In 2008, we published independent assessments of about 300 products (a), including 87 new products: 50 products with new brand names, 20 line extensions; and 17 copies with invented brand names. The following is an overview of the major trends observed in 2008.

Little therapeutic advance
In 2008 we examined 120 new products and indications. Nearly half of new products (n=57) provided no significant advantages over existing options. The large number of drugs that we rated as “Unacceptable” or “Judgement reserved” highlights the inability of regulatory agencies to ensure the safety and efficacy of the products they allow on to the market.

New products: mainly for cancer, HIV infection and rare diseasesµ
Half of the 50 new brand name products that we examined in 2008 were intended for 3 major disease categories. Some drugs improved patient management, but none represented a major therapeutic breakthrough:

• 13 were for cancer (see la revue Prescrire 303 p. 27-30);

• 4 were for HIV infection (see la revue Prescrire 303 p. 42);

• 8 were for rare diseases (other than cancer) (see la revue Prescrire 303 p. 43).

No real therapeutic advance in patient care
Among the new indications and products (new brand names and line extensions) that we examined in 2008, none represented a major therapeutic advance. Indeed, no new products deserved a “Bravo” or “A real advance” on the Prescrire rating scale. Six were rated “Offers an advantage”.

We were unable to assess 9 new products or indications (“Judgement reserved”), signifying that marketing authorisation had been granted prematurely.

Drugs to avoid: a dismal record number in 2008
The number of new products with unfavourable risk-benefit balances was higher in 2008 (23 of 120, 19%) than in 2007 (15 of 141, 11%). Most new products or new indications were intended for three fields in which many drugs were already available: psychiatry, diabetes and cancer.

Multiple new indications, especially for cytotoxic drugs
As in previous years, most new indications for existing drugs involved cytotoxic agents: extension to other disease stages, other cancers, etc.

From the patient’s point of view, however, the benefits were generally unconvincing. There were no tangible improvements in cancer management (see la revue Prescrire 303 p. 27-30).

Rare diseases: little progress
We examined 20 drugs authorised for “orphan diseases” in 2008, but none represented a major breakthrough for the patients concerned (see la revue Prescrire 303 p. 43). Only 2 were rated “Offers an advantage”: hydroxycarbamide in sickle cell syndrome and sorafenib in certain liver cancers. In 4 cases (betaine anhydrous, nelarabine, rufinamide and temsirolimus) the available evidence failed to show a benefit for the patients concerned. Even more troubling, we concluded that 3 of these drugs were “Not acceptable” (dexrazoxane, idursulfase and trabectedin).

Drugs for children: few improvements
The European Paediatric Regulation adopted in late 2006 provides incentives (a longer market monopoly) for companies to conduct more paediatric trials in diseases for which drugs are lacking. These incentives have not yet had the desired effect, as assessment of drugs for children remains minimal.

We examined 11 drugs for use in children in 2008, and found that few represented a real advance (see la revue Prescrire 303 p. 49-50). The lamivudine-zidovudine fixed-dose combination simplifies treatment of HIV infection (la revue Prescrire 296 p. 414). The risk-benefit balance of dantrolene in patients with cerebral palsy is uncertain (Prescrire International 98), as is that of infliximab in severe Crohn’s disease (Prescrire International 96).

The tendency to grant multiple new indications for existing psychotropics is disturbing; for example, fluoxetine for depression in children over 8 years of age (Prescrire International 97) and hydroxyzine for patients who have trouble falling asleep (la revue Prescrire 291 p. 7).

Biosimilars: in practice, simple copies
In 2008 the first “biosimilar” epoetins were marketed in France. Binocrit° (epoetin alfa; Prescrire International 99) and Abseamed° (epoetin alfa; la revue Prescrire 303 p. 20) are both considered biosimilar to Eprex° (epoetin alfa). They cannot be dispensed interchangeably from French community pharmacies, but they are still nothing more than simple copies. Their efficacy and adverse effects are identical, irrespective of the product and international nonproprietary name (INN).

Generics: only some are welcome additions
In 2008 we examined 26 new generic versions of existing products in France. About one-third of them are useful for patients.

Other generics should be avoided, whatever their cost. Examples include bicalutamide in advanced-stage or metastatic prostate cancer and venlafaxine in various psychiatric disorders (depression, social phobia, generalised anxiety).

Notes:
a- There are also new indications, generics, reappearances, changes in labelling, various modifications, name changes, and market withdrawals.

©Prescrire April 2009

Source: Prescrire Int 2009 18 (100) 84-88.