Fifty slides cleared materials review. One slide gets added. That slide shows data from an indication where superiority was never established. "It's a bit off-topic, but it's only one slide" — that self-explanation is local rationalization. By isolating each decision and treating it as harmless in isolation, the full presentation ends up conveying a misleading impression. No lie was told. That is exactly why the person making the materials rarely notices.
So What / So Why — The Core of This Issue
The "so what" (what actually happens) is that primary endpoints disappear and only secondary endpoints remain. One slide positions the secondary endpoint graph large and prominent; the primary endpoint is shrunk and pushed to a corner. Or the primary endpoint slide is never prepared in the first place. During the verbal explanation, only the statistically significant secondary endpoint gets mentioned — the primary endpoint simply goes unaddressed. Each decision looks gray in isolation. As a pattern, the selection is unmistakable.
The "so why" (why it is serious) is that the starting point of information physicians receive becomes contaminated. When deciding on a prescription, a physician begins with the graphs the MR showed and what was said during the visit. If the primary endpoint has been made to disappear from that starting point, even an excellent physician may end up prescribing a drug whose pivotal trial showed no significant difference as though it were effective. Without reading the regulatory review report independently, there is no way to catch this erasure.
What makes local rationalization particularly difficult to address is that the person making the materials does not feel they told a lie. The added slide's data comes from a real clinical trial. The primary endpoint that went unshown does exist. The problem lies in the choice of what to show and what not to show. That choice has to accumulate before the distortion becomes visible at the level of the whole — but at the moment of each individual decision, it feels "fine as a part."
The Architecture of Pressure — Who, Which Deadline, Which Numbers
Quarterly quotas and market share targets are the most direct source of pressure. Symposium bookings arrive the week after a new indication is approved. MRs are told by their managers that "the next six months are decisive" and see their district's share attainment rate published every month. Miss by a few points and next quarter's incentive gets cut. That numerical pressure connects directly to the motivation to show superiority for the new indication.
Division of labor diffuses accountability. Medical Affairs builds the slide deck, the brand team decides what to emphasize, the training department teaches it during MR onboarding, and the MR actually uses it in the field — four stages of division, and no single person is watching what the physician will ultimately take away from all of it. Each person focuses on completing their own step. Medical Affairs says "we clearly labeled it as a secondary endpoint." The brand team says "the relative size of the graphs was a design choice." The MR says "I just used the slides I was given."
Managerial approval dissolves self-censorship. The slide deck was reviewed and approved by a supervisor. A supervisor may even sit in on the symposium. Once the feeling takes hold that "this is what the organization has sanctioned," the weight of individual judgment thins out. Japan's FY2025 monitoring report documents a case in which a manager was present at a symposium where a competitor's product was disparaged — the manager's presence not only failed to deter the violation, it functioned as social proof that the setting was legitimate.
Deadlines narrow cognitive bandwidth. When the window from indication approval to materials review deadline is two weeks, and MR training is a week after that, the central question shifts from "how should this data be communicated" to "how do we fit this data onto slides." "Just add one slide and it comes through" is the line of thinking least likely to be questioned when time is short.
Reconstructing the Inner State — Belief, Feeling, Deep Psychology
The belief (what the person held to be correct) was probably: "This new indication gives patients an additional option. Getting physicians to know about it is my job." Approval of a new indication looks like evidence that the regulatory authority recognized at least some degree of efficacy and safety for that indication. The starting point of "I want to deliver something useful" is, at this moment, sincere.
The feeling (the emotional state in the moment) was most likely a mixture of urgency and conviction: "There are slides that cleared materials review. My manager signed off. If I add just one slide, I can convey that we have an edge in the new indication too. It's a little off the symposium's theme, but now — right after approval — is the biggest window we'll have." The fact that the added slide's data is from the original indication, and that the new indication only showed non-inferiority, sits somewhere in the back of the mind. But in the flow of the conversation in front of them, the decision to "show it" takes precedence over surfacing that fact.
