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

was a great figure skater. Nothing in her life preparedared her to adequately vet whether or not yacks was a safe medication to advertise, no can't, we can't put that on Dorothy Hamil.

her to their demise. Like that really does explain a lot. Now, in fairness, very few people are doctors. It is unreasonable to expect people who are hurting and in some cases literally being driven mad by pain to personally overcome the weight of a multimillion dollar ad campaign and all of the science washing that a big pharmaceutical company can do.

In fact, during the early years of iax's success, it would have seemed as if Cox two inhibitors were medical marvels backed by the best science, and it would have seemed that if you were someone who did what should be like the responsible amount of reading on this subject, not like the amount of reading that we could expect from like a research scientist, because research scientist who we're responsible,

knew the dangers. But if you were, say, like a normal educated person who's like, oh, well, I'm going to read a paper of record and they're reporting on these new drugs written by a medical doctor interviewing other medical doctors. That's really all you, as a layman, should be.

He served in the advisory board of the National Heart, Lung, and Blood Association. He was the Dina and Raphael Recanati Chair of Medicine at Harvard Medical School. He'd worked at a high level for the s and was a listed author on some one hundred and fifty papers. One of his books had been adapted into a TV show, Gideon's Crossing, which I didn't expect to run into a Gideon's Crossing

references amiteral on this episode. It wasn't great, as tom NeSSI writes in the book Poison Pills, even among top level physicians who are generally known as opinion or thought leaders, Groupman stands out it was no small matter. Therefore, when he wrote a linky article for The New Yorker in June of nineteen ninety eight entitled super aspirin new arthritis drug Celebra. Celebra was the name for the drug lender and as celebres, and very close in composition to viox.

The article had been carefully authenticated by the famous fact checking department of The New Yorker, which is an almost perfect record of verifying every piece of information the magazine publishes. Like Hamill, Groupman began his discussion of super aspirin with a personal story. He himself had suffered debilitating pain brought on by oarthritis developed while training for the Boston Marathon. Despite years of searching for relief, he had found no

satisfactory remedy. How or remarkable new class of drugs was offering hope to people like him and millions of others, and Groupman provided the anecdotal story of a firefighter from Nebraska whose arthritis had been alleviated miraculously thanks to super aspirin. A responsible scientist would note that the anecdotal evidence was more fit for a pharmaceutical commercial than an article in

The New Yorker by a doctor. But doctor Grupman did speak with other medical experts, like Harvard's doctor Lee Simon, who had a seat on the FDA's Arthritis Advisory Committee and had been part of an FDA panel to evaluate how to approve super aspirins. This probably shouldn't have been allowed to happen because while he was sitting on that FDA panel deciding how to approve these medications. Doctor Simon was also a paid employee of Seerle conducting clinical trials

for celebres. He did not disclose this conflict of interest, and doctor Grutman's article did not make any note of this fact that might have compromised a source's objectivity.

to in the election. So that's pretty shocking to me that, like they did not require.

anti vaccine cranks seem to be coming out of. So like, it's not totally shocking to me that it's Harvard, you know, but I could absolutely see the danger in someone with a name that big, the H bomb you dropping there, leading people to believe this this in New York must be right, the intellectual elites, you know, leading them all to believe the safety of it.

might not experience side eft, but someone will. There's no drug that has zero side effects of any kind.

You know, absolutely so, Asnessi notes, this should have been a massive and immediate red flag, just as we noted. But yeah, Doctor Grutman's article cited other medical experts making similarly dubious claims. He quoted another Harvard professor, doctor Clifford Saper, as saying super aspirin might hold the key to treating Alzheimer's. Now, this is a case where there was not evidence that

it had efficacy treating Alzheimer's. Doctor Saper had a theory that inflammation in the brain caused by injured neurons led to swelling the damaged brains, and that as a result, viox might help. Right, And that's a perfectly valid thing to want to test.

But rational therapy needs to be buttressed by randomized, controlled human trials to determine what is and what is not effective treatment. That's from the book Poison Pills Now. Theorizing like Sabrid did is of course part of the medical process, but maybe not one that should be presented to the public in a widely read article where like people who've got loved ones suffering from Alzheimer's are going to be like,

oh my god, a miracle drug might be coming through. No, even if it works, it's fucking fifteen years out or whatever, like from you know. Grutman's article also wildly exaggerated the harms of existing insets like Motrin and advil, failing to discuss newer versions that had been approved and came with fewer of the side effects that so called super aspirin was meant to avoid. In his article, Grupman cited the work of doctor James Frees, a professor at Stanford at length.

