Vioxx, a once popular painkiller for conditions characterized by chronic pain, was fully recalled in 2004. It has not been on the market since, and although it was a voluntary recall by manufacturer Merck, the drug was bound to be pulled eventually whether through the company or the U.S. Food and Drug Administration. (FDA) First approved by the FDA in 1999, Vioxx would shortly begin to cause serious problems.
In addition to gastrointestinal issues like pain and bleeding, Vioxx was found to put patients at an increased risk for having a heart attack or stroke. The risk was significant to make a recall necessary. Even though Merck did this voluntarily, the company has been heavily criticized, sued, and fined for being negligent in the selling of a drug that caused so much harm.
Vioxx for Pain
Merck developed the generic compound rofecoxib and named it Vioxx. It was designed to treat arthritis pain primarily, but was also found to be effective at treating some other types of pain. It was hoped that rofecoxib could be a safer alternative to other pain medications for people with chronic pain. There are no painkillers for these people who battle pain on a daily basis that does not carry some risks or include side effects.
When Merck brought Vioxx to the market in 1999, the company marketed it as the answer to this problem. It was supposed to be safer than other non-steroidal anti-inflammatory drugs (NSAIDs) like naproxen sodium and ibuprofen. Although in the same class of drugs, rofecoxib reduces inflammation and targets pain in a slightly different way.
Problems with Vioxx
Unfortunately the promise of a safer pain medication for people suffering every day did not pan out. As with other NSAIDs, Vioxx was seen right away to cause gastrointestinal side effects most commonly. It can cause stomach upset and pain, as well as bleeding, which can become serious with prolonged use. It was expected that as an NSAID, Vioxx would cause at least some gastrointestinal upset.
The most problematic issue, though, was the potential for heart attacks and strokes. In clinical trials Merck found that patients taking Vioxx had an increased risk of these, but the warning information did not appear on labeling until 2002, a questionable move that has been highly criticized. Merck was also criticized for marketing Vioxx as safe while knowing that it carried this risk.
The evidence of the dangers of Vioxx mounted after a study in which Merck researchers investigated how Vioxx might be able to treat colon polyps. The most important conclusion from the study was that patients who had been taking the drug for 18 months or more were at a significantly higher risk of having a heart attack or a stroke as compared to control groups. A later study, after the Vioxx recall, confirmed this, but also found that patients taking Vioxx for less time than 18 months, as little as two weeks, were also at risk.
The 2004 Vioxx Recall
By 2004 it was clear that taking Vioxx could double the risk of having a stroke or heart attack, a risk that was considered too severe to continue using the medication in patients. Merck withdrew Vioxx and other products with rofecoxib voluntarily while the FDA continued to analyze the evidence to come up with a decision about what to do and whether to force a recall. Merck earned billions on Vioxx sales, and in spite of withdrawing it willingly from the market, there is evidence that the company fought hard and put patients at risk to keep it selling for as long as possible.
Senate Hearings and FDA Involvement
The Senate Finance Committee initiated hearings because of the questionable practices of Merck during the entire run of Vioxx up to its eventual recall. The 2004 hearing included several witnesses from both Merck and the FDA to investigate any wrongdoing. These witnesses stated that Merck did now about the fact that Vioxx could cause heart attacks and strokes in patients and that the company knew about the risks relatively early on in the development of the drug.
The witnesses also went so far as to say that many people at Merck actively tried to hide the evidence about the risks. They took steps to make the risks look less than they really were and even designed the clinical trials to make sure that the results seemed more favorable. While all this was going on, the company engaged in unethical marketing, pushing Vioxx as a better alternative and a safer painkiller than competitors.
The wrongdoing didn’t stop with Merck. The evidence from witnesses proved that the FDA was at fault too and that it had a relationship with the drug maker that was far too cozy. The first issue was that the FDA agreed early on to allow Merck to state on its labeling information that it caused less gastrointestinal distress than other NSAIDs. This was later overturned, but while it lasted, it helped Merck to sell more of its product.
The FDA has also been highly criticized for not requiring the warnings about heart attack and stroke on Vioxx labels until 2002. A study from years before that investigated the gastrointestinal side effects did find that there was a stroke and heart attack risk. That study, when published, was missing some of that key information. That left the public out of the loop about the serious risks, but some witnesses say that the FDA knew the facts.
Recall Leads to Lawsuits
Once it became official that Vioxx was recalled due to harmful risks, the number of lawsuits against Merck exploded. The loved ones of people who suffered and died of a heart attack or a stroke while on Vioxx were understandably upset and angry. To find out that the drug maker knowingly sold and falsely marketed a harmful drug meant that people were ready to sue. That Merck made a voluntary Vioxx recall made no difference once the facts were all uncovered.
One of the biggest suits against Merck was a class action lawsuit representing thousands of victims. Merck failed to admit to any wrongdoing in these deaths, but did ultimately agree to a settlement amount of $4.85 billion, one of the biggest in the drug industry to date. Most victims got a piece of the settlement, but in some cases Merck was able to argue successfully against negligence and some families walked away with nothing. Some individual cases also brought large settlements, like the one brought by a Texas family that ended with a $235 million settlement.
In addition to individual and class action lawsuits brought by victims and their families, Merck also faced criminal charges and fines from the federal government and state governments. These government cases accused Merck of illegal marketing of Vioxx and of working with the FDA to hide important information about the dangers of the drug. The company was found guilty of these criminal charges and others and was fined several hundred million dollars.
Vioxx wasn’t on the market more than five years and yet it left a swath of damage in its wake. Thousands of people suffered because the recall came too late. In fact, many people believe the drug should never have made it past clinical trials.