Immunosuppressants, mortality, and risk of cancer

BMJ 2009; 339 doi: http://dx.doi.org/10.1136/bmj.b1645 (Published 03 July 2009) Cite this as: BMJ 2009;339:b1645
  1. Jerry Avorn, professor of medicine,
  2. Sebastian Schneeweiss, associate professor of medicine
  1. 1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School, Brigham and Women’s Hospital, Boston, MA 02120, USA
  1. javorn{at}medsoc.harvard.edu

    New data raise concerns, but don’t yet warrant a substantial change in practice

    The retrospective cohort study by Kempen and colleagues (doi:10.1136/bmj.b2480) forces us to take a hard look at two of the most pressing questions in drug treatment today.1 The first is what are the longer term risks of the increasingly powerful drugs we now prescribe routinely? The second relates to “pharmacoepistemology”—the question of “how we know what we know” about the risks and benefits of drugs.2

    On the first topic, clinicians, patients, and policymakers must live with the fact that drugs are generally approved on the basis of tests that may last just a few weeks or months, even if the drug is designed to be taken for years. Once short term efficacy is shown—even if it is in comparison with placebo, or by the achievement of a surrogate outcome, such as a laboratory test—subsequent drug effects cannot be systematically tracked. A report by the US Institute of Medicine argued strongly that failure to track longer term outcomes constitutes a major gap in the regulatory process.3

    This can be a problem for conventional small molecule drugs—for example, the excess risk of myocardial infarction shown for rofecoxib (Vioxx) and rosiglitazone (Avandia), but it is even more of a …

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