Behind the Bastards
Part Two: The Vioxx Scandal: How Big Pharma Killed More Americans Than Vietnam
Thu, 12 Dec 2024
Robert and Kaveh conclude the thrilling sort of how Merck killed 55,000 Americans with Vioxx and then convinced the media they were the good guys somehow. Sources: https://www.scientificamerican.com/article/a-medical-madoff-anesthestesiologist-faked-data/ https://archive.is/Trdy2#selection-695.1-723.182 https://www.ucsusa.org/resources/merck-manipulated-science-about-drug-vioxx https://web.archive.org/web/20170409143210/https://www.ucsusa.org/sites/default/files/legacy/assets/documents/scientific_integrity/how-corporations-corrupt-science.pdf https://www.masslive.com/news/2010/06/scott_reuben_a_former_baystate.html https://www.jci.org/articles/view/38430 https://archive.is/Yjj91#selection-835.0-993.212 https://www.vice.com/en/article/fraud-misconduct-mistakes-this-blog-finds-the-stories-behind-retracted-papers/ https://www.anesthesiologynews.com/Policy-Management/Article/03-09/Fraud-Case-Rocks-Anesthesiology-Community/12634?ses=ogst https://www.bu.edu/sph/news/articles/2019/the-pain-gap/ https://scholarship.law.stjohns.edu/cgi/viewcontent.cgi?article=1054&context=jcred https://lawecommons.luc.edu/cgi/viewcontent.cgi?article=1234&context=lclr Nesi, Tom. Poison Pills: The Untold Story of the Vioxx Drug Scandal (p. 31). St. Martin's Publishing Group. Kindle Edition.See omnystudio.com/listener for privacy information.
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Oh, we are back. This is Behind the Bastards, a podcast with Dr. Kaveh Hoda and Robert Evans, where Sophie is out of the house right now. So, you know, we're just just the boys, just the boys.
No girls allowed.
Except for the listeners. That's like half our listeners. Please keep listening, ladies. Sorry. I'm so sorry.
We're trying to be better.
I apologize. We didn't mean that. We didn't mean that. Just like Merc didn't mean to kill all those people that they're about to kill. Thanks in part to utilizing Dorothy Hamill's star appeal. Poor Dorothy. She really did not... Again, it's one of those things where it's like we just shouldn't have pharmaceutical ads like the way that we have them because you can't.
Dorothy Hamill was a great figure skater. Nothing in her life prepared her to adequately vet whether or not Vioxx was a safe medication to advertise. We can't put that on Dorothy Hamill.
No part of her training of her many hours prepared her to look critically at the data. Yeah. That was available to her. What was available to her?
Some of it wasn't even available to her. She wasn't getting up at four in the morning every day as an adolescent girl to have the COX-2 enzyme explained to her. No. No, that was like me, not her. Yeah. We had different paths, different journeys. And you're a terrible figure skater. Not that bad. Okay.
I have never seen you figure skate.
Not that bad. I've never seen you figure skate. Can you do a sow cow? Maybe. Sure. Is that like a skateboarding move? Yeah, probably. Yeah. I can do it then. This has been Skate Talk with Robert and Kava, two people who probably don't skate. So when we left our heroes at Vioxx, they just latched upon the brilliant idea of having Dorothy Hamill sell Vioxx.
If you've been wondering how tens of millions of your fellow countrymen could be convinced to vote for a guy like Trump, just remember that an awful lot of them saw a video of a figure skater promising she knew a solution to their chronic pain issues and desperate for relief, millions of people followed her to their demise. 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 IACS's success, it would have seemed as if COX-2 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 scientists who were 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 expected to do to try to like figure out, you know, how safe a medication is. Yeah. And if you were doing that with Vioxx, you would have walked away misinformed. And this brings us to one of the chief medical merchants of Vioxx Disinfo, a Harvard Medical School professor named Dr. Jerome Groopman.
He had embarked on a career as what you might call a professional semi-celebrity doctor, authoring articles for The New Yorker about health and the pharmaceutical industry. which he does today. Dr. Grootman is not someone who you would call a crank. He served in the advisory board of the National Heart, Lung, and Blood Association.
He was the Dina and Rafael Reconati Chair of Medicine at Harvard Medical School. He'd worked at a high level for the FDA and was a listed author on some 150 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 reference. Not familiar with that one. This episode. It wasn't great.
As Tom Nessie writes in the book Poison Pills, even among top level physicians who are generally known as opinion or thought leaders, Groopman stands out. It was no small matter, therefore, when he wrote a lengthy article for The New Yorker in June of 1998 entitled Super Aspirin, New Arthritis Drug Celebra.
