Clear Thinking About Vioxx

The risk is not what you think.

David Henderson & Charles Hooper | January 3, 2005

If you read the news, pay attention to TV commercials for personal injury lawyers, or just get a lot of spam in your inbox, you know that many, many people are in a panic about Vioxx, the drug that was used by patients with arthritis until Merck & Co., Inc. voluntarily withdrew it in September. Some pundits have done the trial lawyers' heavy lifting for them by portraying Merck as an evil corporation concerned only with making money and not at all worried about killing innocent customers in the process. Arianna Huffington, for example, writes that Merck "sacrifice[s] the health of the public on the altar of higher and higher profits."

But before we jump on board the anti-Merck bandwagon, we should realize the stakes involved. If the courts, the FDA, and Congress do not handle the Merck case judiciously, there is great danger that the real victims of this case will include many people reading this article. And they will be victims, not of Merck, but of an overly zealous and out-of-control legal and political system.

The facts are these: (1) Vioxx, like almost all drugs, carries it own risks but also has substantial benefits for many patients, (2) some members of the media, in particular, CBS, have distorted the facts about Vioxx and about Merck, and (3) there is no evidence that Merck broke any law or even that it acted in any way irresponsibly. Let's take these points in turn:

Risks and Tradeoffs

In an October 5, 2004 Wall Street Journal, article entitled "Despite Vioxx Withdrawal, The Benefits of Medicines Can Outweigh the Risks," Andrea Petersen writes:

Even in the case of Vioxx, the likelihood that an individual taking the drug would have a heart attack or stroke is relatively small. In a study of 2,600 patients, there were 15 heart attacks or stroke per 1,000 patients among those who took Vioxx for longer than 18 months. Among those who took a placebo, there were 7.5 heart attacks or strokes per 1,000 patients. And those who took Vioxx for less than 18 months had no increased cardiovascular risk.

In other words, the increased risk of heart attack or stroke from taking Vioxx rather than a placebo was only an additional 7.5 per 1000, or less than 1 in 100. Incidentally, the study cited by Petersen was the so-called APPROVe study, designed to test whether VIOXX could help prevent the recurrence of colon polyps. This study, incidentally, was what led Merck to withdraw Vioxx from the market.

You might argue, contrary to Petersen, that an almost one in 100 increased risk of a heart attack or stroke is fairly substantial. However, we're not talking only about the worst kind of stroke or heart attack. Most strokes and heart attacks do not cause death. Consider the results of Merck's early VIGOR study of Vioxx. VIGOR is the acronym for Vioxx Gastrointestinal Outcomes Research. In June 2000, Merck submitted the findings of this research to the Food and Drug Administration. It was a comparison of results for 4,047 patients given Vioxx and 4,029 given naproxen (Aleve). The results: five patients on Vioxx died of heart attacks and four on naproxen died of heart attacks. In other words, there was one extra death from a heart attack out of 4,000 people on Vioxx. This does seem like a small risk. Making the risk of actual usage even smaller is the fact that all the results were at double the maximum recommended daily dose for Vioxx.

Of course, some people might judge the extra 1 in 4,000 chance of a fatal heart attack as being too big a risk to take. That's fine. No one is forcing people who make that judgment to take Vioxx. The great virtue of freedom to choose is that it allows people to make their own tradeoffs between risk and other things. And one of those other things is pain from arthritis. Which brings us to the tradeoff between risk and pain reduction.

Consider Dave Ellis, a 66-year-old retired pharmacist from Edmond, Oklahoma. For 30 years, he has had degenerative arthritis in his spine. By about mid-February, he will have run through his supply of Vioxx and will not be able to buy more. He tells The Wall Street Journal he "dreads" that day. As Hayes Wilson, a rheumatologist in Atlanta, put it in a December 21 Journal article, "If you live with intractable pain every day of your life, would you take a chance that you would have a heart attack? A lot of my patients would."

So here we have a number of patients who regret that they weren't simply told of the risks and allowed to choose for themselves. And who will argue plausibly that a pharmacist is uninformed about pharmaceuticals?

It's true that no government agency has taken Vioxx off the market. Merck chose to do that. But they made that choice under pressure. Given the huge benefits of Vioxx to a substantial subset of the people taking it, a company unconcerned about lawsuits would have continued to sell it, along with the warning. In this country at this time, however, companies have to be concerned about lawsuits, even from those who have been amply warned. So the danger of lawsuits from people who are warned about the risks is preventing people willing to take those risks from having a drug that would make their lives much better.

Let's not forget why there was a demand for a drug like Vioxx in the first place. It's true that drugs like Aleve and aspirin can reduce the pain from arthritis. But these drugs come with their own side effects: aspirin, Advil, and Aleve, all of which are non-steroidal anti-inflammatory drugs (NSAIDs), can cause gastrointestinal (GI) bleeding. The rate of major GI problems typically seen in clinical trials for NSAIDs like aspirin is two to four percent of patients treated for a year. One researcher reported that at least 6,000 U.S. deaths per year result from NSAID-induced GI bleeding. Other experts have estimated that NSAID-induced GI complications result in 16,500 deaths and more than 100,000 hospitalizations per year in the U.S.

Vioxx, which is certified by the FDA to have GI-protective effects, has produced fantastic results for those most vulnerable to the side effects of NSAIDs. Vioxx was approved by the FDA for the treatment of osteoarthritis, rheumatoid arthritis, acute pain, dysmenorrhea, and migraines. Even at twice the maximum recommended daily dose, Vioxx showed a 57 percent lower rate of serious GI bleeding than the rate for NSAIDs.

Misleading Media