Just a few years after the U.S. Food and Drug Administration (FDA) approved Vioxx, the drug was recalled because of the risk of deadly heart attacks and strokes.
When Vioxx hit the market, the goal was to expand the drug’s reach worldwide to as many patients as possible. While Vioxx patients numbered to about 80 million quickly, most didn’t know that the drug was jeopardizing their health.
Vioxx (rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) and a prescription painkiller, was approved for use by the FDA in 1999. In the years that followed, it was mired in scandal. Merck was accused of misleading doctors and patients about the drug’s safety, fabricating study results to suit the company’s needs, continually thwarting an FDA scientist from revealing the drug’s problems and skirting federal drug regulations.
In 2004, Merck withdrew the drug from the market after a study revealed the drug more than doubled the risk of heart attacks and death. By that point, more than 38,000 deaths were related to Vioxx use, and up to 25 million Americans had taken the drug.
The Vioxx Recall and FDA Scandal
Vioxx caused so much damage and destruction that some have called it the worst drug disaster in history. The Vioxx scandal wasn’t just devastating to the injured patients and their families; it also underscored problems within the FDA. Many suspect that the New Jersey-based Merck and the FDA worked together to keep the drug on the market and quiet the health concerns.
The suspicions about the Merck-FDA tie ran deep. They started early on when Merck tried to convince the FDA that Vioxx was better than other NSAIDs because it caused few digestive tract problems. Even before the drug was FDA approved, the company launched its Vioxx Gastrointestinal Outcomes Research study (VIGOR) to determine the digestive risks. While the study did show that Vioxx was easier on the digestive system than other NSAIDs, it also revealed that it increased the risk of heart problems.
After that, Merck continually hounded the FDA to allow the drug to drop the digestive warnings on the label. In February 2001, the FDA approved Merck’s request to change the drug’s label to reflect that it’s safer on the stomach than other NSAIDs. Although that label change would later be overturned, it was a feather in the Merck cap. About the same time, the FDA ordered the company to send doctors a letter explaining the drug’s heart risks. And it wouldn’t be the first time that Merck’s huge marketing monster was reprimanded.
The whole time that Merck was promoting Vioxx as a superior alternative for those with gastrointestinal problems, the company was also brushing aside the drug’s cardiovascular risks. It wasn’t until April 2002, years after the VIGOR trial results showed the risks, that the FDA and Merck decided to include the heart and stroke information on the drug label. Critics would later point to this as evidence of the cozy relationship between Merck and the FDA and the company’s blasé attitude toward the risks.
When the VIGOR trial results were finally published in the prestigious New England Journal of Medicine, no one knew that it was missing some key information. Later, the public would learn that Merck scientists left out key data on heart patients to make the drug seem safer. The editor of the journal later demanded a correction, but the scientists who conducted the study refused.
While the drug was removed from the market on Sept. 30, 2004, it was just the beginning of the controversies surrounding it. The U.S. Department of Justice and the U.S. Securities and Exchange Commission investigated the company for its deceptive and strong-arm marketing practices. An FDA scientist who discovered the Vioxx heart connection early on said his FDA bosses forced him to quash information that was potentially damaging to Merck. Government officials continually question the relationship between Merck and the FDA.
And perhaps in the most shocking turn of events, and perhaps underscoring Merck’s close relationship with the FDA and other drug-regulatory agencies, advisory panels in both the United States and Canada in 2005 voted that Vioxx could return to the market under certain circumstances and restrictions. So far, Vioxx remains recalled.