Freese himself claims Grutmann distorted his research in order to make claims that Freese was not making about Cox two inhibitors. Now, doctor Grutman was not being bribed by merk nor did he violate the law or medical ethics in any way that I'm aware of other than writing a bad article.

He fucked up, and part of why he fucked up was, in my opinion, he was looking to merge developing medical science with magazine Pop Science in a way that's not wildly different from what Malcolm Gladwell is going to be doing a few years later.

This is how it starts. It raises enough doubt, it raises enough like it makes it vague enough, it makes it cloudy enough that it's hard for people to know what is real and what isn't real. And this is where medical information, like the roots of it begin. It begins in good places sometimes like a Harvard doctor.

A star reporter for the same thing, just completely lying about shit, tricking fact checkers, and it's one of those things doesn't have to happen all that often for people to be like, well, then these outlets are no better than whatever like weird fucking conspiracy, rag info wars or whatever that I like. And you know what, that's kind of on the journalists for fucking up in that way, right,

that's on the newsroom, that's on the editors. That's on to people wanting these big stories that are exciting and that get eyeballs on. Right here, you kind of have the merger of the two. Right, the New Yorker wants an article that gets a lot of people to read it, because fuck, this is a miracle medicine that might help me and my loved ones with things that are really like causing us problems. And as the doctor, you want

to be the first. You want to be the doctor who kind of establishes himself as like, I'm kind of on the ground floor of this breaking for people.

anti inflammatory drugs for patients who'd received orthopedic surgery. Now, the last episode we mostly focused on Murk, and we will later in this one as the bulk of the blame lies with them. But our old friends at Pfiser don't have totally clean clean hands.

the burgeoning field of COX two inhibitor research. The good news is that, in the field Reuben attempted to influence orthopedic surgery, his work had less of an influence than he'd hoped. Most surgeons hesitated to switch to COX two inhibitors because some very good animal studies showed they slowed the rate at which bones heel, which is kind of a big deal if you're in the orthopedic surgery business.

A two thousand and seven editorial in Anesthesia and Analgesia stated that Ruben had been at the forefront of redesigning pain management protocols through his carefully planned and meticulously documented studies.

shoddy research. Murk had deeply questionable science that they funded in an equally dubious way. Back during the FDA approval process, Merk had launched a strategy called Advantage in all caps because it was a very tortured acronym assessment differences between biox and neproxyen to ascertain gastronomical tolerability and effectiveness. An analysis by the Union of Concerned Scientists describes the goal of Advantage as using flawed methodologies toward bias towards predetermined

results to exaggerate the drug's positive effects. Quote as part of their strategy, scientists manipulated the trial data by comparing the drug to neproxen, a pain reliever sold under brand name such as a leave rather than a placebo. And yeah,

we covered that a little earlier. But what's important is that we now know that Merk had a great deal of evidence when they were pushing this study suggesting that like viox massively increased the risk of cardiovascular events, which makes the case that this was not just something where they did a bad study and put this thing next to to proxen and it looked less risky than it does because it was next to a proxy and they conducted that study with new proxyen because they had data

showing that viox massively increased the risk of heart attacks, and they were deliberately trying to hide that.

and just as swiftly, it started to kill people. One of the first to die was Bob Ernst. He was a fit, fifty nine year old triathlete who started taking biox because of recurrent arthritic pain in his hand. His wife, Carol had urged him to try ViOS after seeing an ad and Bob had gone on the medication. On May sixth, two thousand and one, the two at an anniversary date at an olive garden in Keene, Texas. Bob passed away

in his sleep later that night, dead from heart failure. Now, Bob had been in very good shape, but the death of a fifty nine year old man from heart failure is simply not the kind of thing that most pathologists are going to consider super suspicious. It was Carol herself who got suspicious, so since started digging into Bob's one medications is the only thing. He was prescribed biox. Even as early as two thousand and one, there were studies

showing that Vyas was bad for heart health. Murck had successfully buried many of them, but there was still stuff that you could find with enough digging online. And that's exactly what his wife did. She found a lawyer, Mark Lanier, who made to take her case. In the book Poison Pill does a wonderful job of chronicling the work that

they did. I'm going to have to give you a summary here, which is that in August of two thousand and five, a Texas state jury awarded almost twenty five million dollars to Carol Earnst in compensatory damages and more than two hundred million impunitive damages.

