key: cord-0767259-zvaljkh7
authors: Hashimoto, Takanao; Murayama, Anju; Mamada, Hanano; Saito, Hiroaki; Tanimoto, Tetsuya; Ozaki, Akihiko
title: Evaluation of Financial Conflicts of Interest and Drug Statements in the Coronavirus Disease 2019 Clinical Practice Guideline in Japan
date: 2021-11-24
journal: Clin Microbiol Infect
DOI: 10.1016/j.cmi.2021.11.019
sha: ecbd8cf76d30a32257e2c301a51deb91863c885d
doc_id: 767259
cord_uid: zvaljkh7

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Overall, our study found significant FCOI between the government COVID-19 CPG authors 11 and pharmaceutical companies. We further note poor management of these FCOI by the 12 Ministry. The $39,490 average personal payments and high prevalence of CPG authors with 13 FCOI were consistent with our previous studies [3, 4] . Although government-sponsored CPGs 14 are reportedly more transparent and associated with less FCOI than those not sponsored by the 15 government[1], we did not observe this with the Japanese COVID-19 CPG. evidence supporting the use of included COVID-19 drugs. For example, the CPG recommended 1 favipiravir without rigorous evidence supporting its efficacy. Indeed, neither the World Health 2 Organization nor the United States National Institute of Health recommended favipiravir. In 3 contrast, tocilizumab was not recommended despite a recent rigorous systematic review 4 confirming efficacy for the treatment of . Interestingly, while both manufacturers 5 of these drugs made payments to COVID-19 CPG authors, the manufacturer of tocilizumab paid 6 more. Therefore, the discrepancies in the recommendations suggest that FCOI do not always 7 result in potentially inappropriate recommendations.

We propose that the Ministry ensures a more transparent and rigorous approach to CPG development. This should include a more balanced author selection process, full COI disclosure, 11 systematic evidence quality assessment, and appropriate recommendations based on established 12 CPG development methodology.

This study was funded in part by the Medical Governance Research Institute. This non-profit 16 enterprise receives donations from pharmaceutical companies, including Ain Pharmacies, other independent non-profit news organization dedicated to investigative journalism. However, none 1 of the entities providing financial support for this study contributed to the design, execution, 2 data analyses, or interpretation of study findings and the drafting of this manuscript. 

All authors had full access to all the data in the study and take responsibility for the data's 11 integrity and the accuracy of the data analysis.

Study concept and design: All authors. 14 15 Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: All authors. We evaluated the personal payments, including speaking, consulting, and writing reimbursements, and scholarship donations from pharmaceutical companies using the payment data from 2017 to 2019, which were disclosed on those companies' websites. Table released in 1959) was previously developed and distributed by MSD K.K. in Japan. However, MSD transferred the manufacturing and marketing approval of dexamethasone to generic companies such as Nichi-Iko Pharmaceutical Co., the largest pharmaceutical companies marketing generic drugs in Japan. Since only generic dexamethasone was available in Japan during the study period we excluded payments from companies marketing dexamethasone from the list of companies manufacturing COVID-19 drugs. Also, Gilead (remdesivir) is not a member of the Japan Pharmaceutical Manufacturers Association, so the payments from this company to healthcare professionals were undisclosed. Results: Positive The median number of organ support-free days was 10 (IQR, −1 to 16) in the tocilizumab group, 11 (IQR, 0 to 16) in the sarilumab group, and 0 (IQR, −1 to 15) in the control group. The median adjusted odds ratios (primary model) were 1.64 (95% CI, 1.25 to 2.14) for tocilizumab and 1.76 (95% CI, 1.17 to 2.91) for sarilumab as compared with control, yielding posterior probabilities of superiority of more than 99.9% and 99.5%, respectively. 

Favipiravir (Fujifilm Toyama Chemical) Drug considered for off-label use for COVID-19

Open-label Study 25 hospitals in Japan Receiving favipiravir from day 1 (N=44) Receiving favipiravir from day 6 (N=45) Median age

Primary endpoint: Proportion of subjects with clearance of SARS-CoV2 in nasopharyngeal swab by Day 6. Duration

Results: Neutral. Achieved clearance of SARS-CoV2 by day 6 in 66.7% (95% CI: 51.4-81.2) of the early treatment group and 56.1% (95% CI: 40.1-73.4) of the delayed treatment group

Sponsor: Japan Agency for Medical Research and Development Company contribution: Fujifilm Toyama Chemical provided favipiravir and members of the Independent Data Monitoring Committee