At the level of deep psychology, four drivers are layered together.
First, ② local rationalization ("just one slide"). This is the crux. Treating the addition as a "part" makes the responsibility for the overall impression disappear from conscious awareness. As the monitoring report notes, "introducing a slide with content somewhat outside the symposium's theme within the presentation created a risk of misunderstanding" — from the recipient's perspective, the slide functions as one piece inside a total context, but from the presenter's perspective it is mentally separated as "merely an addition."
Second, ③ the sin of omission (not saying it; not saying it unless asked). The person who never prepared a primary endpoint slide will explain that they "didn't include it because it didn't fit the theme" rather than saying they "didn't show it." Passive non-disclosure — "I didn't say it because no one asked" — carries far less psychological weight than active falsehood. That is why guilt rarely surfaces.
Third, ④ externalizing responsibility. When a physician points out the absence of statistical significance, the response is to cite an expert: "Professor [X] has stated that meaningful efficacy can be expected, so there is no problem." By transferring the responsibility for the choice to a KOL, the MR retreats to the position of "a messenger who conveyed information." The MR who showed only the Japanese subgroup analysis and explained it as being "because physicians ask for Japanese data" (FY2019 case ②-13) follows the same structure — the recipient's supposed demand is used to justify the presenter's own selection.
Underlying all of this is ① motivated reasoning (conclusion first, data second). The conclusion "this drug is effective" is fixed in advance, then supporting data is sought. Even if the primary endpoint shows no significant difference, a favorable number can be found somewhere — a secondary endpoint, the Japanese subgroup, a long-term adherence subset. Foregrounding that data does not feel like "telling a lie"; it feels like "choosing the good information."
The Real Incidents Behind This Analysis
Case 1 — Metabolic Regulator, "Just One Slide" (FY2024/FY2025)
Recorded as the same incident in two consecutive MHLW monitoring reports (FY2024 and FY2025). Following approval of a new indication for a metabolic regulating agent, a symposium was held at a monitored medical institution. The responsible MR was explaining the drug and tumor lysis syndrome when the report records the following:
"Although it was just one slide, the MR showed data from a comparative trial against an existing drug and explained that 'the drug in question has superiority over the existing drug.' However, this data was from the original indication, not the newly approved indication, and for the new indication there was only non-inferiority data against the existing drug. Introducing a slide with content somewhat outside the symposium's theme within the presentation created a risk of misunderstanding."
This is one of the few documented cases where the phrase "just one slide" appears verbatim in a monitoring report. Despite having only non-inferiority data for the new indication, superiority data from the original indication was inserted as "one slide" — the problem with this act is that the person responsible used the characteristic language of local rationalization. "Just one slide" is a rhetorical minimizer. See also the analysis edition on cherry-picking (Analysis Vol.02).
Case 2 — Joint Function Improvement Drug, Secondary Endpoint Enlarged (FY2022)
FY2022 report, case ②-2. An online product information session for a joint function improvement drug drew scrutiny for both the slides shown and the verbal explanation provided by the company representative. The report's findings are specific:
"In the slide used during the explanation, within a single slide the secondary endpoint graph was printed larger than the primary endpoint graph." "During the explanation, without mentioning that it was a secondary endpoint result, the representative explained efficacy using the secondary endpoint."
Manipulating the relative size of graphs within a single slide is a technique that can pass through materials review undetected. The fact that both are "present on the slide" is technically true, but the viewer's eye is drawn to the larger graph. "Without mentioning that it was a secondary endpoint result" is a textbook instance of ③ the sin of omission. Further detail is included in the cherry-picking analysis edition (Analysis Vol.02).
Case 3 — Primary Endpoint Never Prepared; KOL Deflection (FY2025)
The FY2025 monitoring report records two consecutive cases in which local rationalization and externalized responsibility appeared together.
