Merck Failed to Disclose Heart Attack Data About Vioxx®, Medical Journal Charges
WALTHAM, MA -- December 16, 2005 -- Researchers in a study involving the arthritis drug Vioxx® failed to disclose that three patients suffered heart attacks while taking the drug, the New England Journal of Medicine has charged (Editorial, December 8, 2005). The omission led to false conclusions, according to the Journal, and "calls into question the integrity of the data." The Journal has asked the authors to correct the study, which was funded by Vioxx®'s manufacturer, Merck.
First published in November, 2000, the VIGOR (Vioxx® Gastrointestinal Outcomes Research) study compared the stomach problems of arthritis patients taking Vioxx® to those of patients taking a more traditional painkiller, naproxen. It also monitored heart problems. The published report stated that 17 heart attacks occurred among Vioxx® users, rather than 20 heart attacks. This understated the significance of the heart attacks in Vioxx® patients, which were actually five times that of naproxen users.
The Journal editors became aware of the three additional heart attacks in 2001, when the Food and Drug Administration made updated data publicly available. By following Vioxx® litigation and internal company memos, the editors later concluded that two authors knew about the additional heart attacks four-and-a-half months before the article was published, when there was more than enough time to make revisions. The editors also examined a computer diskette and found that the VIGOR authors deleted information from the manuscript two days before it was submitted for publication.
Recent Vioxx® Case Ends in Mistrial
The New England Journal's charges come at a time when Merck may face up to 7,000 lawsuits from injured Vioxx® users. The VIGOR study has figured prominently in recent court trials.
This week, a federal judge declared a mistrial in a case brought by the widow of Richard Irvin, a 53-year-old former college football player and company manager who died of a heart attack while taking Vioxx®. Although the jury was unable to reach a verdict, the mistrial does not necessarily help Merck. Some experts thought that the case would be decided in favor of the company because Mr. Irvin had only taken Vioxx® for less than a month. However, the mistrial may signal that some jurors are willing to link heart attacks and strokes to short-term Vioxx® use. Even more important, a retrial of the case could allow in new evidence such as whether Merck tried to mislead the New England Journal and the public about the VIGOR study.
In state courts, Merck has won one Vioxx® case and lost another. A Texas jury awarded $253.5 million to the wife of Robert Ernst, an active 59-year old man who died after taking Vioxx® for eight months (see our story about Ernst, et. al. v. Merck & Co Inc.). However, Merck prevailed in a New Jersey lawsuit in which a mail carrier died of a heart attack after using Vioxx® for two months.
Vioxx® Was Recalled in 2004
Merck recalled Vioxx® in September 2004 amid extensive publicity about the drug's link to heart attacks and strokes. Also known as rofecoxib, Vioxx® is a nonsteroidal anti-inflammatory drug (NSAID) that blocks cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. Vioxx® interferes with the form of cyclooxygenase known as COX-2, and is therefore referred to as a COX-2 inhibitor.
Other COX-2 inhibitors include Bextra® (valdecoxib) and Celebrex® (celecoxib). Bextra® was recalled in April, 2005 because it increased the risk of heart attacks, strokes and blood clots. The drug was also associated with Stevens-Johnson syndrome, a severe skin allergy that causes a painful blistering of the skin and mucous membranes. Celebrex® remains on the market, although it has also been linked to heart attacks and strokes.