Learning from Past Incidents

Working backward from real deviations is faster than teaching norms in the abstract. Selective data manipulation, exaggerated claims, neglect of safety information, undisclosed conflicts of interest — nine categories of incidents, dissected from primary sources. Nine chapters.

A Map of Violations Drawn from 7 Years and 186 Cases — Why Ordinary Practitioners Err

In the seven years since Japan's Sales Information Provision Activity Guidelines took effect (2019), healthcare-institution monitors captu…

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The numbers are right. The conclusion is wrong. — How data repurposing and manipulation create false impressions

Incidents in this category share a common structure: the figures are accurate, but the meaning is manufactured.

The Art of "Selecting" Data — How Cherry-Picking and Axis Manipulation Harm Clinical Practice

Starting a graph's vertical axis partway up the scale, removing the comparator arm's data, displaying a convenient secondary endpoint prom…

"We had no basis for that claim" — How unsupported explanations and unreliable data cause harm

"I've heard it hasn't caused problems at other facilities." "A prominent physician was recommending it." "Based on its mechanism, it shoul…

Stepping Outside the Approval Boundary — Incidents Involving Unapproved Indications and Dosage Regimens

"It is off-label, but..." "There are physicians at other institutions who use it that way." These phrases mark the entry point into the mo…

Inflating with Words and Visuals — What Exaggerated Claims Do to Clinical Practice

"STRONG." "The ultimate." "Superior." "The only drug." When these words appear in product presentations, what evidence actually supports t…

Talking Only About Efficacy, Staying Silent on Risk — The Structure of Safety Information Neglect and Seven Years of Documented Cases

The most frequently documented violation in pharmaceutical promotional activities is an informational imbalance: efficacy is explained in…

No Comparative Data, Rumor-Driven Fear — How Disparagement of Competing Products Actually Happens

"The biosimilar has poor purification." "Two patients on Drug B ended up needing surgery — this is an emergency situation." These are word…

Hidden Interests — What Evidence Delivered Without COI Disclosure Actually Tells You

A conflict of interest (COI) exists when a researcher or speaker receives fees or funding from a pharmaceutical company in ways that could…

When the "How" of Sales Becomes the Problem — Prescription Circumvention, Skipped Review, and Falsified Records

There are practices that become inappropriate through sales conduct alone, without any distortion of evidence.