Part One: The Vioxx Scandal: How Big Pharma Killed More Americans Than Vietnam - podcast episode cover

Part One: The Vioxx Scandal: How Big Pharma Killed More Americans Than Vietnam

Dec 10, 202458 min
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Episode description

Robert sits down with Dr. Kaveh Hoda to talk about Vioxx, a pain medication released by pharmaceutical giant Merck even though they knew it caused fatal heart attacks.

(2 Part Series)

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Transcript

Speaker 1

Also media, Welcome back to Behind the Bastards, a podcast where Sophie is not in the room right now. So doctor cave Hoda and I are are the foxes watching the hen house? That is also we're we're also the hens.

Speaker 2

I am the producer, I am the captain.

Speaker 1

Now we're like hin foxes, like like a cat dog situation. Although I imagine a hen fox. The fox is just going to try to eat it's hin. That's part of its butt, I imagine.

Speaker 2

I love your quaint country colloquialisms. It's great. I don't know what they mean.

Speaker 1

But oh yeah, you're probably too young for that cartoon. I was the right age for it.

Speaker 2

Now.

Speaker 1

Yes, doctor Hoda miser care expert legally my doctor, Do you have any do you have any theories that you can't prove, that are unprovable, that are probably nonsense, that you nonetheless believe about health? About health? Yeah, yeah, I got a lot.

Speaker 2

As a doctor. I feel like I should. Uh you know, I will talk to you at great length about how supplements are a fantastic waste of time. Uh And I will tell you in detail, and I have on many episodes why they're more dangerous generally than they are good and you should only use them with strict instructions from your physician. But that being said, I feel like ginger really helps me in like a power up way that

it doesn't. I know it doesn't, but I love it, and the placebo effect is so strong for me that, you know, Yeah, Ginger's my magic thing, my little magic creation in my mind that works more than it really does.

Speaker 1

Yeah, I'm not big on supplements. I do take my doctor advised me to take for blood pressure, calcium and potassium.

Speaker 2

Uh so I do.

Speaker 1

I do. I do some of that, which I've noticed I don't get cramps as much as I used to, So I guess I guess I'll call that a win. I do love looking it into the different potential side effect. I love going on to like biohacking subreddits and seeing people talk about like the side effects they're having with with various weird supplements they're taking to never die. Although

my favorite is the Lion's Main subreddit. So Lion's Main is like a mushroom that does have like some it does have like an effect on your your your brain right, Like there's there's actually some like studied benefits of Lion's maine. But it's like it's a pretty mild supplement, but there's this group of people who are convinced that like taking it once has like destroyed their life in the way that like a huge dose of psilocybin. Mushrooms might have

like mind alter effects. And it's like, man, everyone at people, I don't put like it in their smoothies.

Speaker 2

I don't.

Speaker 1

I don't think it's the fucking lions main that's giving you nightmares for the last seven years of your life.

Speaker 2

I mean that is that is That's the kind of thing I hear a lot about, Like every medication you name it out there, someone has had someone blames that medication for their life being in shambles. Yeah, and you know it's medication we're talking about today. Lots of risks, It's true. They all they all do some more than others. I think we're probably going to discuss here. But uh, yeah, I don't know if Lion's maine, which I'm not familiar with, really so it's us.

Speaker 1

It's a mushroom, you know, it's got you know, some mushrooms have like, uh neurological impacts and stuff on people. But you know, my My particular favorite medical theory, doctor doctor Hoda is that obviously cigarettes are bad, terrible for for almost everyone, nearly always horrible. But I think there's a slightly less than one percent of the population that have a genetic abnormality that makes cigarettes make them live forever. Because every now and then I'll meet you know, sometimes

in like little corners of the world or whatever. I've met f like little old ladies in Japan or like ninety six, and they're like, yeah, I've been chainsmoking cigarette since I was like eleven years old or something like that, and it's like, clearly it works for you. Like there's some some minority of the population that cigarettes make and vulnerable.

Speaker 2

I feel like this is that meme of the plane that returns from war with the bullet holes. You're never gonna hear me say cigarettes are okay. They know what they've done, they know.

Speaker 1

I know they've killed They've killed uncountable more people than war in the twentieth century, and war killed so many people in the twentieth century. But every now and then I'll meet some like ninety year old woman who smokes four packs a day and she's doing fine. So clearly clearly science doesn't understand everything about the maligned cigarette.

Speaker 2

Don't smoke cigarettes, okay enough.

Speaker 1

Don't vape o vape that's the one that worries I mean, like, especially since all of my friends vape heavily. It's one of those like, yeah, but it's got to be doing something right, Like it's got something.

Speaker 2

Like oh, for sure, for sure, I'm a huge fan of vaping. Either there is harm reduction. There's a good argument about that, but I'm not You're not going to see me promote vaping either.

Speaker 1

That said, you know, when we get into the whole what is it responsible to tell people to do or not? A lot of times the greatest harms are things that people like cigarettes, were told by their doctors are great for them. And today we're going to tell one of those stories, a story of a drug that became the lead seller for a major pharmaceutical company that was backed by an alliance of physicians who had shall we say, some you know, financial interest in finding that this thing worked.

Today we're talking about vox, which is I think an infamous name now in the annals of medical science. People tend to know what I'm talking about. But if you don't this killed more Americans than the Vietnam War. Like that, that's the story we're getting into today. What do you know about ViOS.

Speaker 2

You know, I was too young to really be I wasn't really practicing medicine when it happened, but I did know about it, and I've heard some about it since then. I'm really very fascinated by the story and I'm really looking forward, yeah to getting into it today. So I'm excited about that. I will say I think it was It feels like a turning point in regards to how people looked at pharmaceutical companies. I think it was really like a sentinel event in that, Like I think doctors

were always skeptical of pharmaceutical companies. We still are, but I think that was when people started to become cynical. That change started. It's because of what happened with Viox and VIAX.

