Journal Questions Vioxx Absorption
The New England Annual of Medicine and drug company Merck & Co. are clashing over a able absorption about the painkiller Vioxx.
Vioxx was removed from the exchange in September 2004 because of applicable that it raises the blow of amore beforehand and stroke.
Merck, the maker of Vioxx, adjourned the study, which appeared in The New England Annual of Medicine's Nov. 23, 2000, edition.
Now, the journal's agents is analytic the study's abstracts and results. In an editorial, they calendar that three amore attacks a allotment of Vioxx users weren't mentioned in the study.
"The achievement that these three [heart attacks] were not included made certain calculations and abstracts in the commodity inaccurate," abode the editorialists. They included the journal's editor-in-chief, Jeffrey Drazen, MD.
A Merck annual absolution counters that the biologic accession is "confident in its research" and that the three amore attacks in canon "did not materially change any of the abstracts in the article."
About the Study
The absorption that prompted the argument was declared the VIGOR absorption (Vioxx Gastrointestinal Outcomes Research). It focused on gastrointestinal problems in people with rheumatoid arthritis who took painkillers, including Vioxx.
The VIGOR study's abstracts aswell included amore attacks the patients had while taking the painkillers. The admiral acclaimed 17 amore attacks in the Vioxx group, compared with four who took accession biologic declared naproxen.
Actually, there were 20 amore attacks in the Vioxx group, abode Drazen and colleagues.
Data Left Out?
The journal's editors abode that they abstract astern in November of this year that "at diminutive two of the authors knew about the three added [heart attacks] at diminutive two weeks afore the authors submitted the ancient of two revisions and 4.5 months afore advertisement of the article."
That admonition came to afire during abreast lawsuits about Vioxx, the editors note.
They add that "it appears that there was abounding time to awning the data" on those three amore attacks in the absorption afore its advertisement in the journal.
The editors aswell calendar that added abstracts on heart-related accessory accoutrement appeared to acquire been deleted from the study's adjustment on a computer diskette two days afore the absorption was ancient submitted to the journal.
"Taken together, these inaccuracies and deletions anxiety into canon the integrity of the abstracts on adverse cardiovascular challenge in this article," the editors write. "We acquire asked the authors to accept a about-face to the journal."