Vioxx, Merck and the NEJM

Watergate for Merck? The NEJM has uncovered some data in Vioxx’s VIGOR trial – suggesting a cover-up:

A top editor of the New England Journal of Medicine says that he was stunned to find out that data linking Vioxx to cardiovascular risk was deleted from a major study his journal published five years ago–and that it appears that Merck researchers may have deleted that data.

“I was somewhere between surprised and stunned,” Dr. Gregory Curfman, executive editor of The Journal, says. “They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health.” . . .

. . . Just days after Merck recalled Vioxx from the market, editors at the Journal discovered a diskette containing earlier versions of a manuscript for a crucial Vioxx clinical trial called VIGOR that they had published in November 2000.

The early versions of the manuscript contained a blank table entitled “CV events”–which is standard jargon for cardiovascular events. Time stamps in the software indicated that the table was deleted two days before the manuscript was submitted to the New England Journal on May 18, 2000. “When you hover the cursor over the editing changes, the identity of the editor pops up, and it just says ‘Merck,’” Curfman says.

It also appears that VIGOR’s lead author may be in trouble:

Curfman says he called lead author Claire Bombardier of the University of Toronto, on Monday, indicating that the statement would be published. She told him that she would begin working on a correction. However, in an e-mail to, Bombardier said that the VIGOR paper appropriately disclosed the data and that the authors were working on finalizing a response to the editorial.

Catharine Whiteside, dean of medicine at the University of Toronto, said today that she has yet to talk to Dr. Bombardier. “In the event that information is brought to light in which we would need to investigate Dr. Bombardier, we would initiate due process,” Whiteside says.

Evan Schaeffer takes a look at the hit Merck’s stock took this afternoon. thinks the NEJM is in bed with the plaintiff bar:

Why make a press release at 5 pm on the day of the closing argument? This looks like an attempt to affect the federal trial””and the NEJM editorial writers say they got their information from a deposition.

Even assuming improper data mining (i.e., would Merck have disregarded the scope of the study to provide positive data?) where is the proximate causal harm from the chronological difference between the NEJM Bombardier publication and the release of the full study?

In after-market trading, Merck stock dropped 6%. One day I’m going to open a hedge fund and make a mint just on plaintiff-planted press releases.

Derek Lowe with his take.

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