4月にJJNSに投稿したレターだが、以下の理由でリジェクトになった。すでに鈴木先生がレターを8月に出され、それに対する著者の反論とエディターの見解が公開されている。まあ、通常は同様の内容のレターでも複数のレスポンスがあれば載せるのが普通だが（「あの」津田論文に対して大量のレターが出たことは記憶に新しい）、それはいい。
https://onlinelibrary.wiley.com/doi/abs/10.1111/jjns.12258
https://onlinelibrary.wiley.com/doi/abs/10.1111/jjns.12275
https://onlinelibrary.wiley.com/doi/full/10.1111/jjns.12282
せっかくなので、共著者の許可を得て投稿したレターをここに紹介する。ざっくりした内容はすでにメディカルトリビューンで述べた。
06-Sep-2019
Dear Prof. Iwata:
I write you in regards to manuscript # JJNS-2019-0189 entitled "Validity concerns on the analysis of Nagoya City surveillance data on adverse events after human papilloma virus immunization." which you submitted to the Japan Journal of Nursing Science.
Thank you for your letter.
We have already published a similar letter and our policy is to only publish one comment letter.
Validity concerns on the analysis of Nagoya City surveillance data on adverse events after human papilloma virus immunization.
Kentaro Iwata1, Shungo Yamamoto2, and Kenichi Yoshimura3
- Division of Infectious Diseases Therapeutics, Kobe University Graduate School of Medicine, Kobe, Japan
- Department of Infectious Diseases, Kyoto City Hospital, Kyoto, Japan
- Innovative Clinical Research Center (iCREK), Kanazawa University Hospital, Kanazawa, Japan
Correspondence: Kentaro Iwata, Division of Infectious Diseases Therapeutics, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo 650-0017 Japan. E-mail: [email protected]
Keywords HPV vaccine, adverse effects
We read Yaju et al (2019). with interest regarding the safety of human papilloma virus (HPV) vaccines in Nagoya, Japan. However, there are several concerns regarding the validity of the study design and results. First, most outcomes the authors asserted as "more likely" on vaccinated group did not have statistical significance, hence one cannot imply the safety concerns on HPV vaccines based on non-significant odds ratios (ORs). In addition, p-values on the right column on each table are very confusing and misleading since they are merely about interactions on variables, not about the difference in the incidence of given symptoms which should have been shown instead. Second, on many symptoms on adjusted ORs in fact favored the vaccinated group, which the authors considered as selection bias by being healthier vaccinees. However, the bias also could exist on "presence" of adverse effects since vaccinated persons, particularly with excessive media coverage, can over-report the presence of symptoms, particularly among those who were vaccinated recently (such in 15-year old vaccinees in the current study). Third, use of age and "study period", while those two being apparently correlated, makes their clinical interpretation difficult. In addition, use of “study period” as a variable, which is different in definition in each arm could cause erroneous results by logistic regression analysis. Fourth, we are not certain of the appropriateness of the use of covariate interaction between vaccination and study period as an explanatory variable in model 3. Fifth, comparison between 15-16 year-old unvaccinated and all-age vaccinated group is simply wrong since the latter have longer time period to experience any symptoms, which is suggested by figures in the study. Finally, we are aware that M. Yaju, the first author, is a member of YAKUGAI Ombudsperson “Medwatcher Japan” and it is active in making accusation on “drug-induced disasters” (as cited in http://www.yakugai.gr.jp/en/ viewed on April 26, 2019). She must have disclosed this serious conflict of interest upon submitting the manuscript.
Acknowledgements
None.
Disclosure
There is no conflicts of interest.
Author contributions
K.I. initiated the conception of the letter and drafted it. S.Y. and K.Y. fully took part in its content and revised significantly. All authors read and agreed on the final version of the letter.
Reference
Yaju Y, Tsubaki H. Safety concerns with human papilloma virus immunization in Japan: Analysis and evaluation of Nagoya City’s surveillance data for adverse events. Japan Journal of Nursing Science January 2019, DOI:10.1111/jjns.12252
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