Federal court releases medical journal e-mails over Vioxx study
NEW ORLEANS -- In the world of scientific research, the language was strong stuff. "Your explanation lacked scientific objectivity," an editor for the New England Journal of Medicine wrote to a researcher whose study, published in 2000, has become a major focus of federal and state lawsuits involving the painkiller Vioxx.
"That's pretty serious. That's pretty serious," Dr. Mark Frankel, director of the Scientific Freedom, Responsibility and Law program at the American Association for the Advancement of Science, said Wednesday. Researchers are expected to be utterly impartial. "This is serious criticism. Obviously, this case has implications far beyond the journal," Frankel said. He said he is looking forward to reading the researchers' response. Dr. Claire Bombardier, the lead researcher from the University of Toronto, has sent a response to the journal, and the university will comment once it is published, university spokesman Steven de Sousa said Wednesday. A brief statement from the journal said communications with authors are confidential. "Once our concerns have been fully pursued and answered, we will publish the results," it said. The e-mail from its executive editor, Dr. Gregory D. Curfman, was released Tuesday by U.S. District Judge Eldon Fallon, who is in charge of pretrial matters for all 4,050 federal lawsuits against manufacturer Merck & Co. Another 5,150 cases have been filed in state courts, many of them in New Jersey. So far, the jury message has been mixed. A Texas state court awarded $253 million in damages, though state law will cut that to at most $26.1 million. A New Jersey state court absolved Merck. The first federal trial ended with a jury hung 8-1 in Merck's favor, and will be retried starting Feb. 6 in New Orleans. In all three trials, each side has cited Bombardier's study, called VIGOR, as proving its point about whether Merck promptly disclosed the drug's cardiac risks. But while the federal jury was deliberating whether Merck was responsible for Richard Irvin's death in Florida, the New England Journal of Medicine published an editorial criticizing researchers for leaving out critical data from the VIGOR report. Lawyers for Irvin's widow have said the editorial bolsters their claims that Merck hid the drug's dangers. The company pulled the drug in 2004, after another study found that taking it for at least 18 months doubles the risk of heart attacks. Kent Jarrell, a spokesman for Merck's attorneys, repeated earlier statements: nothing was hidden; the heart attacks occurred after a study cut-off date; and the Food and Drug Administration had all of the data before the study was published. Attorneys for the company questioned Curfman on Tuesday. "We are prepared when that issue comes up in any trial to explain what happened and how we believe that everything was done properly by Merck," Jarrell said Wednesday. In his e-mail to the VIGOR study's lead author, Curfman listed five points which the journal expects the authors to make in a correction. One was omission of three heart attacks from the data; another that including them "would have invalidated your claim" that only people already at risk of a heart attack were at a greater risk from Vioxx. The article doesn't mention a cut-off date for reporting heart attacks, Curfman wrote, and even if it had, NEJM and other journals expect updates. "This is especially important for a potentially serious drug adverse effect" such as a heart attack, he wrote. Curfman's comment about lack of objectivity came in a written discussion of the study's statement that people taking naproxen had one-quarter as many heart attacks as those on Vioxx because naproxen protects the heart. It should have noted the flip side _ the possibility that Vioxx might be harmful, Curfman wrote. "The relative risks were presented so as to favor naproxen and discount the possibility that rofecoxib might be harmful."
"That's pretty serious. That's pretty serious," Dr. Mark Frankel, director of the Scientific Freedom, Responsibility and Law program at the American Association for the Advancement of Science, said Wednesday. Researchers are expected to be utterly impartial. "This is serious criticism. Obviously, this case has implications far beyond the journal," Frankel said. He said he is looking forward to reading the researchers' response. Dr. Claire Bombardier, the lead researcher from the University of Toronto, has sent a response to the journal, and the university will comment once it is published, university spokesman Steven de Sousa said Wednesday. A brief statement from the journal said communications with authors are confidential. "Once our concerns have been fully pursued and answered, we will publish the results," it said. The e-mail from its executive editor, Dr. Gregory D. Curfman, was released Tuesday by U.S. District Judge Eldon Fallon, who is in charge of pretrial matters for all 4,050 federal lawsuits against manufacturer Merck & Co. Another 5,150 cases have been filed in state courts, many of them in New Jersey. So far, the jury message has been mixed. A Texas state court awarded $253 million in damages, though state law will cut that to at most $26.1 million. A New Jersey state court absolved Merck. The first federal trial ended with a jury hung 8-1 in Merck's favor, and will be retried starting Feb. 6 in New Orleans. In all three trials, each side has cited Bombardier's study, called VIGOR, as proving its point about whether Merck promptly disclosed the drug's cardiac risks. But while the federal jury was deliberating whether Merck was responsible for Richard Irvin's death in Florida, the New England Journal of Medicine published an editorial criticizing researchers for leaving out critical data from the VIGOR report. Lawyers for Irvin's widow have said the editorial bolsters their claims that Merck hid the drug's dangers. The company pulled the drug in 2004, after another study found that taking it for at least 18 months doubles the risk of heart attacks. Kent Jarrell, a spokesman for Merck's attorneys, repeated earlier statements: nothing was hidden; the heart attacks occurred after a study cut-off date; and the Food and Drug Administration had all of the data before the study was published. Attorneys for the company questioned Curfman on Tuesday. "We are prepared when that issue comes up in any trial to explain what happened and how we believe that everything was done properly by Merck," Jarrell said Wednesday. In his e-mail to the VIGOR study's lead author, Curfman listed five points which the journal expects the authors to make in a correction. One was omission of three heart attacks from the data; another that including them "would have invalidated your claim" that only people already at risk of a heart attack were at a greater risk from Vioxx. The article doesn't mention a cut-off date for reporting heart attacks, Curfman wrote, and even if it had, NEJM and other journals expect updates. "This is especially important for a potentially serious drug adverse effect" such as a heart attack, he wrote. Curfman's comment about lack of objectivity came in a written discussion of the study's statement that people taking naproxen had one-quarter as many heart attacks as those on Vioxx because naproxen protects the heart. It should have noted the flip side _ the possibility that Vioxx might be harmful, Curfman wrote. "The relative risks were presented so as to favor naproxen and discount the possibility that rofecoxib might be harmful."
posted by Chris Placitella at 11:03 AM
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