Celebra was the name for the drug later known as Celebrex and very close in composition to Vioxx. The article had been carefully authenticated by the famous fact-checking department of the New Yorker, which has 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 arthritis developed while training for the Boston Marathon. Despite years of searching for relief, he had found no satisfactory remedy. Now a 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 Dr. Groupman did speak with other medical experts, like Harvard's Dr. 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, Dr. Simon was also a paid employee of Searle, conducting clinical trials for Celebrex. He did not disclose this conflict of interest, and Dr. Grootman's article did not make any note of this fact that might have compromised a source's objectivity. That's actually pretty shocking, I have to say.
That's real bad. I mean, because... I mean, I know it's not a medical journal that he's writing in, but that is like the New Yorker, though. Like, I mean, yeah, you would think he would he would know he should know better. Like that is like if you write anything. I wrote a piece in the BMJ recently and I had to disclose everything, including who I was voting for. Yeah. You know, in the election.
So it's like in who I donated money to in the election. So that's pretty shocking to me that like they did not require that.
They didn't require that. It's unclear to me if Groupman knew that Dr. Simon was a paid employee of Searle. But I don't think Groupman is doing as much of his due diligence as he ought to. What Simon is doing is obviously the more shady of the thing. But it's one of those. This is what I say when I'm like. You really I just made that comment about like people being led by a figure skater.
But like, yeah, again, if you're yeah, if you're doing your research, you could still get misled about this stuff.
Right. I mean, by a Harvard doctor. I mean, if COVID has done nothing else, it has also raised some doubts about, you know, the. reputation of places here in the Bay Area, like UCSF and Stanford, where a lot of anti-vaccine cranks seem to be coming out of.
So it's not totally shocking to me that it's Harvard, but I could absolutely see the danger in someone with a name that big, the H-bomb you're dropping there, leading people to believe this. And New Yorkers, the intellectual elites, leading them all to believe the safety of it.
Yeah, and Simon's quotes in The New Yorker are, it's one of those things, he's really relying a lot on the fact that he's this fancy Harvard doctor because the shit he is actually saying in this article is shit no doctor should ever say. He described Celebrex as incredible and told Dr. Grootman that unique among all other medications ever created, it had no side effects whatsoever.
He specifically stated there are no side effects, which those don't exist. You might not experience side effects, but someone will. There is no drug that has zero side effects of any kind. It's not a drug if it's that way.
If I am doing the safest procedure in the world, I am never, ever going to say this is no risk because that's like jinxing it. Why would you do that? You never do that. It's just stupid. It's untrue. That is zero shocking. I mean, this is maybe that's a big old red flag.
Wow. Yeah. And this is this is, I think, where it gets into, like, the value of actually having a higher level of like.
Kind of medical like medical even training may not be totally the right word, but like word, but like in school so that because that's the sort of thing it is easy to like train people to have people in general layman be aware of like, oh, if I see that, if I see somebody claiming there are zero side effects for anyone of this medication, that's something you shouldn't. That's sketchy, you know?
Absolutely. Yeah.
So as Nessie notes, this should have been a massive and immediate red flag, just as we noted. But yeah, Dr. Grootman's article cited other medical experts making similarly dubious claims. He quoted another Harvard professor, Dr. 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. Dr. Saper had a theory that inflammation in the brain caused by injured neurons led to swelling that damaged brains, and that as a result, Vioxx might help, right? And that's a perfectly valid thing to want to test, right?
But you shouldn't go out in an article and be like, this might cure Alzheimer's based on that, because that's just a theory, right?
And it's read by people understandably who are going to then relate it to somebody else as this is what it does. This is like we think it does this. And like there's so many steps. There's so many steps. There's years of steps between point A and point B in that.
Yep. And yeah, so, quote, Dr. Saper said that Celebrex probably has to break open the vicious cycle of inflammation and Alzheimer's. Quite an astonishing statement in and of itself, and even more so since he did not cite results of a single human study.
Yet the claim is part of an age old school of medical thinking that holds that logic and what makes sense or rational therapy should dictate the practice of medicine. 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 Saper 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 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 15 years out or whatever. Right.
you know groupman's article also wildly exaggerated the harms of existing inseds 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 groupman cited the work of dr james freeze a professor at stanford at length freeze himself claims groupman distorted his research in order to make claims that freeze was not making about uh cox-2 inhibitors
Now, Dr. Grootman was not being bribed by Merck, 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.
Right.
