TUESDAY, Nov. 22 (HealthDay News) -- The U.S. Justice Department
said Tuesday that the drug company Merck will pay $950 million to
resolve investigations into its marketing of the blockbuster
painkiller Vioxx, which was pulled from the market in 2004 after
studies revealed the drug increased users' risks of heart attack
Merck will pay $321.6 million in criminal fines and $628.4
million as a civil settlement. The company will also plead guilty
to a charge of marketing Vioxx as a treatment for rheumatoid
arthritis before the U.S. Food and Drug Administration granted such
Associated Press reported.
In a statement on its website, Merck said the civil settlement
did not constitute an admission of liability or wrongdoing.
"We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx," said Bruce N. Kuhlik, executive vice president and general counsel of Merck.
In November 2007, Merck agreed to pay $4.85 billion to settle
approximately 50,000 lawsuits from plaintiffs who said they or
family members were injured or had died after taking Vioxx.
Vioxx was approved as a painkiller by the FDA in May 1999, but
the government did not initially approve the drug for rheumatoid
arthritis. As a result, doctors could prescribe Vioxx for patients
with rheumatoid arthritis, but Merck couldn't market the drug for
that use. The FDA approval for rheumatoid arthritis came in April
But the Justice Department said Merck marketed and promoted
Vioxx for rheumatoid arthritis for three years, even after getting
a warning letter from the FDA in September 2001, the news service
As part of Tuesday's settlement, Merck also entered into an
agreement concerning its sales, marketing, publication, and pricing
activities. The Justice Department said the agreement strengthens
oversight of the company, since it will require senior company
officials to complete annual compliance certifications, and the
company must post information about physician payments on its
website, according to the
Vioxx was initially part of a trio of drugs called cox-2
inhibitors, which also included Bextra and Celebrex. These drugs
were at first hailed as a means of treating pain without causing
gastrointestinal problems like bleeding, as can happen with related
analgesics known as nonsteroidal anti-inflammatory drugs
NSAIDs include cox-2 inhibitors and common over-the-counter
drugs, such as ibuprofen (Advil, Motrin), naproxen (Aleve), and
But, the cox-2-mediated stomach protection came at a price. In
September 2004, Vioxx was pulled from the market after studies
showed its long-term use was linked to an increased risk for heart
attacks. In April 2005, Bextra was pulled because of similar fears,
as well as evidence of increased risks for a rare but potentially
fatal skin reaction.
Celebrex remains the only cox-2 inhibitor sold in the United
States, and its label carries a black-box warning detailing
potential heart risks.
In December 2005, the editors of the
New England Journal of Medicine accused researchers and Merck
of withholding key heart risk data that showed up in one of the
first large trials of Vioxx. The findings from that trial were
published in the journal. Specifically, the editors charged that a
study published in November 2000 was submitted to the journal after
information about three heart attacks among Vioxx trial
participants had been deleted by Merck, which funded the study.
In a statement at the time quoted by the
AP, Merck said the additional heart attacks "did not materially change any of the conclusions of the article." Merck also said the additional heart attack data was not included in the study because the heart attacks were reported after Merck's cut-off date for including study data.
For more on cox-2 inhibitors, including Celebrex (celecoxib),
U.S. National Institutes of Health.