait, there's more.
Speaker 1: Sixty five percent of the funding for human drug regulation
Speaker 1: comes directly from user fees submitted by pharmaceutical companies. Now
Speaker 1: this has had some positive outcomes because their funding comes
Speaker 1: from these fees. The FDA has gotten a lot faster
Speaker 1: at responding to manufacturers about what they need in their applications.
Speaker 1: The whole process of getting new medicines approved has gotten
Speaker 1: a lot speedier. Seven it took twenty nine months to
Speaker 1: get FDA approval or denial. By fourteen, it took thirteen months.
Speaker 1: By two eighteen, it was down to ten months. President
Speaker 1: Trump personally promised to streamline the process by which drugs
Speaker 1: were approved, and his administration seems to have delivered in
Speaker 1: this respect. Now that can be good, as we've seen
Speaker 1: in the COVID responses. Sometimes you need stuff approved very rapidly,
Speaker 1: but usually you don't. One of the things that these
Speaker 1: changes have done is they've led to an increase from
Speaker 1: thirty eight percent to sixty one in the number of
Speaker 1: first time approvals on new drug applications in diseases where
Speaker 1: there are a few existing medications and even more streamlined
Speaker 1: approval process means that eight nine percent of applications get
Speaker 1: approved the first time, often and under eight months. This
Speaker 1: is all coincided with a huge surge in the number
Speaker 1: of new drug applications because you can get them said
Speaker 1: yes a lot quicker and get him out there and
Speaker 1: start making fucking money. So that is impressive if you
Speaker 1: don't account for the fact that an awful lot of
Speaker 1: these new drugs getting expedited approvals are fucking horrible. And
Speaker 1: I'm gonna quote from Michael White from the University of
Speaker 1: Connecticut here. While the number and speed of drug approvals
Speaker 1: have been increasing over time, so have the number of
Speaker 1: drugs that end up having serious safety issues coming to
Speaker 1: light after FDA approval, and one assessment, investigators looked at
Speaker 1: the number of newly approved medications that were subsequently removed
Speaker 1: from the market or had to include a new black
Speaker 1: box warning over sixteen years from the year of approval.
Speaker 1: These black box warnings are the highest level of safety
Speaker 1: alert that the FDA can employ, warning users that are
Speaker 1: very serious verse event could occur before the user fee
Speaker 1: was approved of medications were removed or had new black
Speaker 1: box warnings as compared to twenty seven percent afterwards. Now
Speaker 1: that jump alone is not great, right, but it's also like,
Speaker 1: you know, six percent, that's not the worst thing in
Speaker 1: the world, But when you really dig into the data,
Speaker 1: it's it sounds a lot worse than that. Actually, matt um,
Speaker 1: it does. It does. And I'm gonna quote now from
Speaker 1: a write up I found by CNN, about a third
Speaker 1: of the drugs the FDA approved between two thousand and
Speaker 1: one and two thousand ten were involved in some kind
Speaker 1: of safety event after reaching the market, According to a
Speaker 1: study published in Tuesday in the Journal of America the
Speaker 1: American Medical Association. The authors found that in that time,
Speaker 1: two and twenty two novel therapeutics were approved, and there
Speaker 1: were a hundred and twenty three post market safety events
Speaker 1: involving seventy one products that required FDA action. Manufacturers needed
Speaker 1: to add sixty one boxed warnings also commonly called a
Speaker 1: black box warning to call attention to serious risks. In
Speaker 1: fifty nine cases, some communication had to warn the users
Speaker 1: about a product safety. Three therapeutics were withdrawn from the market. Now,
Speaker 1: remember how I said that the FDA expedites approval requests
Speaker 1: for drugs to treat illnesses where there aren't a lot
Speaker 1: of existing treatments. That's good again, if there's like a
Speaker 1: plague or something that you need to get out quick,
Speaker 1: but it also means there's an extra financial incentive for
Speaker 1: a pharmaceutical corporation to get a medicine approved to treat
Speaker 1: an illness that doesn't have a lot of medicines for it.
Speaker 1: This includes all of the mental illnesses, right, yeah, really
Speaker 1: shortage of medicines because maybe in a lot of cases
Speaker 1: medicines don't help that much. With a lot of studies,
Speaker 1: we're fighting not not to be against medications. A lot
Speaker 1: of great medications out there, but there's a lot of
Speaker 1: fucking problems with mental health medications, and it's very fucking
Speaker 1: easy to get an approval for a mental health medication. Um.
Speaker 1: And that for a while, mental health medication was just
Speaker 1: doing electricity on your brain. So you know, at this point,
Speaker 1: if it's in pillform, people are like, yeah, proven you
Speaker 1: don't you would think that it wasn't worse now, but
Speaker 1: in some ways it is. Um so that a m
Speaker 1: A journal report noted that drugs used for mental illness
Speaker 1: had a higher number of events UM like negative health
Speaker 1: and safety events. And most of these drugs, and most
Speaker 1: of accelerated drugs are approved on trials with fewer than
Speaker 1: a thousand patients. Because the bar is lower, they don't
Speaker 1: need to show that it works on many people. If
Speaker 1: you can jig a trial with a hundred people with
Speaker 1: a thousand people and show that it works like five
Speaker 1: people or whatnot, you can fucking get approval and expedited
Speaker 1: as well. Yeah, yeah, you can get it done really quickly.
Speaker 1: And there's a good book. We're not going to get
Speaker 1: into it much because I'm kind of focusing on the FDA.
Speaker 1: There's a whole book written about all of the different
Speaker 1: ways in which the the medical testing industry, like the
Speaker 1: industry that is designed to determine whether or not drugs work,
Speaker 1: is heavily compromised because most of those studies are funded
Speaker 1: by the pharmaceutical companies. There's all sorts of ways they
Speaker 1: funk with the data. A lot of those scientists wind
Speaker 1: up getting like cushy jobs afterwards and stuff with these companies.
Speaker 1: There's all sorts of ways like that's a big part
Speaker 1: of how a lot of very like negative like that's
Speaker 1: how they That's how a lot of like negative aspects
Speaker 1: of different foods like sodas and ship get hidden for
Speaker 1: so long. Because you can kind of have a study
Speaker 1: of five people that you control, and you can make
Speaker 1: it kind of say whatever you want. The book is
Speaker 1: called Unsavory Truth, How Food Companies skew the science of
Speaker 1: what we eat, and it includes a lot of detail
Speaker 1: on the pharmaceutical industry to It's by a woman named
Speaker 1: Mary and Nestleie no relation to the candy people. Um again,
Speaker 1: we're not really going to get into that, but yeah,
Speaker 1: I I should, you know, I should read one quote
Speaker 1: from this about the way in which industry funded research
Speaker 1: favors the sponsors commercial interests. So I'm gonna read a
Speaker 1: quote from that book here. Sheldon Crimsky, a Toughs University
Speaker 1: professor who studies industry manipulation of science, dates the discovery
Speaker 1: of this funding effect to the mid nineteen eighties, when
Speaker 1: social scientists realized that if they knew who paid for
Speaker 1: a study, they could predict its results. One funding effect
Speaker 1: investigation from the late nineteen nineties looked at studies on
Speaker 1: the safety of calcium channel blockers for reducing blood pressure.
