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Part Two: The Vioxx Scandal: How Big Pharma Killed More Americans Than Vietnam - Behind the Bastards | Wave AI Podcast Notes

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

Behind the Bastards

Thu Dec 12 2024

Summary

Podcast Summary: Behind the Bastards – Part Two: The Vioxx Scandal: How Big Pharma Killed More Americans Than Vietnam

Introduction to the Vioxx Scandal

In this compelling episode of Behind the Bastards, hosts Robert Evans and Dr. Kaveh Hoda delve deep into one of the most infamous pharmaceutical scandals in history: the Vioxx debacle. Released on December 12, 2024, this episode meticulously unpacks how Merck's aggressive marketing and deceptive practices led to widespread harm, ultimately claiming more American lives than the Vietnam War.

Merck’s Deceptive Practices and the Rise of Vioxx

The episode opens with a critique of pharmaceutical advertising, notably criticizing the use of celebrity endorsements like Dorothy Hamill’s promotion of Vioxx without proper vetting or understanding of the drug's risks. Evans emphasizes the irresponsibility of leveraging trusted figures to market potentially dangerous medications:

"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." [04:23]

Merck's Vioxx, a COX2 inhibitor designed as a "super aspirin," was heavily promoted as a breakthrough with minimal side effects. However, internal studies revealed significant cardiovascular risks, which Merck chose to obscure rather than address.

Key Figures and Manipulation of Scientific Research

Evans introduces Dr. Jerome Grupman, a Harvard Medical School professor who authored a misleading article in The New Yorker promoting Celebrex, a drug similar to Vioxx. Grupman's failure to disclose conflicts of interest and reliance on anecdotal evidence raised significant ethical concerns:

"He described Celebrex as incredible and told Dr. Grupman that unique among all other medications ever created, it had no side effects whatsoever." [11:42]

Another pivotal figure discussed is Dr. Scott Rubin, an anesthesiologist whose fraudulent research bolstered the false safety claims of Vioxx and Celebrex. Rubin's manipulation of data and publication of 21 falsified studies under Pfizer’s funding highlight the systemic issues within Big Pharma:

"He completely falsified at least 21 of his published papers, all of which claim to show how well super aspirins could benefit postoperative healing." [58:04]

The Legal Battle and Public Backlash

The narrative shifts to the personal story of Carol Ernst, whose husband Bob died of a heart attack linked to Vioxx use. Her pursuit of justice led to a landmark lawsuit against Merck, resulting in a substantial financial verdict:

"In August of 2005, a Texas state jury awarded almost $25 million to Carol Ernst in compensatory damages and more than $200 million in punitive damages." [24:19]

Despite the victory, Merck's defense painted the lawsuit as another example of frivolous litigation, akin to the infamous McDonald’s coffee spill case. This portrayal contributed to public skepticism and backlash against the victims seeking justice.

Impact on the FDA and Public Trust

Evans and Hoda critically examine the FDA’s role, highlighting failures in oversight and the agency's inability to swiftly act on emerging evidence of Vioxx's dangers. Internal Merck communications revealed a blatant disregard for safety in favor of profits, sowing distrust in regulatory bodies:

"Internal Merck analyses in 2000, 2001, and 2002 showed that Merck was worried about lost profits if warnings or precautions were put on its label." [30:25]

Hoda expresses deep concern over the future of the FDA, fearing increased deregulation could lead to more pharmaceutical malfeasance:

"It's terrifying to me to see what's going to happen to our FDA. It's going to be the golden age of diarrhea." [31:26]

Concluding Reflections and Broader Implications

In their concluding remarks, Evans and Hoda reflect on the broader implications of the Vioxx scandal for the pharmaceutical industry and public health. They lament the loss of trust in medical institutions and the enduring impact of corporate greed on patient safety:

"They are trading lives for dollars. The longer they know, the more they get to sell this stuff without a warning is worth it to us, right?" [40:22]

