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Merck Faces New Questions Over Vioxx Risks, Research

April 15, 2008 at 6:40 PM EST
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Pharmaceutical company Merck knew in 2001 that its arthritis drug Vioxx could harm patients and used staffers to "ghostwrite" favorable research on the drug, articles in the Journal of the American Medical Association report. Susan Dentzer examines the charges.
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JIM LEHRER: Now, developments today on the story about what the makers of the painkilling drug Vioxx knew and when they knew it. Vioxx was pulled from the market in 2004.

Here now is our health correspondent, Susan Dentzer.

And today’s revelations or today’s story has to do with the report in the Journal of the American Medical Association. What was its basic finding?

SUSAN DENTZER, NewsHour health correspondent: There were actually three articles, Jim, with three different kinds of allegations, one of which was an allegation that Merck withheld from the Food and Drug Administration some data in 2001 that — the allegation is if the FDA had had this full data, it might have acted sooner against Merck and against Vioxx.

Another allegation, and in fact…

JIM LEHRER: And this is data that related to Vioxx and the increase in risk, health risks involving the heart and strokes, right?

SUSAN DENTZER: Yes.

JIM LEHRER: OK.

SUSAN DENTZER: And specifically overall deaths in this one particular case.

JIM LEHRER: OK, all right.

SUSAN DENTZER: In addition to that, the charge has been made that Merck did not have a so-called data safety and monitoring board, an outside board specifically looking at some trials that Merck undertook to test Vioxx for use in patients with Alzheimer’s to either prevent Alzheimer’s progression or to prevent it altogether.

And the allegation is that Merck did not have this board in place to watch what was going on in the trial and a board that could have called a halt to the trial and surface some of these data that are now in question.

JIM LEHRER: But the basic use — back to the first one — was not the — the primary use of Vioxx was not for Alzheimer’s. It was for arthritis and as a pain reliever, right?

SUSAN DENTZER: That’s correct.

JIM LEHRER: OK.

SUSAN DENTZER: It was approved for treatment as a pain reliever primarily for use in patients with arthritis.

JIM LEHRER: OK, now the third allegation?

SUSAN DENTZER: The third allegation was that Merck also systematically did what many pharmaceutical companies are said to do, which is that, when it was conducting these trials and accumulating data, when it came time to publish those in journals, like the JAMA, the Journal of the American Medical Association, what it did was either hire outside companies to write up these studies first or it had Merck employees, Merck researchers, write up those studies first.

And then it went, the allegation goes, shopping around for outside academic scientists who would put their names on the studies so that they would, in effect, be prestigious enough to be published by medical journals.

Signs of higher heart attack risk

JIM LEHRER: All right, now let's back up and put all this in a context. It was pulled from the market in 2004. The story I read is that there were 20 million people who were regular users, not regular users, but users of Vioxx. Is that correct?

SUSAN DENTZER: Yes, had used it worldwide.

JIM LEHRER: And where did the health risk come from? And what did this show? The studies that were either rigged or were not done well, what did they finally demonstrate?

SUSAN DENTZER: Well, to this day, we honestly do not know what caused the problem, but what was, in fact, demonstrated was that, in a certain group of patients, there was a doubling of the risk overall of heart attack and stroke from taking Vioxx. And this is what eventually led Merck to pull the drug off the market in 2004.

But the early signs that indicated there might be some problem had surfaced very early after the drug was approved in 1999. And what happened was a long argument between Merck and the FDA and others about what these signs meant.

You can imagine, in older patients with arthritis, heart attacks are very common events. Strokes are very common anyhow.

JIM LEHRER: Anyhow, whether they take Vioxx or not, right.

SUSAN DENTZER: So if you have an increase in the numbers of heart attacks, how do you know that that's being caused by the drug, as opposed to the fact that these people are sick to begin with? So this is what was in dispute for many, many years.

And essentially what these articles published today are saying is that there specifically was an effort by Merck to withhold some data that would have shown that the risk of death was about three times in groups that were taking these drugs versus those who were taking dummy pills in these trials.

Merck's response to allegations

JIM LEHRER: Now, what does Merck say about today's reports?

SUSAN DENTZER: Merck says, first of all, it denies the allegations that it withheld the data. It does point out that it eventually did give the FDA these data in 2003. So FDA sooner or later got them, and FDA agrees with that.

What Merck also says is that they published study data that did show a difference in your likelihood of death from if you took the drug versus not. So that information was out.

And Merck says the dispute all along was, what does this mean? As I said earlier, was it a statistical fluke in the studies? Was it due to the fact that these are sick people to begin with and had heart attacks? Or was there really something causing a higher rate of heart attacks?

And Merck says we now know the answer to that. The drug was pulled off the market in 2004. Merck is now settling more than 20,000 lawsuits involving 47,000 plaintiffs over this. So, in effect, it says this is old news.

JIM LEHRER: And it's not over yet, because these cases -- many of these cases are still pending. There have been a couple of really huge verdicts already, have there not?

SUSAN DENTZER: Yes, and Merck in the end won more than twice as many of these suits as it lost. But now all of this has been rolled into this settlement which is underway, and eventually many of these plaintiffs will be paid.

JIM LEHRER: And that will eventually close this whole case, you think, eventually? We don't know when, though.

SUSAN DENTZER: Well, as we see, this was really a watershed event in U.S. drug safety and regulation, and the repercussions continue with all of this still coming out.

A new role for Susan Dentzer

JIM LEHRER: Well, Susan, a personal note, you are -- this is your last week as health correspondent here for the NewsHour. Thank you for all the great things you have done. And tell us where you're going and what you're going to be doing.

SUSAN DENTZER: Well, thank you, Jim. It's been a privilege to be here.

I'm going off to be the editor-in-chief of the journal Health Affairs, which is the nation's leading publication journal in health policy. And I'll be overseeing the publication of all the articles that come out in the journal, as well as the articles we publish on our Web site, and taking us probably into new media platforms in the future.

JIM LEHRER: Now, who are the readers of your magazine? What's the target audience?

SUSAN DENTZER: The target audience primarily -- the purpose of Health Affairs is to take research about our overall health care system. I like to say there's what goes on inside your body in health care and there's everything that goes on outside your body in health care.

And that's the part that Health Affairs focuses on, everything outside the inside of your body: the hospital system, the insurance, everything else.

JIM LEHRER: Out there.

SUSAN DENTZER: So we take research that's done by prominent academic researchers. It's a peer-reviewed journal, so we don't publish anything that doesn't pass muster with the top people in the field.

And the audience primarily is supposed to be policymakers. It's supposed to put this information in the hands of people who, in theory, can work to create a better health care system.

JIM LEHRER: Well, that's good news for you. It's bad news for us that you're leaving, but there's still good news, is that you're still going to be available to come on the NewsHour occasionally and do exactly what you just did in the Vioxx case.

SUSAN DENTZER: With great pleasure. It's been an honor to be associated with the show, Jim.

JIM LEHRER: Well, we look forward to seeing you again. And my best to you. Thank you very much, Susan.

SUSAN DENTZER: Thank you.