WSJ vs. NEJM

Via Health Care Renewal, the Wall Street Journal goes after the New England Journal of Medicine:

The New England Journal is joining the ranks of academic publications risking their reputations as non-partisan arbiters of good science in order to rumble in the political tarpits.

The facts and timing of the Merck ambush certainly suggest as much. Late last year the New England Journal published an 'Expression of Concern' about a Vioxx study it carried in 2000, baldly accusing researchers of omitting key data to make the painkiller appear more safe.

What has Dr. Curfman [Executive Editor of the New England Journal] in a dither is the fact that three more participants [in the group treated with Vioxx] also suffered heart attacks - although only after the cutoff date that had been determined by an outside safety panel for the study.

In fact, as prominent scientists have since attested, the authors were simply following the rules of science. 'If the outcomes truly occurred after the close of the study, then they don't belong in the study,' Brian Strom, an epidemiologist at the University of Pennsylvania, told Nature magazine. . .

Unfortunately, the attack on Merck isn't isolated, but is part of a growing trend among scientific journals that have joined business-bashing and other liberal campaigns.

To the untrained eye, 3 more heart attacks doesn't sound like a big deal.  But in the context of the study, 3 additional heart attacks increased the rate of heart attacks from 17 to 20.  We call that statistically significant, my friends.  If an organization is supposed to stand up for science, doesn't that mean reporting it?  Not hiding it?  Pharmaceutical companies are the ones keeping science for the sake of science off the table.  That's through multiple efforts, most recently the realization that companies are excluding both the name of the drug studied and final results in several trials on the new clinical trial registry. 

WSJ's "anonymous" (read: pharma lobbyist) op-ed contributor doesn't like the negative press for pharmaceutical companies and decided to nit-pick on one unspoken rule of trial reporting.  But shame on the person arguing that severe events like heart attacks shouldn't be considered because they occurred after the study.  This isn't a game about when adverse events should "count" -- it's health.  Merck seriously paid for hiding their results -- billions of dollars in lost revenue and even more tarnished image. 

Even so, this is a curious op-ed from the WSJ, mostly because the NEJM basically pushed through this new clinical trial reporting system which is now aiding pharmaceutical companies.  NEJM is also chock full of multi-page bright colored pharmaceutical ads.  And historically, if the journal has had any bent at all, it's been to the right.  If anything, NEJM's "expression of concern" was an assertion of power, a declaration from that it won't be used as a pawn in pharma's games and be dragged down in the dirt of public opinion as well.

Comments

[Martin]

I just re-read both the expression of concern and the original article. While the points that NEJM makes are valid, they also indicate that the editors did a poor job of reviewing the manuscript. First off, by allowing the investigators to use Vioxx as the reference, rather than naproxen makes it more difficult to realize the magnitude of the increased risk of Vioxx relative to naproxen (relative risk curves are logarithmic, so they can be difficult to interpret). In addition, there were no tables in the original article disclosing CV risk, it was only briefly mentioned in the text. I will grant that some of this criticism is coming from hindsight--i.e. knowing now that all coxibs should be carefully vetted for CV safety. All that said, the WSJ is ridiculously out of line. Especially since the Bombardier article makes no mention of when the safety database was closed--implictly they asserted that there had been no undisclosed events from the start of the trial to the last moment before printing the journal.

[Peter]

I don't know of any study where adverse events that happened after the predetermined close date of a study (when the analysis begins)were included in that publication. Another paper might report on post study follow up or an extension period of a study. Otherwise, analysis begins with a closed file at the end of the study and that analysis is what gets published. It is also interesting that a publication scandal accusing P & G and researchers at Sheffield University of not including 40% of data because it would not support their pre-study hypothesis and marketing message for their osteoporosis drug (exposed Dec 5) has not been mentioned at all in the US media. It has been reported in the British papers and SLATE Magazine by a NY writer. Very odd.