Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005-2017.
clinical trial
drug utilization
interrupted time series analysis
research scandal
Journal
Journal of epidemiology
ISSN: 1349-9092
Titre abrégé: J Epidemiol
Pays: Japan
ID NLM: 9607688
Informations de publication
Date de publication:
05 Jul 2021
05 Jul 2021
Historique:
pubmed:
7
7
2020
medline:
19
8
2021
entrez:
7
7
2020
Statut:
ppublish
Résumé
Breaches of ethics undermine the practice of medicine. In Japan, two major scandals involving clinical research and drug marketing occurred after the publication of clinical trials. To study the effects of those scandals, we evaluated changes in the use of first-generation angiotensin II receptor blockers (ARBs) after publication of relevant clinical trials and also after the subsequent scandals. We conducted a quasi-experimental design of an interrupted time series analysis (ITSA) on nationwide monthly drug-market data covering 12 years (2005 to 2017) in Japan. The main outcome was the use of first-generation ARBs (valsartan, candesartan, and losartan). The two exposures were the publication of ARB-related clinical-trial results (October 2006) and subsequent ARB-related scandals involving research and marketing (February 2013). A generalized estimating equation model was fitted for ITSA with a log link, Poisson distribution, robust variance estimators, and seasonality adjustment. The publication of clinical trials was associated with 12% increase in the use of first-generation ARBs in Japan, and the subsequent ARB-related scandals was associated with 19% decrease. The decrease in the use of first-generation ARBs after the scandals was greater than the increase in their use after the publication of clinical-trial results. The net effect of the two exposures was a 9% decrease in the use of first-generation ARBs. The scandals were associated with decrease in the use of first-generation ARBs, and that decrease was greater than the increase associated with the publication of "successful" clinical trials, making the net effect not zero but negative.
Sections du résumé
BACKGROUND
BACKGROUND
Breaches of ethics undermine the practice of medicine. In Japan, two major scandals involving clinical research and drug marketing occurred after the publication of clinical trials. To study the effects of those scandals, we evaluated changes in the use of first-generation angiotensin II receptor blockers (ARBs) after publication of relevant clinical trials and also after the subsequent scandals.
METHODS
METHODS
We conducted a quasi-experimental design of an interrupted time series analysis (ITSA) on nationwide monthly drug-market data covering 12 years (2005 to 2017) in Japan. The main outcome was the use of first-generation ARBs (valsartan, candesartan, and losartan). The two exposures were the publication of ARB-related clinical-trial results (October 2006) and subsequent ARB-related scandals involving research and marketing (February 2013). A generalized estimating equation model was fitted for ITSA with a log link, Poisson distribution, robust variance estimators, and seasonality adjustment.
RESULTS
RESULTS
The publication of clinical trials was associated with 12% increase in the use of first-generation ARBs in Japan, and the subsequent ARB-related scandals was associated with 19% decrease. The decrease in the use of first-generation ARBs after the scandals was greater than the increase in their use after the publication of clinical-trial results. The net effect of the two exposures was a 9% decrease in the use of first-generation ARBs.
CONCLUSIONS
CONCLUSIONS
The scandals were associated with decrease in the use of first-generation ARBs, and that decrease was greater than the increase associated with the publication of "successful" clinical trials, making the net effect not zero but negative.
Identifiants
pubmed: 32624520
doi: 10.2188/jea.JE20200181
pmc: PMC8187611
doi:
Substances chimiques
Angiotensin Receptor Antagonists
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
410-416Références
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