Speaker 1

I think it's also important, Like Vias, the scandal hits kind of right as you know, before we're really starting to realize what has gone down with the h with the prescription painkiller epidemic, like when that's starting to really take off and we start to realize how fucked up some of what Purdue did. And so this one two punch, it really is responsible. I think that's very salient what

you said. It's really responsible for a lot of I mean, for like RFK is about to be the director of Health and Human Services right, Like it has a lot to do with that, because this is hard for people to imagine, Like folks my age, I have always grown up with big Pharma being like the devil, right in part because like as soon as I turned eighteen nineteen, I was hanging out with a lot of hippies, but in part because like there were a lot of like

really really high body count pharmaceutical company scandals, and it is hard for some people to remember that, like, pharmaceutical companies used to be very popular and well regarded in a lot of cases, in part because the generation, the generation that was kind of running the world in the eighties and nineties had largely lived through like and we're still close to Oh, polio is this nightmare that just

sweeps through and devastates like a generation. You know, you have these flues and then suddenly you have half as many friends after the flu passes and that stops being a thing. And they're really the first generation you know, kind of the later boomers that didn't have to deal with that, but we're close enough to it to like really appreciate, like, Wow, medical science did us as solid.

Speaker 2

Yeah, And we've drifted just far enough from that now that people have forgotten and revising whole parts of history.

Speaker 1

And I mean part of the problem is that shit like the Vox scandal and like the produe pharmaceutical scandals are closer to us than for example, fucking people being an iron lungs or whatever.

Speaker 3

You know.

Speaker 1

Recency bias is a hell of a thing. But since time immemorial, mankind has struggled against a terrible and implacable enemy, pain. Luckily for us, mother nature has provided a perfect painkiller, opium, that could be used as the basis for a variety of excellent medicines that really do exactly what they say they're going to do. Unfortunately, these medicines come with a downside, which is that when you start taking them, you might

not ever want to stop taking them. For some people, this destroys their life and take a sip of my cratem tea. And since all the all the health cops out there don't like people pill popping, like doctor House even though he made it look incredibly sexy. Did he.

Speaker 2

Hate that show?

Speaker 1

Oh man, you're not not a house fan. Huh No, it's just so ridiculous.

Speaker 2

I mean, all of those shows, Scrubs is the only one that's watchable for me.

Speaker 1

Scrubs. Really yeah, I mean I did rewatch. I like to imagine that the movie Platoon is like a like the the what you might call it the prequel, the prequel.

Speaker 2

Toy said it.

Speaker 1

Yeah, that's why doctor Cox is the way he is. He had to spend that night hiding under his friend's bodies in a trench line. You had to watch Willem Dafoe die. Spoilers for the movie Platoon, which is older than most of you, might be illder than me. I don't remember when Blagin came out anyway. So because of you know, health cops don't like people becoming horrible pill

addicts and destroying their lives. There's a market, a massive market for anyone who could create a thing that is an effective painkiller that doesn't also inspire people to break into cars for drug money. Right, there's a lot of money and a painkiller that does not have the kind of abuse potential that opiates have. A Ceda medaphin was discovered back in the eighteen eighties, but it took us intol the nineteen forties to actually figure out how to use it as a drug. And for reasons that are

more complex than it's really worth getting into. Because of how it was discovered, a ceda medaphin could never be patented right, which means pharmaceutical companies are not super attracted to a ceda medaphin right because like, well, you know, you can't only sell it for so much of every one can make the damn thing. This meant that pharmaceutical companies had to get creative marketing it in order to make it profitable. As a result, tailand All became a

foundational part of the marketing drugs story. McNeil, the company that started selling acid of metaphine in the US, initially framed it as a painkiller for children. And the way the ad campaign that they use is very weird for some reason, and I've never found out why, but for unclear reasons, they had a huge number of toy fire trucks and the way that they first sold Thailand all was they like stuffed fire trucks to the brim with

pills of tailan All and like made that. That was their marketing ploy to like get little parents to buy tilant All for their small show.

Speaker 2

Always love fire trucks. Kids love Thailand All too. They love their Tilan Hall, they love their living damage, and they love their fire trucks. This is a thing about kids.

Speaker 1

This is why I'm going to try to make the chief Christmas toy of this season the little Doctor House pill popper set where because kids, you can take as much tilt All as you want.

Speaker 2

Right, you'll be like a big cane. That's dispenser, right, and that's your little house toy for kids.

Speaker 1

Takes your little house toy for kids. Yeah, now this worked better than any it had any right to work. Advertising was easier back then. I imagine today if you tried to sell parents on a chat, which is like a firetruck Philip Bills, I don't know this would make me feel good about any of this, But you have to remember so jaded.

Speaker 2

Now that's a problem. We're jaded.

Speaker 1

We're jaded, and like, prior to Thailand All, the chief method of dealing with pain for small children was to give them a spoonful of heroin and hope they woke up the next day right like. They literally sold it as a cough medicine for children. So the fire truck plan worked well. It worked so well that McNeil gets bought by Johnson and Johnson. And that's actually when it gets the name thailand All. McNeil's not selling it under tiland All Johnson and Johnson, which, for whatever reason is

a great name. I don't know why. Doesn't make much sense to me. Easier remember, Yeah, So, in subsequent decades, tailand All was found to be useful in numerous medical applications as a painkiller, a fever reducer, and about a million other things. It was joined in the mild painkiller category by Bear's aspirin, which had its roots in herbal medications that had been used by peoples around the world

since time immemorial. The Assyrians and Sumerians had actually been using willow leaves as treatments for various ailments, and a variety of plants containing sallasitic acid have been used in similar ways all over the globe. So Aceta metaphine and aspirin both quickly became foundational pieces of any medicine cabinet,

but they weren't perfect. One issue that both painkillers had is that they could interact with other drugs or just interact badly with certain patients to cause substantial stomach distress. In the most severe cases, this could result in stomach

ulcers and sometimes life threatening stomach ulcers. So, you know, this is one of these problems, is like you want to be able to give people as much of this as they need because it's you know, non adict diven helps with a lot of things, but there's some hard limits based on what this does to people's stomachs well and livers.

Speaker 2

I mean menafin, Yeah, you know, that's worldwide one of the biggest causes of liver failure from people taking too much a cedum, menaphin, and and then yeah, these other nonstroidal anti inflammatory drugs. They're the kind of thing that make me a gastro introologist have to go in the middle of the night to go put a scope into someone's stomach because they're bleeding a ton in the setting of you know, somebody's who's swallowed too much advil or something like a leave or something.