sent along to the FDA. And the FDA really just didn't do the work to actually like figure this out very quickly, and so it wasn't until fourteen months later in April of two thousand and two that the FDA actually forced through changes and how viox was labeled to reflect the evidence of risk. Merk took no action on their own to warn users about the fact that they

knew that viox was causing heart attacks. Now, in the Leader trial that would develop from all this, CEO Raymond Gilmartin would claim that Vyox wanted to add a warning label the instant they were aware of the danger. This was a lie, as Cope and Barry Wright in their

article Mirk in the Viox Debacle. Lanier, that's the lawyer introduced in the Ernst trial internal Mirk documents, which revealed that Merck resisted the FDA's efforts to add warnings to Vyax's label and eventually complied in ways that the Ernst jury found obscure. You had to dig three levels to see it, one juror stated in March two thousand, when Merk became aware of the Vigor studies findings of a significant increase in cardiovascular events for those taking vax over

into Prox, and Merks scientists expressed concern. In an email message written in March of two thousand, Doctor Edward Skolnik, who was then Merk's head of research, stated the Vigor clinical trial had shown that vyax increased heart risks. The CV events were clearly there, he wrote, despite clear warnings, Merk Deskis decided against conducting studies on the heart attack risks because the marketing executives worried it might hurt Biox sales.

Internal mIRC analyzes in two thousand and two thousand, two, two thousand and one, and two thousand and two showed that Merk was worried about lost profits if warnings or precautions were put on its label. During that period, Mirk was in private negotiations with the FDA over changes to

its Yox label. David Anstis, who at that time was the president of Merk's Human Health division, projected that a strict warning would reduce sales by at least fifty percent after the Vigor study findings in March of two thousand. A second internal mIRC analysis performed in October two thousand showed a significant increase in cardiovascular events for those taking vyox. The mIRC analysis plaintiff's atorney Mark Laneer, has argued was never presented to the FDA nor the media, and certainly

was not given to the physicians for scribing byox. So this is entirely the marketing team and the CEO coming in and saying like this will cut profits, So bury it as long as you can. Every additional year we get to sell this stuff without a warning. Is worth it to us? Right, whatever number of deaths there are, the money this is bringing in is so huge, Like it's fine, right, that's literally a decision being made.

need to teeth to do certain things. When a drug is first approved, there's still a lot of unanswered early safety questions because for most of the studies that are getting them approved, there's like maybe two to four thousand at most patients in a study. Sometimes oftentimes that's not enough to see like the safety evidence and what risks are associated with it. So the FDA has to be there pushing to see more data making sure that it stay safe. Once those numbers come out, they need to

be there to do the post marketing studies. It's it's interesting to me to see it's terrifying to me to see going back to what's coming in the future, what's going to happen to our fdo god and how deregulated it's going to become, and to see what they're going

to be able accomplish. It's it's going to be I mean, I just I mean, I hate to say it, but I think we're going to see more drug induced injuries than ever before because more medicines are going to be coming out and few of them are going to have the post marketing studies to prove it.

in a period totally different from the one we're entering into. Now, Like, what kind of shit is going to go come by now that there's there's no guardrails on any of this stuff, right, Like these fucking MBAs who are managing all of these pharmaceutical companies have absolutely and these marketers have absolutely no restrictions anything that they can shovel into people's faces to make a profit.

companies for the right reason, for reasons like this. You know, when there's real reason to be mad about pharmaceutical companies, more people are upset about like the vaccines that have come out with good data behind them and with good studies in the limited amount of time that they're able to do. You know, it is it is hard. It's

hard for me to wrap my brain around that. How I have to be the one defending pharmacuol companies and I'm asked, skeptical of them as anybody, Yeah, because of shit like this and then stuff we've seen.