I think that's irresponsible, but not malicious or outright criminal. Right. And we are talking about some people who did outright criminal acts in this. I want to make it clear I am not.
accusing dr grootman of doing anything criminal uh the same cannot but it's a slippery slope it is i mean it is you can see why it leads to people doing it you know and i've said this to you before too it's like i think in the past you know when i was earlier in my medical training in my career i didn't care that much about things like that i would probably read it and be like what is he saying what does he mean ah forget it and let it go not worry about that much
But this is how it starts. This is how it starts. It raises enough doubt. It raises enough like it makes it vague enough and 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.
Yeah, it's the same thing where we have this problem in journalism, right?
There's a great movie called Shattered Glass starring Hayden Christensen about a journalist for the New Republic who was like their star reporter, super young, and it turned out all of the stories, he was just making them up, like complete bullshit, like literally just inventing people and things in order to write entertaining stories.
The New York Times a little bit later had another reporter get blown up, 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 that's on the newsroom. That's on the editors. That's on the 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 uh 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 and
I'm here for the treatment of people. And there's going to be people who are going to be upset if Celebrex goes away or if these medications go away because there are people out there who are like, this is the one that works for me. Yeah.
It's fucked. So, again, I just made the point that Grootman was not breaking the law. The same cannot be said for the next doctor we're going to discuss, an anesthesiologist named Scott Rubin.
Starting in the year 2000, Rubin published what would become 21 papers claiming to show evidence that COX-2 inhibitors performed better than non-steroidal anti-inflammatory drugs for patients who'd received orthopedic surgery. Now, the last episode, we mostly focused on Merck, and we will later in this one, as the bulk of the blame Okay.
Pfizer funded a great deal of Rubin's research from 2002 to 2007, effectively picking him up after he'd established himself as an expert in the burgeoning field of COX-2 inhibitor research. The good news is that in the field Rubin attempted to influence, orthopedic surgery, his work had less of an influence than he'd hoped.
Most surgeons hesitated to switch to COX-2 inhibitors because some very good animal studies showed they slowed the rate at which bones heal, which is kind of a big deal if you're in the orthopedic surgery business. Yeah.
Wow, I'm just impressed that the orthopedic surgeons were reading anything. Hey-o! Sorry. Sorry, that's my little dig at the orthopedic surgeons.
It's really the orthopedic surgeons. Sorry. Speaking of orthopedic surgeons, they don't listen to podcasts, so fuck them. Here's some ads.
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And we're back. If you're an orthopedic surgeon, hit me up. I got too many bones. I could use a couple less, probably. So Rubin's work formed an influential mass of positive-seeming scientific PR arguing in favor of drugs like Vioxx and Celebrex as safer super aspirants. An article in Scientific American notes, a 2007 editorial in Anesthesia and Analgesia said,
stated that Rubin had been at the forefront of redesigning pain management protocols through his carefully planned and meticulously documented studies.
Did he say that himself? He called his own studies meticulous? No, no.
That's what an editorial, how the editors of the paper described him. I see. And there's only one problem with these carefully, the 20 or so carefully planned and meticulously documented studies that he had authored over a 12-year period. They were all complete bullshit, fraudulent in every way.
Now, we will talk more about Rubin later because a lot of his story occurs after the collapse of Vioxx, but it's important to note that just as Pfizer underwrote Rubin's shoddy research, Merck had deeply questionable science that they funded in an equally dubious way.
Back during the FDA approval process, Merck had launched a strategy called ADVANTAGE, in all caps because it was a very tortured acronym. assessment differences between Vioxx and naproxen to ascertain gastronomical tolerability and effectiveness.
An analysis by the Union of Concerned Scientists describes the goal of Advantage as using flawed methodologies biased 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 naproxen, a pain reliever sold under brand names such as Aleve rather than a placebo."
and yeah we we covered that a little earlier but what's important is that we now know that vermerc had a great deal of evidence when they were pushing this study suggesting that like vioxx 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 naproxen and it looked less risky than it does because it was next to naproxen they conducted that study with naproxen because they had data showing that vioxx massively increased the risk of heart attacks
And they were deliberately trying to hide that, right? This is all stuff that came out later as a result of the Senate investigation and numerous court cases. So yeah, we know that Merck had a lot of evidence showing this was dangerous and that they deliberately hid it. And we know that this was incredibly profitable for Merck. From 1999 to 2004, Vioxx made them $2.5 billion a year on average.
It swiftly became the best-selling drug in Merck history and one of the best-selling drugs of all time. And just as swiftly, it started to kill people. One of the first to die was Bob Ernst. He was a fit 59-year-old triathlete who started taking Vioxx because of recurrent arthritic pain in his hand. His wife Carol had urged him to try Vioxx after seeing an ad and Bob had gone on the medication.
