A study by the U.S. Food and Drug Administration that says Vioxx could have caused up to 140,000 cases of serious heart disease in the United States since 1999 has finally been published in the Lancet, a British medical journal. Dr. David Graham, lead researcher on the study, made headlines recently when he accused the FDA of withholding publication of the study and threatening to dismiss him if he announced its findings.

Its manufacturer, Merck and Company, recalled Vioxx in September of 2004 after studies linked it to an increased risk of heart attacks and strokes in patients. The study by Graham and his colleagues compares the incidence of coronary heart disease in patients taking Vioxx and other non-steroidal anti-inflammatory drugs known as COX-2 inhibitors.

After analyzing information from 1.4 million California patients who has used Vioxx, Celebrex or similar drugs between 1999 and September of 2004, they found 8,143 of these people suffered coronary heart disease in the study, including 1508 who had sudden cardiac deaths. Graham announced that the U.S. national estimate of the case-fatality rate was 44%, suggesting that many of the excess cases attributable to Vioxx use were fatal.

In commentary for the article, also published in the Lancet, Simon Maxwell and David Webb of the University of Edinburgh urged researchers to study the risks of similar drugs such as Celebrex and Bextra.

Source: “Study linking Vioxx to heart problems finally published,” CBC News, January 25, 2005.