to doctors. Salespersons were also ordered to avoid discussing heart health risks and instead hand over a cardiovascular card to physicians which said Vyox is protecting the heart rather than potentially harming it. To take care of all of their questions oh good, you give me a card. Well, you got you guys got card money. There must be nothing wrong with this stuff could afford this kind of embossing. My god, look at that. It's okay, guys, they gave me a card.

dubbed Dodgeball. Sales trainees could only move on to the next round of the card game if they gave Merk approved answers to doctors questions raising Vyox safety concerns, or dodged such questions altogether.

more detailed questions. They're going to keep drilling to get the answers. And then the one they love are the ones they call the peacocks, which you just have to kind of stroke their feathers, tell them they're pretty and smart, and those are the ones they're going to sell your medication. I mean they they know the psychology of doctors very well, probably better than doctors do. So it is there's the

farm reps. It's changed maybe a little bit, but this was this was like the most evil time of the farm reps. Oh, they had the most power and doctors were the least prepared to deal with. Right. Right.

weren't used to being sold to this way. Yeah, it's like when they first started getting Americans hooked on cigarettes, and like people had never seen an advertisement before and they're like a cowboy, well I'm buying a cigarette now, So a later congressional inquiry found that Merk leadership divided the studies on vyos into approved and background studies, and any study that showed a danger to heart health was considered a background study, and so their salespeople were forbidden

to discuss them with doctors. This was a violation of company policy now all through two thousand and one. In two thousand and two, the FDA sent letters to Merk poking at it for failing to properly disclose the dangers of viox, but it still took again fourteen months for any sort of labeling change to be mandated. Part of why is that officials within the FDA were in the

tank for Merk, not all of them, but enough. At later Senate committee investigations, an FDA scientist testified that he had brought forward concerns about viox to his superiors and been pressured to shut up. Another researcher who had gone to the FDA with complaints was Girk and Paul Singh, a Stanford professor who claimed that a Merck senior executive complained to his superiors at the university when he reported

yox to the FDA. Singh claimed I was warned that if I persisted in this fashion, there would be serious consequences for me, because, of course MRK has the ability to donate a lot of money to a university like Stanford. Now still, some brave academics continued to blow the whistle, as this paragraph from a New York Times article by

Alex Berenson, Gardner, Harris, and Barry Meyers summarizes. In two thousand and one, the first major study critical of the drugs appeared in the Journal of the American Medical Association. The report, written by Eric J. Tapol, and cardiologist at the Cleveland Clinic, reanalyzed data from several clinical trials of viox and celebrates. It reported that both drugs appeared to increase the risk of heart attack and stroke, but that

the danger from biox appeared higher. Doctor Tapol, the chairman of the Clinics Department of Cardiovascular Medicine, immediately called for trials tol whether or not the drugs increased cardiovascular risk. Merck and Pfizer both rebuffed that request and said that the Cleveland Clinic report was flawed because it failed to do, among other things, to include data from other studies. Doctor Tipol became a harsh critic of both drugs, but his ire focused on viox and MERK. Even before his two

thousand and one report repaired. He said in a recent interview that company scientists came to Cleveland to try to convince him not to publish it. Murk officials denied doing so.

A year later, a study by doctor Wayne Ray, an epidemiologist at Vanderbilt University, found that medicaid patients in Tennessee who were taking high doses of vyos greater than the recommended long term dosage of twenty five milligrams daily had significantly more heart attacks and strokes than similar patients who were not taking high doses.

you don't really give that much of a shit. But there are people plenty of people who know exactly what they're doing, right, And like those people who know exactly what they're doing just don't care. They don't feel bad about the fact that they're getting people killed.

that's probably a good truck stop. And you're going to go in there and behind the counter there should be a wall of pills and you're just going to ask for all of them, and you pour that into a cup. And this is critical. You mix it in with mountain dew code red, not Baja blast. That'll fuck it up. Do not mix Baja blast in mountain dew code red. And then shoot that ship as fast as possible. And

that's gonna get rid of your soul. And then you're ready to join us on the front lines fighting the demons.

it's about damage control. Their official justification was that they just had a long term clinical trial which showed that some patients developed cardiovascular problems after taking the drug for eighteen months. The data showed fifteen heart attack, strokes or blood clots per thousand people over three years, compared with seven and a half cardiac events in the general population.