Speaker 1

Yeah, and I think that probably doesn't didn't make it as much into my research, just because in the seventies they didn't have as much data on that made sure they all they're all focused at least on the ulcers. But yeah, like the there's a there's a great bluegrass song called codeine with the lyrics Codeine, Codeine, You're the

nicest thing I've seen for a while. And if you know anything about codine, it's the worst of the painkillers to get high on, which makes the song better because if you are the kind of person for whom like codeine is the nicest thing you've ever encountered, your life has been a hard life.

Speaker 2

Yes, you have had a bad light.

Speaker 1

So by the late twentieth century, pharmaceutical researchers had started poking around both compounds to try to find ways to create new variants that didn't have any of those downsides. They called these hypothetical medications super aspirins, because research pharmacologists

aren't great at naming things terrible, terrible, terrible. The quest for a super aspirin seems to have really started in nineteen seventy one when a gaggle of British researchers, I think that's how you term a group of researchers tried to unravel the mystery of why aspirin and thailand all work. Again, we knew these things were good painkillers, and we knew they did other stuff. The method of action was unclear to us at this point, which is a startling amount

of the time. True with drugs. There's a lot of medications you might be on that the doctors don't precisely know why it does what it does. We have somebody, but like a.

Speaker 2

Lot of this is still being you want to know. Yeah, with a lot of things we do in medicine that we yeah, were we just they seem to work, it doesn't.

Speaker 1

It definitely helps. We're not sure why. But in this case, the research research board fruit. As author Tom NeSSI describes in his excellent book Poison Pills quote, when an injury takes place in the body, chemicals known as prostaglandins rush into the wound site to deal with the swelling, heat, and pain. Prostaglandins have important functions for human well being. They play a part in ovulation, to protect the stomach from acids and to ensure that blood clots normally. The

latter effect explains why asprom reduces heart disease. It prevents clumps of blood from forming that can potentially block an artery. Prostaglandins actually make nerve endings more sensitive to pain. N s A I, d's in, SAIS and insetes.

Speaker 2

Yeah.

Speaker 1

Insades reduce the production of prostaglandin and thereby relieve the pain associated with swelling and soreness. Unfortunately, in the process of doing so, they irritate the stomach. Sometime after this discovery, scientists found that a substance called cyclooxygenase or COX, was produced as part of the mobilization of prostaglandin and was the enzyme that actually controlled pain and inflammation.

Speaker 2

You're doing a fantastic job, by the way, a moment, you're doing a really good You didn't call it Cox, by the way, Cox.

Speaker 1

Yeah, I was going to because doctor Cox.

Speaker 2

Yeah, yeah, in his honor. But this is interesting. I didn't expect I was going to be getting this like trip down medical school, like memory lane. This is fantastic. You're doing great.

Speaker 1

We try to be complete. Also, doctor Cox isn't born on the fourth of July, which you can consider a stealth sequel to Platoon if you assume that Williem Dafoe actually survived his injuries in Platoon?

Speaker 2

Was he in.

Speaker 1

He's the crazy vet in Mexico that fucking Tom Cruise meets when they're both like doing drugs and hanging out with prostitutes after losing their legs. Yeah, it's great, oh Man, that movie rules. So these researchers began to theorize that COX might include an additional substance that was separately the cause for stomach irritation. If someone could find an isolate said substance, it might allow for the creation of a

super aspirin. But no one even knew if this theoretical substance was real, and pharmaceutical companies didn't exactly feel an immediate urge to jump on the matter because they had

no idea if this was even a thing. Fast forward to nineteen ninety A pharmacologist named Needleman gets close to isolating the COX enzyme that he believes is causing all of the problems he hasn't actually doesn't actually find it, but he's confident enough in its existence for reasons that I'm sure makes sense to biochemists that he gives it a name Cox.

Speaker 2

Two.

Speaker 1

Research goes on, and in July of nineteen ninety two, several teams of researchers in Montreal announced that they have isolated two enzymes COX two and one, of which COX two seems to be the causal agent behind the side effects in SAIDs provoke in some patients. Right, So nineteen ninety two they found finally this thing they've been looking for for like twenty years. Right, this is the reason they believe why your aspirin or whatever can cause stomach olcers.

So the researchers used that if you can find a medication that blocks COS two and you compound it with like a painkiller with a seat of metaphine or whatever, then you'd have a super aspirin capable of being prescribed much more often to even more people. Aspirin sales at that point are already like fifty billion tablets per year, So the amount of money on table for the first pharmaceutical company to figure this out is mind boggling, because

then you get to patent it. Then you are the only one that has the aspirin that doesn't cause stomach ulcers, right, and for like whatever twenty years, you're the only one who gets to sell that shit. That's so much fucking money, right, Like, yeah.

Speaker 2

It's one of the most commonly used medications in the world.

Speaker 1

Yes, or this is like an unfathomable fortune. We're talking like an oil and gas industry level fortune is on the table here, and so a fucking race begins, right, And the two major companies that are going to wind up really throwing their money, throwing their hats into the table and to get into the super aspirin ring are our old friend Pfizer and our new friend Merk. Now, today, again, any pharmaceutical company you mentioned, people tend to say, like,

fuck these guys. But in the late nineteen eighties and early nineties, people did not feel that way about Merk. They were very much considered to be one of the good guys. Now, I know that kind of sounds crazy, but I want to read a quote from an article by David Colp and Isabelle Berry in the Journal of Civil Rights and Economic Development. In its missions value statement, the company stresses that its business is preserving and improving

human life. Merk's mission statement continues, we value above all the ability to serve everyone who can benefit from the appropriate use of our products and services. Throughout its history, Mirk has often lived up to its state admission. In the nineteen thirties, after streptomycin was developed by a Merk scientist, Merck gave up its patent protection since it believed the drug was too important a medical breakthrough to keep to itself.

Other companies were allowed to produce streptomycin, and Merk lost potential profits. The nineteen eighties, when Merk found a cure for river blindness caused by a parasitic worm. The company had given away, free of charge, forty million pillars a year to African nations to treat and cure this. So Merks seems pretty good. Coming into the nineties, You're like, hey, maybe there's a company that I actually believes what it is they put. They gave up money, you know, a

lot of it, so that sounds pretty great. But coming into the nineties, Murk is also staring down the barrel of a big problem a lot of its massive wealth, because this is a very wealthy company coming into the nineties. Was based on a pair of cholesterol drugs, zocore and Preachol, which were both about to lose their twenty year patent protection starting in the early two thousands, so not yet in about a decade, but a Decade's not a lot

of time in terms of like researching a new medicine. Right, If you've only got a decade or so over your two big profit engines are going to.

