Relevancy: B

The APS message accurately interprets the reference’s findings and presents them in a clear and balanced way.

2.1

All APS must be accurate, complete and clear so as to promote credibility and trust. Statements or illustrations must not mislead.

2.3

APS must be presented in a manner that accurately interprets valid and representative research findings.

2.3.1

Statements that are out of context or distort the conclusions of the author(s) are not acceptable.

3.1

Claims and/or quotations in Advertising/Promotion Systems must be consistent with, and within the limitations of, the Health Canada TMA. Any APS containing direct or indirect product claims and/or quotes from scientific literature must include a complete listing of the scientific references. Labelling must be authorized by Health Canada. See Making Comparisons, Section 5, for claims that are of a comparative nature.

3.1.4

Claims based upon laboratory or animal testing reports should be separated and cannot be used to imply clinical significance, unless there is evidence of a valid clinical correlation.

3.1.5

Claims or quotations that are out of context or inconsistent with the conclusions of the cited author(s) will not be accepted.

3.1.6

Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of a product claim must not be relegated to a footnote, (for example, an indication or dosage that is limited or that is restricted to a specific group of patients must not form part of a footnote and must be contained in the body copy).

3.1.10

Secondary endpoints should be clearly identified as such and the primary endpoint of the study should be presented in close proximity when warranted.

3.5

APS containing claims or quotes that emphasize only positive features of a pharmaceutical product, while ignoring significant negative findings, are not acceptable.

3.5.1

The body copy must contain reference to any negative findings in a prominent manner.

3.6

Quotes excerpted from published or unpublished scientific literature must be verbatim as presented in the source, and in context. Any deletions should be identified by a series of dots. Deletions of negative findings or other significant information relative to the product and or its use(s) will not be acceptable.

3.7

Claims or selected quotations must not refer to other products or different formulations of the same active ingredients unless authoritative data are available to warrant cross-referencing between products. See Equivalence, Section 5.13

4.1

All data presented in Advertising/Promotion Systems (APS) including: charts, graphs, tables or other reproductions extracted from reference studies or other sources or reproduced by artwork, must be accurate, complete and clear. The source(s) must be identified. Each adaptation of data should be so labelled and the source(s) indicated.

4.1.1

In charts, graphs, tables and other reproductions extracted from the reference studies; the advertiser must not introduce data or imply conclusions that do not appear in the references.

4.1.2

An advertisement should include all pertinent titles, legends and other designations appearing in the reference.

4.1.3

Adaptations of data must be presented in a manner that does not add or subtract from conclusions of the author(s) unless required under a separate provision of the Code.

4.2

Statistics must be presented so as to accurately report the findings and to help make reliable and valid conclusions.

4.2.1

Statistical information should include dosage and the level of significance (e.g. confidence interval [CI] and/or p-value), in the presentation. Where confidence intervals and p-values are both available, the manufacturer may decide to report both. The use of 95% CI is encouraged in preference to p-value. Information such as patient numbers, time span, dosage, etc. that are needed to assess the data, may appear in the web link destination containing the Terms of Market Authorization (TMA).

4.2.3

Reporting clinical trial results in relative or proportional terms may lead to misinterpretation of the true benefit and degree of a treatment effect. APS which present results using these methods of reporting, namely relative risk (RR) or relative risk reduction (RRR), must also include an indication of the absolute treatment effect. This can be presented as absolute risk reduction (ARR), number needed to treat (NNT) and/or the actual comparative clinical results or rates. The overall presentation should reflect the true magnitude of benefit and not magnify the clinical effect. Undue emphasis on treatment effects in relative terms, by means of graphic presentation or differences in type size, is not acceptable.

4.3

Data presentations which are misleading or ambiguous, or which distort the original meaning or interpretation, either directly or by implication, are in violation of the Code.

4.3.1

Company-generated charts/graphs, etc. from pooled studies may not be acceptable.

4.3.2

Company-generated charts/graphs, etc. must not distort the conclusions of the author(s) by visual manipulation.

5.4

The claim is of clinical relevance in humans, i.e. relevant to treatment selection, and, where this is not readily apparent, its clinical relevance can be justified by the sponsor, and

5.5

The evidence generated to substantiate the claim is conclusive and based on:

i) Consideration of all relevant data, and

ii) Scientifically accurate, unbiased, reproducible data obtained from studies conducted and analyzed to current scientific standards using established research methodologies and validated end points, and

iii) Appropriate interpretation of the data (Note 2).

5.6

The claim and its presentation should:

i) Identify the compared entities (Note 3), and

ii) The medicinal use related to the claim where this is not readily apparent (Note 4), and

iii) Not obscure the therapeutic use of the advertised product/ingredient (Note 5), and

iv) Not attack the compared drug product(s)/ingredient(s) in an unreasonable manner, and

v) Be expressed in terms, language and graphics that can be understood by the intended audience.

Advertisers are responsible for ensuring that comparative claims that fall within the scope of these Health Canada Principles, meet these requirements. Furthermore, all comparisons must satisfy the requirements of the full PAAB Code, including the following provisions:

5.10.1.iii

iii) For comparisons of non-clinical data (e.g. pharmacokinetics and pharmacodynamics), no direct or indirect clinical conclusions may be made in advertising unless a strong correlation can be established (e.g. where the rate of absorption is a direct measure of the onset of symptom relief).

5.10.1.iv

iv) Price comparisons that imply or suggest therapeutic equivalence are not acceptable. A disclaimer may be appropriate.

5.12

Context. Selective data presentations or claims which distort study findings, or which are out of context with study conclusions, are not acceptable.

5.12.1

All advertising is subject to Code requirements for risk/benefit balance.

5.15

Scare tactics. Advertising that induces fear or uses scare tactics to introduce unwarranted concern will not be accepted.