Who protects physicians and patients from guidelines?

gust 2010); its position in the guideline is very prominent [1] . The development of this new guideline must have started in close temporal relationship to dronedarone’s EU market approval in November 2009, given the usual time requirements for the completion of such work. The explicit positioning of the compound in the new guideline resulted in an increased rate of prescription. However, complaints by physicians and patients about side effects and a relatively low efficacy accumulated rapidly. In January 2011, a public letter (a ‘Dear Doctor letter’) to all German physicians warned of serious hepatotoxicity necessitating liver transplantation. On July 7, 2011, the drug’s manufacturer reported that a large phase IIIb study (PALLAS) in patients with atrial fibrillation had to be prematurely stopped as dronedarone had caused a significant increase of cardiovascular events such as stroke or myocardial infarction versus placebo [2] . The manufacturer pointed out that in PALLAS, patients with permanent atrial fibrillation were included, whereas in ATHENA, which was the pivotal trial leading to market approval, only patients with nonpermanent atrial fibrillation were included. In the interim, the full paper has Medical guidelines are typically generated by medical associations to guide physicians through the jungle of biomedical knowledge, empirics and opinions. They are normative and, often, particularly in Europe, are regarded as binding for physicians; thus, in law courts, they are highly influential documents. However, according to good medical practice, guidelines should not be applied without a critical assessment of the individual case. Though an existing guideline may seem easily applicable, doctors are under obligation to search for the special features of the patient and to act accordingly which may suggest a deviation from the guideline. Nonetheless, in daily practice guidelines often are regarded as if they were laws; during basic and advanced medical education adherence to guidelines is a major objective. What if specific guidelines do not reflect rigorous or complete scientific data, as is often the case? Many guidelines are putatively based on the ‘level of evidence C’, which is essentially the absence of strong evidence and, thus, are largely the product of the inferences and opinions of the writers. This question was triggered once again by a recent event. The new antiarrhythmic drug, dronedarone, became part of the new guidelines for the treatment of atrial fibrillation by the European Society of Cardiology (AuReceived: December 15, 2011 Accepted after revision: January 13, 2012 Published online: March 1, 2012