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

③-1 Analgesic / Healthcare professional website video
A product introduction video on a medical professional site featured a physician recommending the drug as the "first-line choice" for pain management in elderly patients, without presenting any basis for not selecting alternatives. The package insert states: "Adverse reactions are more likely to occur in elderly patients."
Violation: Use of an individual physician's opinion, unsupported by sufficient evidence, as promotional material.

③-2 Endometriosis drug / Verbal briefing by representative
At a hospital briefing, the representative stated that the product "tastes better than competing products." When pressed for the basis, it emerged that the representative had personally taken the drug and was offering their own sensory impression. No evidence existed.
Original text: "It was the representative's own impression from having taken the drug personally; there was no evidence."

③-3 Kampo preparation / Verbal briefing
The representative brought comparative materials and explained that the product was "cheaper than competing products, has more published papers, and is of higher quality." In fact the daily drug cost was higher for the company's product, and number of publications is not a measure of quality.
Violation: Superiority claim over a competitor based on inaccurate information.

③-4 Analgesic / Verbal briefing
The representative cited non-involvement of CYP enzymes and glucuronide conjugation as the basis for claiming "no drug interactions, safer than competing products." The package insert lists drugs requiring caution with concomitant use, and no empirical evidence was provided.
Original text: "Superiority over other drugs was explained on the basis of mechanism of action alone, without presenting empirical evidence."

③-5 Diuretic / Presentation slides
At a pharmacy department study session, the representative stated definitively that "administration to heart failure patients reduces rehospitalization." The original paper's primary subject was the relationship between urinary aquaporin-2 and the drug; rehospitalization was not a study objective. Clinical guidelines note only that "some reports suggest this, but a long-term outcome benefit has not been established."
Violation: Inadequate evidence presented using definitive language.

③-6 Acid suppressant / Verbal briefing
The representative encouraged use of the 5 mg formulation for maintenance therapy of reflux esophagitis. The regulatory review report documented only a reduction from 10 mg once daily; no supporting research existed for the claimed equivalence or superiority of 5 mg twice daily.
Violation: Evidence-free explanation based on extrapolation from a different dosage strength.

③-7 Anticancer drug / Representative-provided photograph
During a packaging change briefing, the representative said "I'd like you to make use of this" and provided a photograph of a conference poster that had not undergone peer review. The poster contained errors in the interpretation of results.
Violation: Use of a photograph of an unreviewed poster abstract as informational material.

③-8 Kampo preparation / Slides and product brochure
At a department briefing, the representative stated the drug was "effective in all cases." Of the ten patients dosed, three "did not return for follow-up and could not be evaluated," meaning only seven patients were actually assessed. This data also appeared in the product brochure.
Original text: "This constitutes information provision that lacks reliability."

③-9 Emollient / Product brochure
Multiple brochures contained numerous items of unreliable data. The basis for efficacy and safety after switching was a single-arm study without a crossover design. Patient profiles and evaluation criteria were not described in sufficient detail. The claim that the product "can be applied in less time" rested solely on inference from a patient questionnaire.
Violation: Promotion using data of insufficient reliability and inadequate description.

③-10 Antibacterial drug / Verbal briefing
At a department briefing, the representative used non-inferiority trial data on eradication rates to deliver an explanation that emphasized the product's superiority.
Violation: Superiority claim derived from a non-inferiority trial.

③-11 Uterine fibroid drug / Verbal briefing
The representative used early post-dose data from a non-inferiority trial to verbally state that "efficacy is seen more rapidly compared with existing drugs."
Violation: Superiority claim derived from a non-inferiority trial.

③-12 Antiallergic drug / Verbal briefing
At a pharmacy briefing, the representative stated that because the drug was "not restricted for pilots under the Ministry of Land, Infrastructure, Transport and Tourism's guidelines for aviation crew medication, it does not cause drowsiness." The representative had no knowledge of the background to those guidelines. When asked about the basis for claiming "no unpleasant taste or odor after crushing," the representative could not answer.
Violation: Explanation grounded in an inappropriate source; subjective claim without basis.

③-13 Antiviral drug / Verbal briefing
The representative stated that the drug "reduces viral titer more rapidly and may reduce transmission risk." Changes in viral titer and time to viral shedding cessation were secondary endpoints; no direct data on reduced transmission existed.
Violation: Superiority over other drugs claimed without direct supporting data.