Speaker 4

Time from really to get to market. Yeah, you got to start cooking. Yeah, you got to start moving. In addition to that, five of their best selling medications, including pepsid, were set to lose patent protection even soon in ninety nine, so they are looking at a looming, very serious problem for their profitability.

Speaker 2

This is such a recurring theme with pharmaceutical companies. I just did an episode about a medication called Zygris, which was like, it sounds awesome, It sounds awesome. It's this medication that was touted as like this new breakthrough therapy for sepsis, and it was super exciting, ended up falling apart for a lot of different reasons and being withdrawn and end up being a big marketing scandal in my opinion.

But at the end of the day, it all started because they were losing their patent on their big like sellings and medications like the one, The things that were making them tons of money were about to run out and they needed a new like cash stream as quick as possible. So things started happening probably faster than they should have.

Speaker 1

Yeah, yeah, yeah, And that's like that is the story here as the story a lot of the time right where these and I don't think this is a bad idea, Like the idea that drugs eventually age out to get generic is like kind of necessary in order to in our system at least in order to make it even have a chance of being affordable for some medications. But it does it leads to this as well.

Speaker 2

I don't know.

Speaker 1

Again, we don't need to go on another single payer healthcare rant, but like we have, so there's so many little things that are fucked up about, like even the things that seem like they make sense that also lead

to fucked up outcomes. And because of how much money is at stake in these basins and how expensive it is to be a pharmaceutical company, right, Like, it's not cheap and most of the medications that they like, one of the things you have to accept as a pharma company is that most of the things you try to make into a medicine aren't going to work, right, Like,

that's just and that's kind kind of the story. Here is a medication that if they had done more, spent more time, they would have realized this was not a viable product. But they've got shareholders to please.

Speaker 2

Right, and when the money start to shift from research and development in these companies to marketing, which it does more and more, and I.

Speaker 1

Mean really happening in the nineties.

Speaker 2

Yeah right, I'm assuming that's that their problem here, That's a.

Speaker 1

Big part of it. Yes, so you know, murk is coming into the nineties, not quite a five alarm fire yet, but definitely like a serious situation. And super Aspirins seems like it might be the salt solution to their problems and maybe even the key to greater profits than ever before. And speaking of greater profits than ever before, you know, who's making money like they've never made money.

Speaker 2

Oh, I'm the people who deserve to the people are the people who sponsored this podcast. They're the ones that deserve the most of the money.

Speaker 1

That's right. The products and services that support this podcast are literally the only ethical people in capitalism. And you can just trust them. Give them your wallet, give your kids, you know, hand with children over to our sponsors. They'll take care of them, they'll raise them as their own. You know better than better than we would, better than you would. Yeah, exactly, you know, just trust them and we're back. I didn't mean to imply that none of

you were good parents. It's just that our sponsors are incredible parents, you know.

Speaker 2

That much better.

Speaker 1

They've never they've never yelled at me, never yelled at me, never even spanked me, and I deserved it sometimes. So you paid money for that sort of thing, I have. No, we don't even saying shit like that. The subredit's gotta get real uncomfortable, very fast. Okay, So super Aspirin seems like it could be the solution to their to Merk's problems. In nineteen ninety four, a new CEO takes over at Merk, and this is we were just talking about the shift

from R and D to marketing. This is perfectly emblematic of that because Merk's new CEO is a guy named Raymond gil Martin. Now, the previous CEO, Raymond is an NBA from Harvard, right, which means he doesn't know anything about anything but making making money in the most sketchy ways possible. Whereas the previous CEO of Merk had been doctor Roy Vagelos, an actual medical scientist with a research background.

Speaker 2

Very famous.

Speaker 1

So yes, yes, yeah, so R goes from famous and widely respected medical researcher as their CEO to a guy with an MVA NBA from Harvard.

Speaker 2

Yeah. The Vagelos Award is like this award that's still given out to like people who are like doing humanitarian work for like in the pharmaceutical world. So yeah, like this is a major shift, a major shift away from somebody who was I think ostensibly a very good person from all the towns, a very good person, good researcher. Yeah, to something very different.

Speaker 1

Yeah. Maybe maybe the answer is, if you're going to be the CEO of a pharmaceutical company, you should have like watched a sick child die at a hospital. Like I don't mean to be blunt, blunt, but it seems like it leads you to do things like give up patents on life saving medication.

Speaker 2

For rotation, a rotation in the hospital.

Speaker 1

I keep thinking about, like fucking the polio vaccine guy who he was, like, I think his direct his direct question quote when asked if he was going to patent it was like would you patent the sun?

Speaker 2

Yeah?

Speaker 1

Sulk, yeah, real, real, real, g real Chad so Raymond's career up to that point this is the business guy. See new CEO Mark had included eight years as a consultant for Arthur D. Little, which lists as run of its great achievements, which is it. It's like Mackenzie kind of. It's a consulting firm and it listed as one of its great achievements the privatization of British rail So those of you over in the UK, sure you love this guy. Also, there was this time that they used a bucket of

sow's ears to make a silk purse. I don't know why this is listed as an achievement of the Arthur D. Little company, but it is. He worked as the CEO at a medical device company after that, until he was hired by Merck as their first outside CEO for the express purpose of seeing them through the looming patent cliff scenario. So he was brought in as kind of like an emergency guy right now. It was Raymond who decided that

Merk's future would be in super aspirin. Alongside their chief scientist, doctor Edward Skolnik, he launched a crash program to bring a cox to inhibitor pain medication to market. The name they picked for the wonder drug that did not yet exist, but they were going to have that they were going to hang the company's future on was Viox.

Speaker 2

Now.

Speaker 1

Time was of the essence here. Doctor Needleman, the guy who had failed to discover Cox two but had gone ahead and named it anyway, worked at a company called g D. Seerle which was a division of Monsanto and was leading research into a new inside that would eventually

be called Celebrex. And while Celebrex was under development, Pfizer bought Seerrel from Monsanto and started throwing money into Celebrex as part of what was turning into a vicious competition to be the first pharmaceutical company to bring one of these new super aspirints to market. And there's probably a lot to be said about Celebrex. I am not competent

to say it. I will say that it is currently a medication that the FDA says there's not evidence of significant harms for There is debate about that to this day. But that's all I can say on the matter because I'm not a not an expert on this. There are some activists who are very angry that Celebrex is still on the market. The FDA has said it's more or less fine. That's where we are with Celebrex.

