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Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018
IMPORTANCE: Both the commercial sector and academia play a vital role in medicine development. Ongoing debates exist on their contribution and the value of medicinal products entering the market. OBJECTIVE: To identify the provenance and clinical benefit of medicines that entered the French market b...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10660249/ https://www.ncbi.nlm.nih.gov/pubmed/37983026 http://dx.doi.org/10.1001/jamainternmed.2023.6249 |
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author | Osipenko, Leeza Potey, Philippe Perez, Bernardo Kupryjanczuk, Alexandra Angelov, Filip Schuster, Alexandra Mossialos, Elias |
author_facet | Osipenko, Leeza Potey, Philippe Perez, Bernardo Kupryjanczuk, Alexandra Angelov, Filip Schuster, Alexandra Mossialos, Elias |
author_sort | Osipenko, Leeza |
collection | PubMed |
description | IMPORTANCE: Both the commercial sector and academia play a vital role in medicine development. Ongoing debates exist on their contribution and the value of medicinal products entering the market. OBJECTIVE: To identify the provenance and clinical benefit of medicines that entered the French market between 2008 and 2018. DESIGN AND SETTING: In this cross-sectional study, the provenance of each medicine in the French market was established via a review of multiple sources documenting at least 2 matching findings per product. The clinical benefit was assigned using the matched scale developed from the Prescrire and Haute Autorité de Santé (HAS) gradings. The χ(2) test was used to analyze the proportions and frequencies of medicines graded by Prescrire and HAS by origin, therapeutic category, and clinical benefit. MAIN OUTCOMES AND MEASURES: The origins and therapeutic categories of medicines. Clinical benefit based on Prescrire and HAS grading. Concordance of Prescrire and HAS grading. RESULTS: Of the 632 medicines that entered the French market between 2008 and 2018, 464 originated (73%) in the commercial sector, and 168 originated (27%) in the academic setting or in collaboration with commercial enterprises. Prescrire graded psychotropic agents (13/14 [93%]), whereas HAS graded respiratory agents (24/25 [96%]) as the highest percentage of medicines that provided no added benefit. Prescrire graded 360 medicines (77.6%) that originated in the industry and 108 medicines (64.3%) that originated in the academic setting (P = .001) to have no added clinical benefit. HAS assigned such grading to 331 ([71.3%] industry) vs 104 ([61.9%] academia) (P = .02). Based on the Prescrire grading, academia invented more medicines delivering some added benefit 57 (33.9%) vs 98 (21.1%) invented by industry (P = .001). HAS grading on some added benefit 51 ([30.4%] academia) vs 121 ([26.1%] industry) did not reach statistical significance (P = .29). However, HAS grading on substantial added clinical benefit reached statistical significance in favor of academia (13 [7.7%] vs 12 [2.6%] in the industry; P = .003), whereas Prescrire grading did not (1.8% academia vs 1.3% industry; P = .64). CONCLUSIONS AND RELEVANCE: More than 70% of medicines that entered the French market during the 10-year period originated in the commercial sector. Although most medicines were not graded as providing clinical benefit, medicines originating in the academic setting were more likely to be graded as conferring clinical benefit than those originating in the commercial setting. |
format | Online Article Text |
id | pubmed-10660249 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | American Medical Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-106602492023-11-20 Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018 Osipenko, Leeza Potey, Philippe Perez, Bernardo Kupryjanczuk, Alexandra Angelov, Filip Schuster, Alexandra Mossialos, Elias JAMA Intern Med Original Investigation IMPORTANCE: Both the commercial sector and academia play a vital role in medicine development. Ongoing debates exist on their contribution and the value of medicinal products entering the market. OBJECTIVE: To identify the provenance and clinical benefit of medicines that entered the French market between 2008 and 2018. DESIGN AND SETTING: In this cross-sectional study, the provenance of each medicine in the French market was established via a review of multiple sources documenting at least 2 matching findings per product. The clinical benefit was assigned using the matched scale developed from the Prescrire and Haute Autorité de Santé (HAS) gradings. The χ(2) test was used to analyze the proportions and frequencies of medicines graded by Prescrire and HAS by origin, therapeutic category, and clinical benefit. MAIN OUTCOMES AND MEASURES: The origins and therapeutic categories of medicines. Clinical benefit based on Prescrire and HAS grading. Concordance of Prescrire and HAS grading. RESULTS: Of the 632 medicines that entered the French market between 2008 and 2018, 464 originated (73%) in the commercial sector, and 168 originated (27%) in the academic setting or in collaboration with commercial enterprises. Prescrire graded psychotropic agents (13/14 [93%]), whereas HAS graded respiratory agents (24/25 [96%]) as the highest percentage of medicines that provided no added benefit. Prescrire graded 360 medicines (77.6%) that originated in the industry and 108 medicines (64.3%) that originated in the academic setting (P = .001) to have no added clinical benefit. HAS assigned such grading to 331 ([71.3%] industry) vs 104 ([61.9%] academia) (P = .02). Based on the Prescrire grading, academia invented more medicines delivering some added benefit 57 (33.9%) vs 98 (21.1%) invented by industry (P = .001). HAS grading on some added benefit 51 ([30.4%] academia) vs 121 ([26.1%] industry) did not reach statistical significance (P = .29). However, HAS grading on substantial added clinical benefit reached statistical significance in favor of academia (13 [7.7%] vs 12 [2.6%] in the industry; P = .003), whereas Prescrire grading did not (1.8% academia vs 1.3% industry; P = .64). CONCLUSIONS AND RELEVANCE: More than 70% of medicines that entered the French market during the 10-year period originated in the commercial sector. Although most medicines were not graded as providing clinical benefit, medicines originating in the academic setting were more likely to be graded as conferring clinical benefit than those originating in the commercial setting. American Medical Association 2023-11-20 /pmc/articles/PMC10660249/ /pubmed/37983026 http://dx.doi.org/10.1001/jamainternmed.2023.6249 Text en Copyright 2023 Osipenko L et al. JAMA Internal Medicine. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License. |
spellingShingle | Original Investigation Osipenko, Leeza Potey, Philippe Perez, Bernardo Kupryjanczuk, Alexandra Angelov, Filip Schuster, Alexandra Mossialos, Elias Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018 |
title | Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018 |
title_full | Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018 |
title_fullStr | Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018 |
title_full_unstemmed | Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018 |
title_short | Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018 |
title_sort | provenance and clinical benefit of medicines introduced to the french market, 2008 to 2018 |
topic | Original Investigation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10660249/ https://www.ncbi.nlm.nih.gov/pubmed/37983026 http://dx.doi.org/10.1001/jamainternmed.2023.6249 |
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