NIXING Vioxx

	September 30, 2004
	Merck & Company pulled its arthritis drug, Vioxx, off the market Thursday after trials showed an increased risk for heart attacks and strokes. Susan Dentzer examines the impact of the drug recall.

MARGARET WARNER: What's behind Merck's decision today to yank its blockbuster arthritis drug Vioxx off the market? For that, we turn to our health correspondent, Susan Dentzer. The Health Unit is a partnership with the Henry J. Kaiser Family Foundation. Susan, first just briefly explain what is Vioxx and how did it become such a hot drug for arthritis? SUSAN DENTZER: The experts I talked to were calling this a true drug disaster given the importance of Vioxx in this market. Vioxx is part of a family of drugs, anti-inflammatory drugs that includes very common over the counter medications like aspirin, and ibuprofen. This part of the family, though, that Vioxx is in, is called a cox-2 inhibitor drug, specifically developed to guard against a common side effect of all these anti-inflammatory drugs, which is bleeding in the stomach and the intestine. Sounds like an easy side effect, but it's quite a dangerous one. 8500 deaths a year estimated to result from it, 50,000 hospitalizations. So the cox-2 drugs like Vioxx were developed to guard against that side effect, still provide some pain relief and some inflammation relief. Interestingly enough, though, not more than these other drugs that like ibuprofen and aspirin which are much cheaper. MARGARET WARNER: Now, how did Merck discover this cardiovascular risk? Because I gather the study they were doing wasn't about that at all. SUSAN DENTZER: That's right. This particular study was a study to see whether Vioxx was effective in preventing a recurrence of colon cancer polyps in patients who had already had those polyps removed. So Merck was looking to get another so-called "indication" for this drug. However, it was also looking at another issue, a safety issue that actually had a risen as long ago as 2000 in a separate study that Merck did. That study did in fact show that if you took Vioxx and compared it to another anti-inflammatory drug, Naproxen, those patients who took Vioxx had a higher risk then of heart attacks and strokes. So this new study was also looking at that issue, did you have more heart attacks and strokes if you took Vioxx. MARGARET WARNER: The answer of course was yes. How much riskier? What are we really taking about here? SUSAN DENTZER: A huge increase in the so-called relative risk. Double the risk if you were on Vioxx versus a placebo, a dummy pill. To any given individual in the study, this was a big study, 2600 people for three years, to any given individual in the study the risk was small. But if you look at statistically it essentially was a 1.9 percent risk for the dummy pill population, a 3 and a half percent risk for the Vioxx population; it was almost a doubling of the risk. If you extrapolate across the huge population of people taking Vioxx, two million people currently, huge numbers of people experienced heart attacks and strokes due to this drug, probably thousands and thousands of additional deaths. MARGARET WARNER: Now, how could a drug, such a popular drug be on the market for five years and this not have been discovered before or not proven before? SUSAN DENTZER: Well, the risk was known, as I say, as far back as 2000. And those study results were published. In fact, because those study results were available, the Food and Drug Administration and Merck had agreed to put a warning in the label, the information made available to physicians, showing clearly that patients who took this drug had a higher risk of heart attack and stroke than taking this other common drug, Naproxen. So that was known. What really wasn't understood though is essentially how big the risk is. And I think what this study has shown now with incredible statistical clarity, this risk was really and actually that because many people are on this drug for a very, very long period of time, this also showed that after 18 months on the drug, the risk was really, the increased risk was enormous. MARGARET WARNER: We think most patients, people would say how could a drug like this even get on the market without this risk having been discovered? Is it something to do with the way drug trials are done in terms of getting on the market in the first place? SUSAN DENTZER: Yes, it's very much a structural issue, and experts I talked to today like Tom Moore of George Washington were emphasizing this. What is going on here is that to get a drug on the market, a drug company only has to prove, it has to prove that it's effective, and it has to demonstrate safety over a relatively short period of time, six months sometimes, six weeks. These are drugs now that are made to take for a long time for chronic conditions like arthritis. So we don't have a mechanism except when those drugs are on the market for a long time to determine just how risky they are. MARGARET WARNER: Now briefly you mentioned there could have been thousands of deaths. Is there something else that's going to play out here? SUSAN DENTZER: Clearly. Clearly. Already there are lawsuits developing against this, Merck the manufacturer will almost certainly have to make a very large payout. And there will probably be a restructuring of the whole way we do these drug trials. MARGARET WARNER: Susan, thank you. SUSAN DENTZER: Thanks, Margaret.