The New England Journal of Medicine and Drug Company Merck.
Weight Loss Bullet Journal - Journal Questions Vioxx Study
The study that requested controversy was called the study of force (VIOXX Gastrointestinal results of results). Focused on gastrointestinal problems in People with rheumatoid arthritis taking painkillers, including VIOXX.
Data from the study of force also included cardiac attacks that patients had Taking the painkillers. The researchers observed 17 cardiac attacks in VioXX Group, compared to four who took another medicine called Naproxen.
In fact, there were 20 cardiac attacks in the Vioxx group, write Drazen and colleagues.
The editors of the magazine write they learned at the end of November this year that "at least two of the authors knew the three [heart Attacks] at least two weeks before the authors presented the first of two revisions and 4.5 months prior to publication of the article. "
This information came to light during recent processes on VIOXX, the Note of publishers.
Add that "it looks like there was enough time to include the data "in these three cardiac attacks in the study before its publication in the diary.
Editors also note that other data in facing collateral effects appeared have been excluded from the study manuscript on a two computer floppy days before the study was submitted for the first time to the diary.
"Taken together, these inaccuracies and exclusions request Integrity of data at cardiovascular events adverse in this article " Editors write. "We ask the authors to send a correction to the Newspaper. "
Merck disputes the notion that these three heart attacks substantially It affected the results of the study.
The company says that "believes that it is important to emphasize that The company promptly and appropriately released the results of the force study. "
" Merck communicated correctly on the benefits and possible risks of Vioxx and extensively released the vigor data for the scientific and medical doctor communities, and in the press, "The Declaration continues.
The Merck Declaration also notes that the results were" precisely and accurately described "from a pre-specified cut for analysis. The three Other cardiac attacks took place after the pre-specified cutting date and therefore It was not part of the study, as published in the magazine, says Merck.
However, MERCK emphasizes that he released these cardiac attacks to the FDA in 2000 and 2001 and physicians, public and media.
The drug company adds that only recently learned from the editorial and "Anxious to provide a more complete answer" to her.
Bombardier, who works at the University of Toronto, replied by email. Her Statement reads:
"in response to the editorial that appeared today in Nejm, I believe that the role of vigor discloses the data according to the pre-specified Analysis plan. Events that occurred after the pre-specified cutting date have been publicly known since the FDA Advisory Committee in February 2001. The Authors will be preparing an answer to the editorial, but the little Nejm warning we did not have time to finish still. "
