Merck’s Vioxx Withdrawal Illustrates Power of Regulation by Trial Lawyers

Published December 1, 2004

Merck & Co. withdrew the popular drug Vioxx from the market in September, after data from a clinical trial supported claims the medication was associated with an increased risk of heart attack and stroke.

Vioxx is an anti-inflammatory drug used to treat arthritis and acute pain without the stomach irritation caused by other non-steroidal anti-inflammatory drugs (NSAIDs). At the time of its recall, Vioxx was being evaluated in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. The millions of people worldwide who benefitted from access to Vioxx are the real losers in the recall of the popular prescription pain reliever. But just try to tell that to the trial lawyers.

Lives Saved Far Outweigh Cost

Of course, it’s easier to count those few people whom statistics suggest may have died in greater numbers than expected, even if only from natural causes, than to count those whose lives might have been extended by access to a drug that has been taken off the market. The latter have no right to sue.

For instance, family members of the 16,500 patients who die annually of bleeding ulcers caused by older pain relievers can hardly be expected to attribute the deaths of their loved ones to a drug they couldn’t take. Yet under current law, those who die of a heart attack while taking a drug have every right to sue–even if the drug did them far more good than harm. And they have a right to sue even if the death of a family member cannot be proven to have been caused by the drug itself.

The evidence that Vioxx was dangerous was pretty slim. Over the course of a multi-year study that followed nearly 2,600 people, 45 of the patients taking Vioxx experienced heart attacks or strokes, compared to 25 people taking a placebo. The number of people in each group who actually died was five.

But even though the death rate was equal, Merck took the extreme step of removing Vioxx from the market. The most likely reason for the withdrawal? To reduce the risk of medical liability. Already Merck has started setting up a reserve fund from which to pay future medical claims. Hundreds of people already have lined up to sue for damages.

Patients Lobbied for Lotronex

Another drug that was withdrawn after reported patient deaths was Lotronex, which was just about the only drug on the market at the time to treat serious forms of intestinal and bowel disease.

To public health officials, the risk of the drug was huge. About one in every 350 women who took it for six months suffered a serious side effect called ischemic colitis–blocked blood flow to the intestine. But to the people who had no other effective treatment, a 349-in-350 chance to lead normal lives was a relatively small risk. For many irritable bowel syndrome suffers, Lotronex was the only drug that controlled symptoms sufficiently to allow them to lead normal lives.

After its recall, thousands of people who had been taking Lotronex lobbied the Food and Drug Administration (FDA) for renewed access to the drug. In 2002, two years after removing the drug from the market, the FDA allowed these patients highly restricted access to Lotronex–a drug that literally transformed their quality of life.

Drug Was Helping Millions

It is unlikely that Vioxx improved patients’ quality of life to the same degree as Lotronex. But prior to its recall, about two million people worldwide were taking Vioxx. It is estimated about 100 million people have taken it since it was approved about five years ago. Future patients will be denied its benefits because Merck rationally chose not to risk losing billions of dollars in damage suits.

The reason people paid more for Vioxx–10 to 15 times more than less-expensive pain relievers–is because it caused less post-operative bleeding and protected the stomach against ulcers cheaper medications often cause. The less effective, less expensive generic and over-the-counter pain relievers are poor targets for lawsuits.

In all likelihood, there is probably little, if anything, wrong with Vioxx. In clinical trials conducted prior to FDA’s approval of the drug, Merck followed almost 4,000 patients over the course of a year. Researchers found no sign that Vioxx caused heart attacks, although they did notice an increase in high blood pressure among patients taking the drug.

Patients taking Vioxx can still buy similar drugs, such as Bextra and Celebrex. These drugs will now face closer FDA scrutiny as the agency checks for a “class effect”–a similar consequence taking place in similar drugs. Since their use also precludes taking aspirin daily to prevent heart attacks, they also may be found to have a slight association with coronary events and ultimately suffer the same fate as Vioxx.

If this occurs, even if no death can be positively attributed to anything more than natural causes due to heart disease, these drugs will also likely be a future target of trial lawyers seeking cash.

The ones who suffer the consequences are the patients, and they should be allowed to decide whether a drug like Vioxx is worth the risk, rather than having the decision made for them by other people’s lawyers. What is truly unfortunate is that the only people to benefit from the development of lifesaving drugs removed from the market due to these lawsuits are the trial lawyers.

Devon M. Herrick ([email protected]) is a senior fellow at the National Center for Policy Analysis.