english.prescrire.org > Positions > Therapeutic progress > Second-line drugs: no to second-rate evaluations

Theme: Therapeutic progress

New products or techniques are only worthwhile if they translate into better care for patients. Clinical data may mean little in terms of improving patients’ health, and lives. How can we know genuine progress when we see it? 

Second-line drugs: no to second-rate evaluations

It is not acceptable that second-line treatments should be even more poorly evaluated than first-line drugs.

A treatment often proves inadequate or causes too many adverse effects, especially in oncology. The doctor then has to opt for an alternative or second-line treatment. Unfortunately, the data available from clinical trials of these drugs is often even more meagre that for first-line drugs.

A marketing authorisation was granted for sunitinib, a second-line drug for kidney cancer, on the basis of fragmentary results (non-comparative trial, effectiveness assessment based on the tumour rather than the patient’s state of health).

There is another, better option, since sorafenib has been approved for the same indication, but on the basis of a much more thorough placebo-controlled, double-blind trial.

Patients in the situation of being offered a second-line treatment are not second-rate patients. Health authorities committed to prioritising health over business interests must demand comparative evaluations that are both pragmatic and reliable for these patients, and not allow pharmaceutical companies to use second-line indications merely as stepping stones to get their products to market as quickly as possible.

©Prescrire 2007

Source: "Deuxième ligne" Rev Prescrire 2007; 27 (283): 324.
More information:
 
Declaration on
therapeutic advance
in the use of medicines
ISDB 2001