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New England Journal of Medicine damaged by its conduct over Vioxx, says former editor of BMJ

The conduct of the New England Journal of Medicine in the dispute involving the VIGOR trial and the drug Vioxx has raised doubts about the journal’s integrity, according to a former editor of the BMJ.

Writing in next month’s Journal of the Royal Society of Medicine, Richard Smith questions the conduct of the NEJM and in particular editorial decisions which delayed the publication of corrections in the journal.

Commenting on his article, Dr Smith said:

“It is unfortunate that the New England Journal of Medicine waited five years before publishing a correction to its VIGOR study, which was published in November 2000. Concerns about the correctness of the study were raised with the NEJM’s editor, Jeff Drazen, as early as August 2001, the drug was withdrawn in 2004 and yet it wasn’t until December 2005 that the journal published its first correction.”

“The journal has suggested that all the correct data were available on the Food and Drug Administration website but, in my view, that is not good enough. Doctors, pharmacists and health professionals do not obtain their information by searching through copious data on the FDA website; they get it from leading journals,”

he said.

“The journal failed its readers. It has damaged its reputation,”

Dr Smith added.

Before Vioxx was withdrawn from the market, Merck bought 900,000 reprints of the article from the NEJM at an estimated cost of US$700,000 - $830,000 to use in promoting the drug.

The VIGOR (Vioxx Gastrointestinal Outcomes Research Study) trial involved 8000 patients who received naproxen or rofecoxib (Vioxx), a Cox-2 inhibitor expected to have fewer gastrointestinal side effects than common non-steroidal anti-inflammatory drugs (NSAIDs). Patients given naproxen experienced 121 side effects compared with 56 in patients taking rofecoxib. Vioxx was voluntarily withdrawn by Merck in 2004 in the light of evidence suggesting it increased the risk of heart attacks and stroke.

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Lapses at the New England Medical Journal [PDF 45k]

‘Lapses at the New England Medical Journal’ by R Smith is published in the August 2006 issue (Vol. 99) of the Journal of the Royal Society of Medicine.

JRSM is the flagship journal of the Royal Society of Medicine. It has been published continuously since 1809. Its Editor is Dr Kamran Abbasi.