Speaker 1: Nearly all authors nineties percent who concluded that the drugs
Speaker 1: were effective, reported financial ties to their manufactures. Only thirty
Speaker 1: seven percent of authors who doubted the effectiveness had such ties,
Speaker 1: and two thousand three a systemic review of more than
Speaker 1: one thousand biomedical research studies came to a similar conclusion.
Speaker 1: Investigators with industry affiliations were nearly four times more likely
Speaker 1: to come up with pro industry conclusions than those without
Speaker 1: such ties. See, that's why we don't trust doctors. If
Speaker 1: you want to know why they're there's a reason people
Speaker 1: are so distrustful about like the vaccines in the medical industry.
Speaker 1: Like they should be distrustful, just not in this specific case. Really, yeah,
Speaker 1: I mean, it's just it sucks because it's like every
Speaker 1: time I hear an anti vaxer talk, I'm always like,
Speaker 1: there's part of me that understands exactly where you're coming from,
Speaker 1: minus the part where you're completely ignoring all subsequent data
Speaker 1: as to the efficacy of these like vaccines. But it's
Speaker 1: like I get it because like, yeah, nine out of
Speaker 1: ten doctors think that this drug is good. Also, nine
Speaker 1: out of ten doctors are paid for by the company
Speaker 1: that makes this drug. It's just yeah, maybe a better
Speaker 1: solution would be to tax all of the billionaires until
Speaker 1: they're not billionaires, to dissolve all pharmaceutical corporations, and to
Speaker 1: take all of their patents and property and money and
Speaker 1: put it in a trust run or administered by, you know,
Speaker 1: an agency made up of scientists who are purely paid
Speaker 1: and supported by the taxpayer, whose job is to make
Speaker 1: pharmaceutical stuff happen. Maybe just off the topic I did
Speaker 1: I I I've actually invented a whole system. Um it's
Speaker 1: called Marxist uh Robertism. Yeah, that's that's that's very heavily
Speaker 1: based on what I what I another word, I invented socialism. Yeah. Yeah,
Speaker 1: I'm the first person to figure this out. I have
Speaker 1: a lot of great ideas. We're going to freeze a
Speaker 1: lot of seeds to see if it makes them cold tolerant,
Speaker 1: a lot of cool stuff. Try that out. Try that yeah.
Speaker 1: So uh yeah, one area where all of this ship.
Speaker 1: Uh this uh horrific. But so and again it's like
Speaker 1: one of those the basic idea by which this problem
Speaker 1: started as like reasonable, Well, these companies should have to
Speaker 1: prove their medicine works. They should be conducting studies to
Speaker 1: show that the stuff is safe and that it does
Speaker 1: what it says it does. Very reasonable thing to propose
Speaker 1: in like nineteen when it is like pushed. But you
Speaker 1: see the obvious problem, which is that, well, they're not
Speaker 1: gonna fun to study because they care so much, because
Speaker 1: their primary interest is profit, their primary interest is not
Speaker 1: helping people. A lot of the doctors and stuff, their
Speaker 1: interest is helping people. And like one of the things
Speaker 1: that I will say, a lot of those people who
Speaker 1: those scientists whose results are heavily skewed by the fact
Speaker 1: that they're being paid by pharmaceutical companies. It's not because
Speaker 1: they're like evil or even know what they're doing. It
Speaker 1: just happens. Um. It's likewise, I don't talk about the
Speaker 1: fact that has an island where they allow you to
Speaker 1: hunt children for sport very often. You know, um, because
Speaker 1: I'm swimming in those bucks. Baby, you're just filled with
Speaker 1: Salisbury steaks that you're gonna cook fresh tonight. They stakes
Speaker 1: made from the children hunted on their private island. You know,
Speaker 1: it's good stuff. You taste the fear, you know. So
Speaker 1: one area where this whole problem may have had a
Speaker 1: major impact both the fact that they're conducting the industry
Speaker 1: is conducting these studies, um, and that this approval process
Speaker 1: it's a lot easier to get mental health medication approved
Speaker 1: is in the treatment of schizophrenia. In recent years, the
Speaker 1: World Health Organization has released two studies which find that
Speaker 1: long term outcomes for schizophrenia patients in three developing countries.
Speaker 1: This is the term that they use. I don't prefer
Speaker 1: that term, but I'm reading from a study they did
Speaker 1: so skip long term outcomes for schizophrenia patients and three
Speaker 1: developing countries were actually better than in the United States
Speaker 1: and five other developed countries. Now, why how can this be? Well,
Speaker 1: it's not entirely known, but one probably the leading theory
Speaker 1: is that the countries with better outcomes for treating schizophrenia
Speaker 1: only used anti psychotic meds acutely, not chronically. So they
Speaker 1: give people They're not like rejecting this medication, but they
Speaker 1: use it when someone is having an issue, when they're
Speaker 1: having a psychotic breakers and not daily. You know. Um,
Speaker 1: only sixteen percent of patients in those countries were on
Speaker 1: regular maintenance doses of antipsychotics. Is supposed to basically everybody
Speaker 1: with schizophrenia in the United States, right, That is the
Speaker 1: standard of care um for most people who are dealing
Speaker 1: with that here. And we have worse outcomes in these
Speaker 1: countries with a lot less money to spend on their
Speaker 1: medical system, and that maybe why. A subsequent Harvard study
Speaker 1: found that schizophrenia outcomes for patients in the United States
Speaker 1: have declined over the last twenty years, and at present
Speaker 1: they are no better than they were in the nineteen twenties.
Speaker 1: Fuck like the electrocution days, right Like, we've gone back.
