In August 2001, a Seattle pharmacist called a radio show on which Jeffrey Drazen, the top editor of the New England Journal of Medicine, was appearing.
On the air, the pharmacist, Jennifer Hrachovec, begged Dr. Drazen to update an article in the journal that touted the benefits of the painkiller Vioxx while playing down its heart risks.
Dr. Hrachovec had been reviewing data on an FDA website indicating that patients in a Vioxx clinical trial had suffered more heart attacks than the journal article about the trial reported.
"It bothers me there is more data from the trial than has ever been published and the New England Journal still hasn't published an editorial or any kind of update," she said.
"My concern is that doctors are still using this and exposing their patients to higher risks of heart problems and they just don't even know that that's the case."
Hrachovec challenged Jeffrey Drazen, editor of the NEJM, about the Vigor study in a call to a Seattle radio show Aug. 14, 2001.
Hrachovec: "With this study in particular, it bothers me that there is more data from the trial than has ever been published and the New England Journal still hasn't published an editorial or any kind of update to let readers and clinicians using this drug and giving it to patients who they think will benefit from a better side-effect profile.
My concern is that doctors are still using this and exposing their patients to higher risks of heart problems and they just don't even know that that's the case."
Drazen: " We can't be in the business of policing every bit of data that we put out. We think that that's the role of people who know the field. And when they think that the field has advanced to the point where something which was true at the time it came out may no longer be true .
Having brought that evidence to our attention in the form of a manuscript or a letter, we can judge whether there's enough new information and put it out if we believe that the re-analysis is correct."
But wait!
In June 2001, Dr. Hrachovec and a doctor reviewing the drug for a Seattle health insurer had writen to the NEJM, noting the FDA posting.
They warned the journal that the Vioxx results it printed were incomplete and made the drug appear safer than it was.
The journal refused to publish the letter, saying space was limited.
It acknowledges that during this period it never asked Merck, the FDA or the article's authors about the discrepancy, believing that it was the responsibility of the authors to report new data.
So the Vioxx machine rolled on and on.
Three years later, Merck pulled Vioxx from the market, citing higher risk of heart attacks and strokes in some patients.
An estimated 20 million Americans took Vioxx.
Read the whole WSJ article here.
2 comments:
So much for the integrity of the NEJM. Read this carefully and you can see that they have no ethics. Actually, Merck seems to have done the right things and NEJM tried to discredit everyone else to deflect attention to their bad jusdgement.
I agree, those editors seem to have some questionable ethics
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