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Ethical aspects of new medicines targeted at treatment of RA
  1. Rheumatology Division
  2. Hospital Xeral-Calde
  3. Lugo, Spain
  1. Dr M A González-Gay, Section of Rheumatology, Hospital Xeral-Calde Lugo, c/ Dr. Ochoa s/n, 27004 Lugo, Spain miguelaggay{at}

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We read with interest the article reported by Kreutzet al “European regulatory aspects on new medicines targeted at treatment of rheumatoid arthritis”.1 The use of placebo studies for the development of new medicines in patients with rheumatoid arthritis (RA) remains controversial.2 Placebo studies are useful when testing the effectiveness of new drugs. However, in two studies that compared two active disease modifying drugs with placebo the radiological deterioration was about four times higher in those patients with placebo.3 ,4 In view of this, in 1999 Emery and Smolen suggested that long term placebo studies should be a thing of the past in patients with active RA.5 Nowadays, there is enough evidence that single or combined treatments can modify RA. Thus, for example, in a recent prospective and observational study patients with severe RA who responded to methotrexate had a reduced mortality.6 Also, in three randomised controlled trials Sharp et al demonstrated retardation of radiographic progression by the use of leflunomide.7Observations like these support the possible discontinuation of placebo in studies of active RA. Moreover, patients enrolled in placebo control studies should receive information on the potential risk of permanent and irreversible damage in those receiving placebo without any active disease modifying drug. Finally, at present it is difficult to establish whether six months without any active disease modifying drug in those receiving placebo is acceptable.


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  • Dr García-Porrúa is a member of the Galician ethical committee for clinical investigation (northwestern Spain).

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