Speaker 1: We had gotten a lot better for a while, but
Speaker 1: we we've gone back. Um journalist Robert Whittaker has investigated
Speaker 1: the subject heavily, and he puts blame on a shamefully
Speaker 1: lax testing process for medication for schizophrenia, the result of
Speaker 1: all of the systems we've just discussed. Quote. When you
Speaker 1: look at the short term studies of antidepressants and antipsychotics,
Speaker 1: the evidence of efficacy in reducing symptoms compared to placebo
Speaker 1: is really pretty marginal and fails to rise to the
Speaker 1: level of a clinically meaningful benefit. Furthermore, the problem with
Speaker 1: all of this research is that there is no real
Speaker 1: placebo group in the studies. The placebo group is composed
Speaker 1: of patients who have been withdrawn from their psychiatric medications
Speaker 1: and then randomized to placebo. Thus, the placebo group is
Speaker 1: a drug withdrawal group, and we know the withdrawal from
Speaker 1: psychotic drugs can stir myriad negative effects a medication naive
Speaker 1: placebo group would have a much better outcome. In short,
Speaker 1: the research on the short term effects of psychiatric drugs
Speaker 1: is a scientific mess. In fact, a two thousand seventeen
Speaker 1: paper that was designed to defend the long term use
Speaker 1: of antipsychotics nevertheless acknowledged in an off hand way that quote,
Speaker 1: no placebo controlled trials have been reported in first episode
Speaker 1: psychosis patients. Antipsychotics were introduced sixty five years ago, and
Speaker 1: we still don't have good evidence that they work over
Speaker 1: the short term in first episode patients. Still still it's
Speaker 1: it's it's a very unlike you dig into it, it's
Speaker 1: very messy. I should note there are researchers and scientists
Speaker 1: who criticize Whittaker's work. Here one of the reasons I
Speaker 1: tend to trust him number one, there's other experts that
Speaker 1: back him. Number two. When he's interviewed by I found
Speaker 1: this in a Scientific American article. He linked lists lengthily
Speaker 1: all of the different criticisms of his work, and he
Speaker 1: links to responses he's made to all of them, and
Speaker 1: he points out the ones I think these have some
Speaker 1: these guys have some points. I think these guys are
Speaker 1: fascile you know. One of the reasons that I tend
Speaker 1: to think he's probably onto something, um, because he actually
Speaker 1: addresses the criticism and has rebuttals to it. Yeah, Yeah,
Speaker 1: he's he's taking it seriously as as scientists as opposed
Speaker 1: to like going for you know the thing um, And
Speaker 1: his arguments feel extracredible to me because the same sorts
Speaker 1: of problems that he outlies are in dimmick when you
Speaker 1: look at other major failures of the f DA. So
Speaker 1: it's not just with these medications he's criticizing. It happens
Speaker 1: all over the goddamn time, um. And a strong argument
Speaker 1: could be made that if the lidamide came before the
Speaker 1: FDA Approval Board today, it probably would have wound up
Speaker 1: in pharmacies across the country because there were no sleeping
Speaker 1: medications that were safe for pregnant women. And if the
Speaker 1: lidamide is able to get like a thousand person study
Speaker 1: that kind of sort of shows that then yeah, then
Speaker 1: suddenly boom, we've got a lot of philidamite up in air,
Speaker 1: you know study and uh all know those babies who's
Speaker 1: like arms are on their legs and legs on their arms,
Speaker 1: that's actually just that's like part of it. They like
Speaker 1: to They like that. Everybody likes that. Ye helps, Mr
Speaker 1: just holding you back? Yeah exactly, it's trust me, dude,
Speaker 1: he's into it. We're all we're Mr Potato heading on.
Speaker 1: They don't need elbows. What do you get cooked by
Speaker 1: an elbow? No, thank you? Straight onto the band. Oh yeah,
Speaker 1: we've got machines for them to breathe through. It's fine. Yeah.
Speaker 1: So this all brings me to the very sad story
Speaker 1: of viox. Near the end of the nineteen nineties, Mirk
Speaker 1: went to the FDA to get approof for by Ox,
Speaker 1: a pain killer meant for patients with arthritis. They believed
Speaker 1: it was superior to older pain killers because it had
Speaker 1: fewer gastro intestinal side effect so they're arguing, like, this
Speaker 1: is a safer pain killer for people with arthritis. To
Speaker 1: support their case, they presented the FDA with eight studies
Speaker 1: which had a grand total of fifty four hundred total subjects.
Speaker 1: So that is well under an average of a thousand
Speaker 1: subjects per study. Right, that's not a lot of people
Speaker 1: to prove that your for for for number one arthritis
Speaker 1: is very common, right, A ton of people need medication
Speaker 1: for arthritis. That's not a shipload of subjects to prove
Speaker 1: that a medication is safe, right, that it really is not.
Speaker 1: In November of nine, they asked the FDA for approval.
Speaker 1: They seem to have realized their case that it was
Speaker 1: safer rested on pretty thin ground. So as they're going
Speaker 1: for approval, they launched the Box gastro Intestinal Outcomes Research Study,
Speaker 1: or VIGOR. This study would have more than eight thousand participants.
Speaker 1: So that's good. That's almost twice as many participants as
Speaker 1: they've had in total and all the other study. Now
Speaker 1: we're starting to get you know that that that could
Speaker 1: establish a broader base that to to show that this
Speaker 1: is science here. So but this is after they start
Speaker 1: this big study, after they've approved, or after they have
Speaker 1: filed for approval with the FDA, and before the VIGOR
Speaker 1: study is finished. The f d A approves by OX
Speaker 1: in May of nineteen ninety nine off the strength of
Speaker 1: those small studies and nothing else. Fucking roll the dice.
Speaker 1: What do you need, right, it's their own Fuck them.
Speaker 1: VIGOR doesn't report its first results from the study until
Speaker 1: October of nineteen ninety nine, and they were promising VOX
Speaker 1: patients seemed to have fewer ulcers and less bleeding than
Speaker 1: patients taking the proxen, which was the kind of standard previously.
Speaker 1: But then in November of nineteen ninetnine, things started to turn.
Speaker 1: And I'm gonna quote from NPR here. At the second
Speaker 1: meeting of the Vigor Safety Panel, the discussion focuses on
Speaker 1: heart problems. As of November one, nineteen seventy nine patients
Speaker 1: out of four thousand taking bax have had serious heart
Speaker 1: problems or have died, compared with forty one taking the proxi.
Speaker 1: In the minutes of the panel's November meeting, note that
Speaker 1: while the trends are disconcerting, the numbers of events are small.
Speaker 1: The panel votes to continue the study and to meet
Speaker 1: again in a month. And this would have been fine
Speaker 1: if the medicine hadn't already been out Right, If you're
Speaker 1: just doing this research, sure, this is what happens. Right,
Speaker 1: if you're studying some number of people that you test
Speaker 1: medications on are gonna die. It's going to happen. For
Speaker 1: you can't get medication and not have that happen from
Speaker 1: time to time. In a by deal world, you would
Speaker 1: not start selling it in mass until you had concluded
Speaker 1: this research. We finished finished the project and then decide
Speaker 1: whether or not the public can have it. So, in
Speaker 1: December of nineteen nine, the Safety Panel has what will
Speaker 1: be its last meeting. They're told that as of December one,
Speaker 1: nineteen nine, the risk of serious heart problems in death
Speaker 1: among BIOX patients is twice as high as the approxim group.
Speaker 1: So no, it's not a safer It is twice as
Speaker 1: likely to kill your ass. But your stomach feels better
Speaker 1: when you're dying of a heart attack, Yeah you do,
Speaker 1: you tell me, feels better as you as you fucking
Speaker 1: dropped to the ground. Now, the research board monitoring this,
Speaker 1: like safety board monitoring the study, decides to continue on,
Speaker 1: which is a questionable decision in of itself, right, Continuing
Speaker 1: the study at this point is like, well, but it
Speaker 1: kills twice. Maybe that's all we need to know about this.
Speaker 1: Bring in a thousand more guys. Let's just let's just
Speaker 1: be sure. Let's run through some more of them. Come on,
Speaker 1: So they did tell merk like, this board is like,
Speaker 1: you can keep doing the study, Um, but you should
Speaker 1: develop a plan to analyze the cardiovascular results of the
Speaker 1: study before the study ends, right, so that you can
Speaker 1: actually determine really what the effect on people's hearts is
Speaker 1: as soon as the studies over, because we're seeing some
Speaker 1: stuff that's concerning, and Mark is like, no, we're not
Speaker 1: gonna do that. Um, we're gonna We're gonna wait, We're
Speaker 1: gonna let a couple more studies get done within another
Speaker 1: couple of years and then we'll see if it's bad
Speaker 1: for people's hearts. And the safety panels like cool. That
Speaker 1: sounds cool too. We wanted to do it now, but
Speaker 1: it sounds fine to do it later or never. Oh no,
Speaker 1: I never looked at it like that before, But thank
Speaker 1: you for opening our eyes. That will just not do
Speaker 1: with the thing. Funnily enough, Matt. The head of that
Speaker 1: safety panel was a guy named Wine Blatt, who also
Speaker 1: served on an advisory board for Merk, owned seventy two
Speaker 1: th dollars in Mark stock, and worked as a paid
Speaker 1: consultant for Mark. Yeah, he seems like he seems unbiased.
