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A Bayer AG (BAY.F) Drug, the European Medicines Agency and Transparency... or the Lack Thereof



7/11/2013 7:36:17 AM

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In yet another instance in which transparency involving pharmaceuticals has been questioned, the head of the Swedish organization that assesses health care products has criticized the European Medicines Agency for its closed-mouth approach to allowing physicians to resume use of a controversial Bayer drug that had been suspended several years ago. In a letter published in The Lancet, Mans Rosen complains the EMA refused to make available the scientific information that was the basis for its recommendation last year to lift a suspension for Trasylol, which is used to control bleeding during heart surgery (see the EMA statement here). Rosen is director of the Swedish Council on Health Technology and Assessment. His missive is the latest example of the tussle over the disclosure of data involving prescription drugs. In recent months, the pharmaceutical industry has come under increasing pressure to release patient-level clinical trial data and two drugmakers have taken legal action to prevent the EMA from releasing data in response to Freedom of Information requests.

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