TRENTON, N.J., Dec. 8, 2005

Journal: Merck Hid Vioxx Results

Medical Publication Alleges Drug Maker Concealed Bad Outcomes In Study

  • Play CBS Video Video More Trouble For Vioxx?

    A medical journal accused the makers of Vioxx of concealing the fact that three people suffered heart attacks during a study before the drug was pulled from the market. Elizabeth Kaledin reports.

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    • Dr. Alise Reicin, Merck's vice president for clinical research, testifies in court in this Oct. 14, 2005, file photo. The drug maker concealed bad outcomes of a Vioxx study, according to a Dec. 8, 2005 editorial in the New England Journal of Medicine. Reicin was one of the study's authors.

      Dr. Alise Reicin, Merck's vice president for clinical research, testifies in court in this Oct. 14, 2005, file photo. The drug maker concealed bad outcomes of a Vioxx study, according to a Dec. 8, 2005 editorial in the New England Journal of Medicine. Reicin was one of the study's authors.  (AP (file))

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None of the three extra heart attacks was fatal, but that all three of those patients were in a group at low risk of heart attack, Curfman said.

The journal editor said he learned of the extra heart attacks and deleted data — including the number of patients in the study who died — when he gave a deposition on Nov. 21 for attorneys representing Vioxx plaintiffs in the Houston trial and three other federal trials slated for early next year. At the deposition, the plaintiff lawyers showed him documents they subpoenaed from Merck, including a July 2000 internal memo containing the deleted data.

Curfman said he and Morrissey spoke Monday with two researchers who led the study and the two, who do not work for Merck, said they would submit a correction to the journal as the editors requested.

The third author of the study was Dr. Alise Reicin, Merck's vice president for clinical research. Reicin testified on Wednesday in the Houston trial that the company never misled doctors and the public about studies linking heart attacks to Vioxx.

Plaintiff's attorneys declined comment in Houston on Thursday when asked if the New England Journal revelations might prompt them to ask for a mistrial. Attorneys in that trial are honoring the judge's request that they not to speak to the media until a verdict is reached. The jury ended deliberations on Thursday without reaching a verdict.

Merck withdrew Vioxx, once one of its top-selling drugs, from the market on Sept. 30, 2004 after other research showed the popular arthritis drug doubled risks of heart attacks and stroke with long-term use. The company now faces at least 7,000 lawsuits over Vioxx and legal liability some analysts have estimated could reach $50 billion. Those problems were part of the reason Merck last week announced plans to cut 7,000 jobs and close eight manufacturing and research facilities around the world as the first step in a sweeping reorganization.

Dr. Eric Topol, chairman of cardiovascular medicine at the Cleveland Clinic, first published his concerns about Vioxx's safety in 2001 after finding discrepancies between the Journal article and data at the FDA. In a videotaped deposition shown at the Houston federal trial, Topol accused Merck of scientific misconduct by misrepresenting data.

Topol said he felt vindicated by the journal article. "This is what I've been asserting for some time," Topol said.

An official at the University of Toronto said lead article author Dr. Claire Bombardier could not be reached for comment.

©MMV, CBS Broadcasting Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.

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