Speaker 1: That's a legic guy. That's a that's a legit dude.
Speaker 1: How would you like it if I read your resume
Speaker 1: every time you're advocating for things that put money in
Speaker 1: your pocket? H Yeah, Now the company pushed the can
Speaker 1: down the road. And sold by Ox for nearly two years.
Speaker 1: In January of two thousand two, epidemiological studies started coming
Speaker 1: out that warned that biox was giving people heart attacks
Speaker 1: and strokes and huge numbers. That's January. Nothing gets done
Speaker 1: until September, when the weight of evidence is so high
Speaker 1: that Mirk begins to withdraw their drug from the market.
Speaker 1: And it's still being sold until I think like two
Speaker 1: four to a lot of people. Jesus. By the time
Speaker 1: they finally get it off the market, twenty million Americans
Speaker 1: have taken it. Now, the Lancet estimates that thirty eight
Speaker 1: thousand people at least died from taking via x. That's
Speaker 1: a pretty good yeah, they got ked now, this estimate
Speaker 1: is likely optimistic. Dr David Graham was a scientist at
Speaker 1: the FDA for more than twenty years when he started
Speaker 1: speaking out about bi ox, and he's actually still working
Speaker 1: for the FDA when he begins doing interviews about how
Speaker 1: this happened. Here is a right up on him from
Speaker 1: Fraud Magazine. Quote between nine and two thousand four and
Speaker 1: estimated twenty million Americans took by Ox, eighty million worldwide,
Speaker 1: said Graham. The recipient of the two thousand five Cliff
Speaker 1: Robertson Sentinel Award at the recent sixteenth Annual a c
Speaker 1: f E Fraud Conference and Exhibition. We've estimated that up
Speaker 1: to a hundred and forty thousand patients who took BIAX
Speaker 1: suffered heart attacks. Of this number, sixty thousand died, said Graham.
Speaker 1: Um Yox as a poster child for what's wrong with
Speaker 1: the f d A and why I believe FDA reform
Speaker 1: is so urgently needed. And if Dr Graham's calculations are correct,
Speaker 1: if sixty people died from biox, that's too box killed
Speaker 1: more Americans than Vietnam, like holy shit, right, and based
Speaker 1: on just like who tends to get arthritis? Most likely
Speaker 1: a number of the people had killed probably survived Vietnam
Speaker 1: only get iced by biox. They got marked by biox.
Speaker 1: They lived through a pungi stick trap. But they couldn't
Speaker 1: make it through the new f d A. Well, you
Speaker 1: lose to the Vietcong and then you lose to Mark
Speaker 1: sucks Merk and the Vietcong shaking hands with killing killing Americans.
Speaker 1: So yeah, um and Dr Graham has since claimed that
Speaker 1: the f d A not only did they were they
Speaker 1: lax and allowing this to happen. They actually took direct steps,
Speaker 1: he alleges, to stop scientists from speaking out against the
Speaker 1: drug before it could be approved. In November of last year,
Speaker 1: Graham testified before the Senate Finance Committee that the FDA
Speaker 1: had silenced him and his call leaks from reporting on
Speaker 1: the risks of Box and other drugs. The FDA has
Speaker 1: let the American people down and sadly betrayed a public trust,
Speaker 1: Graham said during his testimony. He alleged that because the
Speaker 1: FDA is unduly influenced by the pharmacy industry, it is
Speaker 1: incapable of protecting America against another Box. We are virtually defenseless.
Speaker 1: That's good. Yeah, that's nice to know, you know. Yeah,
Speaker 1: it's good to know that they you know, they started
Speaker 1: off good, but this is yeah, they've they've fallen into
Speaker 1: the lava at this point, you know, there in the suit,
Speaker 1: they're choking people to death. Yeah, there's fingerprints all over
Speaker 1: their helmet. If you if you watch the high res
Speaker 1: versions of the original movies, because they didn't expect TVs whatever,
Speaker 1: get that good? Yeah? Yeah, yeah, it was supposed to good.
Speaker 1: So this is a claim that the America is defenseless
Speaker 1: because the FDA is fundamentally compromised by the pharmaceutical industry.
Speaker 1: This is a claim that does is there fur their
Speaker 1: focus to do that. We're gonna have to turn back
Speaker 1: to the story of a drug. You might be a
Speaker 1: fan of. I certainly am a fan of our old
Speaker 1: buddy oxy code. Oh yeah, now, I love me samopi.
Speaker 1: It's right, but we have to acknowledge they're a problem
Speaker 1: for the country. There a problem for me. Yeah, yeah,
Speaker 1: I can no longer part that is a problem for
Speaker 1: me that I had had couldn't after I left from
Speaker 1: Central America. Yeah, oh god, it was pretty fun just
Speaker 1: being able to pick up a bottle of liquor and
Speaker 1: a box of code ow like on the same trip
Speaker 1: that I got my tortillas. God man, those are the
Speaker 1: day you know. I for years as an addict, I
Speaker 1: would dream of going to a place where I could
Speaker 1: just get over the counter like morphine and whatnot. And
Speaker 1: I mean, I do think that is how it should work.
Speaker 1: And I think it not really a problem if you
Speaker 1: were not getting millions of people hooked on opiates telling
Speaker 1: them that it's going to manage their pain, when makes
Speaker 1: the pain much worse than like makes the problems long
Speaker 1: term much worse. Oxy OxyContin is one of the most
Speaker 1: evil things in the world because of the fact that
Speaker 1: it uh it sucks like it's not it's not good.
Speaker 1: It's it's not like morphine, which has like into some
Speaker 1: liquid morphine of fucking Now the language these actually, you know,
Speaker 1: feel good. They will destroy your life by the whole share,
Speaker 1: of course, lots of things will. But what's what's even
Speaker 1: more evil about oxycontent is that like this, they got
Speaker 1: people hooked on an opiate that sucks and better than content.
Speaker 1: But like, yeah, that we're now we're getting into the
Speaker 1: weeds of which ones are good and which ones are bad? Um,
Speaker 1: all of them are better than fucking coding, which is
Speaker 1: trash the worst and you cannot ivy uh, you can't
Speaker 1: shoot up Cody and just let let you guys know that.
Speaker 1: Don't even go through ANIFL access. I learned that the
Speaker 1: hard way. I was blind for sixty seconds. Anyways, that's
Speaker 1: the good stuff you brought me on for this one.
Speaker 1: We're both fans. But the opiate crisis is obviously a
Speaker 1: massive titanic tragedy that has caused um maybe more damage
Speaker 1: than almost anything else to particularly Middle America UM and
Speaker 1: we've got we did a two party unproduce pharmaceutical UM
Speaker 1: in the Sackler family who profited off of this primarily.
