Eli Lilly Trulicity promotional email: “significant” HbA1c/weight and CV risk reduction claims found not misleading (AUTH/3686/8/22)

A health professional complained about three efficacy/outcomes claims in an Eli Lilly promotional email for Trulicity (dulaglutide). The PMCPA Panel ruled no breach of the ABPI Code (2021) Clauses 6.1 and 5.1.

What happened

• A promotional email (ref PP-DG-GB-1212) to UK healthcare professionals listed “Four reasons to consider Trulicity”.
• The complainant challenged three claims as unclear/misleading:
  • “Significant HbA1c reduction”
  • “Significant weight loss*” (with footnote: “Trulicity is not indicated for weight loss. In clinical trials, weight change was a secondary end point.”)
  • “Reduction of risk of major adverse cardiovascular (CV) events in both a type 2 diabetes primary and secondary CV prevention population”
• The complainant said it was unclear what the improvements were against (e.g., no treatment vs standard of care), and that the email did not include patient/trial details or statistical significance.
• The complainant also argued that weight loss was presented as a secondary endpoint without stating the primary endpoints.
• Eli Lilly responded that the statements were non-comparative, consistent with the SPC, substantiated by references, and would be understood by the intended audience as changes versus baseline; it also highlighted the transparency footnote about weight loss not being an indication.

Outcome

• No breach of Clause 6.1 (claims/information/comparisons must not be misleading).
• No breach of Clause 5.1 (high standards).
• No additional sanctions (as the case was no breach).

Clauses considered

• Clause 6.1 Requirement that claims/information/comparisons must not be misleading
• Clause 5.1 Requirement to maintain high standards at all times

Sanctions

• None (No breach case).

Why this matters

• “Significant” claims can be attacked if the audience could reasonably infer a comparator or magnitude that is not stated.
• Short-form email promotions often omit trial context; even when not required, lack of context can increase complaint risk—especially where the email implies class choice (“When initiating a GLP-1RA…”).
• Secondary endpoint claims (e.g., weight change) are a common flashpoint, particularly in metabolic disease where weight-loss indications exist for other products.

Where teams slip up

• Using “significant” without clarifying whether it is statistical significance, clinical significance, or both.
• Assuming the whole recipient pool has the same disease-area sophistication (the Panel queried whether all recipients would be familiar with diabetes management).
• Relying on references alone while the main body could be read as implying head-to-head or class superiority.
• Highlighting secondary endpoints without clear framing (and without careful alignment to the study’s hierarchy and testing strategy).

Control that would have prevented it (or reduced risk)

• A standard “claim hygiene” checklist for emails: define what “significant” means, specify endpoint/timepoint, and ensure the study design/comparator is clear (even in brief form).
• Medical/legal/regulatory review that explicitly tests “reasonable inference” by non-specialist HCP segments (e.g., pharmacists/nurses not focused on diabetes).
• Template language for secondary endpoint claims (what study, what endpoint status, and a clear non-indication statement where relevant).