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Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017

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...

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Autores principales: Fukuma, Shingo, Ikenoue, Tatsuyoshi, Yamada, Yukari, Saito, Yoshiyuki, Green, Joseph, Nakayama, Takeo, Fukuhara, Shunichi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Japan Epidemiological Association 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8187611/
https://www.ncbi.nlm.nih.gov/pubmed/32624520
http://dx.doi.org/10.2188/jea.JE20200181
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author Fukuma, Shingo
Ikenoue, Tatsuyoshi
Yamada, Yukari
Saito, Yoshiyuki
Green, Joseph
Nakayama, Takeo
Fukuhara, Shunichi
author_facet Fukuma, Shingo
Ikenoue, Tatsuyoshi
Yamada, Yukari
Saito, Yoshiyuki
Green, Joseph
Nakayama, Takeo
Fukuhara, Shunichi
author_sort Fukuma, Shingo
collection PubMed
description 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: 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: 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: 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.
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spelling pubmed-81876112021-07-05 Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017 Fukuma, Shingo Ikenoue, Tatsuyoshi Yamada, Yukari Saito, Yoshiyuki Green, Joseph Nakayama, Takeo Fukuhara, Shunichi J Epidemiol Original Article 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: 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: 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: 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. Japan Epidemiological Association 2021-07-05 /pmc/articles/PMC8187611/ /pubmed/32624520 http://dx.doi.org/10.2188/jea.JE20200181 Text en © 2020 Shingo Fukuma et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Original Article
Fukuma, Shingo
Ikenoue, Tatsuyoshi
Yamada, Yukari
Saito, Yoshiyuki
Green, Joseph
Nakayama, Takeo
Fukuhara, Shunichi
Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017
title Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017
title_full Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017
title_fullStr Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017
title_full_unstemmed Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017
title_short Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017
title_sort changes in drug utilization after publication of clinical trials and drug-related scandals in japan: an interrupted time series analysis, 2005–2017
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8187611/
https://www.ncbi.nlm.nih.gov/pubmed/32624520
http://dx.doi.org/10.2188/jea.JE20200181
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