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 drugs.
This evaluation follows 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.
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 our annual financial report in each Prescrire International June issue).
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.
>Click here to download the rules (pdf 275 Ko, in French).
Therapeutic advance is defined as better efficacy, fewer or less severe adverse effects (for similar efficacy), or safer or more convenient administration. 2009: two minor advances. In 2009, as in 2008, none of the new drugs we examined was awarded the Golden Pill award or mentioned on the Honours List.
However, two drugs that had already been on the market for several years were granted useful new indications.
Caspofungin, an antifungal echinocandin, was approved as last resort therapy for some children with invasive aspergillosis, a rare but frequently fatal opportunistic infection. Clinical evaluation in this setting is still limited, but caspofungin is a welcome treatment option.
Thalidomide was approved for first-line treatment of multiple myeloma in patients over age 65. Two trials conducted by the same team showed that adding thalidomide to the standard melphalan + prednisone combination prolonged overall survival by at least 1.5 year in 50% of patients. However, three other trials showed no increase in overall survival; therefore, the precise survival benefit remains to be determined. Thalidomide has frequent and potentially severe adverse effects, including neuropathy and venous thrombosis. It is also highly teratogenic.
Stagnant situation
Once again, in 2009, the paucity of new products offering even a modest therapeutic advantage stands in stark contrast to the large number of new products exposing patients to unjustified risks: about 20 per year over the last 5 years.
The international system of incentives intended to encourage real therapeutic advances is clearly not working. There are also flagrant shortcomings in the marketing authorisation procedures and post-marketing pharmacovigilance.
If they are to regain the trust of patients and healthcare professionals, drug regulatory agencies and drug companies must shift the focus to more rigorous and more transparent clinical studies designed to meet important health needs.
©Prescrire April 2010
Source: Prescrire Int 2010; 18 (106): 86.
> Cick here to download the full results of the 2009 Prescrire Awards (pdf, 191 Ko).
