"The dabigatran debate is a good example which raises issues concerning post-marketing surveillance, and pharmaco-vigilance," Jacobs said. "Who takes responsibility? Industry? Independent researchers? National bodies?"
"I personally tend to favor the latter, since the stakes are very high for new drugs, and it is difficult for industry-backed research to overcome conflicts of interest that inevitably arise," he added.
As far as dabigatran is concerned, Jacobs said that physicians should be cautious, especially when prescribing it to patients with known heart disease. The issue will only be clarified as more data about the risk accumulates and how it measures up against the dangers of bleeding posed by warfarin, he said.
For more on Pradaxa, visit the U.S. National Library of Medicine.
SOURCES: Ken Uchino, M.D., director, Vascular Neurology Fellowship Training Progam, Cleveland Clinic, Ohio;Jeremy Jacobs, M.D.,lecturer, geriatric medicine,Hebrew University Medical Center, Jerusalem, Israel;William O'Neill, M.D., professor, cardiology, and executive dean, clinical affairs, University of Miami School of Medicine; John Smith, M.D., Ph.D., senior vice president,clinical development and medical affairs, Boehringer Ingelheim, Ridgefield, Conn.; Jan. 9, 2012, Archives of Internal Medicine, online
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