Boehringer Ingelheim breached Code over Spiriva promotion implying exacerbation reduction as a reason to prescribe (AUTH/2843/4/16)

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Key facts

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Case number	AUTH/2843/4/16
Company	Boehringer Ingelheim
Complainant	Anonymous, non contactable
Product	Spiriva (tiotropium)
Therapy area	Chronic obstructive pulmonary disease (COPD)
Materials at issue	Journal advertisement (ref UK/SPI-121330, Aug 2012); slide deck for rep training and use with/by health professionals (ref UK/SPI-131788, Feb 2014)
Main issue	Claims implied COPD exacerbation reduction was a primary reason to prescribe, without clearly setting it in the context of the licensed indication (maintenance therapy to relieve symptoms)
Authority asked company to respond to	Clauses 2, 3.2, 7.2, 9.1 and 15.9
Breach clauses	3.2, 7.2, 9.1 (all x2) and 15.9
No breach clauses	2
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	25 April 2016
Case completed	16 September 2016
Appeal	No appeal
Applicable Code year	2015 (Panel rulings made under 2016 Code as substantial requirements had not changed)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, non-contactable complainant challenged promotion of COPD inhalers, highlighting concerns about off-label-style messaging around exacerbation reduction.
The complaint focused on a Spiriva (tiotropium) journal advertisement (ref UK/SPI-121330, Aug 2012) stating: “With a long-term record of success in reducing symptoms, exacerbations and hospitalisations vs placebo ...”.
Spiriva’s licensed indication was “as a maintenance bronchodilator treatment to relieve symptoms of patients with COPD”.
The PMCPA also reviewed a slide deck used to train representatives and also used with/by health professionals (ref UK/SPI-131788, Feb 2014) which presented “Reduced exacerbations” as an outcome, with the licensed indication only appearing in prescribing information on the last slide.
Boehringer Ingelheim argued the claims were referenced to the SPC and Tashkin et al (2008), and that SPC section 5.1 included exacerbation and hospitalisation data; it denied breaches.

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The Panel accepted that COPD symptoms and COPD exacerbations are different concepts (per NICE and GOLD), even if better symptom control may reduce exacerbation likelihood.
The Panel stated that references to reduced exacerbations can appear in promotion of maintenance therapy, but must be clearly set in the context of the licensed indication (the primary reason to prescribe).
The journal advertisement was ruled misleading because it did not differentiate the licensed indication (symptom relief) from benefits of therapy (exacerbation reduction), making exacerbation reduction appear to be a reason to prescribe in its own right.
The slide deck was ruled misleading for presenting exacerbation reduction as a reason to prescribe per se, not as a benefit of using Spiriva for its licensed indication; it was also ruled to advocate a course of action likely to breach the Code.
No breach of Clause 2 was ruled (the Panel did not consider the matter brought discredit on, or reduced confidence in, the industry).

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