A single line about a returned material — "I can't accept the way it was said" — set me thinking. Why does a correct point draw someone's resistance? Instead of pushing through with "it's context, so please read between the lines," what does it take to hand that point over as a reason — to make plain, at the level of principle, why the point is right? Borrowing help from psychology and legal philosophy, I trace it one step at a time from the review desk.

01It started with "I can't accept the way it was said"

One afternoon, a person from the business division stopped me in the corridor. In their hand was a printout of a material (= a leaflet or booklet explaining a drug, handed to doctors and patients) that I had sent back. Their opening words were these: "I understand the review point. I've no complaint about the substance. But that person's way of saying it — I just can't accept it."

I took it back to my desk and read the point again. There was a sentence that made the indication (= the range in which a drug is recognized as effective) look one step wider than the approved line. My request was to delete it. Measured against advertising rules (= the laws and rules setting out what may be written in drug advertising), the point was right. Looking at it myself, the fix was needed.

Right — and yet the other person was upset. The first thing I doubted here was neither the tone nor the character of the person who raised the point. Perhaps the problem was not a shortage of correctness, but that the correctness had not reached the other person in the shape of a reason — an account of why it was right. The same "please delete this" changes the listener's face completely, depending on whether it sounds like "delete it because the rule says so" or arrives as "by this line of reasoning, this one sentence crosses the boundary."

What I want to look at in this piece is not a knack for wording, nor the chemistry between two people. It is the root that sits further upstream. Why, in principle, is that point right? If that stays unclear and I push through with "it's context, so please sense it," then the more correct the point is, the more it invites pushback.

Let me plant one seed first. When a person is left in a state where things don't add up inside them, they feel uncomfortable. Psychology calls this cognitive dissonance (= that itchy, unsettled feeling when your own beliefs, or a belief and an action, don't match). The stiffness in that voice that stopped me in the corridor is tied to this dissonance. In the next section, I open it up.

02Why the most correct points get refused

Right after I send word that a material is being returned, there is a moment when the voice on the phone quietly hardens. I have felt it many times. "But we made this carefully." In that one line, the true shape of the refusal shows.

Inside that person's head, two things are colliding. One is the self-assessment: I made this carefully and in good faith. The other is the fact: this material needs a fix. The two won't sit together well at the same time. If a carefully made thing needs a fix, then somewhere the care fell short. The unease born here is the cognitive dissonance I set down a moment ago. This idea was put together more than half a century ago by the psychologist Leon Festinger (= the person who studied dissonance).

The question is how to make that unease go away. There are two roads. One is to accept the fact and lower the self-assessment — "yes, a fix is needed." The other is to push the fact back — "this point is off." People drift easily toward the second, which takes less effort. Guarding the image of "I did this properly" is the easier path. So the most correct points don't arrive straight.

There is another matter — speed. The psychologist Daniel Kahneman (= the person who studied the habits of human judgment) says our heads have two ways of working. One is fast thinking, which moves on the spot. The other is slow thinking, which settles in to reason.

Fast thinking

Close to reflex. The flash of irritation the moment a return is seen isn't a reasoned conclusion — it comes from here. A defensive reaction.

Slow thinking

It takes effort. Tracing why this one sentence crosses the line is this side's work. It doesn't start up right away.

The voice hardened on the phone because fast thinking worked first — before slow thinking had begun to follow the grounds of my point. So that stiffness is not the person's character, nor hostility toward me. It is the workings of how the human head is built, showing through.

I take this view. Blame the stiff voice on character, and I brace too, and it turns into a plain quarrel. Take it back in as a mechanism, and what I do changes. I wait for the fast reaction to pass, and, so that slow thinking can start moving, I hand over the grounds of the point — not as an order to delete, but in the shape of a line of reasoning that can be traced. I don't thrust correctness at them as bare correctness. I unpick it into grounds and hand it over. From here on, section by section, I look at how that handing-over is done.

03"Because it's context" is not a reason

One morning, a review record a junior colleague had filed said this: "Inappropriate in context." That was all. I put red ink beside that one line. It isn't wrong. The point itself is right. But this won't move the person who made the material.

