Editors of medical journal accuse Merck of manipulating study data

• The editors at one of the world's leading medical journals have accused researchers and Vioxx manufacturer Merck & Co. of withholding key heart risk data that showed up in one of the first large trials of the now-withdrawn arthritis painkiller.
• Specifically, the editors of the New England Journal of Medicine charged that a major study published in November 2000 was submitted to the journal after information about three heart attacks among Vioxx trial participants was deleted by Merck, which funded the study.
• "It changes the level of risk and changes one of the conclusions [of the study] that only people at high risk were at risk."
• In addition, electronic records showed "a pre-submission version of the study from which data, including the number of heart attacks and deaths, were deleted by a Merck editor two days before submission," Curfman told HealthDay.
• An expression of concern is the procedure established by the International Committee of Medical Journal Editors (ICMJE) for announcing concern about the validity of previously published work.
• Despite its publication date, the unusual accusation was released Thursday afternoon just as jurors in Houston began their deliberations in the first federal trial against Merck involving the drug.
• The study now questioned by the journal editors was called VIGOR (Vioxx Gastrointestinal Outcomes Research), and its conclusions had been frequently cited by Merck in the current trial and elsewhere as proof of Vioxx's safety.
• As the Vioxx trial in Houston moved along, the third against Merck so far, the plaintiff's attorneys subpoenaed Curfman, the journal's executive editor.
• The memo indicated that at least two of the three VIGOR authors knew of the problems at least two weeks before submitting the first of two revisions, and four-and-a-half months before actual publication, of the study.