③-14 Hyperphosphatemia drug / Product brochure
A brochure stated that the product is "less likely to get stuck in dentures," but provided no basis for the claim and identified no comparator.
Violation: Pharmaceutical characteristic presented as a benefit without sufficient evidence.

③-1 Parkinson's disease drug / Verbal briefing
The representative described "cases of switching to this product due to its higher potency" and used only a dopamine equivalency conversion table as the basis for a superiority claim, despite the absence of any head-to-head comparison trial.
Original text: Superiority explained using only a dopamine equivalency conversion table, citing "cases of switching to this product due to its higher potency."

③-2 Antirheumatic drug / Leave-behind material
The material stated that the drug "can be used safely in patients with renal impairment." In fact, patients with renal impairment had been excluded from the Phase III trial, and pharmacokinetics had been assessed only after single-dose administration.
Violation: Safety described without adequate verification.

③-3 COPD drug / Verbal briefing
Efficacy and safety were explained using only a reference trial (FULFIL) rather than the pivotal approval trial (IMPACT). The representative used different trials depending on the patient type being discussed; relying solely on the reference trial provided inaccurate and insufficient information.
Violation: Explanation based only on the reference trial, not the pivotal trial.

③-4 Analgesic / Verbal briefing
When a physician asked for the evidence that the drug had fewer adverse effects, the medical science liaison replied that "there is no data from direct comparison with other products; a physician survey suggests fewer adverse effects" — citing only an unpublished questionnaire.
Violation: Safety superiority claimed without scientific basis, using only a survey result.

③-5 Renal anemia drug / Verbal briefing
Despite the RMP and appropriate use guide flagging thrombosis as a risk requiring attention, the representative verbally stated that the drug "may improve thrombosis risk compared with existing drugs."
Violation: Risk warnings in the RMP ignored; lower risk than competing drugs claimed without clear basis.

③-6 Hypnotic / Online seminar
The physician speaker at a sponsored seminar stated that "a prominent physician told me that [drug class] sleep aids are very good drugs." The sponsoring company bears supervisory responsibility for this statement.
Violation: Baseless recommendation (company liability).

③-7 Renal anemia drug / Verbal briefing
Patients with rheumatoid arthritis were excluded from the domestic Phase III trial. The representative nonetheless verbally stated that "efficacy can be expected in patients with inflammatory diseases such as rheumatoid arthritis."
Violation: Efficacy claimed for a patient population excluded from clinical trials.

③-8 Glaucoma / ocular hypertension drug / Verbal briefing
When a competing product went out of supply, the representative stated that the company's product "can serve as a substitute" without presenting any comparative trial data or clinical guideline reference. The two products have different mechanisms of action and no comparative trial has been conducted.
Violation: Product described as a substitute for a mechanistically different drug without evidence.

③-9 Anticancer drug / Verbal briefing
Although the total adverse event rate was identical to that of the existing drug and the difference in Grade 3 or higher events was only a few percentage points, the representative stated that "there is a trend toward fewer Grade 3 or higher adverse effects, indicating superiority." On drug interactions, the representative said: "I have never personally been consulted about this, so it doesn't need much attention" and "hematologic toxicity is something we're used to — it's not a big deal" — both without any supporting data.
Original text: "I have never personally been consulted about this, so it doesn't need much attention."

③-10 Diuretic / Verbal briefing and leave-behind material
Using post-marketing surveillance data, the representative explained that "there are fewer adverse effects after discharge than at the time of admission." The material recorded only days of administration; it was not a hospitalization-versus-discharge comparison study. The representative independently reinterpreted the data as "up to day 7 = inpatient, day 8 onward = outpatient."
Violation: Information provided based on the representative's own interpretation, disregarding the study design.

③-11 Nocturnal enuresis drug / Verbal briefing (product information meeting)
Without any request from the clinician, the representative displayed a screen capture from a commercial news website and stated that "although the current guidelines do not include this drug, it is expected to receive a Grade A recommendation in the next revision" — a claim based on unconfirmed information.
Violation: Efficacy promoted using unconfirmed information sourced from a commercial news outlet.

Parkinson's disease drug / Online
Without being asked, the representative stated that "concurrent administration inhibits absorption of the other drug" — a claim not found in the package insert, regulatory review report, or product summary.
Original text: "We were told that concurrent administration inhibits the absorption of that other drug."
Violation: Arbitrary information provision without scientific basis.

