1 bd de la Re´publique 78000-Versailles, France
Received 7 September 2004; accepted 13 October 2004
Available online 5 November 2004
According to Hippocratic tradition, the safety level of a preventive medicine must be very high, as it is aimed at protecting people against diseases that they may not contract. This paper points out that information on the safety of hepatitis B vaccine (HBV) is biased as compared to classical requirements of evidence-based medicine (EBM), as exemplified by a documented selectivity in the presentation or even publication of available clinical or epidemiological data. Then, a review is made of datasuggesting that HBV is remarkable by the frequency, the severity and the variety of its complications, some of them probablyrelated to a mechanism of molecular mimicry leading to demyelinating diseases, and the others reproducing the spectrum ofnon-hepatic manifestations of natural hepatitis B. To be explained, this unusual spectrum of toxicity requires additionalinvestigations based upon complete release of available data.