On May 6, 2001, the two had 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 59-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 and started digging into Bob's one medication. This is the only thing he was prescribed, Vioxx. Even as early as 2001, there were studies showing that Vyax was bad for heart health. Merck 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. And the book Poison Pills 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 2005, a Texas state jury awarded almost $25 million to Carol Ernst in compensatory damages against and more than 200 million in punitive damages.
Now, that latter verdict was lowered quite a bit due to a Texas law, but it would be fair to call this a massive victory against Merck. And much of the case against Merck hinged on the fact that in June of 2000, Merck had provided a tranche of early user data to the FDA that revealed Vioxx users had four times as many heart attacks as people on naproxen. They didn't state this, though.
This was in the data. You could find it if you analyze the data. But it was not in any of the conclusions that Merck sent along to the FDA. And the FDA really just didn't do the work to actually figure this out very quickly. And so it wasn't until 14 months later in April of 2002 that the FDA actually forced through changes and how Vioxx was labeled to reflect the evidence of risk.
Merck took no action on their own to warn users about the fact that they knew that Vioxx was causing heart attacks. Now, in the later trial that would develop from all this, CEO Raymond Gilmartin would claim that Vioxx wanted to add a warning label the instant they were aware of the danger. This was a lie, as Cope and Berry write in their article, Merck and the Vioxx Debacle.
Lanier, that's the lawyer, introduced in the Ernst trial internal Merck documents, which revealed that Merck resisted the FDA's efforts to add warnings to Vioxx'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 2000, when Merck became aware of the Vigor study's findings of a significant increase in cardiovascular events for those taking Vioxx over naproxen, Merck's scientists expressed concern. In an email message written in March of 2000, Dr. Edward Skolnick, who was then Merck's head of research, stated the Vigor clinical trial had shown that Vioxx increased heart risks.
The CV events were clearly there, he wrote. Despite clear warnings, Merck decided against conducting studies on the heart attack risks because marketing executives worried it might hurt Vioxx sales. Internal Merck analyses in 2001 and 2002 showed that Merck was worried about lost profits if warnings or precautions were put on its label.
During that period, Merck was in private negotiations with the FDA over changes to its Vioxx label. David Anstis, who at that time was the president of Merck's human health division, projected that a strict warning would reduce sales by at least 50%.
After the Vigor study findings in March of 2000, a second internal Merck analysis performed in October 2000 showed a significant increase in cardiovascular events for those taking Vioxx. The Merck analysis, plaintiff's attorney Mark Lanier has argued, was never presented to the FDA nor the media. and certainly was not given to the physicians prescribing Vioxx.
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.
You know, it's like the it's what's interesting to me is looking at these things is what could the FDA have done better in some of these circumstances? It's hard because some of the information just not being given to them in what seems like a very fraudulent manner. But they need to have the power 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 2,000 to 4,000 at most patients in a study. Oftentimes, that's not enough to see 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 stays safe once those numbers come out. They need to be there to do the post-marketing studies. 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 FDA. Oh, God.
and how deregulated it's going to become and to see what they're going to be able to accomplish. It's going to be, 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 fewer of them are going to have the post-marketing studies to prove it.
And that's that's what's fucking scary, right? Is that like we're talking this is a massive failure by the FDA to. that happened when it was funded, right? We can argue it should have been funded more, but that happened in a period totally different from the one we're entering into now. What kind of shit is going to come by now that there's no guardrails on any of this stuff, right?
These fucking MBAs who are managing all of these pharmaceutical companies and these marketers have absolutely no restrictions on anything that they can shovel into people's faces to make a profit. It's funny.
I'm like, you know, I get a lot of shit online for being like a pharma shill. Yeah. Because like, you know, I promote vaccines like because they work and they're great. And, you know, I can go into that in great detail if you like. But like the...
The funny thing is the people, those people who are so against drug companies, so few of them are against drug companies for the right reason, for reasons like this. You know, when there's a real reason to be mad about pharmaceutical companies, more people are upset about drugs.
Like the vaccines 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 the pharmaceutical companies. And I'm as skeptical of them as anybody. Yeah. Because of shit like this and stuff we've seen like this.
And it's, yeah, it's just fucking, I mean, what's coming is going to be sick, folks, in a very literal term. But what happened in the past was pretty sick, too.
So it took about four years for the Carol Ernst legal case to wind on against Vioxx, right, from her realizing there was probably something wrong with her husband's medication to actually getting a victory, which is actually pretty quick for one of these lawsuits.
Yeah.
The company continued to push the mountain of disinformation during this time about their new star medications, dangers. One February 2001 sales memorandum forbade sales reps from discussions on a study that raised heart concerns when they talked to physicians, right? Can't talk about this study about heart attacks from our medication when you sell it to doctors.
