In Nov. 2007, drugmaker Merck & Co. announced it would pay $4.85 billion to resolve claims that anti-inflammatory medication, Vioxx, caused heart attacks, strokes and even death.
In May 1999, the FDA approved Vioxx based on studies of approximately 5,000 patients. The study suggested Vioxx worked by blocking an enzyme linked to pain and swelling. Some studies also indicated that this mechanism contributes to blood clotting and high blood pressure.
Those studies did not indicate an increased risk for cardiovascular events in patients treated with Vioxx.
Vioxx was approved under the FDA’s six-month priority review instead of the standard 10-month review process. The agency granted Merck a priority review for Vioxx because the painkiller could provide a significant therapeutic advantage over existing approved NSAIDs.
In June 2000, Merck conducted a study called VIGOR (Vioxx Gastrointestinal Outcomes Research) to study its effects on the gastrointestinal tract. NSAIDs can cause ulcers and other GI problems by interfering with the stomach’s ability to protect itself from gastric acids.
VIGOR showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID. But it also revealed that patients taking Vioxx had a five times greater risk of heart problems than those treated with naproxen.
Merck officials tried to explain the outcome by suggesting that naproxen helped protect the heart rather than Vioxx damaging it. As a result, new safety information was added to its safety label. They also began a longer-term study of the drug to obtain more data on heart attack and stroke risk with chronic use of Vioxx.
In 2001, Merck launched the APPROVe trial (Adenomatous Polyp Prevention on Vioxx) to determine whether the 25mg dosage effectively prevented colon polyps’ recurrence. The study was stopped, however, after researchers discovered that patients taking Vioxx continually for 18 months had a twofold greater risk for serious cardiovascular events than patients taking a placebo.
Three years later, Merk announced it would withdraw Vioxx from the market worldwide based on findings from the APPROVe trial.
About 20 million Americans took Vioxx in the five-and-a-half years it was sold. During that time, Vioxx generated roughly $2.5 billion in sales. The company was hit with thousands of lawsuits shortly after pulling it off the market.
Beasley Allen’s Andy Birchfield, Benjamin Locklar, P. Leigh O’Dell and W. Roger Smith III played an integral role in the settlement program and getting Merck to agree to settle.
“To say that the APPROVe study was the first indication that [Merck] had of a(n) [increased cardiovascular] risk is untrue,” Beasley Allen’s Andy Birchfield told Bradley. “They had warning sign after warning sign, study after study that suggested a significant, a substantial increase in risk.”
Even after the studies showed risk, Merck continued to sell the drug knowing it could seriously harm or even kill people.
“Merck needed a blockbuster drug. They had drugs coming off patent and needed a big revenue source,” Birchfield explained.