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Journal Questions Vioxx Study

Editorial Notes Three Unreported Heart Attacks in Vioxx Users; Drugmaker Responds
By
WebMD Health News
Reviewed by Louise Chang, MD

Dec. 9, 2005 -- The New England Journal of Medicine and drug company Merck & Co. are clashing over a past study about the painkiller Vioxx.

Vioxx was removed from the market in September 2004 because of concerns that it raises the risk of heart attack and stroke.

Merck, the maker of Vioxx, funded the study, which appeared in The New England Journal of Medicine's Nov. 23, 2000, edition.

Now, the journal's staff is questioning the study's data and results. In an editorial, they note that three heart attacks among Vioxx users weren't mentioned in the study.

"The fact that these three [heart attacks] were not included made certain calculations and conclusions in the article inaccurate," write the editorialists. They included the journal's editor-in-chief, Jeffrey Drazen, MD.

A Merck news release counters that the drug company is "confident in its research" and that the three heart attacks in question "did not materially change any of the conclusions in the article."

About the Study

The study that prompted the controversy was called the VIGOR study (Vioxx Gastrointestinal Outcomes Research). It focused on gastrointestinal problems in people with rheumatoid arthritis who took painkillers, including Vioxx.

The VIGOR study's data also included heart attacks the patients had while taking the painkillers. The researchers noted 17 heart attacks in the Vioxx group, compared with four who took another drug called naproxen.

Actually, there were 20 heart attacks in the Vioxx group, write Drazen and colleagues.

Data Left Out?

The journal's editors write that they learned late in November of this year that "at least two of the authors knew about the three additional [heart attacks] at least two weeks before the authors submitted the first of two revisions and 4.5 months before publication of the article."

That information came to light during recent lawsuits about Vioxx, the editors note.

They add that "it appears that there was ample time to include the data" on those three heart attacks in the study before its publication in the journal.

The editors also note that other data on heart-related side effects appeared to have been deleted from the study's manuscript on a computer diskette two days before the study was first submitted to the journal.

"Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article," the editors write. "We have asked the authors to submit a correction to the journal."

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