Intended for healthcare professionals

Letters Orphan drugs

Regulation is flawed

BMJ 2010; 341 doi: (Published 07 December 2010) Cite this as: BMJ 2010;341:c7016
  1. Carl E Counsell, reader in neurology1
  1. 1University of Aberdeen, Aberdeen, UK
  1. carl.counsell{at}

Something is fundamentally wrong with a drug regulatory system that makes it increasingly difficult to do independent pragmatic trials of widely used but unproven drugs yet licenses a ridiculously expensive drug with no randomised evidence that it improves clinical outcomes over the cheap unlicensed preparation.1 2

Quality control is …

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