Hoda acknowledges the duality of Big Pharma's role, recognizing their critical contributions to medical advancements while condemning their unethical practices:

"I have a lot of mixed emotions about pharmaceutical companies in general. We need to continue to pick at them, analyze them, be super critical of them, but also be fair about what they can do." [60:24]

Notable Quotes with Timestamps

Robert Evans [04:23]: "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."
Dr. Kaveh Hoda [31:26]: "It's terrifying to me to see what's going to happen to our FDA. It's going to be the golden age of diarrhea."
Robert Evans [40:22]: "They are trading lives for dollars. The longer they know, the more they get to sell this stuff without a warning is worth it to us, right?"
Dr. Kaveh Hoda [60:24]: "I have a lot of mixed emotions about pharmaceutical companies in general. We need to continue to pick at them, analyze them, be super critical of them, but also be fair about what they can do."

Conclusion

Part Two: The Vioxx Scandal serves as a sobering exposé of the lengths to which pharmaceutical companies like Merck will go to maximize profits at the expense of public health. Through thorough analysis and poignant discussions, Evans and Hoda shed light on the critical need for transparency, accountability, and stringent regulatory oversight in the pharmaceutical industry to prevent such tragedies in the future.

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Transcript

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Robert Evans (5:37)

This has been Skate Talk with Robert and Kava, two people who probably don't skate. So when we laughed 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. 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 COX2 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 the amount of reading we could expect from a research scientist, because research scientists who were responsible knew the dangers. But if you were, say, 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 deter, like, figure out how safe a medication is. 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 Grupman. He had embarked on a career as what you might call a professional semi celebrity doctor, authoring articles from the New Yorker about health and the pharmaceutical industry, which he does today. Dr. Grootman is not someone who you would call LeCrank. He served in the advisory board of the National Heart Lung and Blood Associ. He was the Dina and Rafael Reckonati 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.

Robert Evans (24:26)

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 by the Union of Concerned Scientists describes the goal of Advantage as using flawed methodologies, bias towards predetermined results to exaggerate the drug's positive effects. As part of their strategy, scientists manipulated the trial data by comparing the drug to Naproxen, a pain reliever sold under brand name such as Aleve rather than a placebo. And yeah, we covered that a little earlier, but what's important is that we now know that Vermeerk had a great deal of evidence when they were pushing this study suggesting that 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 they deliberately hit it. And we know that this was incredibly profitable for Merck. From 1999 to 2004, Vioxx made them two and a half billion dollars 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 ke, 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 Vioxx 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 and more than 200 million in punitive damage. 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 like Merckx sent along to the fda. And the FDA really just didn't do the work to like 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 reveal 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 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 2000, 2000, 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 negotia 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.

Robert Evans (36:13)

Right, right. It's also this kind of like there's less of an inbuilt, like 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. 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 consider background study. And so their salespeople were forbidden to discuss them with doctors. This was a violation of company policy. 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, his superiors, and been pressured to shut up. Another researcher who had gone to the FDA with complaints was Gurkan Paul 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 St. 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 meyer 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 cardiologist 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. Tapol, 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. Tapol became a harsh critic of both drugs, but his ire focused on Vioxx, 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 25mg daily had significantly more heart attacks and strokes than similar patients who were not taking high doses.

Robert Evans (43:28)

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 no 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 US 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 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 the 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 frivolous lawsuits hurting innocent corporations. Like this woman spills coffee in her own. 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 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 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 loop 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 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 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 whole 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 medicine evidence. And this is number one, that fucking dude debating Lanier on stage as a Hoover Institute guides 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.

Kaveh Hoda (60:24)

I mean, you know, I. 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. 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're gonna 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. 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 at cost. These great, like, vaccines. And people still accuse him of being a pharma shill, even though he works completely outside of the pharma world. So I'm very torn about pharmaceutical 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 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 over sight 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 I'm very depressed is the answer to your question.