Salespersons were also ordered to avoid discussing heart health risks and instead hand over a cardiovascular card to physicians, which said Vioxx is protecting the heart, right? rather than potentially harming it. That ought to take care of all of their questions. Oh, good. You gave me a card. Well, you guys got card money. There must be nothing wrong with this stuff.
No one shady can afford this kind of embossing. My God, look at that. It's okay, guys. They gave me a card. We're good. The Ernst lawsuit was not the first or last against Merck. Most were brought by survivors of heart attacks or, more often, the family members of people who had perished. Merck upped their game, as this passage from Kolpenberry's article makes clear.
Merck prepared an in-house training game for Vioxx sales representatives dubbed Dodgeball. Sales trainees could only move on to the next round of the card game if they gave Merck-approved answers to doctors' questions raising Vioxx safety concerns or dodged such questions altogether.
wow dodgeball they're literally playing dodgeball with their death medicine you know questions about their death medicine it is death medicine it is interesting like they they the way they train their reps like they train them to deal with different types of doctors they're very smart they recognize that there's like four or five different types of doctors and they range from like
The owl, which is like the name they'd give one when they're training sessions, which is the guy you want to avoid, the person you want to avoid because they're going to ask the 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 that are going to sell your medication. I mean, 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 like the most evil time of the farm reps.
They had the most power and doctors were the least prepared to deal with it.
Right, right. It's also this kind of like, there's less of an inbuilt immunity within the medical community because you guys weren't used to being sold to this way. Yeah, it's like when they first started getting Americans hooked on cigarettes and people had never seen an advertisement before and they're like, a cowboy? Well, I'm buying a cigarette now. Yeah.
Ah, so a later congressional inquiry found that Merck leadership divided the studies on Vioxx 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. Ah.
Now, all through 2001 and 2002, the FDA sent letters to Merck poking at it for failing to properly disclose the dangers of Vioxx, but it still took again 14 months for any sort of labeling change to be mandated. Part of why is that officials within the FDA were in the tank for Merck, not all of them, but enough.
At later Senate committee investigations, an FDA scientist testified that he had brought forward concerns about Vioxx to his superiors and been pressured to shut up. Another researcher who had gone to the FDA with complaints was Gurkenpal Singh, a Stanford professor who claimed that a Merck senior executive complained to his superiors at the university when he reported Vioxx 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, Merck has the ability to donate a lot of money to a university like Stanford. Now, still, some brave academics continue to blow the whistle, as this paragraph from a New York Times article by Alex Berenson, Gardner Harris, and Barry Myers summarizes.
In 2001, the first major study critical of the drugs appeared in the Journal of the American Medical Association. The report, written by Eric J. Topol and cardiologists at the Cleveland Clinic, reanalyzed data from several clinical trials of Vioxx and Celebrex. It reported that both drugs appeared to increase the risk of heart attack and stroke, but that the danger from Vioxx appeared higher.
Dr. Topol, the chairman of the clinic's Department of Cardiovascular Medicine, immediately called for trials to determine 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.
Dr. Topol became a harsh critic of both drugs, but his ire focused on Vioxx and Merck. Even before his 2001 report appeared, he said in a recent interview that company scientists came to Cleveland to try to convince him not to publish it. Merck officials denied doing so.
A year later, a study by Dr. Wayne Ray, an epidemiologist at Vanderbilt University, found that Medicaid patients in Tennessee who were taking high doses of Vioxx, greater than the recommended long-term dosage of 25 milligrams daily, had significantly more heart attacks and strokes than similar patients who were not taking high doses.
Back when Alex Berenson used to write useful things.
Yeah. It's okay. His career has moved forward now. He doesn't have to do that anymore. Yeah. I don't know. It's it's it's it's all pretty bad. Right. Like that's I mean, terrible. There's a degree to which like at least you can see these these heroes who tried to do something, even though, you know, your university is telling you stop.
Merck is sending scary guys to your door to be like, are you sure you want to publish that study?
Yeah. It is funny. I didn't realize until this how slow moving a car wreck this was. Yes. This is a whole thing that's been happening for a while. I didn't realize that. It's more nefarious than I expected.
Yeah. Yeah, well, because Merck, there's no argument. They don't know exactly what they're doing. They are trading lives for dollars. They know eventually we'll have to stop selling this stuff because we know how dangerous it is. But every day we get to keep selling it. We're recouping that investment. We're making a profit.
And whatever we have to pay out in the end is going to be less than what we're making.
I wonder how they justified it to themselves if they did. Money, money, money! I know, I know. And your listeners are like, what the fuck is wrong with this guy? What kind of... Does he not listen to the show? Does he not understand? But I mean, like, I feel like everybody thinks... Box sheesh, baby. But like... The people, the head of this farm company, they're doing this now.
