German agency refuses to rule on drug’s benefits until Pfizer discloses all trial results

BMJ 2009; 338 doi: (Published 22 June 2009) Cite this as: BMJ 2009;338:b2521
  1. Ned Stafford
  1. 1Hamburg

    An independent scientific institute that conducts healthcare research and evaluations mainly on behalf of Germany’s public health insurance regulator has accused the drug giant Pfizer of “concealing” research data on its depression treatment reboxetine.

    The Institute for Quality and Efficiency in Health Care, which is based in Cologne and known in Germany as IQWiG, contends that Pfizer has refused to provide a complete list of all published and unpublished trials of reboxetine, which was approved in 1997 in Germany and marketed by Pfizer as Edronax.

    If the institute says it is unable to assess the benefit of the drug because of lack of data, it is likely that health insurance companies in Germany may refuse to reimburse its cost.

    “Deception through concealment is no trivial offence,” said the institute’s director, Peter Sawicki. “By concealing study data, the manufacturer is depriving patients and doctors of the opportunity to make an informed decision on …

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