And even if you believe this Merk study, which I think is kind of trying to pad how bad it is, that's still much worse's that's still.

scalding McDonald's coffee syndrome. Now, you probably heard the story about the woman who had a hot coffee spill in her lap at McDonald's drive through, and she sued them and got a bunch of money. This is a thing that especially when I was younger. I think more people know their real story now, But you would see viral memes all the time. You'd see it in like newspapers. You know, it was really a thing like my parents'

generation loved to hate on. It was particularly a big thing for like conservatives who were angry at how mean all these slight, these frivolous lawsuits hurting innocent corporations, Like this woman spills coffee in her own lap, and like the reality was McDonald's had the coffee way higher than they were legally allowed to have it. They should not have been selling or handing people coffee hot and it gave her third degree burns to like her entire genital area.

Like it was a hideous, hideous, life altering injury that she suffered because they were not doing what they legally should have been doing. Anyway, we don't need to rant on this, but at the time this happens, a lot less people realize the true story there, and so there is this big backlash against frivolous lawsuits against companies and what the murk vax lawsuits initially get lost in that right.

When Carol von Ernst won her case against Merk, A lot of pundits of the day kind of looped this in with the McDonald's coffee case as another example of our sue happy culture run amok. From the book Poison Pills,

Carol Earnst. Lawyer Mark Lanier was blasted by everyone from physicians to newspaper columnists for winning the trial by twisting the facts and relying on nothing but an ignorant jury of hicks, despite the fact that his witnesses included some of the best known physicians and scientists in the world. Even as the Texas jury was deliberating, Merk's lead attorney, Jerry Lowry, said if he Lanier had any evidence causes arrhythmia,

this case would have been over three weeks ago. A few months after the trial verdict, CNBC broadcast a debate between Lanier and Richard Epstein, the James Parker Hall Distinguished Service Professor of Law at the University of Chicago and a senior fellow at the Hoover Institute. The professor had written an op ed piece for The Wall Street Journal and said that physicians lamented the fact that they could no longer use the drug. Many leading newspapers, including The

Washington Post, also mocked the Ernst trial. In an editorial entitled the viox Hex, the Post wrote that the Texas jury in that case awarded two hundred and fifty three point four million to the widow of a man who died of a heart attack triggered by arrhythmia, which is not a conditioned Viyax has been proven to cause. The Post said, the jury was confused about the medical evidence.

And this is number one, that fucking dude debating Laneer on stage as a Hoover Institute guides right wing thing tape. But number two, you've got all these like big publications going like, oh, these it's a Texas jury. So clearly they're hicks. They don't understand our big cities science. They just got bamboozled by this smooth talking law who just hated Merk.

and they're actually, you know, very well, could be a good use for some of these uses and stuff, right, I mean, even viox could have had specific uses for very well chosen patients. And they'll never get to that. Those patients will never get to that. They'll never get to have that benefit of a medicine that could actually work.

Because again, instead of all the money going into research development figuring out exactly who benefits and who gets harmed from it and who should have it and who shouldn't, they spent all their money and energy in finding ways to sell it and for as long as possible, and they painted themselves into a corner at the end, and they couldn't at that point and then say, okay, well, actually the only these small set of people should use the medication because the risk is then worth it in

these the small subset. But they couldn't do that. They had to withdraw completely. So it's just so stupid on so many levels. It's so it's such a waste, and it's a waste of all the time and effort that went into making the medication. Again too, because again the concept behind the medication, looking at COX two inhibitors, looking at ways to selectively attack those pain the pain pathways, shut down the pain pathways before they cascade into inflammation

and pain. It's all smart, it's good. And now now it's my knowledge, I don't know if people are even thinking about this anymore. And like we still have problems with ensades end says still cause problems. Lots of health problems still come from advil leve I profen. They still cause me headaches because I have to go and take care of people believing because of them that cause hard issues,

kidney problems, liver problems. Like people should be we should be researching new paid medications and worrying about how to do that right as opposed to how to make as much money off of as possible. But that's not where we are, it's not who we are. So I don't know why I'm saying this.

