Physician E-Mail Describes "Messy" Vioxx Problem
Posted by
Robert WolfJanuary 30, 2006 9:23 AMAn editor for a prestigious medical journal sounded pleased, yet exasperated in an e-mail to another scientist as they went over an editorial criticizing researchers for leaving out critical data from a study of the painkiller Vioxx.
"Thanks again with all the time you have spent on this Vioxx situation. The more we get into it, the messier it becomes," Dr. Gregory D. Curfman, executive editor of the New England Journal of Medicine, wrote in an e-mail made public Tuesday by the federal court in New Orleans.
The email in question was sent Dec. 3 to one of the journal's "peer reviewers," who is an independent scientist that critiques studies before final publication. In this case, the reviewer was going over the "expression of concern" which the journal published Dec. 8. "An expression of concern is one step short of retracting the article," Curfman wrote.
According to a Newsday article, the e-mails were released to Merck & Co. lawyers who wanted to see them before they questioned Dr. Curfman about the editorial. Plaintiffs' attorneys had seized upon the comments to bolster their contentions that Merck concealed the drug's dangers.
The study, known as VIGOR, was published in 2000. It was paid for by Merck, which currently faces 9,200 lawsuits, 4,050 of them in federal court. VIGOR has been a key issue in the three Vioxx trials so far. Each side has claimed the study proves its point about whether Merck promptly disclosed the drug's cardiac risks. Two state trials had conflicting results, and a federal trial ended with a hung jury.
Merck pulled Vioxx in September 2004 after research showed it doubled the risk of heart attacks and strokes after 18 months' use.
The journal's editorial said VIGOR's authors failed to mention three of the patients who had heart attacks while taking the painkiller in a medical study, and that they also deleted other relevant data before submitting their article for publication.
Attorneys for a Florida woman whose husband died after taking the drug for a month have said they plan to use the editorial when the case is retried starting Feb. 6. Their first trial, in Houston, ended with the jury split 8-1 in Merck's favor.
The journal had tried to keep the e-mails under seal. U.S. District Judge Eldon Fallon, who is in charge of pretrial matters for all of the federal cases, refused, but did say the peer reviewers' identities could stay secret.
Curfman and managing editor Stephen Morrissey wrote, among other things, that the authors slanted their explanation of why people taking Vioxx had more heart attacks than people who took the other drug used in the test. The article suggested that the other drug, naproxen, might protect against heart attacks, but never acknowledged the other side of the hypothesis: that Vioxx, also known as rofecoxib, might be harmful, the editors wrote.
"Your explanation lacked scientific objectivity," they wrote. "The relative risks were presented so as to favor naproxen and discount the possibility that rofecoxib might be harmful."
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