Antirheumatic drug / Online group interview
With no head-to-head clinical efficacy trial available, the representative stated that the product has "higher selectivity and is superior to existing drugs in the same class."
Original text: "It has higher selectivity and is superior to existing drugs in the same class."
Violation: Superiority over other drugs claimed without scientific basis.

Iron deficiency anemia drug / Email and telephone
Regarding a condition listed as an "important potential risk" in the RMP, the representative stated that "no adverse events have been observed, so it is not a clinical problem."
Original text: "We were told that because no adverse events have been observed, it is not a clinical problem."
Violation: RMP potential risk minimized using inaccurate information.

Cancer pain drug (patch) / Verbal briefing
The representative stated that "competing products have stronger adhesion and are more painful to remove, so our product is superior." No evidence on adhesion strength existed.
Original text: "Competing products have stronger adhesion and are more painful to remove, so our product is superior."
Violation: Superiority over other drugs claimed without scientific basis.

Dialysate / Online
Efficacy was explained using data not found in the package insert, regulatory review report, or product summary, with no source citation. No comparison with the conventional product that formed the basis for approval was mentioned.
Original text: "Explanations about efficacy were given while using data for which no source was identified."
Violation: Use of data whose source is unidentified and which cannot be independently verified.

Anticoagulant / Online
With no direct head-to-head comparison trials between the drugs, the representative stated that "this product has been assessed as significantly safer than other drugs in terms of bleeding risk."
Original text: "This product has been assessed as significantly safer than other drugs in terms of bleeding risk."
Violation: Safety superiority claimed without direct comparative evidence.

Multiple sclerosis drug / Brochure
No long-term administration trial data existed, and the RMP identified "long-term safety" as an "important missing information" item. The brochure nonetheless used phrases such as "with an eye on long-term prognosis" and "looking ten years ahead."
Original text: "Expressions such as 'with an eye on long-term prognosis' and 'looking ten years ahead' were used."
Violation: Long-term efficacy implied through casual copywriting without scientific basis.

Suppurative disease drug (topical) / Online
The representative stated that "once-daily application is sufficient" and used a graph from the oral formulation as the basis. When asked whether efficacy data existed for the topical formulation, the representative answered "no."
Violation: Dosing regimen explained without evidence, ignoring the difference in dosage form and route of administration.

Metabolic drug / Online
The amended package insert document stated that "there is no increase in mortality risk from MACE or malignancies, etc." When queried, the representative replied that "the risk has not been clearly established" — but a verification trial was ongoing at the time.
Original text: "There is no increase in mortality risk from MACE, malignancies, etc."
Violation: Absence of information equated with safety, generating a false impression.

Insomnia drug / Telephone
The representative stated that the product — which has no score line — "can be split in half." No data existed on half-tablet dosing; the company's official website advised against splitting; a separate document stated that "efficacy and safety of splitting or crushing have not been investigated."
Violation: Explanation based on a convenient over-interpretation of the evidence without verification.

Antiviral drug / Telephone
The representative stated by phone that "this product is highly effective against [indication]." When later questioned, the representative denied having said this. The company's official website carried only a press release on preclinical data, yet the representative had described clinical efficacy as established.
Original text: "This product is highly effective against [indication]."
Violation: Preclinical data described as if it were confirmed clinical efficacy.

Renal anemia drug / In-person (drug class comparison)
When asked for the evidence behind the claim that the product "shows earlier onset of effect than drugs in the same class," the representative produced comparative materials against a renal anemia drug with a different mechanism of action — not a pharmacologically similar agent.
Original text: "This product shows earlier onset of effect than drugs in the same class."
Violation: Vague comparator scope used to generate a misleading impression.

Renal anemia drug / In-person (thromboembolism)
No clinical trial data showed fewer thromboembolic events; the representative nonetheless stated that the product is "characterized by a gradual rise in Hb and carries low thromboembolism risk" — an explanation that could be interpreted as indicating lower risk than competing drugs.
Original text: "Characterized by a gradual rise in Hb and low thromboembolism risk."
Violation: Thromboembolism risk minimized without evidence.

Rheumatoid arthritis drug / Slides
An indirect comparison across different Phase III trials was used to emphasize that "this product has a lower incidence of herpes zoster than drugs in the same class." The drug's own RMP lists herpes zoster as an "identified important risk."
Original text: "This data compares results from different Phase III trials and does not constitute a direct comparison."
Violation: Safety risk minimized or overstated using internally inconsistent data.

