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New drugs and indications in 2017: numerous innovations offering no progress

Marketing authorisations often granted too hastily: patients are exposed to medicines with uncertain harm-benefit balances.

Each month Prescrire conducts an independent and systematic analysis of new substances and new indications for drugs that are already on the market, as well as new dosages and new pharmaceutical forms. The object of this exercise is to identify which new medicines offer real advances for patients.

In 2017, the Prescrire team analysed 92 drug evaluation dossiers. The yearly review is published in the April 2018 issue of Prescrire International. Prescrire's editors found that 10 drug innovations offered therapeutic progress, 6 of which were notable advances. Nearly half (45) of the innovations did not offer patients any advances, and 15 new drugs were more harmful than useful.

Over the years, it has been shown that the evaluation of medicinal products for marketing authorisations is too often over-hasty and based on insufficient clinical data, on the pretext of giving patients faster access to "therapeutic innovation". This is compounded by medicines agencies' inertia when it comes to withdrawing or suspending the marketing authorisation of a drug whose adverse effects are disproportionate to the expected benefits.

Healthcare professionals have a central role to play in opting for drugs that have a demonstrated clinical benefit and in protecting patients from exposure to drugs that are poorly evaluated, have no tangible therapeutic benefit or are more harmful than useful. It is a question of resisting the mass medicalisation of society, which has major consequences for victims of adverse effects and drug dependence. Medicalisation has also led to a waste of public resources, exacerbated by the exorbitant cost of some drugs.

©Prescrire 1 April 2018

"Drugs in 2017: a brief review" Prescrire Int 2018; 27 (192): 110-111. (Pdf, free).

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Download the full review.
Pdf, free

For more information:

Prescrire's ratings of new
products and indications
over the past 10 years
(April 2018)

See also:

The Prescrire Drug Awards
for 2017
(January 2018)