Put yourself in their place. Told "inappropriate in context," what should you fix? Where is the trouble? The person who wrote it can't see. They can't argue back, and they can't be convinced. All that's left is to reluctantly delete it because "the review people say so." That isn't persuasion — it's just pushing through on the strength of who holds the power.

I tell the junior colleague to write three things separately. First, what do you want to claim? Here, "this one sentence should be deleted." Second, what are the grounds? "This expression points to something outside the approved indication (= the range the country has recognized this drug may be used for)." Third, why do those grounds lead to the claim? "Because an expression pointing outside the indication breaks the very role a material carries — to convey correct information." Only when these three are in place does a point stop being a private opinion and become a coherent argument (= a way of carrying a case that convinces the other person with reasons).

What I'm building on here is the way of assembling an argument shown by the philosopher Toulmin. He held that at the core of a convincing case there are three parts. There is a claim (the conclusion you want to state), there is data supporting it (= visible grounds), and there is one more — the warrant (= the thread connecting why those grounds support the conclusion). This third one is the easiest to drop.

PartIn this caseWhat happens if it's missing
ClaimThis one sentence should be deletedWhat you want done doesn't come across
Data (grounds)It points outside the approved indicationIt looks like mere like or dislike
WarrantBecause pointing outside the indication breaks the material's role"Why is it bad" hangs in the air

Stop at "because it's context," and this warrant part is hidden whole. So to the other person it looks like the reviewer's whim (= that day's mood or a person's discretion). They suspect that if someone else looked at the same material on another day, it might pass. Only when the grounds are put into words does the point reach a conclusion anyone would reach the same way — a public thing.

04The "trust" at the root of the grounds

A newcomer once asked me straight: "How far is it written in the rules?" Which page of the rulebook do you open to find the answer to this judgment? I answered honestly: it isn't written out in full.

Rules matter. But for each and every material you meet in the field, there isn't a correct answer prepared in advance. Why can't it be written out in full? Because a medicine is, in the first place, an odd kind of thing.

Consider it. With a medicine, you can't tell good from bad by looking. Even with the same white tablet, one that works and one that doesn't can't be told apart just by holding it. On top of that, it always carries both an effect and a side effect (= an unwanted, harmful action on the body). And the same drug comes out differently in different people. Some it works well on; in others the side effects run strong. A thing like this fills its role as a medicine only when correct information comes with it. If the information is missing or bent, the same tablet becomes harm.

So rules are not a restraint forced on you from above — that's how I explain it to the newcomer. Rules are the shape society hopes a pharmaceutical company will take, copied into words. The rules a pharmaceutical company sets for itself (= the industry's own voluntary agreements) and the law both have their root in the same place. As long as you handle so unusual a thing as a medicine, you carry a responsibility to put it out into the world with correct information alongside. Understanding what the rules are for, and then taking on that responsibility as your own — that, I think, is the true shape of a rule.

You can't tell by looking

A drug's good or bad can't be judged even in the hand. So correct information stands in for the contents.

Effect and side effect are a set

There is no drug with only good actions. Only when both are told correctly can it be used safely.

It comes out differently in different people

It doesn't work the same on everyone. Information supports the judgment of the person who uses it.

And at the base of this responsibility sits an unseen trust. Neither doctors nor patients doubt each drug one by one. On the premise that good drugs are being used correctly, they see the doctor and take what is prescribed. If this premise collapses, medicine itself doesn't hold together. You could call it a thread of trust (= a relationship of people expecting, and being expected of, one another). I put red ink on a material not to feel clever about catching a small rule breach. It is to guard this quiet trust. Follow the grounds of a point far enough, and in the end you always arrive here.

05The purpose fills the edge that isn't written

On one sentence of a material, I stuck a note. It was worded to make the effect look a little larger than the approved range. The person who made it said, "That expression isn't on the list of prohibited items." I take those words in for a moment. True, that's so. That very turn of phrase isn't written in any rule.

