Vioxx side effects could have been known years earlier

Vioxx was a blockbuster drug. Launched by Merck & Co., Inc., in 1999 as a treatment for painful arthritis, its annual sales soon reached $2 billion. The benefits were much the same as other anti-inflammatory painkillers, which sold for a fraction of the cost, but Vioxx (the generic name is rofecoxib) was designed to be less irritating to people's stomachs than older drugs in this class, cutting the risk of potentially dangerous internal bleeding. A multi-million dollar advertising budget didn't hurt its popularity either.

The success story came to an abrupt end in 2004, when Merck voluntarily pulled Vioxx from the market. A large trial had been stopped early when it became obvious that the drug was increasing the risk of heart attacks and strokes. In 2007, Merck agreed to pay $4.85 billion to settle thousands of lawsuits brought by people claiming to have been harmed by Vioxx.

The litigation over Vioxx has meant the release of some previously unpublished trials, which have now been analyzed by researchers. The researchers—who have all acted as consultants for patients taking legal action against Merck—wanted to know whether, if the trial data had been available earlier and analyzed on an ongoing basis, we could have discovered the risks of Vioxx sooner.

They used a technique called a cumulative meta-analysis. A meta-analysis involves using statistical methods to combine the results of smaller trials together, which gives you a better statistical picture than looking at each trial on its own. The cumulative part means that you add each new trial to the analysis as soon as it becomes available, giving you an idea which way the research is heading.The researchers say that, by June 2001, enough trials had been done to show a 95 percent likelihood that Vioxx increased people's risk of death, a heart attack, or a stroke. They argue that had this kind of analysis been done at the time, the risks of Vioxx would have been apparent nearly three and a half years before it was withdrawn by its manufacturer, potentially saving thousands of people from life-threatening side effects.

The researchers couldn't have performed their study while Vioxx was still on the market, since not all the trials had been published. The Food and Drug Administration Amendments Act of 2007 means that pharmaceutical companies now have to make trial results public, but they're only expected to provide a summary of the results, and not the individual patient data that researchers used here.

What you need to know. Doctors and patients need reliable information if they're to make informed choices about drugs. Making trial results more widely available can only benefit patients.

—Philip Wilson, patient editor, BMJ Group

ConsumerReportsHealth.org has partnered with The BMJ Group to monitor the latest medical research and assess the evidence to help you decide which news you should use.

Learn how to effectively talk to your doctor about your care and health concerns, and find out how the Best Buy Drugs program can help you save money on your prescription drugs.