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

Channel / Product area: Product brochure / Oncology (anticancer agent)
What was done: A comparison graph of VEGFR inhibitory activity against a comparator drug translated the original paper's vertical-axis labels "Less potent" and "More potent" as "軽微な阻害作用" (mild inhibitory effect) and "著明な阻害作用" (marked inhibitory effect). The visual framing gave the impression that only the promoted product possessed "marked" inhibitory activity.
The violation: Replacing the original authors' neutral language with translations that carry a strong evaluative gradient exaggerated the product's competitive advantage. A textbook case of translation choice as exaggeration.
Source quotation: "The translation of expressions from the original paper was inaccurate."

Channel / Product area: Journal advertisement / Anti-allergy agent
What was done: The advertisement used "STRONG" as its headline catchphrase. All clinical trials for the approved indication were either single-arm or placebo-controlled; no evidence existed that the product was more effective than any comparator.
The violation: Without head-to-head trial data, the word "STRONG" created a false impression of superiority over other agents.
Source quotation: "The expression 'STRONG' was used without any evidence that efficacy was superior to other agents."

Channel / Product area: Verbal explanation / pharmacy hearing materials / Antibacterial agent
What was done: During a pharmacy department hearing, the company representative highlighted the product name's etymology — which included a word meaning "outstanding" — and emphasized that the drug possessed "outstanding efficacy." The clinical trial was a non-inferiority study against a comparator.
The violation: The product name's etymology was repurposed as a promotional claim, describing a non-inferiority drug as having "outstanding efficacy."
Source quotation: "The product name's etymology, for which sufficient evidence was lacking, was used for promotional purposes."

Channel / Product area: Product brochure / Analgesic
What was done: The brochure sequentially presented data linking NSAIDs to blood pressure elevation, data showing no blood pressure change with the promoted product, and a general statement that hypertension is a risk factor for chronic kidney disease. The combined effect created the impression that the product has less adverse impact on renal function — even though the product is contraindicated in patients with severe renal impairment.
The violation: A logical chain connecting blood pressure to renal function was used to inflate safety claims. A drug with a contraindication in renal impairment was made to appear safe.
Source quotation: "Safety was exaggerated on the basis of a leap in logic."

Channel / Product area: Product brochure / Antithrombotic agent
What was done: The brochure included a "DIC treatment algorithm" listing the promoted product alongside a comparator. The cited paper, however, described a single institution's clinical protocol covering only the comparator; the promoted product was not mentioned in the original paper. The source citation was also inaccurate.
The violation: One hospital's internal protocol was presented as though it were a guideline supporting use of the promoted product, inflating the evidence base for that product.
Source quotation: "A single institution's clinical protocol was presented in an exaggerated manner, as if it were a treatment guideline."

Channel / Product area: Promotional flyer / Glaucoma and ocular hypertension treatment
What was done: A flyer for this generic product carried the catchphrase "superior intraocular pressure-lowering effect." No supporting evidence was cited.
The violation: A generic product with no proprietary efficacy data used the word "superior" without any evidentiary basis.
Source quotation: "The word 'superior' was used without basis to exaggerate the drug's effect."

Channel / Product area: Presentation slides / Hemophilia treatment
What was done: A product presentation introduced clinical trial results under the heading "outcomes were favorable." When asked to define the standard for "favorable" — the trial had no control arm — the representative replied that there was no defined benchmark and that it was "based on the judgment of specialist physicians."
The violation: Results from an uncontrolled single-arm trial were described as "favorable," and an individual physician's opinion was used as the evidentiary basis for efficacy.
Source quotation: "Single-arm trial results were presented as 'favorable' on the basis of an individual physician's opinion."

Channel / Product area: Product brochure and verbal explanation / Analgesic
What was done: An MR acknowledged that "no direct comparative trial exists," then used the difference in dissociation half-lives from two subunit binding sites to assert definitively that the promoted product causes fewer adverse effects than a comparator. The regulatory review report stated that adverse event rates were comparable between the two drugs.
The violation: In the absence of direct comparative data, a theoretical mechanism-of-action argument was used to make a definitive claim of fewer adverse effects.
Source quotation: "An explanation asserting fewer adverse effects than other agents was given solely on the basis of a mechanistic rationale."