Speaker 2

Yeah, it's the same family, Yes, and it does have that comes with a warning on it that's more striking than most other ensades. Yes, I know. Actually it's a good question. I don't know how often it's used these days.

Speaker 1

I assume it's pretty rare or not as often as it was.

Speaker 2

For sure.

Speaker 1

It's one of those things where a few years ago there was a very scary study about heart effect like heart problems that it could cause, and then a few years later there was a study that suggests like, well, no, maybe we got that one wrong. Maybe it's no worse than other drugs in this class. Again, that's all I can really say about Celebres because I'm not qualified to judge a medication that there's still a lot of debate over.

Speaker 2

I don't have a lot more to add to it either, But it feels like there's other ensades out there that, yes, that we use a little frequently. It seem a little safer. Yeah.

Speaker 1

Yeah, But what you need to know is that Pfiser is putting there, is putting their money into Celebres after they acquire Merle, and you know vox is going to be the attempt made by Mark to do the same thing. So throughout the mid nineteen Ninetieskvet Merk scientists worked on VOCs, rushing it through stages of medical testing, harassed by the knowledge that any delay or bad finding. And when I

say bad, not in a scientific sense. It's not bad scientifically to find out a drug doesn't work, but bad for the company if this drug doesn't work because they're on a timetable, would stop them from beating Pfizer and unfortunately forever. There were signs right from the beginning that viox might be dangerous. The first evidence of this was presented in the mid nineteen nineties by doctor Garrett Fitzgerald, a Merck consultant who was also professor of cardiovascular medicine

at the University of Pennsylvania. He warned the company that Vyax might harm the walls of the blood vessels protecting the human heart. I'm going to quote again from the book Poison Pills by Tom NeSSI, which, if you're looking for like a really good exploration of how a pharmaceutical company does evil, Poison Pills is very well written. He suggested that Mark set up a series of experiments to

test this theory, few of them wherever performed. Other scientists cautioned that yox was related to kidney damage an increase in blood pressure that could be linked to heart problems. Doctor Fitzgerald also found similar problems with the drug in the same class as vyax, called Celebres, made by rival drug company Pfiser. Like Merk, Pfeiser denied the finding of any cardiovascular problems with its drug, but cleverly began its own campaign to portray viox as the more dangerous of

the compounds. That's smart at this point and victually warns them the drug is not on market. He is trying to stop it from getting to market by saying, like, there's some real evidence. This is sketchy, you should carry it more studies, and Murk is just kind of like, but what if we didn't.

Speaker 2

It's like when you've.

Speaker 1

Been like spending like crazy all month, and you know, you probably like you might be running down to the limit, but you're just like going to the grocery store hoping that like your card works this one more time or something. So now, at this point, there was no hard evidence of harm to the human heart, in large part because Merk had refused to do the studies that doctor Fitzgerald advised.

This changed in nineteen ninety six, when an internal Mirk study showed that people who took viox in high doses suffered more heart problems than people given a placebo. A MIMO was issued internally that noted the treatment period was six weeks versus placebo. The initial dose of viox was one hundred and seventy five milligrams, but in mid study the dose was lowered to one hundred and twenty five milligrams.

Adverse events of most concern were in the cardiovascular system i e. Heart attack, stable angina, rapid fallen hemoglobin and hematopec crip, dangerous blood problems and some subjects. So that's bad. Those are all really bad. Yeah, results, that's yeah.

Speaker 2

You're almost officially a doctor because that is correct. That is the appropriate diagnosis is that it's all not good, not good, not good, not good.

Speaker 1

It is important to underline the severity of these results, though. These extremely serious side effects were present after just a few weeks of medication for doses that were just about twice the approved amount for treating acute pain, which was fifty milligrams now twice sounds like a lot, but when we are talking about the way people use medicines, it's really not. People take way more, specially pain medicine than they ought to.

Speaker 2

It keeps me in business. Yeah, people do this. This is like almost You don't even have to take it more than is recommended to run into problems, because sometimes people only take a little and they run into problems in the GI system for example, or other issues that kid needed that can be affected for the heart. But it is a sole underlying known fact that whatever we think people are going to be taking, likely it'll be.

Speaker 1

More, and that is why it's standard in tests like the one they were conducting, actually to test ten times the effective acute dose when doing studies like this to check for side effects, which they didn't do because they knew that the results would be even worse. One doctor who analyzed these results noted, I recall very clearly many occasions where MERK scientists and doctors working with MERK were claiming that viox was safe as placebo, which we've already seen it's not.

Speaker 2

Now.

Speaker 1

The reality is that results like this were a big warning sign and should have been taken as evidence that biax might not be viable as a medication and certainly needed more testing, But Merk went full speed ahead. In November of nineteen ninety eight, they asked the FDA to approve viviocs after testing the drug on fifty four hundred patients. They bragged that they had conducted eight different studies which

had shown owned biox's efficacy. Now, this is where we get into a complicated and uncomfortable topic, medical studies, and why they often don't work the way that they should. In theory, the process of conducting medical studies should identify dangers in new drugs and accurately measure their efficacy. But theory envisions a situation in which drugs are researched by disinterested parties who have no vested interest in anything but

the truth. The reality is that studies are often funded by pharmaceutical companies who, like Merk, might be sweating the arrival of an upcoming patent cliff and headed by a new CEO who lacks the same commitment to medical ethics as his precursor. I'm going to quote now from an article on this in the Union of Concerned Scientists to increase the likelihood of FDA approval for its anti inflammatory and arthritis drug bios. Merk used flawed methodologies biased towards

predetermined results to exaggerate the drug's private positive effects. Internal documents made public in litigation revealed that a Merk marketing team had developed a strategy called Advantage Assessment of Differences between bios and to ascertain gastrointestinal tolerability and effectiveness to skew the results of clinical trials in the drugs favor.

