This week, the editors of the New England Journal of Medicine (NEJM) announced that the authors of a Vioxx study published five years ago omitted data that would have linked the painkiller to a greater relative risk of heart attacks.

The editors claim that Claire Bombardier, M.D., a Toronto rheumatologist, and her co-investigators omitted information about three heart attacks that occurred among patients randomized to Vioxx in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study. Vioxx was intended to relieve people with arthritis and acute pain.

The study, which was published in the Nov. 23, 2000 edition of the journal, reported 17 heart attacks in the Vioxx patients, and four in patients taking naproxen. NEJM's editors say there were actually 20 heart attacks in patients taking Vioxx, and that omission "made certain calculations and conclusions in the article incorrect."

The editorial can be found on NEJM's website. It reads, "Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article."

The editors wrote that they originally thought Bombardier and her colleagues were unaware of the changes, but a memo written in July of 2000 shows that at least two of the authors knew about the extra heart attacks before the article was published.

The journal editors say they have asked Bombardier and colleagues to submit a correction, but Merck, the manufacturer of Vioxx, defends the research. The drug maker says it promptly and appropriately disclosed the results of the study. A press release that came out in response to the editorial reads, "Merck only recently learned of this editorial. We have not had an opportunity to formally respond in the New England Journal of Medicine given the timing of its publication."

Merck pulled Vioxx from store shelves in September of 2004, after it was determined that long-term use of the drug was associated with an increased risk of cardiovascular problems.

Now, the drug is in the midst of a huge legal battle. Hundreds of patients are suing Merck, alleging that people died, or were injured due to cardiac events caused by Vioxx.

Merck lost a trial in Texas state court, but won one in Atlantic City. The first federal trial involving the drug is currently in jury deliberations.

Washington, D.C.-area Pharmacist Maria Bain said this case is troubling.

"But, we shouldn't leap to the conclusion that all studies have sacrificed scientific objectivity to show results desired by the manufacturer of the drugs," she said.

"Still, one wonders how many similar instances may have gone undetected and how peer review and other processes can be improved to address inherent conflicts of interest," Bain said.

© 2006 mydna.com