Are they lying to themselves in some way? And what lie is that, that they're telling themselves? That's the part I don't understand.
They know who to lie to and not. They're lying, I think, to a lot of the doctors and to some of the salespeople. You know, salespeople don't maybe know how to, like,
analyze whether or not this is a a good uh study or whatever so they're just like oh those other studies that showed a danger they're not good for this reason or that reason and like you're just some fucking sales rep that got hired out of college maybe 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 um 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 right
There's just like in every episode I do, there's like this one moment where I turn to you and I'm just like, Robert, why do bad people do bad things? I just don't understand it. I'm so dumb in that way.
My brain doesn't. Yeah. I mean, it's not dumb. You just aren't. You just have a soul. And I'm working to get rid of it. Yeah, well, that's that's the only thing that's going to let us win. We all have to get rid of our souls today, which, by the way, I've got a great new medication for getting rid of your souls. First step, you're going to go to your local, not a local gas station.
Actually, you want to go to a truck stop about 30 or 40 minutes outside of town. Right. If you can actually like see like people like there's more than a half dozen rigs parked outside, 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 shit as fast as possible. And that's going to get rid of your soul. And then you're ready to join us on the front lines fighting the demons.
Don't do that, people.
You'll also be able to see demons. That's a promise. Yeah, you're going to see some shit. You're going to see some demons. Yeah, all of that fucking Ibogaine or whatever the fuck they put those in those pills. Those random trucker pills that they just, they almost call them Adderall, but not quite. Yeah.
I want to go check it out now. I mean, I live in San Francisco, so we don't have like, you know, 40 minutes outside of town is like another town. So I got to like go pretty far.
You got to go down the five to that place that sells split pea soup. And then, yeah, yeah, yeah. You can find some trucker pills there.
Yeah.
Yeah. All right, I'm going to do it, actually. I think this is a good day trip. Yeah, this will be good. Let's go do it together. We'll buy all the trucker pills and we'll see how they work.
Can we live stream that? I think that would be a good thing.
Oh, yeah. Oh, yeah. So in late September 2004, as the death toll mounted and Merck's legal team was buried in cases, they made the decision to pull Vioxx off the market altogether. This is right after the case has been decided against them, there is no longer keeping this cat in the bag, and now 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 18 months. The data showed 15 heart attacks, 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 Merck study, which I think is kind of trying to pad how bad it is, that's still much worse. That's still a real problem. The stock market reacted first, costing Merck somewhere in the neighborhood of $26 billion in a day. But that's not real money. They get it back. You know how the stock market works.
The next reaction came from the families of people who died due to Vioxx, leading to a rush of new lawsuits. But the initial public reaction was beyond muted. It was in fact downright hostile to the victims. And this likely has something to do with a particularly toxic aspect of U.S. culture I call scalding McDonald's coffee syndrome.
Now, you've probably heard the story about the woman who had a hot coffee spill in her lap at a McDonald's drive-thru, 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 the real story now, but you would see viral memes all the time. You'd see it in newspapers. It was really a thing my parents' generation loved to hate on.
It was particularly a big thing for conservatives who were angry at how mean all these, 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 that 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. 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 Merck Vioxx lawsuits initially get lost in that, right? When Carol Von Ernst won her case against Merck, 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 Ernst's 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, Merck's lead attorney, Jerry Lowry, said if he, Lanier, had any evidence Vioxx 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 Vioxx Hex, the Post wrote that the Texas jury in that case awarded $253.4 million to the widow of a man who died of a heart attack triggered by arrhythmia, which is not a condition Vioxx 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 Lanier on stage as a Hoover Institute guy. It's right wing think tank. 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 city science. They just got bamboozled by this smooth talking lawyer who just hated Merck.
It's so fucked up. You're totally right. It was like this era where it was like people like, there has to be personal accountability for this. Like they should have known that there was a small risk with medications. And they, I mean, they're missing the point, which was that the risk of, was obfuscated in the beginning.
I think, I mean, it sounds like, to be honest with you, it's still, at some point, they look back at these medications and they said, you know what, there might be a role for them. And they're actually, you know, very well could be a good use for some of these meds.
Celebrex still has some uses and stuff, right?
I mean, even Vioxx could have had specific uses for very well-chosen patients. Yeah. 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 then say, okay, well, actually, Only these small subset of people should use the medication because the risk is then worth it in the small subset. But they couldn't do it. They had to withdraw completely. So it's just so stupid on so many levels. It's such a waste of time.
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-2 inhibitors, looking at ways to selectively attack the pain pathways, shut down the pain pathways before they cascade into inflammation and pain, it's all smart. It's good.