As part of the strategy, scientists manipulated the trial design by comparing to the drug to neproxin, a pain reliever sold under brand names such as a Leave, rather than to a placebo. The scientists then highlighted the results that neproxyen decreased the risk of heart attack by eighty percent and downplayed the results that viax increased the rate the

risk of heart attack by four hundred percent. This misleading presentation of the evidence made it looked like the proxen was protecting patients from heart attacks and that vax only looked risky by comparison. So instead of comparing this drug to a placebo in which it would have been like Wow, the rate of heart attacks is much higher. They compared it to a drug that reduced the risk of heart attacks and were like, well, of course people have more

heart attacks on this drug. This other drug reduces heart attacks, but that doesn't mean this is danger. Like that's so fucking shady.

Speaker 2

Is It's a bit tricky how they're doing it too, because you know, so far, a lot of what they have done sounds very I mean it sounds sound from a distance. You know, the whole idea of like looking at COX two inhibitors, like looking at medications specifically for this and comparing it, you know, say, hey, look at least we're better than the other medications to some degree. From a high from your way back vantage point, it

all makes sense. It's when you start to like look a little bit more closely that it's questionable, especially given that they seem to know early on that there was high risk of these cardiovascular injuries and that the whole narrative is being shifted to try and take focus away from that. Yeah, it's it's all. This is why it's a difference between marketing and between like a scientist running the program. Yeah.

Speaker 1

Yeah, and that's like that's really the whole story here, right. So Merks fuckery extended to the hiring of ghostwriters to write scientific articles reporting on clinical trials of bias to try and convince doctors and regulators that the medication was safe.

Internal Mirk documents later revealed that in sixteen out of twenty papers reporting on early VYAX clinical trials, a Merk employee was listed as the lead author of the first draft, but in the published versions credit for authorship was given to an outside academic to continue in that from that piece by the Union of Concerned Scientists. In one draft of a Yox research study that did not yet have a prominent outside name attached, MIRK officials listed the lead

author only as external author question mark. A MERK scientist was also found to have removed the evidence of free heart attacks among patients in a data set from the results presented some great stuff.

Speaker 2

I mean, in wonder what numbers were in that paper, but removing three can make a huge difference.

Speaker 1

Yes, yes, especially if you're not talking about a huge study.

Speaker 2

You know, did say anything about how many people were in that study?

Speaker 1

I you know what, I'm sure I could have looked into it, but I did not.

Speaker 2

And I'm wondering if in these studies they were talking about the rates of ulcer bleed and gastric bleeding as well, because I mean that's o sensibly the whole reason that.

Speaker 1

They're doing it was the whole thing that advantage was supposed to show, right, is that it reduced the rate of like peptic ulcer bleeding and stuff. And yeah, just the whole the fact that we have drafts of them just being like, we'll figure out who the author of this piece is later, once we find a science, once we find an outside doctor who you know, wants some cash.

And a lot of times these aren't direct bribes. These are like, okay, you'll stick your name on this and then this research project you want, we'll get a little bit of funding from a from from a Papa merk.

Speaker 2

You know. Not even just that these are all being published in decent journals. I'm sure that just people want to be in good journals. They want to have another publication and you know, New Journal and Medicine or the Lancet or whatever.

Speaker 1

And you you also have to remember people think a lot of people think this is the next big miracle drugs. So yeah, you want you want to you want to have a you want to have a little bit of play in that, right of course.

Speaker 2

Uh so. Yeah.

Speaker 1

The worst piece of evidence against BIOS of this peerod came out the same year Merk asked for FDA approval nineteen ninety eight. Merk Study zero ninety involved nine hundred and seventy eight patients and showed that people on BIOS experienced serious cardiovascular events six times as often as patients taking a different drug or a placebo for arthritis pain.

Merks shelled the study and never published it. Later that same year, a group of medical researchers at the University of Pennsylvania and by the way, thanks to that doctor we named earlier, U of pen really tried to stop biox from being a thing, published a study that showed that COX two inhibitors might interfere with other enzymes that helped prevent heart disease. Warnings were sent to Mercandfiser, who quickly shoved them off into the circular file and kept

right on begging the FDA to say yes. And say yes, the FDA did. They approved bios for use as a painent killer in results in adults in nineteen ninety nine. A minstrel pain medication and an anti inflammatory for people with osteoarthritis. Despite approving the drug, FDA reviewer doctor Villalba warned in his memorandum that there was evidence suggesting vyax caused more frequent cardiovascular events and patients. So Vox goes to market, it immediately becomes a best seller. Celebrex also

goes to market. It drives massive profits for Pfizer. And this is in spite of the fact that particularly viox is not great at I mean, neither drug is really all that good at fighting pain. And I'm going to quote from the New York Times here. When studies on viox and rex became available in nineteen ninety eight nineteen ninety nine, many doctors were disappointed. Neither drug alleviated pain any better than the old medications, and the drugs cost

close to three dollars a pill over the counter. Pain relievers, in contrast, cost pennies a dose, and by the way, they weren't all that much better at preventing ulcers. Some studies suggest like viox was no better at preventing ulcers, although that seems to be unclear now. Analysts say that

the success of viox was critical to MRK. The patents on those popular mark drugs Aspire started expiring in two thousand and two thousand and one, which opened them up to eric competition, and Vyox comes through and is I mean almost immediately billions of dollars a year in profits for the company. Michael krint Savage, a drug industry analyst at the investment bank Raymond Jameson Associates, says vax was

Merk savior. It's as simple as that, like he puts it down, as the company might have gone on or under at least, you know, probably been acquired if it hadn't been for a Yox.

Speaker 2

I mean, I remember at the time it was huge. It was I had never seen a campaign like it about that I remember. I think it was one of the first times I remember really having like being conscious of like how much a medicine was being marketed, you know.

And you know, I think it's one of these medicines where it's like, you know, maybe five to ten percent of the people who are using it maybe had some benefit, real benefit where they maybe it did help them from a gastric ulcer perspective, maybe they didn't have the option of taking another medicine. But for the other ninety percent of people there taking it, it wasn't necessary for them. It wasn't something that they needed, and it was just increasing their risk of heart attack or stroke. And I

think that this is I bet you. I mean, you probably know this, but I bet up to this point this was the most that ever been spent on direct marketing.

Speaker 1

Yeah, I mean, and that is what we're actually about to talk about is the marketing campaign, which surprise, surprise, involves beloved figure skater Dorothy Hamill.

Speaker 2

But I knew it.

Speaker 1

Yes, she's the great monster in this in all of our episodes, every episode we have ever done, Dorothy Hamill and building into this.

