ArticlePloS one2021
Potential negative impact of reputed regulators' decisions on the approval status of new cancer drugs in Latin American countries: A descriptive analysis.
Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
3 citing papers in PubMed.
- [High-cost medicines: the difficult balance between individual and collective rightsMedicamentos de alto custo: o difícil equilíbrio entre direitos individuais e coletivos].Revista panamericana de salud publica = Pan American journal of public health · 2024Article
- Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis.Lancet regional health. Americas · 2023Article
- Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review.The Lancet regional health. Europe · 2021Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMany new cancer drugs are being approved by reputed regulatory authorities without evidence of overall survival benefit, quality of life improvement, and often based on clinical trials at high risk of bias. In recent years, most Latin American (LA) countries have reformed their marketing authorization (MA) rules to directly accept or abbreviate the approval process in case of earlier authorization by the European Medicines Agency (EMA) and the US Food and Drug Administration, mainly. This study assessed the potential impact of decisions taken by EMA regarding the approval of new cancer drugs based on no evidence of overall survival or in potentially biased clinical trials in LA countries.
designDescriptive analysis.
settingPublicly accessible marketing authorization databases from LA regulators, European Public Assessment Report by EMA, and previous studies accessing EMA approvals of new cancer drugs 2009-2016. MAIN OUTCOME AND MEASURES: Number of new cancer drugs approved by LA countries without evidence of overall survival (2009-2013), and without at least one clinical trial scored at low risk of bias, or with no trial supporting the marketing authorization at all (2014-2016).
resultsArgentina, Brazil, Chile, Colombia, Ecuador, Panama and Peru have publicly accessible and trustful MA databases and were included. Of the 17 cancer drugs approved by EMA (2009-2013) without evidence of OS benefit after a postmarketing median time of 5.4 years, 6 LA regulators approved more than 70% of them. Of the 13 drugs approved by EMA (2014-2016), either without supporting trial or with no trial at low risk of bias, Brazil approved 11, Chile 10, Peru 10, Argentina 10, Colombia 9, Ecuador 9, and Panama 8.
conclusionsLA countries keep approving new cancer drugs often based on poorly performed clinical trials measuring surrogate endpoints. EMA and other reputed regulators must be aware that their regulatory decisions might directly influence decisions regarding MA, health budgets and patient's care elsewhere.
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