Merck May Have Concealed Heart Attack Events in Vioxx Study

December 8th 2005

The New England Journal of Medicine made a public allegation stating that two of the authors of the Canadian-led study withheld data concerning Vioxx.  The original study was first published in the New England Journal of Medicine back in November 2000. 

There were three heart attacks withheld by two researchers among the subjects taking the drug.  The heart attacks were not disclosed according to the journals editor-in-chief, executive editor and co-author.  This information was made public in a press release by the journal.  

There were other adverse cardiovascular events that were deleted from the original data / manuscript just two days before it was submitted for publication.  This has come to light after an analysis of a computer disk.

This could be damaging for Merck since there are numerous lawsuits involving the pain killer Vioxx.  The New York Times claims ” Merck misrepresented the results of a crucial clinical trial of Vioxx to play down the drug's heart risks”.  Two of the authors listed on the paper were employees of Merck.  Dr. Alise Reicin and Deborah Shapiro were both employees, and Dr. Reicin is Mercks’s vice president for clinical research.  The journal did not name these or any other researchers as the ones that modified the data.

It was reported by the Toronto Star that Merck has defended the research stating that the “three heart attacks had occurred after a pre-specified cut-off date”.  The journal (NEJM) press release also stated “Nevertheless, these additional events were disclosed to the FDA in 2000, presented publicly at the FDA's advisory committee in February 2001, and included in numerous press releases subsequently issued by Merck."

The Star also reported that Dr. Claire Bombardier, lead author of the original study funded by Merck and rheumatologist at the Toronto’s Mount Sinai Hospital said “I believe that the VIGOR paper appropriately disclosed the data as per the pre-specified plan of analysis."