And now, to my knowledge, I don't know if people are even thinking about this anymore. And, like, we still have problems with NSAIDs. NSAIDs still cause problems. Lots of health problems still come from them. Advil, Aleve, Ibuprofen, they still cause me headaches because I have to go and take care of people bleeding because of them. They cause heart issues, kidney problems, liver problems.
Like, people should be—we should be researching new pain medications and— worrying about how to do that right, as opposed to how to make as much money off of it 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.
I'm just. No, I mean, it's it's it's all very frustrating, right? Like the way that this worked is just comprehensively bad for everybody but a handful of people at the top of Merck. It's bad for the research scientists at Merck who were not shady motherfuckers whose will always exist under a cloud of suspicion because they worked during the Vioxx era.
It's bad for the people who might have benefited from a VIAX that was rolled out in a more reasonable 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, Dr. Hoda, what's not terrible for anybody? What's that?
The 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. Good.
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And we're back. So we're drawing to a close in this episode. I have a question. Did they actually lose money overall from this?
How much do we know?
No, no, no, no, no. They pay in total a little less than a billion dollars in penalties and additional civil settlements for their victim. They are making two and a half billion dollars a year during the period of time where they're selling this. And it's out for five years. Something like five years. Yeah.
Yeah. Okay.
Yeah. So that's cool. Now, one of my favorite side parts in this story is that the Washington Post takes like a huge, strong stance to defend an unethical mega corporation and got something wrong, which is not a thing that ever happens again.
Anyway, about a year after the Post's article talking about how unfair it is to sue Merck, Harvard School of Public Health issues a public health bulletin warning that Vioxx use was associated with severe heart rhythm disorders and an increased risk of kidney failure.
More research comes out in the following years that further vindicates everyone who tried to warn Merck and the world about Vioxx, the medication that had been prescribed to some 20 million people in 80 countries by the time it was polled. We will never have a comprehensive list of the number of people killed and injured as a result of Vioxx, but what we do know is harrowing.
Dr. David Graham, the associate director for science and medicine in the FDA's Office of Drug Safety, testified before the Senate Finance Committee that Vioxx had been associated with at least 100,000 heart attacks and more than 55,000 premature deaths. That is in the United States. He compared the cost to two to four jumbo jetliners crashing every week for five years. Holy shit.
Striking imagery.
Yes, that's a lot of dead people. God. Mm-hmm. Now, the lawsuits that resulted from this are far too numerous to chronicle, save to note that Merck initially promised to fight each of the 30,000 lawsuits against them independently.
We'll fight every one!
Yes, yes. Then they agreed in 2008 to provide what could have been almost $5 billion as part of the settlement, but I don't know how much of that they actually paid out. And then they pled guilty to a misdemeanor for illegal promotional activity. That was about another $950 million in penalties and civil payments. So they wound up paying a good amount of money.
That's like they lost a good two years or so of the profits that they made. Did Dorothy Hamill do any time? No, no. Dorothy Hamill does not go to prison for her many crimes.
Skating free.
Skates free. For her many crimes. They do plead guilty to a misdemeanor for introducing a misbranded drug to interstate commerce. So that's nice. But no one at Merck is locked up for what they did, nor do any of the scientists who'd agree to help cover up studies or push disinfo suffer lasting career harms, with the notable exception of our friend Scott Rubin.
Paul White, the editor at the Journal of Anesthesia and Analgesia, claims that Rubin's studies showing the benefits of COX-2 inhibitors helped sell billions of dollars worth of both Celebrex and Vioxx. In 2009, he was revealed to have completely falsified at least 21 of his published papers, all of which claimed to show how well super aspirins could benefit post-operative healing.
Pfizer had funded Rubin's work from 2002 to 2007, the years when they were also making bank on a little medication called Celebrex. His employer, Bay State Medical Center, claimed to Scientific American that Rubin had been paid directly by Pfizer for his work, and that he had then 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 bad?
Man, you know, it's giving anesthesiologists a bad name. It is. It is. And these are guys who deal with a lot of fentanyl. Yeah. That is wild. That is, well, I am actually, I would love to read his articles that are totally fabricated.
Oh yeah, there's some good breakdowns on them from scientists who are more qualified than me to talk about it. I would love to look at that. It's a fascinating story. One of my favorite quotes from this is that his employer Baystate, like when people would note that like, well, that's not how pharmaceutical, you're not just supposed to give a single guy cash, right?
Like, that's not how pharmaceutical research is supposed to be done. A spokesman for Bay State Medical Center told Scientific American, I don't know how many dollars went to Rubin or his group. Wow. No idea. Holy hell.
