Monday, May 15, 2006

We Were Hoodwinked!

In a front page Wall Street Journal story, New England Journal of Medicine Executive Editor Gregory Curfman said "We Were Hoodwinked" ("Bitter Pill: How the New England Journal Missed Warning Signs on Vioxx"; subscription required). He was defending himself and his journal against accusations that the journal should have published corrections to a pivotal VIOXX study report it published. The report omitted critical heart attack data (see "Merck's Hand in the Cookie Jar"). Only 5 years after the fact did the NEJM publish a "Expression of Concern" to correct the record.

It turns out, however, that it was the
NEJM that hoodwinked us, and by us I include the Wall Street Journal and other press.
Hoodwink -- "Back in the 16th century, 'wink' meant to firmly close the eyes, not the brief, jaunty wink we know today. To 'hoodwink' someone was to literally blindfold them with a hood, often the sort used by executioners. Hoodwinking was also a tactic of thieves, who would throw a hood over their victims' heads before robbing them. This literal sense of "hoodwinking" was joined in the 17th century by the metaphorical sense of "hoodwinking" we use today -- to blind someone by trickery or deceit in order to take advantage of them." [Word Detective]
When the NEJM published its "Expression of Concern" it denied that the timing was related to a planned release of Dr. Curfman's deposition at the first Vioxx trial in Texas.
Although the New England Journal wasn't on trial for anything, the deposition produced a number of damaging admissions by Dr. Curfman. He acknowledged that neither the peer reviewers nor journal editors challenged the authors' heart-attack theory about naproxen as it was presented in the article. "Yeah, we signed off on this," he said, according to a transcript of his testimony. "And I have many times had second thoughts about having done that." [WSJ]
Now NEJM concedes the timing was connected to the trial. This tells all about how the NEJM hoodwinked us:
A public-relations specialist who has advised the journal since 2002 predicted the rebuke would divert attention to Merck and induce the media to ignore the New England Journal of Medicine's own role in aiding Vioxx sales.

"I believe that given what a public punching bag Merck has become, there is more than enough information and more than enough context in the statement to drive the media away from NEJM and toward the authors, Merck and plaintiff attorneys," wrote Edward Cafasso, a Boston-based public relations consultant, in a late-night email to journal staffers hours before the expression was released. Mr. Cafasso later added, "In my view, this disclosure may very well be seen as the final straw for Merck on the Vioxx matter." [WSJ]
That was the "trickery" part of the hoodwinking process. Here's the "deceit" part. In its "Expression of Concern" NEJM claimed that the authors of the paper in question -- Merck employees -- had deleted data days before the publication. It was widely reported by the press (and bloggers like me as well) that the missing data concerned the number of heart attacks suffered by participants in the trial. This, however, was not the case.
The statement was ambiguous about what data the authors deleted, hinting that serious scientific misconduct was involved. "Taken together, these inaccuracies and deletions call into question the integrity of the data," the editors wrote.

In reality, the last-minute changes to the manuscript were less significant. One of the "deleted" items was a blank table that never had any data in it in article manuscripts. Also deleted was the number of heart attacks suffered by Vioxx users in the trial -- 17. However, in place of the number the authors inserted the percentage of patients who suffered heart attacks. Using that percentage (0.4%) and the total number of Vioxx users given in the article (4,047), any reader could roughly calculate the heart-attack number.

Dr. Curfman says it would have been easier on readers to give the exact number and admits "both the authors and the editors slipped up" in not including it. [WSJ]
"Slipped up" indeed! What the f**k are you paid for?

NEJM's "Thirty Pieces of Gold"

Dr. Curfman and the NEJM sold out to Merck for a pittance and have clearly done everything in their power to prevent damaging evidence about VIOXX from coming out (from them at least). The journal sold "more than 900,000 reprints of the article, bringing in at least $697,000 in revenue. Merck says it bought most of the reprints."

Repeatedly in the WSJ story, Curfman refuses to take any responsibility for not catching the errors in the article (the article did leave out data on heart attacks; this data was available on the FDA Web site for years). In fact, he passes the buck to the FDA: "The data were in the hands of a regulatory agency and we felt it was now up to them to take appropriate action."


This kind of cowardly "blame the other guy" tactic seems endemic to our higher institutions, including the federal government. I have yet to hear, for example, "the buck stops here" regarding the Katrina or the Iraq weapons of mass destruction debacles.


It's All About PR

The day after the expression of concern, Mr. Cafasso emailed colleagues: "The story is playing out exceptionally well."
PR people probably study the tactics and insights of P.T. Barnum who used exotic phrases to mislead people (such as "This Way to the Egress", which fooled people to exit an exhibit when they thought they'd be treated to another side show). Barnum is also famous for pointing out that "a sucker is born every minute." Shame on us for being suckered.

PR professionals, however, should remember this piece of advice attributable to Barnum: "You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all of the time."

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