The Troubling Story of Vioxx

Were you aware of how twisted the system was before you started doing this litigation, before you started going over the peer-reviewed papers and finding out where they did? Were you aware of how the system was set up? It came in two stages. After I finished my residency in family medicine, I did a Robert Wood Johnson fellowship for two years. And that was a wonderful training in epidemiology and research design and statistics. That's where I got these skills that I came back and drew on. But family medicine is very hard in an academic environment. The purpose of the fellowship was to train academics in family medicine to increase the prestige of family medicine, which seems like a good idea. But family medicine is very difficult in an academic environment because the family docks a low man on the totem pole in the hospital and all the specialists often don't treat them with the respect they deserve. And I decided that my calling was to go be a doctor in a smallish town. And I did that for 20 years. But I had this Robert Wood Johnson fellowship training always in the back of my mind. And as we got through the late 90s, it became clear that the drug companies were influencing what was in the journals. And then the drug, do you remember the drug Vioxx? Yes. It was an arthritis drug. I have a friend who had a stroke after taking Vioxx. Yeah. So yeah, I got a letter from a mother whose child died, 17-year-old child died from taking Vioxx, eight samples of Vioxx. But Vioxx came along and there was an article in the New England Journal that Merck had sponsored and it said it was safe and was advantageous, not because it was any more effective but because it reduced the risk of serious GI problems. And then there was another article in the New England Journal of Medicine that fessed up to cardiovascular problems. But the review article said this may be due to the play of chance because there were only 70 events and such a small number of events is subject to statistical variation. And I knew that that was crazy because there were only 53 serious GI events, which was the whole reason for selling this $2 billion a year drug was that it was safer on the GI tract and there were only 53 events. It was an anti-inflammatory, right? Yeah, exactly. So the idea was that that was better than non-steroidal anti-inflammatories? Exactly, because it didn't upset the stomach the same way. The science was elegant and it might have worked, but it didn't. And in changing that balance, it made the blood more likely to form clots. The physiology was a little more complicated than just stomach or no stomach. And is something like this, the issue is the size of the trial because you could have 10 people and none of them can have a problem, but you could have 10,000 people and you could have quite a few problems. So you have to make this study as large as possible so you get all this biological variation between human beings where different things affect different people in different ways. That's part of it. And you can have a study of 8,000 people where you leave out three heart attacks and you flip the statistics and claim that there's not a cardiovascular risk. Okay. And it was fraud. It was fraud. And you couldn't tell the fraud from the article in the New England Journal. They, Merck had submitted this data to the New England Journal and they did what peer reviewers do, which is not have the data, but make sure that the article makes internal sense. They published the article and then this review article came along and they gave a little bit more insight into the cardiovascular problems, but they blew it off as the play of chance because there are only 70 events and that was crazy. And at that point I was sitting in my office at lunchtime reading, taking a break between sessions reading this article and I said, that's it. I got to find out. I got to figure this out. There's something so wrong going on here that it's beyond my comprehension. So an article was published in JAMA two weeks later that had a footnote that led to FDA, an FDA website that had enough data to see that Merck had been fraudulent about the heart attacks. And when I saw that, I said, I'm going to leave practice and I'm going to figure this out. And I worked for two years on a book called Overdosed America. It was published in 2004 and it had the Vioxx story in it. And a week after that book was published, Vioxx was pulled from the market. It wasn't my doing. Another study had Merck's, Merck had done a second study that showed the same thing, that the risk of strokes and heart attacks and blood clots was doubled. And at that point they had a pull it because they were hiding the data on this first study. Now the second study came along and it was clear that the jig was up for them. And how long had they been prescribing and distributing Vioxx at that point? It came out in May of 99 and that was September of 2004. So between 20 and 25 million Americans had taken Vioxx and between 40 and 60,000 Americans had died, died from the cardiovascular consequences of Vioxx. In the same ballpark as the number of Americans who died in Vietnam, died from taking this drug that was no more effective at treating arthritis or aches and pains than non-steroidal anti-inflammatories and caused 40 to 60,000 deaths. And what was the punishment for Merck? Merck there were 27,000 plaintiffs in the litigation and they were awarded 4.7 billion. Merck sold $12 billion worth of Vioxx in the four and a half years it was on the market. So they paid the plaintiffs 4.7 billion and the Department of Justice fined them a little bit under a billion dollars but nobody went to jail. Not only that, they're still making profit. That's profit. They Merck, excuse me, Vioxx they probably made a small profit. They took in $12 billion. They had research and development costs and marketing costs and all, manufacturing costs. So a small profit of what, a billion dollars? Maybe they made a billion. Isn't that wild? You can make a billion dollars from lying. Joe it's crazy. Even after being punished. It's crazy and the Merck's chief scientist saw the data from that first study where the three-hearted attacks were omitted and there's an email that the Wall Street Journal published for March 9th, 2000 when they opened up the data on that. And the email, I'm paraphrasing, but the email said something like, it's a shame but the cardiovascular effect is there. But the drug will do well and we will do well. Oh God. And that's written down. It's written down. And no one goes to jail for that. No he's... I mean that is insane. I mean imagine any other thing that you do that's fraud that causes 40,000 deaths? Between 40 and 60. Imagine any other thing. Any other thing that you would sell. Imagine if that was like Oreo cookies or whatever. It's unheard of. It's unheard of and that's why it continues. Because there's not adequate oversight. There's no consequences. There's consequences but... There's slaps on the hand but... Yeah. Usually when the fines are announced by the Department of Justice the stock goes up because the shareholders are happy to have this burden off.