Products evaluated during the previous year in the New Products section of our French edition are eligible for the Prescrire Awards for new drugs and indications (in 2011: issues 327 to 338).
> Rules governing the Prescrire Awards (pdf, in French)
Each month, the Prescrire Editorial Staff presents systematic and comparative analyses of available data on all newly approved drugs in France, and on new therapeutic indications granted for existing drugs. The goal is to help the reader distinguish, among the plethora of lavishly promoted commercial products, those medications worth adding to their drug list or worth using instead of existing products (as well as products to be avoided).
This evaluation is based on rigorous procedures that include a thorough literature search, a large panel of reviewers (specific to each project) and a quality control system to verify that the text is consistent with the data in the references. For further information, see:
> How we work
Total independence
This work is carried out by the Editorial Staff in total independence. Prescrire is financed exclusively by individual readers’ subscriptions: neither the French nor the English edition carries any paid advertising, nor do we receive grants or subsidies of any kind. See :
> Financing
At the end of each year, the Prescrire Drug Awards are based on the review articles published that year, and take into account any new data available since the initial articles were published. The rules governing the Drug Awards are available here :
> Rules governing the Prescrire Awards (pdf, in French)
“Therapeutic advance” is defined as better efficacy, fewer or less severe adverse effects (for similar efficacy), or safer or more convenient administration
2011: a lean year
Once again this year, none of the new drugs we examined was awarded the “Golden Pill” Award. In addition, for the first time since the Awards began in 1981, no new drugs or new indications for existing drugs made it to the Honours List or were even considered Noteworthy. Note that the selection criteria for the Awards have remained unchanged over these 31 years.
Three drugs nearly qualified for an award (for details see > Prescrire's drug ratings). Collagenases extracted from Clostridium histolyticum bacteria (Xiapex°, Prescrire Int n° 122 pp. 285-287), and administered by local injection, may help patients with Dupuytren’s disease when surgery for severe forms cannot be performed, as it reduces digital retractions in about 50% of cases. But little is known of the recurrence rate or the risk of developing autoimmune disorders in the long term.
For the treatment of vitamin E deficiency in the rare children with congenital or hereditary chronic cholestasis, oral pegylated vitamin E (tocofersolan) (Vedrop°, Rev Prescrire n° 333) avoids the need for painful intramuscular injections of vitamin E every 2 weeks. But its clinical assessment is inadequate, and none of the available trials used the marketed formulation of tocofersolan.
Mesalazine (Pentasa°, Prescrire Int n° 119 p. 208), the standard antiinflammatory salicylate, was finally authorised for the treatment of children with inflammatory bowel diseases, but the packaging is not suitable for certain children.
Running out of steam?
2011 was a dismal year for patients and healthcare professionals, given the dearth of new drugs providing real therapeutic advance.
Inadequate marketing authorisation procedures and a failing system of incentives to stimulate therapeutic advance call for urgent action from health authorities.
©Prescrire February 2012
"The 2011 Prescrire Awards" Prescrire Int 2012; 21 (125): 78-82. (pdf, free)