Speaker 1: But now it's time to talk about the FDA's complicity.
Speaker 1: But before we do that, Matt, you know who else
Speaker 1: is complicit? And you having a good time? All the
Speaker 1: sponsors and products, that's right, all conspiring to make you happy.
Speaker 1: Hell yeah, and and to push oxy codo you know,
Speaker 1: yeah for sure? All right, we're back back maybe yeah right.
Speaker 1: I just want to point out I am twelve years sober.
Speaker 1: For anyone out there, for anyone out there, it was
Speaker 1: just like I should try that lot. It has been.
Speaker 1: I always had a rule. I would always take it
Speaker 1: to an honestly problematic degree when I was in places
Speaker 1: outside of the country where I could get it. I've
Speaker 1: always had a rule where I I do not ever
Speaker 1: purchase it in the United States. Never have, never will.
Speaker 1: Every now and then, maybe theoretically a friend has surgery
Speaker 1: and winds up with some extra pills and stuff. But
Speaker 1: like I, it's I've seen it's it's too it's actually
Speaker 1: like pretty fucking horrible. Yeah, I don't have that ability.
Speaker 1: You're like a fucking superhero to me. I can't. I
Speaker 1: got addicted to hookah after I got clean. Straight up, Yeah,
Speaker 1: I got addicted to stuff. I can't help it. I
Speaker 1: know that if I were to let myself let it
Speaker 1: be anything but like a vacation thing, I would immediately
Speaker 1: have a problem and it would destroy my life, right yeah,
Speaker 1: because I have had problems with other substances before to
Speaker 1: the point where I'm like, I, I can see you
Speaker 1: in the rear view mirror, you know. Yeah, it's always
Speaker 1: doing push ups in the brain. Ready, fuck your party.
Speaker 1: That is how it works. Um, So let's talk about
Speaker 1: the FDA's complicity in the opiate epidemic. In two thousand nineteen,
Speaker 1: a state court in Oklahoma tied quote false, misleading, and
Speaker 1: dangerous marketing campaigns by drug manufacturers to quote exponentially increasing
Speaker 1: rates of addiction, overdose deaths, and baby is born exposed
Speaker 1: to opioids. This is yet another damning black mark on
Speaker 1: an industry whose executives should all be flung into the
Speaker 1: sun via catapult. But as this right up from the
Speaker 1: Journal of Ethics of the American Medical Association argues, quote,
Speaker 1: the fact that opioid manufacturers disseminated false claims regarding the
Speaker 1: risks and benefits of opioids for the past twenty five
Speaker 1: years points to a dereliction of duty by the U s.
Speaker 1: Food and Drug Administration, the f REAL agency charged with
Speaker 1: regulating pharmaceutical companies. The FDA's regulatory failures with respect to
Speaker 1: opioids have not gotta noticed. In two thousan seventeen, the
Speaker 1: President's Commissioned on Combating Drug Addiction and the Opioid Crisis
Speaker 1: found that the opioid crisis was caused in part by
Speaker 1: inadequate oversight by the Food and Drug Administration, and the
Speaker 1: National Academy of Sciences publicly called on the FDA to
Speaker 1: overhaul its opioid policies. Last year, a former FDA commissioner
Speaker 1: rebuked the agency he had previously led, saying on the
Speaker 1: television program Sixty Minutes that the FDA it was wrong
Speaker 1: to allow the promotion of opio d s for chronic pain.
Speaker 1: Maybe a little late on that one, buddy, You know,
Speaker 1: better late than never, right, you know that? In this case?
Speaker 1: Really that's that's kind of like going drunk driving killing
Speaker 1: six people and then getting on the news and be like,
Speaker 1: you know what, drunk driving people shouldn't be doing that. Yeah,
Speaker 1: it's bad. It's bad. It's like drunk driving and killing people,
Speaker 1: hundreds of thousands of people for decades and hundreds of
Speaker 1: thousands of people, wiping out entire towns and then just
Speaker 1: going on TV going you know, it's bigger than just me. Yeah,
Speaker 1: this is really a systemic problem because the roads I
Speaker 1: use are everywhere to drive through neighborhoods. Yeah, if you
Speaker 1: think about it, the taxpayers just as part of this,
Speaker 1: you know, you with the making roads mean, with the
Speaker 1: drunkenly driving through intersections and hitting groups of children, killing
Speaker 1: up for the bus. You know, everybody's a part of
Speaker 1: that bus driver stopping for those kids is a part
Speaker 1: of this. You know, no one's hands are clean. Nobody stands,
Speaker 1: So let's stop playing the blame game. You know, why
Speaker 1: don't have to blame people every time I kill six
Speaker 1: hundred thousand Americans. So you might expect all of this
Speaker 1: potent criticism from like again the president pretty big names
Speaker 1: saying the f d A has a problem with the
Speaker 1: way it approves opioids. You might expect that to lead
Speaker 1: the sub changes. But FDA policies for approving and labeling
Speaker 1: opioids remain basically unmodified. As the Journal of Ethics write
Speaker 1: up notes, the agency has refused to undertake a root
Speaker 1: cause analysis to determine what regulatory errors contributed to the
Speaker 1: opiate crisis. Instead, they've closed ranks and sought to defend themselves.
Speaker 1: When Senator Maggie Hassan criticized the agency, the FDA Drug
Speaker 1: Evaluation Director responded by claiming the agency had properly enforced
Speaker 1: the Food, Drug and Cosmetic Act when it approved produced
Speaker 1: new extended release oxycodone in Now that's a lie, Matt,
Speaker 1: not just because it turned out to be bad, but
Speaker 1: because they broke the law when they approved it. If
Speaker 1: they had followed the law, the pills would have been
Speaker 1: listed as having a narrow indication. Um, it's kind of
Speaker 1: what we talked about the schizophrenia mids. This should be
Speaker 1: used in a few specific conditions, acutely right, I only
Speaker 1: be prescribed in limited duration for specific issues. Instead, the
Speaker 1: drug received a broad indication, which allowed perdue to be like, oh, yeah,
Speaker 1: this is good for back pain. You take some of
Speaker 1: this ship Ye, you got a slight headache? Yeah, pull up,
Speaker 1: pull up your car, we'll fill your trunk. Well Senate
Speaker 1: direct to your house, dude, don't worry about don't worry
Speaker 1: about it. Yeah, it's it's so fucking evil because it's like,
Speaker 1: you know, chronic pain is a thing. Are incredibly useful
Speaker 1: for treating people with chronic pain, and there are people
Speaker 1: out there who do need it, and and so it's
Speaker 1: like I'm not one of those people's like oh, putes
Speaker 1: are all bad and whatnot. What's fucked up is to
Speaker 1: make it into something that you would take, like you
Speaker 1: would give it out, like it's fucking Highland. All need
Speaker 1: it for chronic pain, most kinds of long term pain.
