What observation can we make of the new drugs marketed in 2019 ? Like every year, the medical journal Prescribe has published its annual list of medicines, determined on the basis of evaluations published during the past year. The purpose of this classification is “to help subscribers to distinguish, among the new products, those which bring progress for the care of those which are added without progress, or even which should not have been authorized given the uncertainties or their dangerousness “. Because every month, the expert review publishes a comparative analysis of new developments concerning drugs: new substances, new indications, new pharmaceutical forms …
Experts indicate that in 2019, 108 new drugs have been rated by Prescribe, but that this year again, the share of novelties not bringing progress is high (61 rated “Does not bring anything new” out of 108). Only eleven new products presented “notable” progress, six of which were awarded. Three were entered on the “Honor Roll” because they bring clear progress for certain patients compared to the therapeutic means already available, with certain limits:émicizumab (Hemlibra °, prevents bleeding), the tisagenlecleucel (Kymriah °, acute leukemia) and theaxicabtagène ciloleucel (Yescarta °, some lymphomas).
14 new drugs are deemed dangerous
The other three drugs “cited in the charts” have earned their place because they “contribute to improving, modestly, the means of patient care”. It’s about ruxolitinib (Jakavi °, against symptomatic myelofibrosis), trastuzumab emtansine (Kadcyla °, against HER-2 positive breast cancer) and pembrolizumab (Keytruda °, against non-small cell lung cancer). No new product has won the famous “Golden Pill”, attributed to drugs which constitute a decisive therapeutic progress in an area where patients and caregivers were totally destitute, but conversely, fourteen new products were evaluated more dangerous than useful.
These treatments, indicated in red in the classification (marked “No agreement”), relate to various therapeutic areas: for example abemaciclib (Verzenios °) in certain breast cancers, the combination of colchicine + opium + tiemonium (Colchimax °) in acute pericarditis, atataluren (Translarna °) in Duchenne muscular dystrophy in children 2 to 4 years old, chondroitin 1200 mg in oral gel in sachets ( Chondrosulf °) against osteoarthritis and ertugliflozin (Steglatro ° and others) against type 2 diabetes. To sum up, the review indicates that sorting is still necessary since in 2019, only 10% of new products bring significant progress to better care.
Drug packaging: too much risk for children
Sorting is all the more imperative “than the European regulatory system of drug market continues to give pride of place to firms, by not sufficiently protecting patients, as evidenced by the 20% of new products for which the benefit-risk balance is uncertain, even clearly unfavorable, ”she said. The independent magazine also announced its “annual ranking of packaging” (173 drugs) according to several criteria: pictograms, differentiation of dosages within a range, clarity of information presented in the form of diagrams, devices for administering doses, informative and educational interest of the leaflets …
A total of 34 red cards were distributed, punishing a series of faults and dangers. “Too many labels enhance the brands and logos of firms at the expense of information conducive to proper use and preventing errors, such as the composition of the drug. Too many dosing devices are unsuitable for children (syringes which are a source of overdose). Too few bottles are fitted with a safety stopper in the face of the risk of ingestion by a child. Too many records underestimate the risks of the drug “, Say the experts. Note that a palm has been attributed to raltegravir, used against HIV infection in children, due to the presence of an instruction manual for use.