A Quiet Word── The Rightness of the Conference, and the Rightness of Advertising

01A Physician in His Second Week

It was the day I first sat across from a doctor who had joined us in April, in the review office. He had spent fifteen years as a cardiologist in clinical practice before moving to the medical affairs division (= the department in a pharmaceutical company responsible for the medical and scientific side). He had come, he said, because his manager had told him to "go talk to the review office first" before submitting an informational material, due for revision next month, to internal review. In his hand was a proposed one-paragraph addition.

"There was a good presentation at a conference last month. A multicenter prospective trial, with solid endpoints (= the measures used to assess efficacy in a trial). There's a paragraph I'd like to add about a new action of this drug."

I read the draft. The data were cited accurately. The sources were clearly stated. As a passage in an academic paper, there would have been nothing to say. But an action beyond the approved scope (= approval being the procedure by which the state reviews quality, efficacy, and safety and authorizes manufacture and sale, including the indications) was written as if it were established fact.

"Is this action listed anywhere in the package insert (= the official document describing a drug)?"

"No. It's not yet approved. That's exactly why it has value as the latest information."

I looked up.

"Written this way, it risks falling under misleading advertising as defined in Article 66 of the Pharmaceuticals and Medical Devices Act (= the law regulating drug quality and advertising)."

The doctor stopped. His eyes dropped to the draft and traveled the same paragraph twice.

02What Was Inside That Freeze

It was not that he knew nothing. In onboarding training, everyone hears about misleading advertising and the handling of unapproved information. But when it came to his own specialty, and a presentation he trusted, it must have been a different matter. The knowledge was there. It simply had not yet connected to the one paragraph in his hand.

Proposing a new theory at a conference is an ordinary part of science. It has its own etiquette. You may speak of hypotheses — provided you attach the limitations (= the constraints of a study). A presenter always states the limitations in the discussion, takes criticism, and the findings are tempered by it. Sharing new discoveries with peers quickly is what has moved medicine forward. The doctor was faithful to that etiquette. In fact, what was missing from his draft was that one line of limitations. A reservation that could be supplied verbally in the Q&A from a conference podium stays on the page in a material. Paper has no Q&A.

On my side of the desk, meanwhile, is Article 66. No one may advertise, describe, or disseminate false or exaggerated statements about a drug's name, manufacturing method, indications, or performance. It says "no person," so it applies not only to companies but to anyone. Explicit or implicit, either is prohibited. Pull out only the favorable numbers and enlarge them, for instance, and even without writing a single lie you create an impression that the drug "works better than it does." That is implicit exaggeration. And the dividing line runs like this: claiming unapproved indications for an approved drug falls under Article 66 (false or exaggerated claims), while advertising a drug that has not been approved at all falls under Article 68 (the prohibition on advertising unapproved drugs).

His freeze was not the moment of being caught not knowing. It was the sound of two kinds of integrity colliding head-on.

03The Same Words Change Meaning with the Place

"This isn't about your presentation itself being illegal," I continued.

Conference presentations and academic papers are scholarly discussion among scientists, treated differently from "advertising" as the regulations mean it. Article 66 applies to "no person," and yet conference presentations fall outside it — not because of who the presenter is, but because they are not advertising in the first place. Whether something is advertising is judged by whether it meets all three criteria (a framework set out in a 1998 administrative notice). A clear intent to induce the desire to purchase. Explicit naming of a specific product. Being in a state accessible to the general public. If even one is missing, it is not advertising.

So the same content changes meaning. As an academic presentation given purely in the capacity of a researcher, it is scientific discussion. But once a company puts it in a material bearing the name of its own drug and distributes it, it becomes a sales information provision activity (= the administrative term for a company conveying information about its own drugs to healthcare professionals). Speaking at a lecture meeting as a company employee can also fall within this activity, even orally. The podium is not always free ground. This activity has its own guidelines: the basis must be the approved scope, and the information must be accurate, fair, and evidence-based. That said, providing unapproved information when a healthcare professional asks for it is separately permitted, under conditions.

"The content didn't change. The place changed. And when the place changes, the meaning under the law changes."

The doctor was silent for a while, then said, "So when the presenter joins a company, he can no longer introduce his own presentation himself."

"To be precise, only on materials. In academic settings, it is still your presentation."

I once wrote in this diary that just because something appears in a paper does not mean it can go into a material (entry 27). Back then I wrote it as a story about what cannot go into a material. This time, I ran into the same regulation from a different direction — as a story about a presenter who cannot introduce his own findings on a material.

04I Have Fallen the Other Way Myself

I am in no position to lecture. I have made the opposite mistake.

Years ago, invited to a study session for our in-house researchers, I went through their presentation slides marking up expressions one after another. "Avoid the assertion." "This emphasis is risky." One of the researchers said, with a troubled look, "This is a forum for scientific discussion inside the company. If we can't state hypotheses strongly, there is no discussion."

He was the one who was right. I had carried the common sense of regulation into a scientific setting. I had fallen exactly the way the doctor did, only in the other direction. Though if even one of those slides were to leave the company, that would be another matter — and on that point I have not yielded, even now.

The integrity of science lies in sharing the uncertain quickly, as uncertain, and exposing it to debate. The integrity of regulation lies in not letting the uncertain flow to patients and clinical practice dressed as certainty. Science trusts the strength of discussion that withstands criticism among peers. Regulation protects people from the fact that patients without specialized knowledge, and busy practitioners, tend to take what reaches them at face value. Neither is wrong. They are protecting different people.

05An Industry That Needs Interpreters

The paragraph did not go in. The material went out into the world the following month, with the explanation of the approved indications re-anchored to supporting papers and the package insert. As for the new conference findings, the doctor decided himself that "it is not yet time to speak of this in a material."

Months have passed, and he has changed. These days he is the one who asks first: "Would this count as advertising?" And when questions come up within his department, no one is better than he is at translating Article 66 into clinical language. He knows in his bones how a clinician reads which part of a material, and how.

A newcomer freezes because he is standing, bodily, on the boundary between two worlds. Only someone who has struggled in both languages can translate in both directions. This industry needs a few more people who can move between the language of the conference and the language of the law. Those few seconds when the doctor stopped that day were, I think, the beginning of that.

(A detailed explanation of Articles 66 and 68 and the three criteria for advertising is compiled at /compliance/01-pharma-act.html)