Speaker 2

She's the fanos of the behind the Bastard's world.

Speaker 1

That's right. Joseph Stalin would never have accomplished his greatest crimes without Dorothy Hamill's assistance. That's obvious though. Evil historians have been talking about that for decades. Anyway, you know who's not Dorothy Hamill. I don't know why I'm shitting on Dorothy Hamill. None of this is really her fault. Anyway, here's as we're back. Okay, so we're talking the viox marketing campaign. How do you sell America on this drug that is going to get a decent percentage of America killed?

And the answer is figure skating superstar Dorothy Hamill. So yeah, this is this is where the real villain of the story comes into it.

Speaker 2

The haircut is a problem for me.

Speaker 1

I had Hamil's haircut.

Speaker 2

My first girlfriend, The first girl that really smashed my heart into like a billion pieces, scattered them across the globe.

Speaker 1

Was Dorothy Hamill. That has really taking some strays in this episode.

Speaker 2

Just she had Dorothy Hamill's haircut. Oh, which I don't know why at the time didn't bother me, But so now when I see that haircut, I'm like, oh, yeah, that reminds.

Speaker 1

Me of that that lost love.

Speaker 2

Yeah, painful, painful. So for those of you.

Speaker 1

Who don't know what we're talking about, back in the nineteen seventies, an incredible athlete named Dorothy Hamill became one of the most famous people in the world. When she was just nineteen. She performed at the nineteen seventy six Innsbruck Olympics and won the gold. Time declared her America's Sweetheart and as his customary for world class athletes, corporations began offering her embarrassing piles of money to endorse their products. Hamil's first run as a famous person didn't go great.

She married Dean Martin's kid, and then he died in a plane crash. She fell out with her coach. She spent all of her money buying the ice capades, and then wound up burning out and developing a bleeding ulcer. She had another marriage that ended badly and wound up well, not broke, you wouldn't say, but no longer rich, and she suffered from a substantial amount of pain from a lifetime of pushing her body to athletic excess. The pain was bad enough that at the worst Dorothy could no

longer even play with her daughter. Some days she could barely get out of bed. And then her doctor told her to try biox. She would later claim that it was effectively a miracle cure for her, not only soothing her pain, but bringing back her ability to perform on the ice in a way she hadn't in years. In August of two thousand, Hamil made an appearance on Larry King Live with Caitlyn Jenner, and Jenner is also talking about viox and this this. Jenner is also claiming that

like this this really helped her arthritis. She told the audience a heart wrenching story about loss and pain and her miraculous return to the world of the living thanks to Vyos quote. I just I felt old. I felt depressed, tired all the time. I mean, having chronic pain is exhausting. And I got to the point this year I was on tour and I couldn't skate, and so I went to a doctor and we finally got to the bottom of it, and my doctor prescribed VOX for me. And

it's as if I've been given a new life. It's just it's been amazing. I feel twenty years younger. I don't look it, and I don't skate it, but I feel that way.

Speaker 2

Was this when Larry King still had some credibility?

Speaker 1

Oh yeah, he was big at this point. This is like right around the turn of the century. He's still a big, a major major. This is like before infomercial Larry Yes, yes, okay, and this is I mean, maybe this is part of his downfall. But people still take the show series and they take this very seriously. And to be clear, I'm not saying that, you know, even Caitlin or or Hamilorthy were lying about their experiences on viox because some people did gain benefits of this. Yeah,

and you know, so I'm not doubting that. The problem again is that a single person's having a good reaction to a drug is not evidence that the drug is safe.

Speaker 3

You know.

Speaker 1

For example, I know some people in their seventies who have been doing heroin for fifty straight years and are and are fine. That doesn't mean heroin is safe. It means some people are lucky, right, Yeah, or they afore mentioned ninety year old women doing you know.

Speaker 2

Those ancient people who do you get drugs and smokes that you now with a.

Speaker 1

Little burning Man regionals, you run into a lot of elderly people who have been doing drugs for forever. Some of them are very good at it. I've been gas stations sober for years now, Kava, that's Responlifornia sober.

Speaker 2

But you can only get the things you buy at the gas station.

Speaker 1

I don't mess with that marijuana. That shit's dangerous. I just take those trucker yellow jackets that they give to keep people driving long haul awake. You know, I don't know what's in them. They're big and yellow. That means they're safe. Yeah, it's danger'd me red if it was dangerous. They can't put dangerous drugs in a yellow and black pill and call it yellow jackets and it doesn't mean dangerous.

Speaker 2

Yeah.

Speaker 1

So I never take more than like twelve in a day. Yeah, thank god for yellow jackets.

Speaker 2

I just some I sometimes don't know if you're kidding, and I just hope in my heart that you are. And I'm just going to pretend that this is all part of a bit.

Speaker 1

I do the safe thing. I like, open the pill and I pour all the powder in the pill into a glass, and then I pour in a bunch of my krateion into the glass, and then I add a banana for the potassium because your heart level.

Speaker 2

This level of detail is what bothers me.

Speaker 1

The more I don't like it's fine. It's mostly just B twelve in caffeine and god knows what else, because there's absolutely no no agency that looks into what gets put into substances that are sold in gas stations in this country.

Speaker 2

Oh my god, and what little oversight there is is gonna be gone.

Speaker 1

Yes, thanks gone, thank god. Look, RFK Junior might ban the HPV vaccine, but we could get legal heroin.

Speaker 2

It's all one big, organized end of humanity cash grab the next couple of years. Any drug you want to get through is gonna get through god willing.

Speaker 1

Look, if the world's ending, do you want heroin to not be legal?

Speaker 2

That's fair, But it's not gonna be heroin. It's gonna be like, you know, blood pressure pills that the company just gets through and then it makes people's hearts explode, and then the company will just say, hey, we're bank and then they're fine, and then they just move on with their lives, and then people are going to be left in the wake.

Speaker 1

Then no, you're right, they're going to ban prozac and replace it with like polar Bear liver pills. It's just going to be a disaster.

Speaker 2

He was always doing research that in RFK.