But I did not pull back on the strength of its not being written. Rules can't run ahead and write out everything that might happen. Words always leave an edge where judgment is needed. The edge is the part off from the center, where meaning is unclear. In a scene with a clear center, anyone reading reaches the same answer. But out near the edge, no answer comes from looking at the words alone.

The legal philosopher Hart called this the open texture of rules (= the idea that the words of a rule have both a center whose meaning is settled in advance and an edge left open to judgment). Imagine a rule: "No vehicles in the park." A car is out of the question, of course. But a child's tricycle? An ambulance? A real tank set up as a war memorial? The words of the rule don't answer any of these edges on their own.

What fills the edge is the purpose — what the rule exists for. Hart's answer is there too. If the purpose of the park rule is "to keep a quiet, safe place of rest," then how the tricycle and the tank are handled parts from there. Purpose fills the edge that isn't written.

What I lean on in my work has the same shape. The code of the pharmaceutical manufacturers' association (= the promises of conduct pharmaceutical companies set for themselves) places its standard of judgment on whether an action follows the spirit of the code, regardless of whether there is a specific written provision. It isn't a matter of counting off individual banned words one by one. What is the rule for in the first place? To guard patients and medicine from information that isn't correct. Go back to that — that's the stance. Fill the edge with conscience — that's how I take it.

Where the words areWhat settles the answerExample in material review
Center (meaning is clear)Settled by the words themselvesWriting an off-label indication as if it plainly works
Edge (open to judgment)Filled by the rule's purpose and spiritUsing no banned words, yet making only the impression look larger

So to the counter "it's not written, so it's free," I answer this: it's true it isn't written. But what isn't written is not the same as what is allowed. That, we decide by what this rule is for.

06Shared understanding is stacked one at a time

When one explanation didn't get through, I used to pile on words. I'd say the same thing three times from different angles. My voice rose a little. I have almost no memory of that working. The more the explanation grew, the stiffer the other person's face became.

Now I do the reverse. Before adding words, I stop once. Then I check just one thing — how the other person took my point. "How did that land with you?" If the answer that comes back is off from what I meant, I go back to just before the gap. Understanding doesn't grow by the volume of words. It is born only when a shared premise is stacked between two people, one layer at a time.

The psychologist Herbert Clark called this stacking work grounding (= the ongoing effort by speaker and listener to keep checking with each other what they've managed to share so far). A conversation isn't done when one person throws correct information. The receiving side answers "up to here I've understood," and the next thing is placed on that confirmation. The very work of building a shared base is understanding.

There is one more awkward trap here. The social psychologist Lee Ross pointed out that people fall into naive realism (= the plain belief that you see things as they are, without any tinted glasses) about their own view. I feel my own judgment is objective. Facing the same material, the applicant also feels their view is objective. Both think themselves "as-is," and so each finds the other biased.

Put my own view on the desk first

Admit that my judgment is also one way of seeing. If I don't drop the stance that I'm right, the other braces.

Look for common ground first

What we want to protect is the same — keeping the information that reaches patients correct. Start the talk from here.

Check the gap one step at a time

Hear how the other took it, and go back to just before the gap. Understanding can be rebuilt.

Once I could notice this trap, I became able to set my own correctness aside for a moment. Before competing over who is right, I look for a base where the two of us can see the same thing. I stand on the same side and peer at the same material together. It is from there on that a point reaches the other person.

07Acceptance comes from the process, not the conclusion

The same return, yet received in completely different ways. At the material-review desk (= the work of checking whether a drug's advertising or explanatory material strays from the approved content), I have seen that fork many times. Sometimes it comes back quietly: "Understood, I'll fix it." Another time, with the same point, the other person's manner hardens. The weight of the point doesn't change. What changes is the process leading to the conclusion.

The psychologist Tom Tyler says whether a person accepts a judgment moves less on whether the outcome favors them and more on how that outcome was decided. He calls this procedural justice (= whether the procedure reaching the conclusion was fair, rather than the conclusion itself). There are trials you lose yet accept, and trials you win yet leave with a bad taste. Much of the difference lies in the process — that's the idea.

