nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
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Monday, November 12, 2007

WHAT ANTI-INFLAMMATORY MEDICINE DO YOU TAKE?

Merck agrees to settle thousands of Vioxx cases.

In continuing coverage from previous briefings, ABC World News (11/9, lead story, 2:55, Vargas) reported, "For years, the drug, Vioxx (rofecoxib), relieved the pain of arthritis and other conditions," and had "a strong following among doctors and patients alike." Suddenly, "researchers discovered it could be fatal by raising the risk of heart disease and stroke. A flood of lawsuits followed."

The CBS Evening News (11/9, story 3, 2:00, Couric) added that in "one of the largest legal settlements in U.S. history," Merck "agreed to pay nearly $5 billion to settle thousands of lawsuits filed by those who claimed the painkiller Vioxx caused heart attacks and strokes."

On its front page, the New York Times (11/10, A1, Berenson) noted that Merck's settlement agreement "may not seem like a corporate victory. But it is, according to lawyers and drug industry analysts who have followed the Vioxx litigation since Merck stopped selling the drug in September 2004, after a clinical trial showed it raised the risk of strokes and heart attacks." In 2005, "some analysts estimated that Merck would have to pay as much as $25 billion to settle Vioxx claims." However, per this agreement, Merck will pay $4.85 billion, a mere fraction of previous estimates.

Doc D: You could write several books on this fascinating case history, so I wanted to offer a couple of thoughts.

First, the reports don’t really tell you how information on risk emerges, or describe the uncertainty there was when some studies emerged of increased risk, but others said there wasn’t. Studies take time, and have limitations on what you can say they prove. The righteous indignation you heard from some investigators was disingenuous. As a matter of policy, should we pull everything that shows a hint that there may be a problem, even before we confirm it? Remember the study that showed an increased risk of leukemia in children who lived closer to power lines? That turned out to be bogus, but created a media sensation, and took several years to refute. Do we all move away from the wires in the meantime?

Second, they don’t tell you what the risk really is. To say that something increases a risk five-fold isn’t enough. For instance, say that the risk of something is one in ten million. A five-fold increase is five in ten million. In the context of other risks, this is trivial. There’s some of this confusion in the Vioxx story. The data(*) shows that “current” use of Vioxx by a person over 65 would cause one extra first MI in every 700 people (I say “current” because there’s no increased risk in having taken it in the past.) Now, if you are that one person, “one” is a lot. But, overall this is not a “kiss of death” for the population. By comparison, consider Motrin…everybody takes that. Under the same conditions (current use, over 65) motrin causes one extra first MI in every 1000. Different, but not harmless, eh? Where’s the hue and cry about Motrin? Are we scaring ourselves to death?

Third, Merck has been winning almost all the lawsuits because they are able to show that coronary artery disease (CAD) is something that occurs gradually over decades and it’s hard to show that a person with CAD didn’t have an MI because they already had a problem. They want to settle because fighting all these cases, even winning them all, will cost more. So, what we have is a legal system that allows for blackmail to obtain unproven compensation, and Merck has no choice. Remember the silicone breast implant settlement? At the time, $5B was the largest in history….but years later the Institute of Medicine issued a final report that included new data, and re-evaluation of all the old studies, that said that there was no credible evidence that silicone implants were implicated in ANY chronic disease (which is what people alleged). Too late for Dupont to do anything about it, but a lot of people got some free cash.

Fourth, there’s a psychological thing at work here. Most diseases occur due to imperfections in a person’s makeup, whether it’s genes, immunity, whatever. External causes of illness (like exposure to benzene causing leukemia) are rare. However, it’s too threatening to the ego to admit that our weakness is internal to us. The most tragic situations I’ve experienced are those where parents have a child who gets a potentially fatal cancer: they absolutely refuse to admit that it could be anything other than some evil outside influence that caused it, because otherwise they have to admit to themselves that they contributed to the makeup of a child that has to suffer this horrible life. I’ll admit that there are people who think if we eradicate all exposure risks, then many diseases will disappear. I can’t agree: our bodies just can’t go on forever, they fail.

This may sound very harsh, but we can’t compensate everybody who has something bad happen to them. A couple of years ago, people started suing one of the first companies to manufacture mechanical heart valves back in the 60’s, because the valves were starting to break. Well, that’s not good…but they lasted 20-30 years, and before the valve was invented, these people just…died. I don’t know of any other mechanical items that last that long (cars, refrigerators, etc). Something’s not right here.

So, bottom line: if Vioxx was still on the market, and there weren’t better choices, I would take it. Here are some drugs that cause just as many, if not more, bad things to happen to people: diuretics, thyroid hormone, digitalis, all high blood pressure medicines, seizure medicines, penicillin… I could go on forever. Pharmacologically, there aint no free lunch.

D

JAMES J DOUGHERTY, MD, MPH

Opinions solely my own, etc.

* BMJ 2005;330:1366 (11 June)

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