In the first, described as emphasizing only efficacy: "In an online meeting with MRs from Company K, no slide materials were prepared for the primary endpoint at all, and the explanation covered only the secondary endpoints for which a statistically significant difference had been observed." The fact that materials were never prepared indicates intentional selection. This was likely not an oversight — it was probably a judgment that "for this topic, the secondary endpoint numbers are what's appropriate."
The report then documents a Company L case in which ④ externalized responsibility emerges openly. "A Company L representative, presenting a subgroup analysis of Japanese patients, explained that 'a clear difference is also seen in Japanese patients' despite the result being non-significant. When a healthcare professional pointed out the absence of statistical significance, the representative responded: 'Professor [X] has said that meaningful efficacy can be expected, so there is no problem' — using an expert's words to explain efficacy." The moment a challenge is raised, personal judgment is swapped for a KOL's authority in real time. This is ② local rationalization pivoting into ④ externalized responsibility, live.
Inside the Creator ── The Psychology Behind Deviations ── Map of 10 chapters
- Part 1: A Map of Pressure — How Good Intentions Bend
- Part 2: The Creed Trap — "I Want to Help Patients" as the Entry Point
- Part 3: Conclusion First, Data Second — Motivated Reasoning
- Part 4 (this chapter): "Just One Slide" — Local Rationalization
- Part 5: The Choice Not to Speak — The Sin of Omission
- Part 6: Structures That Let You Blame Someone Else — Externalizing Responsibility
- Part 7: The Gravity of Numbers — Quotas and the Psychology of Incentives
- Part 8: The Anxiety of Competition — How Panic Becomes Disparagement
- Part 9: The Silent Organization — Conformity Pressure, Hollow Audits, and the Self That Won't Disclose
- Part 10: Redesigning Pressure — Individual Psychology and Organizational Systems
- "Just one slide" is a rhetorical minimizer. As long as the added slide is treated as a "part," responsibility for the overall impression disappears from the presenter's conscious awareness. The FY2024/FY2025 report case — "although it was just one slide, the drug has superiority over the existing drug" — is one of the few documented records of local rationalization appearing as explicit language.
- Failing to prepare a primary endpoint slide is an active choice. The MR who never made a slide for the non-significant primary endpoint and brought only the secondary endpoint graph (FY2025, Company K) committed what looks like an omission but is in fact information design. The physician has no way of knowing what was never shown.
- Responsibility gets externalized the moment a challenge lands. Responding to a physician's observation that the result is non-significant with "Professor [X] says meaningful efficacy can be expected" (FY2025, Company L) is an extension of local rationalization — personal judgment is traded for a KOL's authority on the spot. Once responsibility for the choice has left the presenter, the opportunity to correct course leaves with it.
- Ministry of Health, Labour and Welfare, "Report on the Monitoring Project for Drug Sales Promotion Activities," FY2022 (project no.: reiwa4)
- Ministry of Health, Labour and Welfare, "Report on the Monitoring Project for Drug Sales Promotion Activities," FY2024 (project no.: 001272195)
- Ministry of Health, Labour and Welfare, "Report on the Monitoring Project for Drug Sales Promotion Activities," FY2025 (project no.: 001520054)
- Ministry of Health, Labour and Welfare, "Guidelines on Sales Promotion Activities for Prescription Drugs" (September 25, 2019), Section 2-2(2)① and Section 2-3(2)③
- Japan Pharmaceutical Manufacturers Association, "Guidelines for Preparation of Product Information Summaries for Prescription Drugs" (mandatory disclosure of primary and secondary endpoints)
- Japan Pharmaceutical Manufacturers Association, "JPMA Code of Practice"
- Kunda, Z. (1990). The case for motivated reasoning. Psychological Bulletin, 108(3), 480–498.
- Bandura, A. (1999). Moral disengagement in the perpetration of inhumanities. Personality and Social Psychology Review, 3(3), 193–209. (moral disengagement and diffusion of responsibility)