Anesthetic / In-person
Without being asked, the representative recommended low-dose administration at 0.6 and 0.3 mg/kg/hr — neither of which appears in the package insert. When asked whether supporting literature existed, the representative replied "no."
Source: Ministry of Health, Labour and Welfare, "Report on the Sales Information Activity Monitoring Project," FY2022
Violation: Off-label dosing regimen recommended without evidence.

Cardiovascular drug / Online
The 2021 treatment guidelines did not include the product. The representative nonetheless stated without basis that "it is expected to appear as a supplement, and while existing drugs are likely to receive Grade B or C recommendations, this product is expected to receive a higher grade."
Original text: "It is expected to appear as a supplement ... this product is expected to receive a higher recommendation grade than those."
Violation: Inclusion in guidelines and a higher recommendation grade promoted without basis.

Respiratory drug / Online
Without being asked, the representative stated — naming a competing company — that "competitors design their products for once-daily dosing, which keeps blood concentrations high and causes more adverse effects; our product uses a delivery technology that produces a smaller peak, making adverse effects less likely." The only basis cited was "a physician's statement," with the caveat "this is for reference only since we have no data."
Original text: "This is for reference only since we have no data."
Violation: Fewer adverse effects than competitor claimed on the basis of a physician opinion, without data; disparagement of a competing company.

Inorganic preparation / Online (information session)
The electronic package insert specified dilution with 100 mL of normal saline and prohibited use with other infusion fluids. The representative volunteered: "I've heard that other facilities have been dissolving it in 50 mL of normal saline or 5% glucose without problems."
Original text: "I've heard that other facilities have been dissolving it in 50 mL of normal saline and that there are no particular problems."
Violation: Proactive promotion of an administration method unsupported by evidence and inconsistent with the electronic package insert.

Immunological disease drug / Online (mechanism of action)
Using a mechanism-of-action comparison slide, the representative stated that "because this product binds at the [X] site, it is superior to other [Y] inhibitors (three products)." When asked whether data or literature supported this, the representative replied that "there is no data or literature demonstrating superiority."
Original text: "The mechanism of action of this product, which binds at the [X] site, makes it superior to other [Y] inhibitors (three products)."
Violation: Superiority over other drugs claimed on the basis of mechanism alone, without evidence.

Immunological disease drug / Online (Japanese patient data)
After presenting graphs from the international Phase III trial, the representative showed a Japanese subgroup graph and stated that "higher efficacy can be expected in Japanese patients." No trial directly comparing the full population with the Japanese subpopulation existed; the regulatory review report noted "no pronounced differences."
Original text: "Based on these results, higher efficacy can be expected in Japanese patients with this product."
Violation: Higher efficacy in Japanese patients claimed without a direct comparison.

Inborn metabolic disease drug / Online
During a web explanation of a package insert revision, the representative stated unprompted that "because this is a lyophilized formulation, its stability against physical shock during transport is higher than that of an injection solution." No evidence existed comparing the stability of the lyophilized and liquid forms.
Original text: "Because it is a lyophilized formulation, its stability against physical shock during transport, etc., is higher than that of an injection solution."
Violation: Superiority based on dosage form claimed without stability comparison evidence.

Antiepileptic drug / Online
The representative described the product as "a drug that covers aspects such as potency of effect." When asked for the basis for "potency of effect," the response was: "There is no data; I have heard this from physicians using it in clinical practice."
Original text: "I have heard this from physicians using it in clinical practice."
Violation: Impression of superior "potency" created without scientific basis.

Oncology drug / Online
Without presenting any data from competing companies, the representative showed five-year follow-up data for their own product and asked: "Competing products' trials have not produced data to this level — what do you make of that, Doctor?" This was framed to elicit a disparaging opinion of competitors.
Original text: "Competing products' clinical trial results have not produced data to this level."
Violation: Own product's superiority implied without direct comparative data; disparaging opinion about competitors solicited.

Iron deficiency anemia drug / Online
During a hospital interview, the representative stated that "this product has lower immunogenicity than the competitor's product and is less likely to cause hypersensitivity reactions." When asked for comparative materials, the representative replied: "There are no relevant materials; an immunogenicity trial comparing the two has not been conducted."
Original text: "There are no relevant materials; an immunogenicity trial comparing with [competitor product] has not been conducted."
Violation: Superiority referenced by naming a competing product without comparative data.