Tyler sorted the pillars supporting that process into roughly four. I check each returned sheet against these four.

Were you heard?

Could you state your case first? Was there room to argue back from the start (= a chance to speak)?

Were you treated with respect?

Were you dealt with as one person doing the work? Not talked down to from above?

Was it neutral?

The same standard no matter who the other is? Not swaying by reviewer or by mood?

Could it be trusted?

Did it feel free of hidden motive? Did it come across that the point wasn't for self-protection or appearances?

When these four are in place, people accept even an unfavorable conclusion more easily. Conversely, even a correct point, if the process is careless, turns resistance not at the content but at the manner. I don't settle for "it's off from the context"; I lay out, one step at a time, why it can be read that way — for this reason. The word "context" sounds to the other person like "that's your feeling." I want to hand it over not as a feeling but as grounds that can be traced.

What is at work here is the fast and slow thinking touched on earlier. The moment a return is received, the fast side moves first. Irritation. An urge to defend. Throw a conclusion straight at that, and it ends with a fast reaction colliding with a fast reaction.

So I use the four pillars as a bridge from the fast reaction to slow deliberation. First hear the view, with respect, on an unswaying standard, in a form with nothing hidden. Arranging the process that way makes it easier, inside the other person's head, for the switch from anger to "true, this one sentence does go too far" to happen. Acceptance is not born from stating a correct conclusion forcefully. It is born from walking a correct process with care.

And I keep this in mind. The real counterpart is not the person across the desk. It is the very thing of a wrongly guided material reaching the hands of patients and medical staff. So my work is not to argue the other person down. It is to arrange the process so that correctness, staying correctness, arrives straight. That is less a matter of technique than of conscience. Treating the other as one person, while delivering the facts to where they should go — I want to hold on to both at once, giving up neither.

Key Points ── 3 to take away
  1. A correct point gets refused not because of the other person's character. The dissonance between self-image and fact, and the fast thinking that fires on the spot, produce the first pushback. Take it back in as a mechanism rather than blaming character, and how you act changes.
  2. "Because it's context" is not a reason. Split it into claim, grounds, and warrant, and hand it over in the shape of a reason for why it's right. The edge the rule doesn't write is filled by the purpose — what the rule is for.
  3. Acceptance comes not from a forceful conclusion but from a fair process. Hear the view, show respect, hold the standard steady, place it with no hidden motive. The one you protect is not the person across the desk but the very information reaching patients and medical staff.
Sources & references
  1. Stephen Toulmin. The Uses of Argument. Cambridge University Press, 2003 (revised edition). (The frame of argument: a claim holds only when supported by data and a warrant.)
  2. Tom R. Tyler. Why People Obey the Law. Princeton University Press, 2006. (People accept a judgment more by the fairness of the process than by whether the conclusion favors them.)
  3. Leon Festinger. A Theory of Cognitive Dissonance. Stanford University Press, 1957. (When self-image collides with fact, people reject the side of the fact.)
  4. Lee Ross, Richard E. Nisbett. The Person and the Situation. McGraw-Hill, 1991. (Naive realism: feeling one's own view "objective" and the other's "biased.")
  5. Herbert H. Clark. Using Language. Cambridge University Press, 1996. (Understanding is born from building common ground by stacking shared premises one at a time.)
  6. H.L.A. Hart. The Concept of Law. Oxford University Press, 1994 (2nd edition). (Rules always have an edge that can't be written out in full, and purpose fills that edge.)
  7. Daniel Kahneman. Thinking, Fast and Slow. Farrar, Straus and Giroux, 2011. (The two layers of fast-thinking reaction and slow-thinking deliberation.)
  8. Japan Pharmaceutical Manufacturers Association. JPMA Code of Practice. Japan Pharmaceutical Manufacturers Association, 2019 revision. (A code of conduct: judge by the spirit of the code, whether or not there is a written provision.)
  9. Ryuichi Nakayama. A History of Legal Thought. Yuhikaku, 2018. (A Japanese-language introduction surveying Hart and other modern legal theory.)