Speaker 1

He's always trying something new. So the fact that this beloved celebrity athlete has gone on Larry King and said exactly what viox PR would want her to say was a godsend. You know, that's the kind of pr no money can buy. Although I have to tell you now that moment was in fact bought and paid for by MERK they had found out that Dorothy was a customer. They had reached out to her with an idea and

a pile of money. Her life story had been used as the basis for an entire marketing campaign, and her appearance on Larry King was just the first step in launching it. Tom NeSSI writes the day after Dorothy Hamill's appearance, even Merks CEO Raymond gil Martin was smitten. He received heart written letters from arthritis sufferers saying they were going to immediately ask their physicians for a viox. Gil Martin

personally congratulated the public relations department. One marketing executive wrote that with Dorothy telling our story, vyox sales were going to soar and overtake celebrates and obsession within the.

Speaker 2

You'll slipped into like your fifties radio announcer voice. You kind of shifted to the nineties. I saw what you did there.

Speaker 1

I love it. I love it. I love it. So yeah, patients are are coming in, They're begging doctors to write prescriptions. Doctors are going, well, shit, how bad could it be. It's basically just aspirin, you know, And a lot of people are suddenly taking viox. Now the FDA does push back a little on this campaign because Dorothy's appearance on Larry King counted as an ad and she had not mentioned that she was being paid by Merk, which you're

not supposed to do. They also had an issue that she was kind of basically saying she had not told people that viox was extremely dangerous if you prescribed it to patients with the history of bleeding ulcers. In fact, she had stated that she was taking it despite her history of bleeding ulcers, which is kind of telling people this is safe to say in the exact situation that the FDA knows. We know it is not safe to

tell people to take it in. So the FDA gets kind of unhappy with this, and Merk replied, she just slipped up. We taught Hammil the proper way to sell our product, but she went off script. They promised to retrain her before following up with any additional advertisements. This happened on September twelfth, two thousand. The next day, in violation of their promise to the FDA, Hamill appeared on a local TV station in Atlanta to urge people to

consider a biox. The FDA never found out about this and might not have cared if they had, if you wanted to get away with something. September twelfth, will actually that was two thousand. Never mind, everything was still fine. I was gonna. I was just like, did I just go over to September twelfth and not make it?

Speaker 2

I feel like that. No, No, it's fine.

Speaker 1

Research didn't happen yet, everything was fine. Plenty of towers

in New York still at this now. The unfortunate reality of the FDA is that it is stand and operated by a lot of people who want to work in the private sector of the pharmaceutical industry someday, and some of these people feel a need to avoid making waves and killing a golden goose that is currently injecting cash into someone they want as a future employer who made a bit of past employer that they're hoping we'll hire them on for a lucrative consulting gig in the future.

Beyond that, the teams at the FDA who we rely on to monitor food and drug advertising are hideously understaffed, operating on a shoe string budget. There may not have been anyone watching Dorothy Hamill's ad on local Atlanta TV because no one was being paid to do so. Now, MERK did change their TV ads for vyox based on the FDA's feedback, and you can see one example of that here. We've got to play just one of these bad boys. Here is Dorothy Hamill's revised vyox ad.

Speaker 5

When I started skating at eight years old, I never thought i'd experience the thrill of winning a medal with all the great memories. Has come another thing I thought I'd never experience, The pain of osteo Arthur writers.

Speaker 6

Yox is here. Medicine for ustioar threat is pain. With one little pill of day, biox can provide powerful twenty four hour relief. Biox specifically targets only the COX two enzyme. A key source of our threat is pain. People with allergic reactions such as asthma to aspirin or other arthreatus medicines should not take bios. In rare cases, serious stomach problems such as bleeding can occur without warning. Tell your

doctor if you have liver or kidney problems. For more information, talk to your doctor about once daily biox for the relief of ostio war threat is pain.

Speaker 5

Perhaps my biggest victory is to be able to plan my day around my life instead of my pain after.

Speaker 6

Your doctor Biox is right for you, bios for everyday victories.

Speaker 2

First of all, I take back what I said about her hair. I think it actually looked really good there. I don't know, like time and the cycle change and fashion.

Speaker 1

I don't know it was the Viox. You don't know. Maybe vix makes your hair look great.

Speaker 2

Everybody. It's a by Biox. It's a brilliant strategy. Like the people who grew up watching her and knew who she was and admired her are that age where they were having lots of the osteoarthritis and joint pains looking for medication. It's a she's the perfect spokesperson. Yeah, and she has that innocence so that you believe, you know.

Speaker 1

Yeah. And the Dorothy hammel Ads are a huge success. Millions of Americans saw their former child sweetheart skating and skiing and living an active, healthy life thanks to this new miracle drug, and millions of them decided I want that for myself, And ultimately tens of thousands of them are going to die as a result. And that's the story we're going to tell in Part two. Kaba can't wait, Yay But first off, do you have anything to plug before we roll out here?

Speaker 2

I do plug is my show. That is the plug that I want to plug is my show. I'm plugging it now. It's called The House of Pod. It is a humor adjacent medical podcast. If you like the subjects, like today's subject, you'll like our show. In fact, one of our most recent episodes is about sort of similar

a little bit less egregious, but similar pharmaceutical shenanigaree. I don't know if that's a word about the medication zygris And and there's all kinds of fun guests like Robert and prop and all the people you know and love here, Margaret. So check out my show, The House of Pod. And if you want, you can follow me at Blue Sky, which I'm giving a shot now. Seems a little bit less fascist.

Speaker 1

Yeah, definitely less fascist. It's got its own annoyances, but all of social media has things that annoy me. So what are you gonna do exactly?

Speaker 2

You can follow me there at Cave MD.

Speaker 1

You can also follow me there and I write, okay, where you can follow me on the other place too, But you know what you could do that I would appreciate most get off the internet. Feed somebody you know do something good in the world. Like it online, I like it. And to listen to podcasts. Keep listening. For the love of God, keep listening. Do not stop listening to the podcast under no circumstances.

Speaker 2

Stop. Will you ever stop? In fact no, just for thinking about stopping. You should listen to extra podcasts today.

Speaker 1

Yeah, you know what, I'll say it right now. If you have stomach holcers podcast on the podcast.

Speaker 2

Your Way Through It podcast Your Way Through.

Speaker 1

It, that's right.

Speaker 3

Behind the Bastards is a production of cool Zone Media. For more from cool Zone Media, visit our website Coolzonemedia dot com or check us out on the iHeartRadio app, Apple Podcasts, or wherever you get your podcasts. Behind the Bastards is now available on YouTube, new episodes every Wednesday and Friday.

Speaker 1

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Speaker 3

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