Speaker 1: There's better ways to deal with it, and like you
Speaker 1: don't actually solve that. You can actually make it better
Speaker 1: if you go into like therapy and stuff and you
Speaker 1: aren't medicating it away, which leads to it's yeah, there's
Speaker 1: we talk about all this in the Sackler episodes. Um
Speaker 1: so I'm going to quote from that a m A
Speaker 1: Journal of Ethics right up again to talk about like
Speaker 1: how illegal it was for the FDA to give this
Speaker 1: broad approval. And it doesn't too face with evidence that
Speaker 1: opioid prescribing had risen beyond levels that could be clinically warranted.
Speaker 1: The FDA convened an advisory committee meeting of tin outside
Speaker 1: experts and asked if the broad indication on opioid label
Speaker 1: should be narrowed to prohibit marketing for common chronic pain conditions.
Speaker 1: Eight of these experts had financial ties to pharmaceutical companies,
Speaker 1: including Perdue, and advised the FDA against narrowing the indication.
Speaker 1: An opportunity to reign in over prescribing early in the
Speaker 1: crisis was lost, and by two thousand thirteen, enough opioids
Speaker 1: were prescribed to provide every adult in the country with
Speaker 1: a full pill bottle. That's so funny. So it's ridiculous
Speaker 1: how many fucking opiates we flooded in, Like the fact
Speaker 1: that we have a bigger problem with opiates now than
Speaker 1: when you could buy morphine at the drug store. It
Speaker 1: should say something. It does. I'm sorry that it says something.
Speaker 1: It's like it's one thing to have it like available
Speaker 1: over the counter, and people discover it and they are
Speaker 1: able to take it. It's problems some of them will
Speaker 1: if your doctors you have to take this forever. Now,
Speaker 1: this is great for you to take forever, and then
Speaker 1: you get horribly addicted, and then the doctor says, actually, no,
Speaker 1: we found it. It's bad and you can't take it anymore,
Speaker 1: and then you wind up buying fucking heroin, like exactly, exactly,
Speaker 1: man um. Yeah. Now, the Food, Drug and Cosmetic Act
Speaker 1: requires that adequate and well controlled studies be conducted before
Speaker 1: products can be approved as safe and effective. The FDA
Speaker 1: generally requires two randomized trials demonstrating efficacy for approval. There
Speaker 1: are a lot of problems with this process, but it
Speaker 1: was not even followed in the case of oxycodone. They
Speaker 1: approved oxy for chronic pain based on a two week
Speaker 1: clinical trial and osteoarthritis patients. Yeah, that should be enough time.
Speaker 1: People don't live longer than two weeks, do they. It
Speaker 1: takes me twenty four hours to realize whether or not
Speaker 1: or opiate is good or not. I just try it out.
Speaker 1: I have a human test subject. So yeah, you take it,
Speaker 1: and you're like, yeah, that's good. Give it everyone, Give it.
Speaker 1: Give it to every man, woman and child in the Midwest.
Speaker 1: Oh my god. You know what empty the swimming public
Speaker 1: swimming pool with pills just failing with oxy is extended release.
Speaker 1: We'll just dive into it like a fucking junkie. Scrooge McDuck.
Speaker 1: So for the next twenty five years is the opiate
Speaker 1: crisis sparked off and then deepened? The FDA continued to
Speaker 1: approve new opioid formulations for chronic pain via the same
Speaker 1: shoddy lack daisical controls, and two thousand six the agency
Speaker 1: moved to a new methodology for conducting efficacy trials on opiates.
Speaker 1: This new methodology, enriched enrollment randomized withdrawal, or e er W,
Speaker 1: became their primary method of determining evidence of opioid efficacy
Speaker 1: for chronic pain. E er W trials are not standard
Speaker 1: double blind, randomized controlled styles, and here's the A m
Speaker 1: A again. In an e er W trial, Prior to
Speaker 1: randomization for a double blind phase, all subjects are made
Speaker 1: physiologically dependent on the opioid and a fourd to six
Speaker 1: week open label phase. Then only the patients who tolerated
Speaker 1: the opioid and found it helpful during the open label
Speaker 1: phase are randomized to remain on the opioid or switched
Speaker 1: to a placebo. Critics of vra W have have correctly
Speaker 1: described this methodology as cooking the books for two reasons. First,
Speaker 1: because only patients who tolerateed the opioid and found it
Speaker 1: helpful are allowed to proceed to randomization. The study is
Speaker 1: not representative of the general population and the results cannot
Speaker 1: be generalized to clinical practice. Second, because daily use of
Speaker 1: opioids causes physiological dependence, efficacy studies are skewed in favor
Speaker 1: of the subjects who remain on the opioid. This is
Speaker 1: because opioid dependent subjects who are switched to placebo experienced
Speaker 1: opiate withdrawal symptoms, including increased sensitivity to pain. Moreover, switching
Speaker 1: opioid dependent subject to placebo renders the study not double blind. Boy,
Speaker 1: all these addicts really like opius. It seems like it works,
Speaker 1: you know. And here's how you know it works is
Speaker 1: when you stop giving it to them, they get fucking weird.
Speaker 1: They don't like it at all. It must mean it's helping. Crying,
Speaker 1: it's helping. Clearly you gotta take it or else you
Speaker 1: start did they just start crying and being in pain? Man,
Speaker 1: that's weird. Nanatin alcoholics says it makes them a better driver. Exactly. Man,
Speaker 1: oh I love that. That is like such a such
Speaker 1: like an evil thing to do. It's really fucked up, right,
Speaker 1: So evil, Like the amount of people who like just
Speaker 1: got addicted to this thing because they were just like,
Speaker 1: you know, cooking the books on this test too and
Speaker 1: fucking But I would have loved to have been a
Speaker 1: part of that study. Yeah, yeah, I just check it
Speaker 1: out a little bit. I don't know. So the a
Speaker 1: m a Journal of Ethics article that blames the FDA's
Speaker 1: decision to rely on e er W as a consequence
Speaker 1: of their clothes, some would say, incestuous ties to the
Speaker 1: pharmaceutical industry. It turns out that that the decision to
Speaker 1: use e er W had been based on a series
Speaker 1: of private meetings between FDA officials and pharmaceutical executives hosted
Speaker 1: at a conference called Impact with two ms, it's an acronym.
Speaker 1: You don't need to know what it's for. The drug
Speaker 1: companies that attended Impact each paid thirty five thousand dollars
Speaker 1: to meet directly with FDA staff. So they have a
Speaker 1: big meeting where these guys pay, and money goes to
Speaker 1: the FDA officials who were invited guests. I don't see
Speaker 1: oh that's a problem, Robert. I don't see that as
Speaker 1: a conflict of interest. No, that's totally normal. It's like,
Speaker 1: fucking listen, it's it's a donation. Yeah, you know, and
Speaker 1: if you don't want to donate, you don't get access. Now,
Speaker 1: when this information dropped, there was a lot of complaints
Speaker 1: about this is being like, oh, it seems like rank
Speaker 1: crony ism is why this is the method by which
Speaker 1: we determine whether or not opiates are good. Despite all this,
Speaker 1: the FDA continues to rely on E er W for
Speaker 1: approving opiates, and as the yeah, yeah, I know, they
Speaker 1: ain't changed that ship, at least not as of the
Speaker 1: writing of that article. Yeah it's cool, it's good ship.