A Pfizer spokesperson insisted the grants were properly dispersed to Bay State in accordance with Pfizer policy, but that they weren't familiar with the records retention policies of Bay State. So, you know. Who knows? Who knows how much money? Between $10,000 and $100,000 at least.
But he was actually asked to pay $360,000 in restitution when he got sentenced in 2010 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 Celebrex. Thankfully, justice was done.
He was given six months in prison and asked to pay $360,000 in restitution to the pharmaceutical companies who'd sponsored his work, the real victims in all this.
Holy shit. Actually, I mean, he did some time. That's something. I mean, I do know doctors that have gone to actual prison for, like, Medicare fraud and that sort of thing, like, done actual time. It's not common, but...
you know it can certainly happen i mean the the things i'm seeing are are there it's always fraud related you know yeah 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 yeah they weren't crimes committed directly against the american government and medicare fraud so that's probably why he only got six months yep
Yeah, and that's the story of Iox. Dr. Hoda, how are you feeling? How are you good?
I mean, you know, again, it comes down to, like, I'm always a little torn when I do episodes or talk about how terrible pharmaceutical companies are because they are terrible, and I have so many problems with them. But there's always a part of me that's like,
They are super important at the same time, and we do need them more than ever to be really focused on 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 are 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-pharmaceutical 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 Dr. Peter Hotez, who's, you know, a friend of the show has come on who has made his own pharmacy or like vaccines, um, at cost, these great like vaccines and people still accuse him of being a pharma show, even though he works completely outside of the pharma world. So I, I'm very torn about pharmaceutical companies in general.
And I think it is very, very, very important, um, that we continue to pick at them, analyze them, be super critical of them, but also be fair about what they 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 risk. 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 and care very little about science. So very depressed is the answer to your question.
Yeah, I mean, there's not much more to say on the matter than that, right? I guess part of what's so frustrating to me is that the sweep of the anti-intellectual crusade that is going to cost so many people their lives is of such catastrophic danger to every positive gain that we've made as a society in the last 150 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? Right. Like someone will catch it. It won't be that bad.
Like and those little acts of malfeasance provide a lot of the fuel, like the distrust, the hatred of, for elites and whatnot. You know, when I say elites, I mean like in the medical sense, right? You've got doctors and people at the FDA who are like in the tank for these sketchy drugs that get people killed. And that means that when we have a fucking pandemic, less people trust them, right?
Like Vioxx is not 0% of why so many people were hesitant. to, 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.
We'll start taking advantage of the situation.
Yeah, that's exactly right. That's exactly right. So, yeah, it's going to be a wild four years. There's going to be so much diarrhea.
Yeah, there's going to be a lot of diarrhea. Look, folks, every year I go to Vegas, I find whichever buffet has the rancidest mussels, and I eat 14 to 15 plates. And that provides me with the internal strength and resilience I need to handle any kind of change to our health and safety food standards. I'm going to be fine in this sick new world, Kava.
I'm going to be eating rancid mussels like a king.
So many, so many foodborne illnesses. So much. It's going to be the golden age of diarrhea.
It's going to be the golden age of diarrhea. The brown age, really. Yeah, that's what we're going to call this. The gilded age and the brown age. Well, actually, we could call it the gilded age, which is an old timey term for like shit encrusted on your ass.
Perfect.
We'll have to explain it, but it works. Yeah, you have to explain it. You have to explain it. But, you know, why does that make it bad? Anyway. No. Yeah. All right.
Thanks for having me. It was a blast. Yeah. It's always good. It's nice seeing you. Nice seeing your face. For your listeners who may have an interest in learning more about medical topics. You can listen to my podcast, the house of pod, anywhere you get your podcast and, uh, follow me at blue sky at Kaveh MD. And, uh, thank you.
Yeah. Thanks for coming on the show.
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One in three women and one in four men experience domestic abuse in their lifetime, and nearly half of survivors delay leaving because they can't bring their pets with them. Purina started the Purple Leash Project to help eliminate one of the many barriers domestic abuse survivors face, a lack of pet-friendly domestic violence shelters. Through the Purple Leash Project,
Purina is helping to create more pet-friendly domestic violence shelters across the country so abuse survivors and their pets can escape and heal together. Visit Purina.com slash purple to get involved.
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Once upon a time, Amazon Music met audiobooks and listeners everywhere rejoiced. Oh, yeah. Because now they could listen to one audiobook title a month from an enormous library of popular audiobook titles, including Romantasy, Autobiographies, True Crime, and more. Suddenly, listeners didn't mind sitting in traffic or even missing their flight. Amazon Music Unlimited now includes Audible. No way.
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