Federal Court Releases Medical Journal E-Mails

posted on:
January 24, 2006

author:
Staff

NEW ORLEANS—An editor for a prestigious medical journal sounded both grateful and 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.

It was sent Dec. 3 to one of the journal’s “peer reviewers,” an independent scientist who critiques studies  before 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.

The-mails were released to Merck & Co. lawyers who wanted to see them before they questioned Curfman  about the editorial. Plaintiffs’ attorneys had seized upon the comments to bolster their contentions that Merck concealed the drug’s dangers. Curfman was questioned Tuesday in Boston. His e-mail also asked for help with calculations needed for tables to be published with the editorial, which was published during deliberations for the first federal trial alleging that Merck withheld information about its product’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 trials so far. Each side says 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. Another state trial began Tuesday in Texas.

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 plaintiffs’ long witness list includes Curfman, Dr. Jeffrey Drazen, the journal’s editor-in-chief; Dr. Robert Steinbrook, its deputy editor, and Dr. Robert Utiger, a former deputy editor. Reached at home, Curfman declined to comment, saying he did not have the documents in question with him. “It’s been a very long day of testimony,” he said.

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.

Kent Jarrell, spokesman for Merck’s attorneys, said he would try to get someone to comment for the company.

The e-mails made public Tuesday also included various drafts of a letter to the study’s lead author, who had asked for copies of all the materials in question and for details of what the journal wanted in the authors’ response.

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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