way to a smaller subset of people. It's bad for all of the tens of thousands of people who lost loved ones and the people who had life altering injuries as a result of it. It's just terrible for everybody. But you know, doctor Hoode, not terrible for anybody. What's that products and services that support this podcast, all of which have been FDA approved, And if we've learned anything this episode, that always means good, good, and we're back. So we're drawing to a close in this episode.

the time it was polled. We will never have a comprehensive list of the number of people killed and injured as a result of viox, but what we do know is harrowing. Doctor David Graham, the Associate Director for Science and Medicine and the FDA's Office of Drug Safety, testified before the Senate Finance Committee that Yax had been associated with at least one hundred thousand heart attacks and more than fifty five thousand premature deaths, that is, in the

United States. He compared the cost to two to four jumbo jetliners crashing every week for five years.

Scott Ruben. Paul White, the editor at the Journal of Anesthesia and Analgesia, claims that Ruben's study showing the benefits of COX two inhibitors helped sell billions of dollars worth of both celebres and vox. In two thousand and nine, he was revealed to have completely falsified at least twenty one of his published papers, all of which claimed to show how else super aspirins could benefit post operative healing.

Pfiser had funded Ruben's work from two thousand and two to two thousand and seven, the years when they were also making bank on a little medication called Celebrex. His employer, Bay State Medical Center, claimed a Scientific American that Ruben had been paid directly by Pfeiser for his work, and that he had been decided how much of that money would fund research and how much would go into his pocket, which sounds fine, that's not sketchy, there's nothing. How could that lead to anything?

ten after pleading guilty of massive fraud. Prosecutors argued that he'd been paid huge money in grants and never performed the studies he'd been paid to conduct. He just pocketed the cash and published lies about celebres. Thankfully, justice was done. He was given six months in prison and asked to pay three hundred and sixty thousand in restitution to the pharmaceutical companies who'd sponsored his work, the real victims and all this holy shit.

are there, it's always fraud related, you know. And actually six months isn't as long as I've seen other people go for what I kind of consider to be lesser crimes, but they weren't crimes committed directly against the American government and medicare frauds, So that's probably why he only got six months.

important world health issues and infectious diseases. And the problem is the things I really care about, the things I think are really important, are not necessarily things that they're going to make money off of, and they just don't really care. So I'm very torn. I have a lot of mixed emotions about pharmaceutical companies in general, and it bothers me when people assume that I am like pro pharmacutical company because I hate them more than anybody really,

I mean, I really do. But at the same time, we do need their help unless we get more scientists like doctor Peter Hotez, who's you know, a friend of the show has come on who has made his own pharmacutic or like vaccines at cost, these great like vaccines, and people still accuse him of being a pharmacial even

though he works completely outside of the farmer world. So I'm very torn about pharmacual companies in general, and I think it is very very very important that we continue to like pick at them, analyze them, be super critical of them, but also be fair about what they can can do, what they should do, and what we should

expect from them. I think we have to be able to look at them critically and look at them in a sort of we have to look at them critically, but we also have to be able to be fair and reasonable about what we expect from a massive corporation.

These are examples, like this case here of things that should never have been allowed to have happened and are going to continue to happen because we aren't going to have the oversight of these companies and it's going to become easier and easier for things like this to happen, which is my fear unless doctors and scientists around the world have the time and energy to really pick apart at every detail and every study that comes from them. But I think even academic medicine is going to be

under the gun in the coming years too. I don't feel great for my friends who have, like who have academic jobs in medicine. I think they're all going to be at who's going to get paid, who's going to be able to get to stay, who's going to be able to get their research done. It's all going to be at the whim of people who know very little about science, who care very little about science. So very depressed is the answer to your question.

fifty years. Is fueled in part by the irresponsibility, greed, and wastefulness of people who knew better who are not ideologues, who are not misinformed, who are just willing to well, the system can handle, you know, me fucking around in this way, or like why shouldn't I get paid?

trust them. Right, Like vax is not zero percent of why so many people were hesitant to trust medical science during COVID, right, and neither is the opiate epidemic. Right, And that that doesn't mean that the people that RFK has a point. It means that, like, if you let people get away with shit like this, and we always do, uh, it'll just keep getting worse. Somebody who is who is absolutely has no limits whatsoever, will start taking advantage of the situation.