Channel / Product area: Slides and verbal explanation / Enteral nutrition product
What was done: At an in-hospital information session, a slide titled "suitable for orally-fed patients" was presented as the first listed product feature and explained actively. The clinical trial had been conducted exclusively in tube-fed patients; no data existed for oral administration.
The violation: A route of administration with no supporting trial data was highlighted as a product feature.
Source quotation: "A route of administration for which no trial data existed was actively presented and explained."

Channel / Product area: Verbal explanation / Antibacterial agent
What was done: An MR showed a graph comparing antibacterial activity against multiple bacterial species and stated verbally that "the product demonstrated higher antibacterial activity than the comparator against every bacterial species tested." The graph visibly showed at least one species for which the comparator had higher activity.
The violation: A verbal claim of superiority across all species directly contradicted the data shown in the accompanying graph.
Source quotation: "The exaggerated expression that the product 'demonstrated higher antibacterial activity than the comparator against every bacterial species' was used."

Channel / Product area: Pharmacy hearing materials / Antibacterial agent
What was done: During a pharmacy department hearing, a medical science liaison described the product as "the ultimate [drug class]" on the basis of its mechanism of action and clinical data.
The violation: A superlative expression — "the ultimate" — was used without objective supporting evidence.
Source quotation: "A medical science liaison from the pharmaceutical company used the exaggerated expression 'the ultimate' in the explanation."

Channel / Product area: Online meeting and verbal explanation / Antipsychotic
What was done: Despite a footnote in the explanatory materials stating that the data did "not represent a comparison between the two treatment groups," the representative used the placebo-superiority results from each product's separate trial to claim that the promoted product and a comparator were equivalent in efficacy.
The violation: Data from trials not designed for head-to-head comparison were used to assert equivalence.
Source quotation: "An explanation was given that ignored the caveat stating the data did 'not represent a comparison between the two treatment groups.'"

Channel / Product area: In-person verbal explanation / Oncology (anticancer agent)
What was done: The trial protocol pre-specified central review as the primary assessment. At a product information session, the representative explained that "while statistical significance was not achieved by central review, significance was achieved by investigator assessment" — presenting the non-pre-specified assessment alongside the primary result.
The violation: The absence of significance on the pre-specified primary assessment (central review) was downplayed, and the investigator assessment was used to overstate efficacy.
Source quotation: "While statistical significance was not achieved by central review, significance was achieved by investigator assessment."

Channel / Product area: Verbal explanation and presentation slides / Diabetes treatment
What was done: When asked for subgroup analysis data in the Japanese population, the MR stated that "a clear difference was seen even in Japanese patients" — despite the analysis not reaching statistical significance. When the absence of significance was pointed out, the MR responded that "Professor X has stated that sufficient efficacy can be expected, so there is no problem," citing expert opinion to sidestep the question.
The violation: A non-significant result was described as "showing a clear difference"; when challenged, the representative substituted authority for evidence rather than addressing the statistical finding.
Source quotation: "A clear difference was seen even in Japanese patients."

Channel / Product area: Patient-facing materials / Antipyretic analgesic anti-inflammatory agent
What was done: A patient-facing document included a diagram implying that this systemically acting transdermal patch was stronger and broader in effect than oral drugs and locally acting patches. The promoted product was illustrated in a deep color reaching the extremities throughout the body; the oral drug was shown in a lighter color covering a narrower area. Only the promoted product's label used the word "systemic" in notably larger text than the comparators.
The violation: Color intensity, size, and coverage area — visual tools rather than words — created an exaggerated impression that the product's effects were both stronger and more extensive, leading patients to misunderstand the drug's comparative profile.
Source quotation: "A diagram was included that gave the impression that the effect was strong and covered a wide area."

Channel / Product area: Online group meeting and brochure / Diabetes treatment
What was done: Regarding an international phase III trial, an MR explained verbally that "this product is the only treatment shown to improve survival," and the same wording appeared in the brochure. The "survival improvement" data, however, came from time to all-cause death, which was a secondary endpoint in the trial.
The violation: A secondary endpoint result was used as the basis for a superlative claim — "the only drug" — overstating the trial's conclusions. Without support from the primary endpoint, the word "only" cannot stand.
Source quotation: "Explaining that this is the only drug shown to improve survival prognosis constitutes an exaggerated expression."