Otorhinolaryngological drug / Online (resistance)
At a new drug interview, the representative stated that "competing products also raise concern about resistance development." When asked for the basis, the representative acknowledged that the drug in question had not been included in susceptibility surveillance and that changes in antimicrobial activity over time could not be assessed.
Original text: "Information was provided that could be regarded as disparagement of a competing product, in the absence of any supporting information."
Violation: Information that amounts to disparagement of a competing product, provided without evidence.

Otorhinolaryngological drug / Online (evaluator comment)
At an information session, the representative stated: "We have received feedback from the safety and efficacy evaluation committee of the Phase III trial that this is a drug that works well and shows promise."
Original text: "Citing the impressions of physicians involved in clinical trial evaluation or authority figures to provide information without scientific or objective basis is not appropriate."
Violation: Information provided without scientific basis by quoting an authority figure's impression.

Kampo preparation / In-person
The representative stated that "unlike competing products, our product contains a specific ingredient and has an antidepressant effect." When asked for evidence, the reply was: "This is animal experiment data; there is no data demonstrating efficacy in humans."
Original text: "This is animal experiment data; there is no data demonstrating efficacy in humans."
Violation: Superiority claimed without human efficacy data or competitor comparison data.

Antacid / laxative / In-person
The representative stated that the product has "less grittiness for patients with dentures." When asked for data or literature, the reply was: "There is no questionnaire or survey; this was based on word-of-mouth from MRs across the country."
Original text: "The response had no evidence; it was based on word-of-mouth information."
Violation: Information provided on the basis of word-of-mouth, without scientific basis.

Hyperkalemia drug / In-person
The representative stated that "this product lowers potassium levels more than the competitor's product" and even provided conversion quantities. When the basis was checked, no evidence was found.
Original text: "References were made to comparative efficacy and formulation comparisons with other drugs, without evidence."
Violation: Superiority over another drug claimed without evidence, including conversion quantities.

Antineoplastic drug / In-person
Asked to explain why domestic trial data showed more adverse effects than in non-Japanese patients, the representative said: "Japanese physicians are diligent, so more reports come in from Japan than from overseas" — without any supporting basis. The regulatory review report in fact flagged the domestic-versus-overseas difference as a safety concern.
Original text: "Japanese physicians are diligent, so more reports come in from Japan than from overseas."
Violation: Domestic-versus-overseas difference explained without evidence; relevant safety information from the regulatory review report not appropriately communicated.

Neuropathic pain drug / In-person (multiple facilities)
Despite the absence of direct comparative data against other drugs in the same class, the representative stated that the product "is more effective than other drugs." Reports of the same explanation came in from multiple facilities.
Original text: "Despite the absence of data from direct comparison with other drugs in the same class, the MR stated that the product 'is more effective than other drugs.'"
Violation: Own product's superiority emphasized without direct comparative data — repeated across multiple facilities.

Antiviral drug / Email campaign
A mass email stated that the product "has fewer drug interactions in polypharmacy patients and is easy to use," without presenting any scientific basis for comparison with competing products.
Original text: "References to comparisons with competing products were made without presenting scientific basis."
Violation: Superiority claimed without evidence, creating a false impression for polypharmacy patients.

Central nervous system drug / Online group interview and in-hospital
The representative presented a graph of the primary endpoint at 18 months and stated that the drug "can delay progression by six months compared with placebo at 18 months, and the gap continues to widen thereafter." The interim analysis of the long-term administration trial had not been published.
Original text: "This is an inappropriate information provision in which efficacy was discussed as speculation, without presenting any evidence."
Violation: Efficacy discussed by speculation without evidence, while long-term efficacy data remained unpublished.

Central nervous system drug / In-person
Using a plasma concentration-time curve, the representative stated that "tablets have a peak, which makes adverse effects more likely, but this product has a flatter profile, making adverse effects less likely." When asked for the basis, the reply was "there is none." The regulatory review report confirmed that adverse effects with this product were slightly more frequent than with the tablet. The representative's supervisor was present and did not intervene.
Original text: "The regulatory review report confirmed that adverse effects were slightly more frequent with this product than with the tablet."
Violation: Fewer adverse effects claimed without evidence; the actual data showed the opposite.