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New drugs in 2004: a lack of innovation

In 2004, therapeutic advances were rarer and less significant than in 2003.

The number of new drugs analysed by Prescrire in 2004 was similar to previous years: 235 new drugs (including 178 generics); 56 notable modifications to marketing authorisations, including 25 new therapeutic indications; 119 additions to existing ranges (including 52 generics); 39 miscellaneous amendments and name changes; 234 drugs withdrawn, 5 as a result of pharmacovigilance problems. But when it comes to the therapeutic advances represented by the new drugs, 2004 differs notably from the previous year, with fewer and less significant advances made. For 2003, 4 innovations represented "a genuine advance", 5 "offered an advantage" and 23 were rated "possibly helpful". In 2004, the number of innovations ranked in these categories was respectively 0, 6, and 12. The 200 to 400 other new products (depending on whether generics and additions to existing ranges are included or not) analysed in 2004 have a benefit-harm balance similar to that of existing drugs. Their evaluation dossiers do not demonstrate any tangible benefit for patients. In 2004, no new drug achieved the highest distinction of "bravo". And, for the sixth year running, Prescrire did not give out its top honour, the "Pilule d'Or".

©Prescrire February 2005

Source: "L’année 2004 du médicament : innovation en panne et prises de risques" Rev Prescrire 2005 ; 25 (258) : 139-148.

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