Speaker 1: So as the a m A Journal of Ethics details,
Speaker 1: the crony ism does not stop here. Quote. For example,
Speaker 1: the two principal FDA reviewers who originally approved produce oxycodon
Speaker 1: application took both took positions at Purdue after leaving the agency. Hey,
Speaker 1: that's just a cool. Yeah, that's just a weird kinky dink.
Speaker 1: Listen your email and all your ex contacts and you're
Speaker 1: just like, hey, do you have like a job with
Speaker 1: a fucking seven figure salaries here? And I don't want
Speaker 1: to like go in you know, if that's possible, Yeah,
Speaker 1: if you could just you know you could. I'll write
Speaker 1: it off of my taxes as hush money. Yeah, I'm
Speaker 1: gonna continue that quote. Over the past twenty years, several
Speaker 1: other FDA staff involved in opioid approvals also left the
Speaker 1: FDA to work for opioid makers. Last January, the head
Speaker 1: of the FDA's analgesic division retired from the FDA to
Speaker 1: start her own consulting business, which promises drug makers help
Speaker 1: to successfully and efficiently bring your products to market. With
Speaker 1: more than thirty years of experience at the f D.
Speaker 1: A but that's fine, that's legal. You know, it's good.
Speaker 1: I mean, you know, you get the inside track on
Speaker 1: how to get people opiates. Yeah, And obviously this is
Speaker 1: how the whole government works, right, But it didn't used
Speaker 1: to be how the FDA works. And I should note
Speaker 1: that the revolving door, as this article states that states
Speaker 1: the revolving door between the FDA and the pharmaceutical industry
Speaker 1: is not just opiates. Two eighteen study found that eleven
Speaker 1: of sixteen FDA medical reviewers involved in approving twenty eight
Speaker 1: products now work for the companies whose products they regulated. Wow,
Speaker 1: it's good stuff, right, it's fine, it's it's great. I
Speaker 1: mean it's just it's so blatant. This is why, like I, oh,
Speaker 1: this is every time I came on this podcast. Man,
Speaker 1: I lose faith in humanity. But some version of this
Speaker 1: would still be happening if they'd never moved to a
Speaker 1: fact where like the f d A is half funded
Speaker 1: by pharmaceutical company applications. Right, correction, it's endemic. But this
Speaker 1: I think that really sped up the process. It's had
Speaker 1: an impact, right, it's very clear to see in the data. Um,
Speaker 1: And it's now the relationships are built on money already,
Speaker 1: and you have like people, you know, it's one thing
Speaker 1: to spend earty years like being completely fucking government funded
Speaker 1: and just telling people no, no, no no on their
Speaker 1: applications not you know, fucking I have no financial ties
Speaker 1: to them. But now you have like kind of a
Speaker 1: sugar daddy that who's going to be courting you and
Speaker 1: has been paying my salary. You know, why shouldn't I
Speaker 1: go to work for the right? Why is this any different?
Speaker 1: And I know this guy, know, Roger over at fucking Fiser, Like,
Speaker 1: wouldn't I work there? He's been paying me since fucking
Speaker 1: day one? Yeah? Yeah, And the f d A is
Speaker 1: complicity with both the opioid crisis and the vi X
Speaker 1: disaster have the highest definite body counts for sure, um,
Speaker 1: but some of the ways that they've really that the
Speaker 1: FDA is really fucked up are less obviously deadly, but
Speaker 1: still very unsettling. Now, if you'll remember, the whole reason
Speaker 1: we have an FDA is because Harvey Wiley was pissed
Speaker 1: that all kinds of foods and drugs and quack tears
Speaker 1: were being shoved full of random horrible ship that was
Speaker 1: not listed in the product, and people didn't know what
Speaker 1: they were getting, right. That's why we got an f
Speaker 1: d A. Is a bunch of people, Harvey Wiley and
Speaker 1: others were like, this seems bad. The main, the primary
Speaker 1: goal of the f d A was to make sure
Speaker 1: people know what the funk they're putting in their bodies,
Speaker 1: right at the end of the day. That's the number
Speaker 1: one reason we have the FDA, to know what you're
Speaker 1: putting in your body and what it does to you.
Speaker 1: G R a S is an acronym that stands for
Speaker 1: generally recognized as safe. This is a category the FDA
Speaker 1: created for food additives that might be stuck in new
Speaker 1: products without being specifically approved but that don't need any
Speaker 1: specific additional approval because they're generally recognized as safe. Now,
Speaker 1: this starts again from a pretty reasonable place. It's so
Speaker 1: that like, if you're making a processed meat, you can
Speaker 1: add vinegar or salt to it, and you know if
Speaker 1: to like get approval from meat with vinegarrants because we
Speaker 1: know what vinegar and salt do? You know what the meat?
Speaker 1: It's fine, you can stick it in there right. Um,
Speaker 1: So I'm gonna quote from NPR again quote. Over time,
Speaker 1: companies have found that it's far more efficient to take
Speaker 1: advantage of the exemption to get their products up on
Speaker 1: shelves quickly. Some of these products contain additives that the
Speaker 1: FDA has found to post dangers, and even ingredients the
Speaker 1: agency has agreed r g R g r A s
Speaker 1: are now drawing scrutiny from scientists and consumer groups that
Speaker 1: dispute their safety. Critics of the system say the biggest concern, however,
Speaker 1: is that companies regularly introduce new additives without ever informing
Speaker 1: the f d A. This means people are consuming foods
Speaker 1: with added flavors, preservatives, and other ingredients that are not
Speaker 1: reviewed at all by regulators for immediate dangers or long
Speaker 1: term health effects. The vast majority of food additives are safe. Somehowever,
Speaker 1: have proved to cause serious allergic reactions or other long
Speaker 1: term health effects. Now a good example of this would
Speaker 1: be micoprotein. This is a kind of fungus product used
Speaker 1: to add protein to vegetarian foods. It counts as g
Speaker 1: R A S, but there's a bunch of lawsuits right
Speaker 1: now that allege a significant number of people have had
Speaker 1: really negative allergic reactions to microprotein, some of them anaphylactic
Speaker 1: shock um, which is mean nobody should take it, but
Speaker 1: it means like it's shouldn't be listed as generally recognized
Speaker 1: as ship as safe if a lot of people have
Speaker 1: like allergic reactions to it. And flexus is incredibly dangerous. Yeah,
Speaker 1: and the the FDA did eventually revoke it's g R
Speaker 1: A S status in two thousand eleven, but a lot
Speaker 1: of people had to get sick. Person. It's kind of
Speaker 1: an example of how like you can just kind of
Speaker 1: shoehorn this stuff in. It's a loophole and it's not
Speaker 1: watched that closely. Probably the most serious problem with though,
Speaker 1: is with all the weird preservatives being stuck into foods. Again,
Speaker 1: most are benign. Most preservatives are, as far as we know, benign.
