The first principle Chapter 1 places on the author is that "the content must be accurate, fair, and objective, grounded in scientific evidence." This sounds abstract, but the detailed rules narrow to a single concrete question: how to cite clinical practice guidelines issued by academic societies. Guidelines are the most frequently consulted external authority in clinical practice — which is precisely why the manner of citation is scrutinized.
A quotation can distort the picture without altering a single word. Which sentence to extract, which clause to bold, what color to frame it in — these choices alone can leave readers with a wholly different impression. What the detailed rules prohibit is not only "falsehood." They close off the technique of selecting facts and reshaping perception through emphasis — that is the practical meaning of "accurate, fair, and objective."
01"Quote verbatim" — how selection creates distortion
Guidelines bring together diverse patient populations, multiple treatment options, and varying strengths of recommendation into a single document. Extracting only the sentence most favorable to one's own product creates an impression inconsistent with the balance the guideline itself embodies. The detailed rules block this at the outset.
Detailed rule: completeness of quotation and disclosure of source location
- Body text must be quoted verbatim. Paraphrasing or condensing is commentary, not quotation.
- When citing from sections that include figures or explanatory passages, the quotation must faithfully reflect the intent the guideline was expressing.
- Citing only the passages favorable to one's own company is not permitted. When quoting from multiple locations within a single guideline, each location quoted must be identified.
The requirement to "identify each quoted location when drawing from multiple passages" is not a formatting convention. It lets the reader trace which portions of the full guideline the author has drawn upon — the minimum unit for guaranteeing verifiability through structure. Without source attribution, a reader cannot detect selective extraction without consulting the full guideline text.
Detailed rule: prohibition on highlighting through color or bold type
- Sections related to one's own company's product must not be set apart with color or bold typeface.
This rule reflects the recognition that formatting is itself part of the message. Underlining the sentence "Recommended as first-line therapy (generic name of own product)" causes every other option on the same page to recede visually. The text is unchanged; the layout alone rewrites the order of priority. The Guide identifies this as a textbook example of expression that is "factual yet misleading," and prohibits the technique.
The prohibition on emphasis applies beyond guideline citations. As a general principle of Chapter 1, any visual amplification of an efficacy impression — arrows, color bands, manipulation of type size — is treated the same as an unsubstantiated claim of superiority.
02Off-label content: an asymmetric obligation that reverses between own and other companies
Guidelines sometimes contain statements that do not match the current domestic approval status. The handling of off-label content differs sharply depending on whether it involves the author's own product or a competitor's, and the two cases are treated in opposite directions.
| Situation | Required action |
|---|---|
| Guideline includes off-label content for own company's product | Do not include the guideline |
| Guideline includes off-label content for another company's product | Include without alteration; add a note that the content is off-label; do not promote the off-label use |
| Any reference to other companies or their products | Must not become disparagement; limit to factual statements |
The asymmetry has a clear rationale. Carrying a guideline that includes off-label content for one's own product creates the risk of steering clinicians toward unapproved use. Altering a guideline to remove a competitor's off-label content would, however, misrepresent what the guideline actually says. Both outcomes violate "accurate and fair" — but the remedies run in opposite directions.
Detailed rule: the off-label notation
- When a guideline contains off-label content for another company's product, the guideline text is not altered.
- The off-label section carries a note stating that it is off-label.
- The note is a factual disclosure only — it must not become an expression that promotes the off-label use.
The note is a warning to the reader, not an editorial judgment on the guideline. It adds the fact "this is not currently approved domestically" and stops there. Inducing the interpretation "therefore this drug should not be used" from that notation is equally prohibited.
03Domestic priority and the standard of translation — the choice of version is itself part of the evidence
Similar guidelines often exist in both domestic and overseas versions. For the same therapeutic area, recommended grades and patient-selection criteria can differ between the two. The detailed rules place a guideline here as well.
Detailed rule: domestic priority and accuracy of translation
- When comparable guidelines exist domestically and overseas, the domestic version takes precedence as a rule.
- Translating an overseas guideline into Japanese is permitted — provided the translation is accurate. Loose paraphrase or omission does not qualify as "quotation."
The basis for domestic priority is consistency with Japan's approval status and clinical practice context. An overseas guideline's recommendations reflect the patient population, the comparator landscape, and the regulatory assumptions of a different jurisdiction. Importing them without qualification creates room for readers to infer that "the same recommendation applies in Japan" — an inference the guideline was never intended to support.
The demand for translation accuracy follows the same logic. Guideline recommendation strength often hinges on a single auxiliary verb — "should," "may," "consider." Rendering these imprecisely is, in effect, a manipulation of how strong the underlying evidence appears.
The rule "quote verbatim" cuts to the core issue. Even without altering the original text, the picture a reader receives shifts depending on what is selected, what is bolded, and which version of the guideline is used. The detailed rules on scientific evidence and citation practice in Chapter 1 are a set of individual prohibitions against each of those maneuvers. Disclosing quoted locations, noting off-label content, preferring the domestic version — none of this is a formatting courtesy. Each measure closes off a specific path by which a statement can be factual yet misleading, protecting verifiability through structure.