AUTH/2163/8/08 Consumers International v Lilly: ED disease awareness website and TV campaign

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Key facts

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Case number	AUTH/2163/8/08
Case reference	Consumers International v Lilly
Complainant	Consumers International
Respondent/company	Lilly (Eli Lilly)
Product(s)	Cialis (tadalafil) (identified as “product 1” in the chart)
Material/channel	Disease awareness website www.40over40.com (including “treat” section chart and downloadable “4t Action Plan”) and associated TV advertisement
Key issue	Whether disease awareness materials indirectly promoted a prescription-only medicine to the public and encouraged requests for a specific POM; balance of safety information in comparative chart
Dates (received/completed if stated)	Complaint received 20 August 2008; Case completed 13 October 2008
Appeal	Not stated
Code year	2008 Code (clauses referenced as same as 2006 though differently numbered)
Breaches/clauses	Applied rulings from AUTH/2151/7/08: Breach of Clauses 22.2, 9.1 and 2; No breach of Clause 22.1. In AUTH/2163/8/08 narrow point: No breach of Clauses 22.1 and 22.2 regarding placement of “product 1”.
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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Consumers International complained that Lilly-sponsored erectile dysfunction (ED) disease awareness materials (www.40over40.com and an associated TV campaign) promoted Lilly’s prescription-only medicine Cialis (tadalafil) to the public.
The complaint focused on a treatment page containing a comparative table of treatment types where “Product 1” was clearly Cialis, and argued the presentation would steer the public towards preferring Cialis and approaching doctors with that preference.
The Panel noted it had already considered the website and TV campaign in an earlier case (AUTH/2151/7/08) and set out those rulings as applicable background.
In the earlier assessment, the TV advertisement referred generally to a range of treatments and directed viewers to the website; it did not name medicines.
The website had sections “talk”, “test”, “treat” and “today”; the “treat” section included a chart comparing features of oral treatments (products 1–3), injections/insertions, and devices, and the chart was also included in a downloadable “4t Action Plan”.
Although products were not named in the chart, the first oral treatment (“product 1”) was Cialis.
The Panel’s concerns (from the earlier case) included that the chart’s features would lead patients to ask health professionals to prescribe a specific medicine, and that safety information was not presented in a factual and balanced way (eg, limited side-effect information and no contraindications for oral treatments).

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Outcome

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The Panel stated that the rulings from Case AUTH/2151/7/08 applied to this case (AUTH/2163/8/08).
On the specific point raised in this case—whether placing Cialis as “product 1” at the top of the table was unacceptable—the Panel did not accept that this, in itself, promoted product 1 above other products.
Therefore, on that narrow point, no breach of Clauses 22.1 and 22.2 was ruled.
However, the report records (via the applied rulings from AUTH/2151/7/08) that the website information including the 4t Action Plan breached Clause 22.2 because the chart was not factual and balanced and would encourage the public to request a specific prescription-only medicine; and that breaches of Clauses 9.1 and 2 were also ruled in that earlier case.

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Clauses

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Clause 22.1: No breach ruled (applied ruling from AUTH/2151/7/08: chart/4t plan not an advertisement to the public for a prescription-only medicine; and in AUTH/2163/8/08 no breach on the narrow “product 1 placement” point).
Clause 22.2: Breach ruled in the applied rulings from AUTH/2151/7/08 (website/4t Action Plan chart not factual and balanced; would encourage the public to request a specific prescription-only medicine). In AUTH/2163/8/08, no breach on the narrow “product 1 placement” point.
Clause 9.1: Breach ruled in the applied rulings from AUTH/2151/7/08 (high standards not maintained by naming medicines and/or giving very specific details about advantages and certain disadvantages).
Clause 2: Breach ruled in the applied rulings from AUTH/2151/7/08 (conduct brought discredit upon and reduced confidence in the pharmaceutical industry).
Clause 1.2: Referenced by the Panel in the applied rulings from AUTH/2151/7/08 (campaign within scope of the Code; could not rely on the exemption where there is no direct or indirect reference to specific medicines).

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AUTH/2163/8/08 Consumers International v Lilly: ED disease awareness website and TV campaign

Key facts

What happened

Outcome

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