Speaker 1: But g r S exemptions mean that we don't really
Speaker 1: have data on how a lot of this stuff affects
Speaker 1: children differently, or whether or not it builds up in
Speaker 1: the body. And I'm not trying to be like hippie dippy, like, oh,
Speaker 1: no preservatives in your food. Man. Stuff is necessary, but
Speaker 1: we should know what it does, and we shouldn't call
Speaker 1: it safe or put it in everything unless we have
Speaker 1: really good data that it's safe. Like you know, we're
Speaker 1: going backwards here. We already established we want to know
Speaker 1: what's inside. Like whiley, I'm not against preservatives or even
Speaker 1: chemicals and food, I eat all sorts of chemicals. We
Speaker 1: should know what they do. Just like it's like it's
Speaker 1: so important. Yeah. I found a recent study by the
Speaker 1: Environmental Defense Fund that looked through eight hundred and seventy
Speaker 1: seven g r A S notices by the f d
Speaker 1: A and found that only one of them was for
Speaker 1: an additive that the manufacturer had done a cumulative effect
Speaker 1: study on this is like determine whether or not it
Speaker 1: builds up in the body and could be harmful. One
Speaker 1: out of eight hundred and seventy seven had they had
Speaker 1: had this done. And this isn't optional, These are required
Speaker 1: by law. You have to do this. One out of
Speaker 1: eight hundred and seventy seven that the FDA had approved
Speaker 1: had actually done this, As the e d F notes quote,
Speaker 1: We found no evidence that the agency either recognized this
Speaker 1: single attempt to follow the law or had objected to
Speaker 1: the emissions and the eight hundred and seventy six other notices.
Speaker 1: They're just sucking Robert stabbing this ship. They don't give
Speaker 1: a fuck. Yeah, they don't even force them to pinky swear.
Speaker 1: They're just like they get money for every one of
Speaker 1: these applications. You know what. You don't want people to
Speaker 1: not send in an application if they haven't done the research.
Speaker 1: You want that fucking box. She's baby Jesus. Well, you
Speaker 1: know that's uh, it's good, that's fine, It's it's all
Speaker 1: really again, this is like anti f DA and that
Speaker 1: there's huge problems with the FDA, But like we need
Speaker 1: an f d A what it's called, But we need
Speaker 1: an agency doing that, right, Like that's why we started
Speaker 1: with like plamide. This is an absolutely necessary part of
Speaker 1: any society, vaguely similar to the one we live in.
Speaker 1: But we've we've broken it, We've allowed it to become broken,
Speaker 1: and it it doesn't work great, and it's a really
Speaker 1: dangerous thing to have as a corrupt organism. And again
Speaker 1: there's like as that we we quoted from that that
Speaker 1: FDA researcher who was like, you know, has been howling
Speaker 1: about box and stuff, and it's like, yeah, it's um,
Speaker 1: there's most I'm sure most of the people trying to
Speaker 1: do those jobs are are fucking rad and even I'm
Speaker 1: sure mostly people who wind up joining the pharmaceutical industry
Speaker 1: they're not thinking like ha ha ha no, but it's
Speaker 1: like they there should be a bias towards distrust and
Speaker 1: dislike of the pharmaceutical companies by the scientists you doing
Speaker 1: this right, Like they should be untrustworthy of them, you know, right,
Speaker 1: I expect the pharmaceutical companies to lie about ship. That's
Speaker 1: what they do. They're salesman, you know, they're like we
Speaker 1: they make they fucking patent just random compounds or like
Speaker 1: does that do anything. No, it's like basically just trying
Speaker 1: out a bunch of things to see if it makes
Speaker 1: your dick hard. And then eventually they'll just be like yeah,
Speaker 1: that makes your dick hard. You need an agency that
Speaker 1: takes the medication and goes like, my dick is still soft.
Speaker 1: You can't just pay someone to be like, yeah, I
Speaker 1: don't know enough. People's dicks got hard. You gotta know
Speaker 1: that it gets you bricked up, Robert, Yeah, it's it's
Speaker 1: you've got. You gotta know that. It allows you to
Speaker 1: fucking lay some goddamn pipe, you know pipe. That's right,
Speaker 1: that's right, that's what when America was great, we knew
Speaker 1: that was what the the FDA was for. Now, yeah,
Speaker 1: you goddamn right. Um, So I don't know, you know,
Speaker 1: I I would like to have an FDA that it
Speaker 1: does not have the problems of our current f d A.
Speaker 1: I don't think that's too much to ask of society.
Speaker 1: There's a lot of a lot of our problems are
Speaker 1: kind of intractable and difficult to figure out a solution too.
Speaker 1: But like, yeah, we should probably have like they should
Speaker 1: probably be advocates for us and not totally wing of
Speaker 1: the pharmaceutical industry. I mean, honestly, it's like weird for
Speaker 1: us to be going backwards on such like an obvious
Speaker 1: fucking thing. It's, uh, we don't want to drink the
Speaker 1: poison milk, and uh, we don't want people pushing a
Speaker 1: bunch of fucking drugs that don't work or funk up
Speaker 1: your life. Yeah, those would be you just go back
Speaker 1: to the Francis days. She was dope. Let's let's hire
Speaker 1: a bunch of people like her and give them all
Speaker 1: very large salaries to be distrustful of the pharmaceutical industry.
Speaker 1: That's like their job, that's the whole job. And we
Speaker 1: spend so much money on stupid ship. We could have
Speaker 1: a we could have a sufficient at least sized team
Speaker 1: of people to to to distrust the pharmaceutical industry professionally
Speaker 1: for the price of a couple of f thirty five
Speaker 1: yeah right, literally two less fucking you know, just jets
Speaker 1: that that bomb Yemen, you know, Yeah, and we we
Speaker 1: take money away from them when they let a drug
Speaker 1: through that kills way more people than reasonable as like
Speaker 1: you know, some side effects, and then then we're bribing
Speaker 1: them to make sure we don't die. Exactly. That's literally
Speaker 1: how it's supposed to work. I mean, just yeah, we
Speaker 1: should be you know, we should be making money off
Speaker 1: of UH, or the FDA should be making money off
Speaker 1: of destroying these pharmaceutical agencies as soon as they fuck up.
Speaker 1: That's what I say. Yeah, I would be sick. That's
Speaker 1: one way to tie it. Tie it in. Wow, Boxy
Speaker 1: sucks and suck it. Well, Matt, do you have any
Speaker 1: plugables for us? Um? Yeah, try it. I'm just kidding. Uh.
Speaker 1: Pod yourself a gun. Uh. The World's Only Sopranos podcasts
Speaker 1: and the film Drunk frodcast me and Vince Vncini talking
Speaker 1: about movies, talking about just life in general. Matt Leap
Speaker 1: jokes on Instagram. I love you guys. Oh well, you
Speaker 1: can find me nowhere. But I have a novel that
Speaker 1: you can pre order, and if you pre order it,
Speaker 1: you'll get assigned a copy. Just google a k press
Speaker 1: after the revolution, order a book now, it will come
Speaker 1: to you with my signature in it. That's pretty neat. Um.
Speaker 1: We also have a live show we do on February
Speaker 1: sevent The ticket info will be in the episode description,
Speaker 1: or you can go do allegedly. I'll do it allegedly
Speaker 1: in the episode description. Dot com slash pot of Bastards allegedly.
Speaker 1: All right, Well, until next time, you know, skim the
Speaker 1: cream off some milk, fill it up. With water, pour
Speaker 1: some worms in there, and you know, I breakfast a
Speaker 1: little bit of cowbrains, get some extra protein up in there.
Speaker 1: You know, you get to gottle grains. You think that's right,