A long-running saga involving a now infamous drug has come to a close with a US$950-million court settlement, but pharmaceutical-industry watchdogs say the outcome has done little to convince them that similar cases won’t arise.
On 19 April a US District Court judge in Massachusetts sentenced Merck for its illegal promotion of the painkiller Vioxx, after the company pleaded guilty to violating marketing laws by promoting Vioxx for unapproved uses. Yesterday’s sentencing concludes the legal actions that were set in motion when the drug was pulled off the market in 2004.
One-third of the settlement is a criminal penalty based on the admission from the New Jersey-based pharmaceutical giant that it promoted the painkiller as a treatment for rheumatoid arthritis prematurely. The off-label marketing occurred between 1999, when the Food and Drug Administration (FDA) approved Vioxx for pain, and 2002, when they approved the drug for rheumatoid arthritis. This means that, for years before Vioxx was withdrawn from the market in 2004 for posing a risk of heart disease, it was prescribed to patients with rheumatoid arthritis without having been proved beneficial.
The remaining $628 million in civil settlements will be split between the federal government and Medicaid programmes in 43 states and Washington DC. In addition to off-label marketing, this settlement derives from allegations that Merck downplayed the cardiovascular risks of Vioxx. The fine will settle claims that doctors prescribed the drug and billed the government for Vioxx, when they might not have if Merck had marketed the drug in earnest.
Hefty penalties are intended to deter Merck and other companies from unlawfully promoting drugs. “The severity of these criminal and civil sanctions should serve as a reminder of this Office, and this Department’s unwavering commitment to holding drug companies fully accountable for failures to comply with their public safety and marketing obligations,” said Carmen Ortiz, US Attorney for the District of Massachusetts in a statement.
However, long-standing critics of Vioxx find little reason for celebration. Eric Topol, director of Scripps Translational Science Institute in La Jolla, California, spoke out against the drug as early as 2001, when he and his colleagues reported that Vioxx (a COX-2 inhibitor) came with a risk of heart attack. “What this [settlement] shows is how long it takes for these things to get resolved,” says Topol. Despite Topol’s study, Merck issued press releases assuring the public that the drug was safe after 2001, and the FDA permitted its patient base to expand the following year by approving the drug for rheumatoid arthritis.
Between 1999 and 2004, annual sales of Vioxx topped $2.5 billion. “If a company can make a couple billion dollars by understating the risks of their drug, then a fine of several hundred million won’t deter them from doing it again,” says Sidney Wolfe, director of the Health Research Group at Public Citizen in Washington DC. In 2007, Merck paid about $4.85 billion in lawsuits to people who claimed that they or their relatives had been injured or killed by Vioxx, but Wolfe says that the punishment still does not fit the crime. “Merck was promoting a drug with unknown benefits and known risks, and it resulted in fatal heart attacks.”